­­Orphazyme A/SCompany announcement                                                                                       No. 73/2020Inside InformationCompany Registration No. 32266355

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Orphazyme provides regulatory update on arimoclomol for NPC

BASEL, Switzerland and NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced a collaboration to develop and commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist – in oncology and women’s health in the U.S. and Canada. Pfizer will also receive an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries.

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Myovant Sciences and Pfizer Announce Collaboration to Develop and Commercialize Relugolix in Oncology and Women’s Health

STAMFORD, Conn., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KORSUVA™ Injection (difelikefalin) for the treatment of moderate-to-severe pruritus in hemodialysis patients. KORSUVA Injection received Breakthrough Therapy Designation from the FDA for this indication. Cara has requested Priority Review for the NDA which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

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Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with...

NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Better Choice Company (OTCQB: BTTR) (“Better Choice”), an animal health and wellness company, has qualified to trade on the OTCQX® Best Market. Better Choice Company Inc. upgraded to OTCQX from the OTCQB® Venture Market.

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Better Choice to Begin Trading on the OTCQX

SAN CARLOS, Calif., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that Maria Fardis, PhD, MBA, President and Chief Executive Officer of Iovance, plans to present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021, at 10:50 a.m. ET. The live and archived webcasts of the presentation and breakout session will be available in the Investors section of the Iovance website at http://ir.iovance.com.

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Iovance Biotherapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021

--Received Gross Proceeds of $110 Million from Previously Announced PIPE Financing----Executed Additional PIPE Financing of $15 Million--EMERYVILLE, Calif., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today announced the closing of the previously announced $110 million private investment in public equity (PIPE) financing, as well as a newly executed PIPE financing for an additional $15 million in gross proceeds resulting from the sale of shares of its common stock at a price per share of $3.71. Gross proceeds from the two PIPE financings total $125 million, before deducting placement agent fees and offering expenses. The PIPE financings are supported by a consortium of high quality new and existing institutional investors with expertise in health care, including Redmile Group, Avidity Partners, EcoR1 Capital, BVF Partners L.P. and Versant Ventures.

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Gritstone Oncology Announces Private Placement Financings Totaling $125 Million

HOUSTON, Dec. 28, 2020 (GLOBE NEWSWIRE) -- via InvestorWire – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announces that it has been featured in a broadcast via NetworkNewsAudio (NNA), a solution that delivers additional visibility, recognition and brand awareness in the investment community via distribution to thousands of syndication points. The audio press release covers CNS Pharmaceuticals’ recent announcement that the Investigational New Drug (IND) application for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM) is now approved and in effect as filed with the US Food and Drug Administration (FDA).

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CNS Pharmaceuticals Featured in Syndicated Broadcast Covering Recent FDA Approval of IND Application

NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it has entered into a definitive agreement to sell its Priority Review Voucher (“PRV”) to United Therapeutics Corporation (Nasdaq: UTHR), based on an agreed valuation of $105 million.

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Y-mAbs Announces Sale of Priority Review Voucher

BOSTON, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today announced results of the primary data cut from its Phase 3 clinical trial evaluating the safety and efficacy of eprenetapopt with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS). The trial did not meet the predefined primary endpoint of complete remission (CR) rate.   Analysis of the primary endpoint at this data cut demonstrated a higher CR rate in the experimental arm receiving eprenetapopt with AZA versus the control arm receiving AZA alone, but did not reach statistical significance. In the intention-to-treat population of 154 patients, the CR rate in the eprenetapopt with AZA arm was 33.3% (95% CI: 23.1% - 44.9%) compared to 22.4% (95% CI: 13.6% - 33.4%) in the AZA alone arm (P = 0.13).

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Aprea Therapeutics Announces Results of Primary Endpoint from Phase 3 Trial of Eprenetapopt in TP53 Mutant Myelodysplastic Syndromes (MDS)

GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

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Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico

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FitTrack Scale Reviews – Best BMI Smart Scale? – Procut Review by Mike Vaughn

These Product Offerings Include CBD Infused: Face Moisturizer, Anti-Wrinkle Cream, Collagen/Tightening/Detoxifying Face Masks, Lip Balm, Hand & Foot Cream, Transdermal Patch, Massage & Body Oil, Body Spray, and Roll-On Product

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Tauriga Sciences Inc. Expands its CBD Infused Skin Care Offerings to Include More Than 10 Different Products

– Company plans to complete rolling submission in the first half of 2021 –

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Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

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Sanofi: Information concerning the total number of voting rights and shares - November 2020

Pompano Beach, Fl, Dec. 24, 2020 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC PINK: BSEM) ("BioStem" or the "Company"), a leading life sciences company specializing in perinatal tissue allografts for use in regenerative therapies, today announced that it has filed its quarterly reports for 2020 to become current with OTC Markets.

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BioStem Technologies, Announces Filing of 2020 Quarterly Reports

HALIFAX, Nova Scotia, Dec. 24, 2020 (GLOBE NEWSWIRE) -- MedMira Inc. (MedMira) (TSXV: MIR), reported today on its financial results for the quarter ended October 31, 2020.

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MedMira Reports First Quarter Results FY2021

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Reversirol Reviews – Best Diabetes Supplement launched? - Product Review by Mike Vaughn

VANCOUVER, British Columbia, Dec. 22, 2020 (GLOBE NEWSWIRE) -- Lui Franciosi is proud to announce the launch of his new YouTube channel. As a pharmacologist and former executive in the pharmaceutical industry, Dr. Franciosi’s videos will focus on topics related to health and pharma care, as well as topics related to entrepreneurship, seniors care and COVID-19.

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Lui Franciosi of Franciosi Consulting Launches YouTube Channel

Annual Meeting to be adjourned solely with respect to Item 2, and Item 2 to be modified to decrease the proposed aggregate number of shares of common stock that the Company would be authorized to issue from 500,000,000 shares to 400,000,000 shares Annual Meeting to be adjourned solely with respect to Item 2, and Item 2 to be modified to decrease the proposed aggregate number of shares of common stock that the Company would be authorized to issue from 500,000,000 shares to 400,000,000 shares

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Ocugen Inc. Announces Plan to Adjourn Annual Meeting of Stockholders, Modify Proposal Regarding Increase in Number of Authorized Shares

Basel, 23 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection for the treatment of early and metastatic HER2-positive breast cancer. “This approval represents a significant step forward in the treatment of HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The innovation of Phesgo significantly reduces the time people spend receiving standard of care therapy with Perjeta and Herceptin, helping to minimise the impact of treatment on their everyday lives. It also addresses the increasing demand across healthcare systems for faster and more flexible treatment solutions.” Phesgo is available as a single-dose vial for SC injection and enables over 90% faster treatment than IV administration of standard of care therapy with Perjeta and Herceptin. SC administration of Phesgo takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.4,5,6 The approval of Phesgo in Europe is based on results from the pivotal phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of Perjeta and Herceptin in the blood and demonstrated comparable efficacy versus IV administration of the two medicines. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy. No new safety signals were identified, including no meaningful difference in cardiac toxicity.7 The development of Phesgo highlights Roche's commitment to improving patients’ experience of cancer treatment, looking beyond efficacy outcomes and focusing on more flexible treatment solutions. Phesgo has the potential to help minimise pressure on healthcare systems by reducing administration time, as well as other costs associated with treatment, such as time spent in the infusion chair and drug preparation.8,9 The COVID-19 pandemic has further highlighted the need to utilise novel approaches that help to manage healthcare capacity to free-up time and resources. About the FeDeriCa study7,10 FeDeriCa is an international, multi-centre, two-arm, randomised, open-label, pivotal phase III study evaluating the pharmacokinetics, efficacy and safety of subcutaneous injection of Phesgo in combination with chemotherapy, compared with standard intravenous (IV) infusions of Perjeta and Herceptin in combination with chemotherapy, in 500 people with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta. Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pathological complete response, meaning there is no tumour tissue detectable in the tissue removed at the time of surgery. Data from the FeDeriCa study were presented at the San Antonio Breast Cancer Symposium in December 2019. The FeDeriCa study met its primary endpoint of non-inferior levels of Perjeta in the blood. The geometric mean ratio (GMR; a type of average used when assessing pharmacokinetics) for the primary endpoint was 1.22 (90% CI: 1.14 to 1.31), with the lower limit of the 90% CI of the GMR=1.14?0.80 (the pre-specified non-inferiority margin). A secondary endpoint of non-inferior levels of Herceptin was also met, with blood concentrations for people receiving Phesgo non-inferior to those receiving IV Herceptin (GMR=1.33 [90% CI: 1.24 to 1.43]; lower limit of 90% CI of GMR=1.24?0.80). A non-inferiority endpoint was chosen for the study to ensure that people were receiving sufficient dosing with Perjeta and Herceptin as compared to the established IV doses at the same treatment intervals. About Phesgo Phesgo combines the same monoclonal antibodies as Perjeta and Herceptin with Halozyme Therapeutics’ Enhanze® drug delivery technology in a novel formulation for subcutaneous (SC) use.4,11  This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection. Halozyme’s Enhanze drug delivery technology may enable and optimise SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – to aid in the dispersion and absorption of other injected therapeutic drugs.11 Pertuzumab in Phesgo is the same monoclonal antibody as in intravenous (IV) Perjeta, and trastuzumab in Phesgo is the same monoclonal antibody as in IV Herceptin. The mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but in different locations. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signalling pathways.12,13 Phesgo is approved in the US for the treatment of early and metastatic HER2-positive breast cancer. The approved indications for Phesgo mirror those of Perjeta. The standard IV formulation of Perjeta in combination with IV Herceptin and chemotherapy (the Perjeta-based regimen) is approved in more than 100 countries for the treatment of both early and metastatic HER2-positive breast cancer. In the neoadjuvant (before surgery) early breast cancer (eBC) setting, the Perjeta-based regimen has been shown to almost double the rate of pathological complete response compared to Herceptin and chemotherapy.14 Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) eBC setting.15 In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.16 About Roche’s medicines for HER2-positive breast cancer Roche has been leading research into the HER2 pathway for more than 30 years and is committed to improving the health, quality of life and survival of people with both early and metastatic HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 25-30% of patients.17 Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla® (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test which identifies people who will likely benefit from these medicines at the onset of their disease. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] O’Shaugnessy J, et al. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO, 2020 Sept 19-21. Abstract #165MO.[2]  Xavier P, et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013;14(10):962-70. [3] Tjalma, et al. Trastuzumab IV versus SC: A time, motion and cost assessment in a lean operating day care oncology unit. Presented at: SABCS; 2016 Dec 6-10; San Antonio, TX, USA. Abstract #P4-21-15. [4] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. [5] US Food and Drug Administration. Prescribing Information for Herceptin. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/. [6] US Food and Drug Administration. Prescribing information for Perjeta. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf. [7] Tan A. et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: Primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS; 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07. [8] Sripada et al. Subcutaneous fixed-dose combination of pertuzumab and trastuzumab for the treatment of metastatic breast cancer in Canada - a budget impact analysis. Presented at SABCS; 2020 Dec 08-11; San Antonio Texas: PS9-55. [9] Roche data on file. [10] Clinical trials.gov. A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer (FeDeriCa). [Internet: December 2020]. Available from: https://clinicaltrials.gov/ct2/show/NCT03493854. [11] Halozyme. Enhanze® Drug Delivery Technology. [Internet; cited December 2020]. Available from: https://www.halozyme.com/enhanze/overview/default.aspx. [12] Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;2014:852748. [13] Baselga J, Swain SM. Novel anticancer targets: revisiting ERBB2 and discovering ERBB3. Nat Rev Cancer 2009;9:463-75. [14] Gianni L, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25-32. [15] Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;13;377(2):122-31. [16] Swain SM, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;19;372(8):724-34. [17] Jarrett A, et al. Experimentally-driven mathematical modelling to improve combination targeted and cytotoxic therapy for HER2+ breast cancer. Sci Rep. 2019;9:12830. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

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European Commission approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with...