Tag Archives: Bayer

December, 2018

5 December
FDA Grants Breakthrough Device Designation to Artificial Intelligence Software for CTEPH Pattern Recognition from Bayer and MSD

Berlin, December 3, 2018 – Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition, which Bayer is currently developing jointly with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA). A …
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28 November
FDA Approves Vitrakvi, the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion

STAMFORD, Conn. and WHIPPANY, N.J., Nov. 26, 2018 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration (FDA) today approved Vitrakvi® (larotrectinib), the first ever oral TRK inhibitor, for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a …
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24 October
Bayer’s Darolutamide Meets Primary Endpoint in Phase 3 Trial in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

WHIPPANY, N.J., Oct. 24, 2018 /PRNewswire/ — The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC), met its primary endpoint. Darolutamide significantly extended metastasis-free survival (MFS) compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were …
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30 August
FDA Approves Bayer’s Jivi for the Routine Prophylactic Treatment of Hemophilia A

WHIPPANY, N.J., Aug. 30, 2018 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The initial recommended prophylactic …
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31 May
FDA Grants Priority Review to Larotrectinib for Treatment of Patients with Solid Tumors Harboring NTRK Gene Fusion

WHIPPANY, N.J., May 29, 2018 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by its collaboration partner Loxo Oncology, Inc. (NASDAQ: LOXO), and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with …
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4 December
Bayer and Loxo Oncology Report Positive Updated Larotrectinib Pediatric Phase 1 Trial Data

WHIPPANY, N.J., Dec. 4, 2017 /PRNewswire/ — Bayer and Loxo Oncology, Inc., (NASDAQ: LOXO), today announced updated clinical data from the larotrectinib (LOXO-101) pediatric Phase I SCOUT trial (NCT02637687). These data are being presented today at the American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer Research in …
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20 November
Bayer Enters Potential Billion-Dollar Discovery Collaboration Agreement with PeptiDream

KAWASAKI, Japan–(BUSINESS WIRE)–PeptiDream Inc., a public Kanagawa-based biopharmaceutical company (“PeptiDream”)(TOKYO:4587) announced today that it has entered into a multi-target discovery collaboration with Germany-based Bayer AG (“Bayer”)(ETR:BAYN). Under the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to identify macrocyclic/constrained peptides against multiple targets of interest selected …
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15 November
Bayer and Loxo Oncology to Co-Develop Cancer Drugs in up to $1.55 Billion Deal

WHIPPANY, N.J., Nov. 14, 2017 /PRNewswire/ — Bayer announced today that the company has entered into an exclusive global collaboration with Loxo Oncology, Inc., a biopharmaceutical company based in Stamford, Connecticut (NASDAQ: LOXO) for the development and commercialization of larotrectinib (LOXO-101) and LOXO-195. Both compounds are being investigated in global …
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30 October
FDA Accepts Bayer’s Biologics License Application for BAY94-9027 for Treatment of Hemophilia A

WHIPPANY, N.J., Oct. 30, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has accepted Bayer’s Biologics License Application (BLA) filing for BAY94-9027, an extended half-life site-specifically PEGylated recombinant human Factor VIII compound, for the treatment of hemophilia A in adults and adolescents 12 years of age and over. …
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15 September
FDA Approves Bayer’s Aliqopa for Treatment of Relapsed Follicular Lymphoma

WHIPPANY, N.J., Sept. 14, 2017 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Aliqopa™ (copanlisib) for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies.1 Accelerated approval was granted for this indication based on ORR. …
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