Category Archives: Global News Feed

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

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

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

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

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