Presentation to be highlighted in the Best of International Liver Congress Presentation to be highlighted in the Best of International Liver Congress

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Altimmune Announces Oral Presentation of Pemvidutide Clinical Data at Upcoming EASL International Liver Congress™ on June 25, 2022

Top-line Efficacy Results Expected in Approximately 6 to 8 Weeks Top-line Efficacy Results Expected in Approximately 6 to 8 Weeks

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VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis

Collaboration with Merck published in Science magazine

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Codexis Announces the Publication of Research Demonstrating Proof of Concept for Chemoenzymatic Site-Selective Bioconjugation of Native Peptides

CY6463 alleviated mitochondrial dysfunction and reduced inflammation in preclinical models of mitochondrial complex 1 deficiency

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Cyclerion Therapeutics Announces CY6463 Data Demonstrating Improved Cellular Energetics in Preclinical Models of Mitochondrial Disease

MONTRÉAL, June 17, 2022 (GLOBE NEWSWIRE) -- ExCellThera Inc. (ExCellThera), an advanced clinical-stage biotechnology company delivering molecules and bioengineering solutions to expand and engineer various cell lines for use in next generation cell and gene therapies, announced today that it has submitted a Type II Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for UM171, a proprietary molecule being studied for use in the expansion and rejuvenation of hematopoietic stem cells.

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ExCellThera announces submission of Drug Master File for UM171

Results to be Presented in Late-Breaking Session Results to be Presented in Late-Breaking Session

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Capricor Therapeutics to Present One-Year Efficacy Results from its Ongoing HOPE-2 Open Label Extension Study at 2022 Parent Project Muscular...

First demonstration of the survival of allogeneic islet cells, cardiomyocytes, and retinal pigment epithelium cells transplanted into an immunocompetent non-human primate model without any immune suppression

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Sana Biotechnology Presents Data at ISSCR 2022 Annual Meeting Showing Survival of Transplanted Hypoimmune iPSC-Derived Differentiated Cell Types...

ANAHEIM, CA, June 17, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today announced that Tom Welch, Executive Vice President of BioCorRx Inc., was featured on LiveNOW from FOX. Mr. Welch discussed BioCorRx’s pilot program with 2B3D, a virtual, augmented, and mixed reality technology company, a first-of-its-kind post-traumatic stress disorder (PTSD) and addiction treatment solutions program for veterans in the metaverse setting.

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BioCorRx Featured on LiveNOW from FOX

NEW YORK and MAINZ, GERMANY, June 17, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data.

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Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

POMPANO BEACH, FLORIDA, June 17, 2022 (GLOBE NEWSWIRE) -- BioStem Technologies® (OTC: BSEM), a leading, innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies will be hosted on Benzinga’s All Access show, which airs on Benzinga TV and Benzinga’s YouTube channel on June 17 2022, at 10:20 AM EST.

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BioStem Technologies® CEO to Appear on the Benzinga All Access Show on June 17,2022

Company Announcement

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Genmab Announces Initiation of Share Buy-Back Program

SAN DIEGO, CA and TAICANG, SUZHOU, China, June 17, 2022 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) ("Connect Biopharma" or the “Company”) announced on June 16, 2022, Connect Biopharma Holdings Limited (the “Company”) received a letter from the Listings Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive business days, the bid price for the Company’s American Depositary Shares (“ADSs”) had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5550(a)(2).

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Connect Biopharma Announces Receipt of NASDAQ Deficiency Notice Regarding Minimum Bid Price Requirement

NEW YORK, June 17, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough immunotherapies via novel routes of monoclonal antibody delivery, today disclosed the receipt of a notice (the “Notice”) on June 14, 2022 from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company is not currently in compliance with the $1.00 minimum bid price requirement for continued listing of the Company’s common shares on the Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”). The Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 days, or until December 12, 2022 (the “Compliance Deadline”), to regain compliance with the Minimum Bid Price Requirement by having the closing bid price of the Company’s common shares meet or exceed $1.00 for at least ten consecutive business days.

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Tiziana Life Sciences Ltd. Receives Nasdaq Deficiency Notice

Oral presentation will outline design of first ever Phase 1/2 clinical trial of regenerative human cell therapy in epilepsy

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Neurona Therapeutics to Present Preclinical Data Supporting Regenerative Cell Therapy, NRTX-1001, in Clinical Development for Chronic Focal Epilepsy,...

BOSTON and JERUSALEM, June 17, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered peptides and therapeutic proteins, today announced that Dr. Phillip Schwartz, the Company’s President of Research & Development and Founder, will resign from his current role effective July 21, 2022 to pursue other opportunities. Dr. Schwartz also stepped down from the Company’s Board of Directors, effective June 15, 2022. Dr. Schwartz’s resignation was not a result of any disagreement with the Company and Dr. Schwartz will remain as a consultant to the Company.

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Entera Bio Announces Departure of Dr. Phillip Schwartz, the Company’s President of Research & Development to Pursue Outside Opportunities

SHANGHAI, China, June 20, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced the appointment of Donna Ambrosino, M.D., and Ralf Clemens, M.D., Ph.D., to the company’s Board of Directors.

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Clover Appoints Donna Ambrosino, M.D., and Ralf Clemens, M.D., Ph.D., to Board of Directors

Saint-Herblain (France) and New York, June 20, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15. As previously announced on April 26, 2022, Pfizer plans to initiate the Phase 3 study of VLA15 in the third quarter of 2022.

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Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced that it has submitted a regulatory filing to the Brazil National Health Surveillance Agency (ANVISA) for UPLIZNA for the treatment of adult patients with anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+) neuromyelitis optica spectrum disorder (NMOSD).

This regulatory submission is an important milestone as we continue to expand our commitment to NMOSD patients around the world, said Vikram Karnani, executive vice president and president, international operations, Horizon. NMOSD is a devastating disease with unpredictable attacks, which can result in potential loss of vision and motor function. We are hopeful that we can bring a potential new treatment option to the estimated ten thousand people living with NMOSD in Brazil.

In the N-MOmentum Phase 3 clinical trial, the largest NMOSD trial to date, UPLIZNA demonstrated a significant reduction in the risk of an NMOSD attack with only two infusions per year, following the initial two loading doses. Additionally, 89% of patients in the AQP4-IgG+ group remained attack-free during the six-month period post-treatment and 83% of patients on treatment remained attack-free for at least four years.1,2

UPLIZNA was approved by the U.S. Food and Drug Administration (FDA) in June 2020, by the Japanese Ministry of Health, Labor and Welfare in March 2021 and by the European Commission (EC) in April 2022. Mitsubishi Tanabe Pharma Corporation has the rights to develop and commercialize UPLIZNA in Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, the Philippines, Singapore and Taiwan. Hansoh Pharmaceutical Group Company Limited, another strategic partner to Horizon, has also recently received manufacturing and marketing approval from the National Medical Products Administration of the Peoples Republic of China for UPLIZNA.

About Neuromyelitis Optica Spectrum Disorder (NMOSD)

NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord, brain and brain stem.3-4 Approximately 80% of all patients with NMOSD test positive for anti-AQP4 antibodies.5 AQP4-IgG binds primarily to astrocytes in the central nervous system and triggers an escalating immune response that results in lesion formation and astrocyte death.6

Anti-AQP4 autoantibodies are produced by plasmablasts and plasma cells. These B-cell populations are central to NMOSD disease pathogenesis, and a large proportion of these cells express CD19.7 Depletion of these CD19 B cells is thought to remove an important contributor to inflammation, lesion formation and astrocyte damage. Clinically, this damage presents as an NMOSD attack, which can involve the optic nerve, spinal cord and brain.6-8 Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure can all be manifestations of the disease.9 Each NMOSD attack can lead to further cumulative damage and disability.10,11 NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent.12,13

About UPLIZNA (inebilizumab-cdon)

INDICATION

UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%) and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

For additional information on UPLIZNA, please see the Full Prescribing Information at http://www.UPLIZNA.com.

About Horizon

Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit http://www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to potential regulatory approval of UPLIZNA in Brazil and the potential benefits of UPLIZNA to patients in Brazil. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include the risk that UPLIZNA does not receive regulatory approval in Brazil, whether, if regulatory approval is received, UPLIZNA will be successfully commercialized in Brazil, and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizons filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.

References

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Horizon Therapeutics plc Submits Regulatory Filing for UPLIZNA (inebilizumab) in Brazil - Business Wire

Abstract: Background Avascular necrosis of the femoral head (ANFH) is a common orthopaedic disease due to bone defects. However, few clear methods to treat ANFH in clinical practice are known. Many findings suggest that promoting the osteogenic differentiation and directional migration of stem cells may be a key method for bone regeneration. Over time, an increasing number of researchers have begun to focus on Chinese medicine and Chinese medicinal extracts; Epimedium is the Chinese herbal medicine studied in the most detail in the field of bone regeneration, and Icariin (ICA) is one of the main active ingredients in Epimedium. Objective This study aimed to explore the effects of ICA on the osteogenic differentiation and migration of bone marrow mesenchymal stem cells (BMSCs) and reveal its mechanism to provide a theoretical basis for the treatment of ANFH. Methods After primary BMSCs were freshly isolated from a normal rabbit and treated with various concentrations of ICA, the activity and proliferation of BMSCs were detected by CCK-8 assay, and the mineralized nodules was detected by Alizarin Red staining, to determine the optimal concentration of ICA. qPCR and western blot were used to demostrate the effects of ICA on the osteogenic differentiation and migration of BMSCs. Osteoblasts-derived exosomes (OB-exos) were extracted and analysed by high-throughput sequencing. Effect of ICA combined with OB-exos were analysed. And miRNA mimic and an miRNA inhibitor were synthetised to verify the osteogenic differentiation and migration of BMSCs alone or co-cultured with ICA. Results The CCK-8 assay and Alizarin Red staining showed that the optimal concentration of ICA is 1107 M. ICA could effectively promote the osteogenic differentiation and migration of BMSCs, and this could be enhanced after co-culturing with OB-exos. The four miRNAs with the greatest concentrations in the OB-exos were let-7a-5p, miR-100-5p, miR-21-5p and miR-122-5p. qPCR and western blot showed that miR-122-5p mimic has positive effects on the osteogensis and migration, and its inhitiotr has negative effects. Simliarly, they could enhance or inhitor the effects of ICA, which means miR-122-5p may be the target of ICA. Conclusion Like the OB-exos, ICA could obviously promote the osteogenic differentiation and migration of BMSCs. The combination of ICA and OB-exos enhanced these effects, in which miR-122-5p plays a pivotal role.

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Mechanism of Icariin regulation of the effect of miR-122-5p in osteoblast-derived exosomes on osteogenesis and migration of bone marrow mesenchymal...

Myeloproliferative neoplasms (MPNs) are a diverse group of chronic hematological diseases caused by the clonal expansion of abnormal hematopoietic stem cells, of which polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) have been extensively studied in terms of clonal expansion, fibrosis, and other phenotypes. For a study, researchers sought to evaluate current research on the impact of different types of MPN on bone health.

Human data were used in research to show that different types of MPN influence bone density, osteoblast proliferation, and differentiation. The majority of data revealed that bone volume is frequently raised in patients with PMF. In contrast, it was slightly decreased or not affected in patients with ET or PV; however, probable distinctions between male and female phenotypes in most MPN subtypes have not been thoroughly examined.

Osteosclerosis in PMF patients was a significant consequence that could result in bone marrow failure, and bone loss seen in some ET or PV patients can result in osteoporotic fractures. Some MPN types were associated with an increase in the number of megakaryocytes (MKs), and various MK-related MPN variables are known to impact bone formation.Investigators discussed known mechanisms involved in the processes, emphasizing the function of MKs and secreted factors. Understanding MPN-related alterations in bone health should lead to better early intervention and treatment of this pathologys adverse effects.

Reference:ashpublications.org/blood/article-abstract/139/21/3127/476662/Myeloproliferative-disorders-and-their-effects-on?redirectedFrom=fulltext

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Myeloproliferative Disorders & Bone Homeostasis: The Role of Megakaryocytes - Physician's Weekly