Geneva, Switzerland, December 14, 2020 – Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development announced today that it has filed a registration statement with the U.S. Securities and Exchange Commission (SEC) for a proposed underwritten public offering of shares, including those to be settled in the form of American Depositary Shares (ADSs). Each ADS represents the right to receive six shares of Addex.  The terms of the offering have not been determined, and the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. The Company will be concurrently offering the shares in Europe (other than Switzerland) in a private placement to qualified investors, and in Switzerland through private placements.

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Addex Announces Filing of Registration Statement for Proposed Public Offering of Securities

Basel, 14 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomised, double-blind ENSEMBLE PLUS study. “More than 170,000 people with MS have been treated with OCREVUS - the only approved B-cell therapy with a twice-yearly dosing schedule - and it is the most prescribed MS medicine in the U.S.,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We constantly strive to improve the experience that patients and their physicians have with our medicines, and we believe people with relapsing and primary progressive MS will find the shorter two-hour OCREVUS infusion time to be more convenient.” The ENSEMBLE PLUS study showed similar frequency and severity of IRs for a two-hour OCREVUS infusion time vs. the previously approved 3.5-hour time in patients with relapsing-remitting MS (RRMS). The first dose was administered per the approved dosing schedule (two 300 mg intravenous [IV] infusions separated by two weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, two-hour time. The primary endpoint of this study was the proportion of patients with IRs following the first randomised 600 mg infusion (frequency/severity assessed during and 24-hours post infusion). The frequency of IRs was comparable between those who received the two-hour infusion (24.6%) and those who received the 3.5-hour infusion (23.1%). The majority of IRs were mild or moderate, and more than 98% resolved in both groups without complication. No IRs were life-threatening, serious or fatal. No patients discontinued the study due to an IR and no new safety signals were detected. The European Medicines Agency (EMA) approved the two-hour infusion time in May of 2020 based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). OCREVUS has twice-yearly (six-monthly) dosing and is the first and only therapy approved for relapsing multiple sclerosis (RMS) (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and primary progressive MS (PPMS). OCREVUS is approved in 94 countries across North America, South America, the Middle East, Europe, as well as in Australia. About OCREVUS® (ocrelizumab) OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved. OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions. About Roche in multiple sclerosis Roche is following the science in an effort to ultimately stop disease progression and preserve function in people living with multiple sclerosis (MS). As a company, we continue to advance the clinical understanding of MS and progression with the aim of bringing the most benefit to people living with MS. About Roche in neuroscience Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne’s muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today. 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. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

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FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

SANTA MONICA, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced an additional commitment of up to $3.5 million from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to advance the clinical development of OPNT003, nasal nalmefene, for opioid overdose. The contract modification increases the total potential value of the BARDA contract to $8.1 million.

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Opiant Pharmaceuticals Announces Additional $3.5 million Funding Under BARDA Contract for OPNT003 Nasal Nalmefene Development Program

– Chair and board member Michael Wolf Jensen will not stand for re-election at 2021 Annual General Meeting –

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Ascendis Pharma A/S Announces Planned Board Transition

YAVNE, Israel, Dec. 14, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has further expanded its NexoBrid® global presence and entered the Middle Eastern markets with the signing of a distribution agreement granting Ghassan Aboud Group (GAG), an international conglomerate based in the United Arab Emirates (UAE), an exclusive right to market and distribute NexoBrid in UAE for the treatment of severe burns. Commercialization of NexoBrid in the UAE will commence upon securing regulatory approval, which is expected within a year.

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MediWound Continues Global Expansion with Distribution Agreement for NexoBrid in United Arab Emirates with Ghassan Aboud Group

NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide a corporate update.

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Mesoblast Corporate Update

LYON, France and CAMBRIDGE, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the completion of enrollment in the TRYbeCA-1 Phase 3 trial in second-line pancreatic cancer.

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ERYTECH Completes Enrollment in TRYbeCA-1 Phase 3 Trial in Second-Line Pancreatic Cancer

NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced top-line results from the landmark DREAM-HF Phase 3 randomized controlled trial of its allogeneic cell therapy rexlemestrocel-L (REVASCOR®) in 537 patients with advanced chronic heart failure1.

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Mesoblast Provides Topline Results From Phase 3 Trial of Rexlemestrocel-L for Advanced Chronic Heart Failure

NEW YORK, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the first patient has been dosed in the Phase 1/2 PROCLAIM clinical trial evaluating PR006, an investigational AAV9 gene therapy delivering the GRN gene, for the treatment of frontotemporal dementia patients with GRN mutations (FTD-GRN).

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Prevail Therapeutics Announces First Patient Dosed in Phase 1/2 PROCLAIM Clinical Trial Evaluating PR006 for the Treatment of Frontotemporal Dementia...

Signals momentum in addressing social equity, tax and banking reform, and the widespread adoption of cannabis in the U.S. Signals momentum in addressing social equity, tax and banking reform, and the widespread adoption of cannabis in the U.S.

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Golden Leaf Holdings Applauds the Historic Passing of the MORE Act

SUNNY ISLES, Fla., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Bespoke Extracts, Inc. (OTC Pink: BSPK), producer of high quality, hemp-derived CBD products, today formally congratulated professional Mixed Martial Artist Cody Law on his big TKO win in the third round against opponent Kenny Champion at Bellator 254 held last night in Uncasville, Connecticut. As previously announced, Bespoke Extracts was Law’s corporate sponsor at the event.

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Bespoke Extracts Congratulates Pro MMA Fighter Cody Law on TKO Win at Bellator 254

CAMBRIDGE, Mass., Dec. 11, 2020 (GLOBE NEWSWIRE) -- TCR² Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing a pipeline of novel T cell therapies for patients suffering from cancer, today announced that the Company plans to discuss interim data from the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors in a premarket press release and webcast to be held on Monday, December 14th, 2020.

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TCR² Therapeutics to Announce Interim Data from Phase 1/2 Clinical Trial of TC-210 in Mesothelin-Expressing Solid Tumors

– Event to be webcast live on Monday, December 14, 2020 at 8:00 a.m. ET –

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Arvinas to Host Webcast Presentation of New Clinical Data from ARV-471 and ARV-110 PROTAC® Protein Degrader Development Programs

BOSTON, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the grant of inducement stock options exercisable for an aggregate of 18,500 shares of Albireo’s common stock. The stock options are exercisable at a price of $39.77 per share, the closing price of Albireo’s common stock on December 9, 2020, the grant date, and were granted as inducements material to the employee’s acceptance of employment with Albireo in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option has a 10-year term and vests over a four-year period, subject to the employee’s continued service with Albireo through the applicable vesting dates. The vesting schedule for each stock option is 25 percent on the one-year anniversary of the employee’s start date with Albireo and 75 percent in 12 equal quarterly installments thereafter. The stock options are subject to the terms and conditions of Albireo’s 2020 Inducement Equity Incentive Plan.

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Albireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Primary endpoint achieved with twice-daily dose group at 28 day time point versus latanoprost control group.

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Aerpio Announces Statistically Significant Topline Results from Razuprotafib Glaucoma Phase 2 Trial

CAMPBELL, Calif., Dec. 11, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (the “Company”), a biopharmaceutical company, today announced that it has received approval from the United States Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) on its Second Amended Joint Prepackaged Chapter 11 Plan of Reorganization of VIVUS, Inc. and Its Affiliated Debtors [Docket No. 339] (the “Plan”).

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VIVUS Receives Court Approval of Joint Chapter 11 Plan of Reorganization

ANN ARBOR, Mich., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) (“Company” or “Kraig Labs”), announced today that it has secured $950,000 in bridge financing and simultaneously filed with the SEC to become a mandatory, fully reporting company. Today the Company filed a Form 8-A to become fully reporting issuer. This financing will also make a significant contribution to that effort.

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Kraig Biocraft Laboratories Secures Bridge Funding and Files to Become Fully Reporting Company

NEW YORK and MAINZ, GERMANY, December 11, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. The vaccine is now authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.

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Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

Demonstrates modularity of Intellia’s in vivo liver insertion technology to durably restore protein, compared to traditional gene therapy

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Intellia Therapeutics Achieves Normal Human Alpha-1 Antitrypsin Protein Levels in Non-Human Primates Through Targeted Gene Insertion for the Treatment...

VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in patient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with encouraging short-term safety and tolerability data using VASCEPA loading dose

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Amarin Reports Encouraging Efficacy and Safety Results from Pilot Study Treating COVID-19 Infected Outpatients with VASCEPA® (Icosapent Ethyl) in...