VANCOUVER, British Columbia, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Lui Franciosi of Franciosi Consulting Ltd. has been intrigued with the growing interest in the use of psychedelic drugs for treating depression, anxiety and addiction. He has been reviewing the scientific literature and the history of these drugs to better understand their merit. The most commonly mentioned drugs and promising alternatives for patients unresponsive to traditional treatments are ayahuasca, psilocybin, dimethyltryptamine (DMT), or lysergic acid diethylamide (LSD). These psychedelics appear to be well-tolerated with the most common adverse effects being transient anxiety, short-lived headaches, nausea and mild increases in heart rate and blood pressure. Overall, they seem to be effective in reducing many disease symptoms. However, the scientific consensus is that even though these substances demonstrate rapid, sustained and well tolerated therapeutic effects with single or even a few doses, there is still a need for large-scale, randomised controlled studies to elucidate their potential safety and use in clinical practice.

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Franciosi Consulting Reviewing the Science and History of Psychedelic Drug Use for Treating Depression, Anxiety and Addiction

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Basel, 5 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA), in combination with Tecentriq® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations. Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomised data from the phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumour activity by potentially amplifying the immune response.1

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Roche’s novel anti-TIGIT tiragolumab granted FDA Breakthrough Therapy Designation in combination with Tecentriq for PD-L1-high non-small cell lung...

Global News Feed Comments Off on Roche’s novel anti-TIGIT tiragolumab granted FDA Breakthrough Therapy Designation in combination with Tecentriq for PD-L1-high non-small cell lung… | January 5th, 2021

MARSEILLE, France, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that Sanofi has made the decision to progress IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. IPH6101/SAR443579 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. Cell 2019).

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Innate’s First NK Cell Engager Selected by Sanofi as Drug Candidate for Development

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Nicox Highlights Successful 2020 Development Progress and Clinical Milestones for 2021

Global News Feed Comments Off on Nicox Highlights Successful 2020 Development Progress and Clinical Milestones for 2021 | January 5th, 2021

ALLSCHWIL, Switzerland, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Polyphor AG (SIX: POLN) announced today that Gökhan Batur, Chief Executive Officer, will take part in a panel discussion at the LifeSci Partners 10th Annual Healthcare Corporate Access Event on Thursday, January 7 from 8:00AM Eastern Standard Time.

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Polyphor to Take Part in Panel Discussion on Novel Oncology Targets at the LifeSci Partners 10th Annual Healthcare Corporate Access Event

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Investors can pre-register for the event here

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AB2 Bio to Participate in Orphan Disease Panel Discussion at the LifeSci Partners 10th Annual Healthcare Corporate Access Event

Global News Feed Comments Off on AB2 Bio to Participate in Orphan Disease Panel Discussion at the LifeSci Partners 10th Annual Healthcare Corporate Access Event | January 5th, 2021

COPENHAGEN, Denmark, January 5, 2021 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the Company has entered into contracts with three European governments for the supply of IMVANEX® smallpox vaccine.

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Bavarian Nordic to Supply Smallpox Vaccines to Three European Countries

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MUNICH, Germany, Jan. 05, 2021 (GLOBE NEWSWIRE) -- ViGeneron GmbH, a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. (Nasdaq: BIIB, Cambridge, Mass., USA) to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. The companies will use ViGeneron’s proprietary vgAAV, novel engineered AAV capsids, to efficiently transduce retinal cells via intravitreal injections.

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ViGeneron signs global collaboration agreement for ophthalmic gene therapy development

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LONDON and RALEIGH, N.C., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that David Zaccardelli, Chief Executive Officer and President, will present a company overview at the H.C. Wainwright Virtual BioConnect Conference. The presentation will be available on-demand starting at 8:00 AM ET on Monday, January 11, 2021.

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Verona Pharma to Present at H.C. Wainwright Virtual BioConnect Conference

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PRESS RELEASE

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Emergex Vaccines signs Collaboration Agreement with Brazil’s Bio-Manguinhos/Fiocruz for the Development of a COVID-19 Vaccine

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Stem Cell Therapy Market is expected to reach 202.77 billion by 2027 from XX billion in 2019 at CAGR of XX %.

The report includes the analysis of impact of COVID-19 lock-down on the revenue of market leaders, followers, and disrupters. Since lock down was implemented differently in different regions and countries, impact of same is also different by regions and segments. The report has covered the current short term and long term impact on the market, same will help decision makers to prepare the outline for short term and long term strategies for companies by region.

REQUEST FOR FREE SAMPLE REPORT: https://www.maximizemarketresearch.com/request-sample/522

Stands for use of stem cells to treat or prevent disease or condition.Bone marrow transplant and some therapies derived from umbilical cord blood are mainly used in stem cell therapy. Advancement, in order to establish new sources for stem cells, and to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes, heart disease, and other conditions, are increased in recent years.

Stem Cell Therapy Market Researchers are making efforts to discover novel methods to create human stem cells. This will increase the demand as well as supply for stem cell production and potential investigation in disease management. Increasing investment & research grants for developing safe and effective stem cell therapy products, the growing patient base for target diseases, concentrated product pipelines, increasing approval of the new clinical trials, rapid technological advancement in genomics, and the rising awareness about the stem cell are expected to drive the growth of the Stem Cell Therapy solutions market during the forecast period.

However, improper infrastructure, insufficient storage systems, nascent technology in underdeveloped economies, Ethical issues related to an embryonic stem cell, low patient acceptance rate, Difficulty in the preservation of stem cell are expected to restrain the market growth. North America is expected to be the largest growing region by 2026; the reason behind that is extensive funding by Government. However, Emerging countries like India, china, Korea have low growth rate as compared to Developed regions in 2017 but increase in awareness about stem cell therapy will lead the Asia Pacific to generate a significant level of revenue by 2026.

Key Highlights of Stem Cell Therapy Market report

Detailed quantitative analysis of the current and future trends from 2017 to 2026, which helps to identify the prevailing market opportunities.Comprehensive analysis of factors instrumental in changing the market scenario, rising prospective opportunities, market shares, core competencies in terms of market development, growth strategies and identification of key companies that can influence this market on a global and regional scale.Assessment of Market definition along with the identification of key drivers, restraints opportunities and challenges for this market during the forecast period.Complete analysis of micro-markets with respect to individual growth trends, prospects, and contributions to the overall Stem Cell Therapy Solutions market.Stem Cell Therapy market analysis and comprehensive segmentation with respect to the Application, End users, Treatment, and geography to assist in strategic business planning.Stem Cell Therapy market analysis and forecast for five major geographies-North America, Europe, Asia Pacific, Middle East & Africa, Latin America, and their key regions.For company profiles, 2017 has been considered as the base year. In cases, wherein information was unavailable for the base year, the years prior to it have been considered.

Research Methodology:

The market is estimated by triangulation of data points obtained from various sources and feeding them into a simulation model created individually for each market. The data points are obtained from paid and unpaid sources along with paid primary interviews with key opinion leaders (KOLs) in the market. KOLs from both, demand and supply side were considered while conducting interviews to get an unbiased idea of the market. This exercise was done at a country level to get a fair idea of the market in countries considered for this study. Later this country-specific data was accumulated to come up with regional numbers and then arrive at a global market value for the stem cell therapy market.Key Players in the Stem Cell Therapy Market are:

Chiesi Farmaceutici S.P.A Are:Gamida CellReNeuron Group, plcOsiris Therapeutics, Inc.Stem Cells, Inc.Vericel Corporation.Mesoblast, Ltd.

Key Target Audience:

Stem Cell Associations and OrganizationsGovernment Research Boards and OrganizationsResearch and consulting firmsStem Cell Therapy Market InvestorsHealthcare Service Providers (including Hospitals and Diagnostic Centers)Stem Cell Therapeutic Product Manufacturing OrganizationsResearch LabsClinical research organizations (CROs)Stem Cell Therapy Marketing PlayersPharmaceutical Product Manufacturing Companies

DO INQUIRY BEFORE PURCHASING REPORT HERE: https://www.maximizemarketresearch.com/inquiry-before-buying/522

Scope of the Stem Cell Therapy Market Report:

Stem Cell Therapy market research report categorizes the Stem Cell Therapy market based on Application, End users, Treatment, and geography (region wise). Market size by value is estimated and forecasted with the revenues of leading companies operating in the Stem Cell Therapy market with key developments in companies and market trends.Stem Cell Therapy Market, By Treatments:

Allogeneic Stem Cell TherapyAutologous Stem Cell Therapy

Stem Cell Therapy Market, By End Users:

HospitalsAmbulatory Surgical Centers

Stem Cell Therapy Market, By Application:

OncologyCentral Nervous System DiseasesEye DiseasesMusculoskeletal DiseasesWound & InjuriesMetabolic DisordersCardiovascular DisordersImmune System DisordersStem Cell Therapy Market, By Geography:

North AmericaEuropeAsia PacificMiddle East & AfricaLatin America

Available Customization:

With the given market data, Maximize Market Research offers customization of report and scope of the report as per the requirement

Regional Analysis:

Breakdown of the North America stem cell therapy marketBreakdown of the Europe stem cell therapy marketBreakdown of the Asia Pacific stem cell therapy marketBreakdown of the Middle East & Africa stem cell therapy marketBreakdown of the Latin America stem cell therapy market

MAJOR TOC OF THE REPORT

Chapter One: Stem Cell Therapy Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Stem Cell Therapy Market Competition, by Players

Chapter Four: Global Stem Cell Therapy Market Size by Regions

Chapter Five: North America Stem Cell Therapy Revenue by Countries

Chapter Six: Europe Stem Cell Therapy Revenue by Countries

Chapter Seven: Asia-Pacific Stem Cell Therapy Revenue by Countries

Chapter Eight: South America Stem Cell Therapy Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Stem Cell Therapy by Countries

Chapter Ten: Global Stem Cell Therapy Market Segment by Type

Chapter Eleven: Global Stem Cell Therapy Market Segment by Application

Chapter Twelve: Global Stem Cell Therapy Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Stem Cell Therapy Market Report at: https://www.maximizemarketresearch.com/market-report/stem-cell-therapy-market/522/

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Stem Cell Therapy Market by Treatment,Application,End Users and Geography Forecast To 2027 - LionLowdown

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy Market by Treatment,Application,End Users and Geography Forecast To 2027 – LionLowdown | January 5th, 2021

SEATTLE, Jan. 4, 2021 /PRNewswire/ -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), is the first manufacturer of Orchard Therapeutics' Libmeldy, which was recently approved by the European Commission (EC) as a one-time therapy for eligible patients with early-onset Metachromatic Leukodystrophy (MLD).

The EC has granted full (standard) market authorization for Libmeldy (autologous CD34+ cells encoding the ARSA gene), a lentiviral vector-based gene therapy manufactured at AGC Biologics' Milan facility. Orchard Therapeutics is already underway with EU launch preparations to support commercial-scale drug manufacturing at the AGC Biologics Milan facility.

"AGC Biologics is delighted to have successfully partnered with Orchard Therapeutics on this great milestone," says AGC Biologics Chief Business Officer, Mark Womack. "We're very proud to be one of few Cell and Gene Therapy CDMOs with commercial experience Libmeldy being the third commercial product we've manufactured and we look forward to continuing our partnership with Orchard to provide this life-changing therapy to those affected by MLD."

"We are very honored to have been a part of the entire clinical journey of this product, from the very first treated patient, all the way to market approval. As manufacturer of both lentiviral vector and drug product, we are proud to support Orchard in treating this devastating disease," says AGC Biologics General Manager of Milan, Luca Alberici.

"The EC approval of Libmeldy opens up tremendous possibilities for eligible MLD children faced with this devastating disease," saysBobby Gaspar, M.D., Ph.D., Chief Executive Officer of Orchard. "We are humbled by the opportunity to bring this remarkable innovation to young eligible patients in the EU, and confident in the capabilities of our partners at AGC Biologics to help us achieve this goal."

MLD is a rare neurodegenerative disorder caused by mutations in the ARSA gene. While there are several forms of MLD, the disorder primarily affects young children and disease progression and life expectancy varies based on age of symptom onset. Libmeldy is designed to correct the genetic cause of MLD by inserting functional copies of the ARSA gene into the genome of a patient's own hematopoietic stem cells (HSCs) using a self-inactivating (SIN) lentiviral vector. It is approved in the EU for children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patients with early-onset MLD.

About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our global network spans the U.S., Europe and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 1,600 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit http://www.agcbio.com.

About Orchard Therapeutics:Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSK's rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us onTwitterandLinkedIn.

About OTL-200/Libmeldy:Libmeldy (autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase-A (ARSA) gene), also known as OTL-200, is approved in the European Union (as appropriate may add: "UK, Iceland, Liechtenstein and Norway" as an alternative can rewrite as "was approved by the European Commission" or something similar) for the treatment of MLD in eligible early-onset patients characterized by biallelic mutations in the ARSA gene leading to a reduction of the ARSA enzymatic activity in children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patients with early-onset MLD.

The most common adverse reaction attributed to treatment with Libmeldy was the occurrence of anti-ARSA antibodies (AAA). In addition to the risks associated with the gene therapy, treatment with Libmeldy is preceded by other medical interventions, namely bone marrow harvest or peripheral blood mobilization and apheresis, followed by myeloablative conditioning, which carry their own risks. During the clinical studies, the safety profiles of these interventions were consistent with their known safety and tolerability.

For more information about Libmeldy, please see the Summary of Product Characteristics (SmPC).

Libmeldy is not approved outside of the European Union, UK, Iceland, Liechtenstein and Norway. OTL-200 is an investigational therapy, which has not been approved by the U.S. Food and Drug Administration or any other health authority.

OTL-200 was developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.

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AGC Biologics Confirms Cell and Gene Therapy Commercial Expertise as Manufacturer of Orchard Therapeutics' Newly Approved Libmeldy(TM) - Daily...

Bone Marrow Stem Cells Comments Off on AGC Biologics Confirms Cell and Gene Therapy Commercial Expertise as Manufacturer of Orchard Therapeutics’ Newly Approved Libmeldy(TM) – Daily… | January 5th, 2021

DGAP-News: MorphoSys AG / Key word(s): Miscellaneous05.01.2021 / 08:00 The issuer is solely responsible for the content of this announcement.

Media Release

MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application for Tafasitamab

- The Swissmedic MAA seeks approval for tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

PLANEGG/MUNICH, Germany and MORGES, Switzerland - January 5, 2021 - MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted the marketing authorization application (MAA) for tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. The MAA seeks approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The MAA will now enter the formal review process by Swissmedic.

The Swissmedic MAA for tafasitamab will be reviewed as part of the U.S. Food and Drug Administration's (FDA) modified Project Orbis, which provides a framework for concurrent submission and review of oncology drug applications among the FDA's international collaborators. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries.

"Currently about 40% of DLBCL patients do not respond to initial therapy or relapse thereafter leading to a high medical need for new, effective therapies," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "The acceptance of the MAA for tafasitamab for review by Swissmedic is a pivotal step towards bringing tafasitamab in combination with lenalidomide to eligible patients in Switzerland."

"Tafasitamab in combination with lenalidomide may represent an important new targeted treatment option for patients with relapsed or refractory DLBCL," said Mike Akimov, M.D., Ph.D., Head of Global Clinical Development, MorphoSys. "We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients with a high unmet medical need."

The Swissmedic application, submitted by Incyte in collaboration with MorphoSys, is supported by data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL and data from the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. If approved, Incyte will hold the marketing authorization, and have exclusive commercialization rights for tafasitamab in Switzerland.

Incyte has exclusive commercialization rights for tafasitamab outside the United States.

About Diffuse Large B-cell Lymphoma (DLBCL)DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide[1], characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter[2]. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL[3],[4],[5].

About L-MINDThe L-MIND trial is a single arm, open-label, multicenter Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant. The study's primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085

About RE-MINDRE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and the EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.

For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

About TafasitamabTafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.

XmAb(R) is a registered trademark of Xencor, Inc.

About MorphoSysMorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya(R), developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at http://www.morphosys.com or http://www.morphosys-us.com.

Monjuvi(R) is a registered trademark of MorphoSys AG.

Tremfya(R) is a registered trademark of Janssen Biotech, Inc.

About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

MorphoSys Forward-looking Statements This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Incyte Forward-looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when tafasitamab might be approved in Switzerland for the treatment of, and whether or when tafasitamab might provide a successful treatment option for, in combination with lenalidomide, certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and the L-MIND and RE-MIND clinical trial programs. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by European regulatory authorities or other regulatory authorities, including the U.S. FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements. # # #

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References[1] Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.[2] Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.[3] DRG Epidemiology data.[4] Kantar Market Research (TPP testing 2018).[5] Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.

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MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application f - PharmiWeb.com

Bone Marrow Stem Cells Comments Off on MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application f – PharmiWeb.com | January 5th, 2021

DUBLIN, Jan. 4, 2021 /PRNewswire/ -- The "Biopreservation Market by Type, Application, End-user, and Geography - Global Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.

Biopreservation is a process that assists in the conservation of biospecimens such as DNA, saliva, and plasma. This process of biopreservation generally increases the durability, shelf life, and purity of the biosamples. The types of equipment in this process include freezers, liquid nitrogen, consumables, and also media & laboratory information management systems.

This process is also used to preserve food and extend its shelf life, specifically by using lactic acid bacteria. Growth in healthcare spending is assumed for better access to quality healthcare and advanced technology products such as biopreservation facilities, thereby widening the growth expectations. Moreover, the bio-banks, hospitals, and gene banks, which are major end-users for this market, are stimulating the key providers to establish technologically advanced biopreservation products to improve patient outcomes. The Biopreservation Market is projected to grow at a rate of 9.2% CAGR by 2026.

The biopreservation market has been analyzed by utilizing the optimum combination of secondary sources and in-house methodology, along with an irreplaceable blend of primary insights. The real-time assessment of the market is an integral part of our market sizing and forecasting methodology. Our industry experts and panel of primary participants have helped in compiling relevant aspects with realistic parametric estimations for a comprehensive study. The participation share of different categories of primary participants is given below:

In the market for biopreservation, the application of biopreservation consists of therapeutic applications, research applications, clinical trials, and other applications. The biopreservation is primarily applied in therapeutics due to the advancements in regenerative medicine & customized medicine, an increase in the shift of cord blood banking, and the rising incidence of chronic diseases.

The end-users of the biopreservation market include biobanks, gene banks, hospitals, and other end users. The biobanks segment is expected to have a major share in the market. The major share of this segment is attributed to the increasing preference for the preservation of stem cells and the rising numbers of sperm and egg banks.

Further, according to the regional market of biopreservation, the North American region is recorded for the colossal share in the market. This is due to the continuous drug developments and the arrival of advanced therapies in the domain of biomedical research. Additionally, the increasing requirement of expensive and improved treatment for patients' chronic diseases is the key factor.

The rising incidence of chronic diseases, including cardiac, renal diseases, diabetes, and obesity, is the crucial factor that will propel the biopreservation market growth in the prevailing period. Government initiatives to encourage stem cell therapies to treat the disease, which will again propel market growth. Conversely, the strict regulations for producing biopreservation products and the evolution of room temperature storage procedures may limit the biopreservation market growth.

Merck KGaA, Avantor, Inc., Bio-Techne Corporation, BioLife Solutions, Inc., Thermo Fisher Scientific Inc, ThermoGenesis Holdings, Inc., Worthington Industries, Inc., Chart Industries, Inc, So-Low Environmental Equipment Co., Inc., Princeton BioCision, LLC, Shanghai Genext Medical Technology Co. Ltd, Exact Sciences Corporation, Helmer Scientific, Inc., CryoTech, Inc., Arctiko, Nippon Genetics Europe, PHC Holdings Corporation, STEMCELL Technologies, Inc., AMS Biotechnology, and OPS Diagnostics. These are the few companies list of the biopreservation market.

Since the rapid increase in the number of research and developments gives the way of potentials for market growth, the biopreservation of biological samples has become a crucial segment. This helps the researchers to access the data of the number of people by the preserved biological samples.

This research presents a thorough analysis of market share, the present trends, and forthcoming evaluations to explain the approaching investment pockets.

This research provides market insights from 2020 to 2026, which is predicted to allow the shareholders to capitalize on the forthcoming opportunities.

This report further offers comprehensive insights into the region, which helps to understand the geographical market and assist in strategic business planning and ascertain future opportunities.

Key Topics Covered:

1. Executive Summary

2. Industry Outlook2.1. Industry Overview2.2. Industry Trends

3. Market Snapshot3.1. Market Definition3.2. Market Outlook3.2.1. PEST Analysis3.2.2. Porter Five Forces3.3. Related Markets

4. Market characteristics4.1. Market Evolution4.2. Market Trends and Impact4.3. Advantages/Disadvantages of Market4.4. Regulatory Impact4.5. Market Offerings4.6. Market Segmentation4.7. Market Dynamics4.7.1. Drivers4.7.2. Restraints4.7.3. Opportunities4.8. DRO - Impact Analysis

5. Type: Market Size & Analysis5.1. Overview5.2. Biopreservation Media5.2.1. Nutrient Media5.2.2. Sera5.2.3. Growth Factors & Supplements5.3. Biospecimen Equipment5.3.1. Temperature Control Systems5.4. Freezers5.5. Cryogenic Storage Systems5.6. Thawing Equipment5.7. Refrigerators5.7.1. Accessories5.7.2. Alarms & Monitoring systems5.7.3. Incubators5.7.4. Centrifuges5.7.5. Other Equipment

6. Application: Market Size & Analysis6.1. Overview6.2. Therapeutic Applications6.3. Research Applications6.4. Clinical Trials6.5. Other Applications

7. End User: Market Size & Analysis7.1. Overview7.2. Biobanks7.3. Gene Banks7.4. Hospitals7.5. Other End Users

8. Geography: Market Size & Analysis8.1. Overview8.2. North America8.3. Europe8.4. Asia Pacific8.5. Rest of the World

9. Competitive Landscape9.1. Competitor Comparison Analysis9.2. Market Developments9.2.1. Mergers and Acquisitions, Legal, Awards, Partnerships9.2.2. Product Launches and execution

10. Vendor Profiles10.1. Merck KGaA10.1.1. Overview10.1.2. Financials10.1.3. Products & Services10.1.4. Recent Developments10.1.5. Business Strategy10.2. Avantor, Inc10.2.1. Overview10.2.2. Financials10.2.3. Products & Services10.2.4. Recent Developments10.2.5. Business Strategy10.3. Bio-Techne Corporation10.3.1. Overview10.3.2. Financials10.3.3. Products & Services10.3.4. Recent Developments10.3.5. Business Strategy10.4. BioLife Solutions, Inc10.4.1. Overview10.4.2. Financials10.4.3. Products & Services10.4.4. Recent Developments10.4.5. Business Strategy10.5. Thermo Fisher Scientific Inc10.5.1. Overview10.5.2. Financials10.5.3. Products & Services10.5.4. Recent Developments10.5.5. Business Strategy10.6. ThermoGenesis Holdings, Inc10.6.1. Overview10.6.2. Financials10.6.3. Products & Services10.6.4. Recent Developments10.6.5. Business Strategy10.7. Worthington Industries, Inc10.7.1. Overview10.7.2. Financials10.7.3. Products & Services10.7.4. Recent Developments10.7.5. Business Strategy10.8. Chart Industries, Inc10.8.1. Overview10.8.2. Financials10.8.3. Products & Services10.8.4. Recent Developments10.8.5. Business Strategy10.9. So-Low Environmental Equipment Co.,Inc10.9.1. Overview10.9.2. Financials10.9.3. Products & Services10.9.4. Recent Developments10.9.5. Business Strategy10.10. Princeton BioCision, LLC10.10.1. Overview10.10.2. Financials10.10.3. Products & Services10.10.4. Recent Developments10.10.5. Business Strategy

11. Companies to Watch11.1. Shanghai Genext Medical Technology Co. Ltd11.1.1. Overview11.1.2. Products & Services11.1.3. Business Strategy11.2. Exact Sciences Corporation11.2.1. Overview11.2.2. Products & Services11.2.3. Business Strategy11.3. Helmer Scientific, Inc11.3.1. Overview11.3.2. Products & Services11.3.3. Business Strategy11.4. CryoTech, Inc11.4.1. Overview11.4.2. Products & Services11.4.3. Business Strategy11.5. Arctiko11.5.1. Overview11.5.2. Products & Services11.5.3. Business Strategy11.6. Nippon Genetics Europe11.6.1. Overview11.6.2. Products & Services11.6.3. Business Strategy11.7. PHC Holdings Corporation11.7.1. Overview11.7.2. Products & Services11.7.3. Business Strategy11.8. STEMCELL Technologies, Inc11.8.1. Overview11.8.2. Products & Services11.8.3. Business Strategy11.9. AMS Biotechnology11.9.1. Overview11.9.2. Products & Services11.9.3. Business Strategy11.10. OPS Diagnostics11.10.1. Overview11.10.2. Products & Services11.10.3. Business Strategy

12. Analyst Opinion

13. Annexure13.1. Report Scope13.2. Market Definitions13.3. Research Methodology13.3.1. Data Collation and In-house Estimation13.3.2. Market Triangulation13.3.3. Forecasting13.4. Report Assumptions13.5. Declarations13.6. Stakeholders13.7. Abbreviations

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Worldwide Industry for Biopreservation to 2026 - Key Drivers, Restraints and Opportunities - Yahoo Finance

Cardiac Stem Cells Comments Off on Worldwide Industry for Biopreservation to 2026 – Key Drivers, Restraints and Opportunities – Yahoo Finance | January 5th, 2021

Start the new year with a sweet treat, warm up your feet and dont forget to look glamorous even if all you do is stay home. Heres to 2021! We have high hopes for you...Lierac Paris's anti-aging premium La Cure Absolute. (Photo credit: Courtesy)28 DAYS TO NEW SKINRelatively new in Israel, the French cosmetic brand Lierac Paris launches its flagship product the anti-aging premium La Cure Absolute, a serum that really makes a difference. According to the company, this is a scientific breakthrough developed in their labs together with Harvard University after 25 years of research. The product has seven different registered patents inspired by anti-aging research and based on micro-emulsions and GDF 11 technology. The new technology promotes cell renewal of up to 50%. The rehabilitation is quick 28 days and the results are quite dramatic. We have been using the serum for a week and already see the difference. The product is especially effective in treating tired-looking skin and deep lines, giving skin a shot of energy and also treating pigmentation. Use morning and evening before your hydrating cream. NIS 599, available in clinics and beauty centers. For more information go to http://www.lierac.co.ilGlamGlow youth potion. (Photo credit: Courtesy)ALL THAT GLAMOpen the year looking more glamorous than ever with Hollywoods most glamorous brand, GlamGlow. Their latest launch is the Youthpotion Rejuvenating Peptide Serum, which promises to add glamour to your look from the first application. Thanks to raspberry stem-cells, hyaluronic acid and red seaweed, this light serum will add a youthful glow to your face and make you feel more glamorous, even if all you wear these days is pyjamas. The texture is light and serum absorbs quickly. Use morning and evening with hydrating cream. NIS 349, available in Superpharm, Mashbir, Be and April stores.

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2021: What are the best self-care products to buy in the new year? - The Jerusalem Post

Skin Stem Cells Comments Off on 2021: What are the best self-care products to buy in the new year? – The Jerusalem Post | January 3rd, 2021

DUBLIN, Dec. 31, 2020 /PRNewswire/ -- The "Cell Therapy Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.

Cell Therapy Global Market Report 2020-30: COVID 19 Growth and Change provides the strategists, marketers and senior management with the critical information they need to assess the global cell therapy market.

Major players in the cell therapy market are Fibrocell Science Inc., JCR Pharmaceuticals Co. Ltd., PHARMICELL Co. Ltd., Osiris Therapeutics Inc., MEDIPOST, Vericel Corporation, Anterogen Co. Ltd., Kolon TissueGene Inc., Stemedica Cell Technologies Inc. and AlloCure.

The global cell therapy market is expected to decline from $7.31 billion in 2019 to $7.2 billion in 2020 at a compound annual growth rate (CAGR) of -1.54%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $10.0 billion in 2023 at a CAGR of 11.55%.

The cell therapy market consists of sales of cell therapy and related services. Cell therapy (CT) helps repair or replace damaged tissues and cells. A variety of cells are used for the treatment of diseases includes skeletal muscle stem cells, hematopoietic (blood-forming) stem cells (HSC), lymphocytes, mesenchymal stem cells, pancreatic islet cells, and dendritic cells.

North America was the largest region in the cell therapy market in 2019. Asia Pacific is expected to be the fastest-growing region in the forecast period.

The cell therapy market covered in this report is segmented by technique into stem cell therapy; cell vaccine; adoptive cell transfer (ACT); fibroblast cell therapy; chondrocyte cell therapy. It is also segmented by therapy type into allogeneic therapies; autologous therapies, by application into oncology; cardiovascular disease (CVD); orthopedic; wound healing; others.

In August 2019, Bayer AG, a Germany-based pharmaceutical and life sciences company, acquired BlueRock Therapeutics, an engineered cell therapy company, for $1 billion. Through this transaction, Bayer AG will acquire complete BlueRock Therapeutics' CELL+GENE platform, including a broad intellectual property portfolio and associated technology platform including proprietary iPSC technology, gene engineering, and cell differentiation capabilities. BlueRock Therapeutics is a US-based biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology, and immunology, using a proprietary induced pluripotent stem cell (iPSC) platform.

The high cost of cell therapy hindered the growth of the cell therapy market. Cell therapies have become a common choice of treatment in recent years as people are looking for the newest treatment options. Although there is a huge increase in demand for cell therapies, they are still very costly to try. Basic joint injections can cost about $1,000 and, based on the condition, more specialized procedures can cost up to $ 100,000. In 2020, the average cost of stem cell therapy can range from $4000 - $8,000 in the USA. Therefore, the high cost of cell therapy restraints the growth of the cell therapy market.

Key players in the market are strategically partnering and collaborating to expand the product portfolio and geographical presence of the company. For instance, in April 2018, Eli Lilly, an American pharmaceutical company entered into a collaboration agreement with Sigilon Therapeutics, a biopharmaceutical company that focused on the discovery and development of living therapeutics to develop cell therapies for type 1 diabetes treatment by using the Afibromer technology platform. Similarly, in September 2018, CRISPR Therapeutics, a biotechnological company that develops transformative medicine using a gene-editing platform for serious diseases, and ViaCyte, a California-based regenerative medicine company, collaborated on the discovery, development, and commercialization of allogeneic stem cell therapy for diabetes treatment.

The rising prevalence of chronic diseases contributed to the growth of the cell therapy market. According to the US Centers for Disease Control and Prevention (CDC), chronic disease is a condition that lasts for one year or more and requires medical attention or limits daily activities or both and includes heart disease, cancer, diabetes, and Parkinson's disease. Stem cells can benefit the patients suffering from spinal cord injuries, type 1 diabetes, Parkinson's disease (PD), heart disease, cancer, and osteoarthritis.

According to Cancer Research UK, in 2018, 17 million cancer cases were added to the existing list, and according to the International Diabetes Federation, in 2019, 463 million were living with diabetes. According to the Parkinson's Foundation, every year, 60,000 Americans are diagnosed with PD, and more than 10 million people are living with PD worldwide. The growing prevalence of chronic diseases increased the demand for cell therapies and contributed to the growth of the market.

Key Topics Covered:

1. Executive Summary

2. Cell Therapy Market Characteristics

3. Cell Therapy Market Size And Growth 3.1. Global Cell Therapy Historic Market, 2015 - 2019, $ Billion 3.1.1. Drivers Of The Market 3.1.2. Restraints On The Market 3.2. Global Cell Therapy Forecast Market, 2019 - 2023F, 2025F, 2030F, $ Billion 3.2.1. Drivers Of The Market 3.2.2. Restraints On the Market

4. Cell Therapy Market Segmentation 4.1. Global Cell Therapy Market, Segmentation By Technique, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.2. Global Cell Therapy Market, Segmentation By Therapy Type, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.3. Global Cell Therapy Market, Segmentation By Application, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

5. Cell Therapy Market Regional And Country Analysis 5.1. Global Cell Therapy Market, Split By Region, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion 5.2. Global Cell Therapy Market, Split By Country, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Companies Mentioned

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Global Cell Therapy Market Report 2020: Market to Recover in 2023 - PRNewswire

Spinal Cord Stem Cells Comments Off on Global Cell Therapy Market Report 2020: Market to Recover in 2023 – PRNewswire | January 3rd, 2021

The name Lonza comes from the river in Switzerland near where the company was originally founded more than a hundred years ago, As such, it has nothing to do with the biomedical products and services that Lonza provides.

Lonza is active around the world and has around 15,000 employees with branches in the Netherlands as well. Such as the one on the BrightlandsChemelot Campus in Geleen. where approximately 250 people work there. This company division started as a start-up in Maastricht in 2005 and developed a production facility for stem cell and gene therapy to combat diseases. It became part of Lonza in 2018.

The reason that Lonza is on the Chemelot campus is due to its strategic location. This is very convenient for having access to all kinds of industry-related services that are already available there, says Willem Dullaers. He is the senior manager of quality control at Lonza in Geleen. Security is well organized, and we use a number of other facilities so that as a company you dont need to arrange these yourself.

The interesting thing about the Lonza production facility in Geleen is that the company isolates living cells and is even able to manipulate them on behalf of pharmaceutical groups. These companies then supply them to hospitals for the treatment of patients, primarily those suffering from forms of cancer. So what does Lonza do exactly and what does it ultimately deliver to those hospitals? is the question for Dullaers. This is not so easy to explain.

We work in cleanrooms at Lonzas premises in Geleen with the aim of selecting body cells from a sample of the patient taken in the hospital via a blood transfusion or bone marrow puncture. For example, body cells that are selected have the ability to fight cancer cells by virtue of their specific properties. If these cells are selected and reproduce in number after being cultured, it can be useful to add DNA to them so that they are able to attack the cancer cells even more effectively. Modification is done using a piece of deactivated virus that is used as a vector to introduce DNA into the selected cells.

Once that process is completed, the number of cells, which is usually very small, is cultivated to a larger quantity so that after various quality checks and the preparation for transport (cooled or frozen) are carried out, the cells are introduced into the patient. It is very common that patients are successfully treated afterward, says Dullaers. He refers to a report that made the world news last year. An Italian two-year-old boy with a rare immune disease (HLH) who was initially given up by doctors, Alex Montresor, was cured after stem cell therapy.

About 30 people are currently working on the production process for cell and gene therapy to treat people, Dullaers adds. The tasks that the biomedical doctors have to perform take time and require careful attention. They have to enter the cleanroom themselves to put the cells through the process to be transformed into stem cell therapies. They have to wear protective, hermetically sealed suits under the strictest safety conditions. That is to safeguard their own safety but also to prevent any potential contamination of the cells. Patients for whom this therapy is intended are often severely debilitated. They are not allowed to get sick as a result of a bacterium or particulate matter that has entered the cultured cells. A check always takes place to make sure that the product is completely clean. If this is not the case, it must be remade as a last resort.

At the moment, Lonza is working on a method to fully automate the culture process of the cells in the cleanroom. A pilot is currently underway at the Sheba Medical Center in Israel. It has a test setup with a so-called cocoon. The cocoon looks like an egg-shaped module of white plastic that is about one meter long. Inside the egg there is a small factory that automates all operations, from cell selection to DNA insertion and preparation for transport and administration.

Over the coming years, this innovative culture method for cell and gene therapy must be approved through clinical trials and by medicinal regulatory agencies such as the U.S. FDA and the European EMA. Only then can this robotized method be applied on a large scale.

I hope it will be achievable within five to ten years, says Dullaers. That will change a lot in terms of affordability and supply options for cell and gene therapy. Because it is such a cumbersome treatment, the costs are high right now. The production also takes a lot of time. Depending on the complexity of the process, the duration varies from a few days to sometimes more than two months, Dullaers notes.

If the entire process can be robotized, fewer people will be needed to do the work. I think that whereas we now work with 150 people, you will be able to do it with 15. However, you will need a different set of employees: People with a software background and an understanding of the machinery.

You can simultaneously fill a room with dozens of cocoons where cell therapies are made. That means that productivity is bound to skyrocket. Consequently, it will also be possible to make more medication based on the cells of individual patients, which will also be cheaper since less staff is needed. The chance of making mistakes is smaller than with work that involves human hands, Dullaers points out.

Another alternative is for hospital laboratories to make the gene and cell therapies themselves. It is conceivable that they would like to have a cocoon in their own hospital that they can use to treat patients.

You can also read the earlier articles in this series here:

The Chinese and Americans are knocking on the Dutch town of Geleens door to test innovative chem tech

Xilloc: Requests from dozens of hospitals worldwide for 3D-printed implants

Dutch Arlanxeo: 85% less CO2 emissions thanks to rubber from sugar cane

Niaga: 100% recyclable mattresses, furniture and carpets have the future

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Lonza's Cocoon will soon make dozens of stem cell therapies all at once - Innovation Origins

Bone Marrow Stem Cells Comments Off on Lonza’s Cocoon will soon make dozens of stem cell therapies all at once – Innovation Origins | January 3rd, 2021

AUSTIN, Texas, Dec. 30, 2020 /PRNewswire/ --Direct Biologics, LLC, announced today that the first patient has been treated under its expanded access protocol for ExoFlo Infusion Treatment for COVID-19 Associated ARDS (EXIT COVID-19).

"The Phase II trial is actively enrolling patients at several sites nationally. It has met several key milestones and is nearing completion," states Co-Founder and Chief Executive Officer, Mark Adams. "We look forward to sharing our results and hopefully proceeding to Phase III very soon."

The expanded access protocol is an open label study to treat patients who often have more advanced disease under a "compassionate use" application.

"The expanded access gives us an opportunity to treat very sick patients who do not have other meaningful options," notes Joe Schmidt, Co-Founder and President. "It also enhances our ability to treat patients at additional hospitals and therefore communities in need across the country."

Chief Medical Officer, Vik Sengupta, MD, adds, "We at Direct Biologics are grateful for every opportunity to help these additional patients in critical need of treatment."

This study is under the same IND application utilizing bone marrow-derived extracellular vesicles to treat COVID-19-associated ARDS. Extracellular vesicles secreted by bone marrow-derived mesenchymal stem cells (bmMSCs) have been studied extensively in preclinical studies of lung disease and inflammation and are notable for their ability to downregulate inflammation and upregulate tissue repair.

Physicians can learn more at clinicaltrials.gov and may request access for a patient by emailing msl@directbiologics.com. Requests for expanded access to ExoFlo must be made by a licensed U.S. treating physician.

About ExoFlo

ExoFlo is an investigational new drug that has not been approved or licensed by the FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides natural bioactive signals that have been shown to modulate inflammation and direct cellular communication.

About Direct Biologics

Direct Biologics, LLC, is headquartered in Austin, Texas, with a recently expanded R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The Company was created to expand the science of regenerative healing by delivering cutting-edge biologic technologies. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of its extracellular vesicle biologic products through the FDA's investigational new drug application process. For more information, visithttp://www.directbiologics.com.

Phone:1-800-791-1021Email:info@directbiologics.com

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Direct Biologics Announces First Patient Treated Under Phase II Expanded Access Protocol Using ExoFlo(TM) to Treat COVID-19 - Tyler Morning Telegraph

Bone Marrow Stem Cells Comments Off on Direct Biologics Announces First Patient Treated Under Phase II Expanded Access Protocol Using ExoFlo(TM) to Treat COVID-19 – Tyler Morning Telegraph | January 3rd, 2021

Bone marrow aspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

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The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.

Europe and North America spearheaded the market as of 2018, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.

In 2018, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.

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Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy. Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others.

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Bone Marrow Stem Cells Comments Off on Bone Marrow Processing Systems Market to Make Great Impact in near Future by -2025 – The Monitor | January 3rd, 2021

Myeloproliferative disorders are disease of blood and bone marrow which have unknown cause and there are wide range of symptoms. The treatment of myeloproliferative disorders generally depends on the type and presence of symptoms. Myeloproliferative disorders is generally considered as clonal disorder which begins with one or more change in the DNA of a single stem cells in the bone marrow. The changes to the hematopoietic stem cell cause the cell to reproduce repeatedly, creating more abnormal stem cells and these abnormal cells become one or more types of blood cells. Myeloproliferative disorders gets worst with time as the number of extra blood cells build up in the bone marrow and bloodstream.

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Emergence of new treatment for the myeloproliferative disorders and availability of novel drug drive the market for myeloproliferative disorders drugs market in the near future. Rising incidence of myeloproliferative disorders and presence of strong product pipeline spur the myeloproliferative disorders drugs market. Growing geriatric population, change in lifestyle and growing awareness among general population is expected to drive the market of myeloproliferative disorders in the forecast period. Advancement in the treatment for oncology further expand the treatment option for myeloproliferative disorders. Various clinical trial undergoing for the treatment of myeloproliferative disorders which further drive the growth of the myeloproliferative disorders drugs market. However, high cost of drug and treatment along with the lack of awareness among the population in developing and under developed nations hinder the growth of myeloproliferative disorders drugs market.

The global myeloproliferative disorders drugs market is segmented on basis of Type, Drug Type, Distribution Channel, End User and Geography.

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Improvement in the symptoms and reduction of in splenomegaly among patients receiving available therapy is expected to boost the market of myeloproliferative disorders. Development in new therapeutic drug and target therapy further drive the market growth of myeloproliferative disorders. Increased research and development and increased funding by the government towards the development of novel therapy spur the market growth. With the discovery of specific gene mutations in myeloproliferative disorders the market is expected to grow in the forecast period owing to increased adoption of new drugs and increased awareness along with the favorable reimbursement scenarios for the treatment of myeloproliferative disorders.

The North America market holds the largest revenue share for myeloproliferative disorders drugs, due to presence of major pharmaceutical players undergoing various clinical innovation, government initiative and increase research and development funding for the Myeloproliferative disorders. Europe is expected to contribute for the second largest revenue share after North America in the global myeloproliferative disorders drugs market, owing to merging treatment option and development of oncology drug discovery and rising prevalence of myeloproliferative disorders. Asia Pacific is expected to show rapid growth, due to increasing number of vascular surgeons and low cost of peripheral interventions. China is expected to register fast growth, due to significant increase in the number of innovative firm and research organization and increasing importance of pharmaceutical research & development activities and investments in research for developing new drugs. Latin America and Middle East & Africa are projected to exhibit sluggish growth in myeloproliferative disorders Drugs market, due to proper healthcare systems and adoption of new drug and therapy.

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Examples of some of the key manufacturer present in the global myeloproliferative disorders drugs market are

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The Myeloproliferative Disorders Drugs Market to grow on an exceptional note in the next 10 years - LionLowdown

Bone Marrow Stem Cells Comments Off on The Myeloproliferative Disorders Drugs Market to grow on an exceptional note in the next 10 years – LionLowdown | January 3rd, 2021