WALTHAM, Mass., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for intravitreal pegcetacoplan, an investigational, targeted C3 therapy, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA is a leading cause of blindness that impacts more than five million people globally.1,2

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Apellis Submits Marketing Authorization Application to the European Medicines Agency for Pegcetacoplan for Geographic Atrophy

SAN MATEO, Calif. and SINGAPORE, Dec. 16, 2022 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced the Company’s participation in upcoming conferences for January 2023. Listed below are meetings that management will be attending around the week of the J.P. Morgan 41st Annual Healthcare Conference.

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ASLAN Pharmaceuticals Announces Participation in January Investor Conferences

If approved, etranacogene dezaparvovec would be the first licensed gene therapy in Europe for people living with hemophilia B If approved, etranacogene dezaparvovec would be the first licensed gene therapy in Europe for people living with hemophilia B

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uniQure announces positive CHMP opinion for etranacogene dezaparvovec – gene therapy for adults with hemophilia B

New York, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough CNS immunomodulation approaches to enhance the functionality of Treg-based therapies, announced today that the Company plans to present at the Biotech Showcase and host institutional investor and partnering meetings at this event, as well as at the LifeSci Corporate Access Event. Both in-person events are taking place January 9-10, 2023 in San Francisco, California.

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Tiziana to Participate in January Investor Meetings

Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis

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Press Release: Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis

POMPANO BEACH, FLORIDA., Dec. 16, 2022 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTCQB: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics, is pleased to announce that its common shares have been successfully up-listed from the OTC Pink Sheet Open Market to the OTCQB Venture Market (the “OTCQB”) by the OTC Markets Group Inc. (“OTC Markets”). The Company’s common shares will begin trading on the OTCQB under the symbol “BSEM” as of the opening of market on December 16, 2022.

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BioStem Technologies Announces Up-Listing to the OTCQB Venture Market

Basel, 16 December 2022 - Roche (SIX: RO, ROG; OTCQZ: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation. If approved, Hemlibra would also be indicated for the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ?1% and ? 5%) with a severe bleeding phenotype. It is estimated that people with moderate haemophilia A make up 14% of the haemophilia A population.3

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CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A

Full-year 2022 product sales guidance maintained at 20-25% growth year-over-year Full-year 2022 product sales guidance maintained at 20-25% growth year-over-year

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Athenex Exits 503B Sterile Compounding Business

MADRID, Spain and BOSTON, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the approval by the EU-intergovernmental organization EUREKA secretariat of funding for the BRAVE Project (Breaking immune Resistance of Advanced cancers by HERV-K Vaccination and Epigenetic modulation) under the Eurostars-3 program. This project will be developed in collaboration with two European partners: the Danish company ImProTher and the University of Copenhagen, and will evaluate the role of iadademstat in several immunotherapy strategies, including checkpoint inhibitors and/or oncological vaccines, in solid tumors.

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ORYZON Awarded EU Grant to Further Explore the Role of Iadademstat in Oncological Immunotherapy Approaches

CHMP Adopts Positive Opinion Based Upon Complete Review of all Pre-Clinical, Clinical Studies and CMC Data

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Amicus Therapeutics Receives Positive CHMP Opinion for Pombiliti™ (cipaglucosidase alfa) for Late-Onset Pompe Disease

Topline data readout from study expected in first half of 2023

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Palisade Bio Provides Update on U.S. Phase 2 Study Evaluating LB1148 for Post-Surgical Abdominal Adhesions

NEW HAVEN, Conn., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that Brad Margus, M.B.A., has stepped down from the company’s Board and Everett Cunningham has been appointed to join.

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Arvinas Announces Changes to its Board of Directors

WOBURN, Mass., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced the final voting results from its 2022 Annual Meeting of Stockholders held on December 12, 2022.

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Biofrontera Inc. Announces Voting Results from 2022 Annual Meeting of Stockholders

NEW YORK and BERLIN, Dec. 16, 2022 (GLOBE NEWSWIRE) -- atai Impact, the philanthropic arm of atai Life Sciences N.V. (NASDAQ: ATAI) (“atai”), today announced the first cohort of the atai Fellowship Fund in Psychedelic Neuroscience (the “Fellowship Fund”) at Massachusetts General Hospital (“MGH”) Center for the Neuroscience of Psychedelics. The $2 million Fellowship Fund was announced in December 2021 to facilitate research into the potential of psychedelics to address unmet patient needs in mental health and support promising graduate students and other trainees in furthering their professional careers in this emerging field.

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The atai Fellowship Fund in Psychedelic Neuroscience Announces its First Cohort at Massachusetts General Hospital

Closing of Three Separate Transformative Capital Financings, Including Two Significant Non-Dilutive Transactions, Generates Combined Gross Proceeds of More than $100 Million Which Reduce Outstanding Debt from $100 Million to $36.9 Million

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Societal CDMO Completes Strategic Recast of Capital Structure Highlighted by Reduction and Refinancing of Outstanding Debt

DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company, pioneer in the exploration and exploitation of bacterial biodiversity to address the urgent, global challenge of antibiotic resistance, announces that, in the context of the receivership proceedings (“procédure de redressement judiciaire”) opened on November 7, 2022, the Montpellier Commercial Court has met on December 16, 2022, and postponed the examination of the case to January 13, 2023. The continuation of the observation period (“période d'observation”) was requested by the bodies of the proceedings and the company DEINOVE.

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DEINOVE - Update on the Receivership Proceedings

PORTLAND, Ore., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Chalice Brands Ltd. (CSE: CHAL) (OTCQB: CHALF) (the “Company” or “Chalice Brands”), a premier consumer-driven cannabis company specializing in retail, production, processing, wholesale, and distribution, today announces select preliminary unaudited financial results for the year ended December 31, 2021. All financial information is provided in U.S. dollars unless otherwise indicated.

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Chalice Brands Reports Select Preliminary Unaudited Fiscal Year End 2021 Results and 2021 Operational Update

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, has received notification from the Nasdaq Stock Market LLC Listing Qualifications Department that it was not in compliance with the minimum bid price requirement set forth in Nasdaq Rule 5450(a)(1) since the closing bid price for the Company's common shares listed on Nasdaq was below US$1.00 for 30 consecutive business days. Nasdaq Rule 5450(a)(1) requires the shares to maintain a minimum bid price of US$1.00 per share, and Nasdaq Rule 5810(c)(3)(A) provides that failure to meet such a requirement exists when the bid price of the shares is below US$1.00 for a period of 30 consecutive business days. These notifications do not impact the Company’s listing on the Nasdaq Global Market at this time. In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until June 12, 2023, to regain compliance with the minimum bid price requirement, during which time the shares will continue to trade on the Nasdaq Global Market. If at any time during the 180-calendar day period, the bid price of the shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement and will consider such deficiency matters closed.

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CENTOGENE Receives Nasdaq Non-Compliance Notice

NEW YORK, Dec. 16, 2022 (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 the European Committee for Medicinal Products for Human use (“CHMP”) has adopted a negative opinion recommending a refusal of the marketing authorization for omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma in Europe.

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The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe

Chair of the Board of Directors, Sean P. Nolan, appointed Chief Executive Officer

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Taysha Gene Therapies Announces Executive Leadership Changes