Pharmaceuticals, Biotechnology and Life Sciences
FDA has published 48 finalized product-specific guidances describing its current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.
BioMarin Pharmaceutical issued a press release on Mondayan in which it announced underwritten offering of $450 million of senior subordinated convertible notes due 2024. BioMarin has also granted the underwriters a 13-day option to buy up to an additional $50 million aggregate principal amount of Notes.
Mylan got Monday receipt of tentative approval from the U.S. Food and Drug Administration under the U.S.President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets.
Bristol-Myers Squibb and IFM Therapeutics have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders.
Portola Pharmaceuticals has resubmitted its Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for AndexXa (andexanet alfa), a reversal agent for Factor Xa inhibitors.
Faron Pharmaceuticals said Friday that Independent Data Monitoring Committee (the IDMC) has recommended that the Interest trial for Traumakine should continue as planned with no changes, consistent with the previous four IDMC recommendations. Faron said it expects to recruit 300 patients during the fourth quarter of 2017.
André C. Muller, CFO of Idorsia, said: “We launched Idorsia on 15 June 2017 with a fully operational research and development engine and CHF 1 billion in cash. For the shortened financial year of 2017, we expect our non-GAAP operating expenses to be between CHF 180-190 million.”
BioMarin Pharmaceutical said Wednesday it plans to expand its development plan for BMN 270, its investigational gene therapy for hemophilia A, to include an additional Phase 3 study of the 4e13 vg/kg dose from its ongoing open-label Phase 1/2 study of BMN 270.
Orexo AB said on Wednesday that Zubsolv tablet’s position has changed from excluded from reimbursement to reimbursed as a preferred product. Zubsolv is buprenorphine and naloxone sublingual tablet (CIII) managed care formulary position with CVS Caremark for patients suffering from opioid dependence.
Arix Bioscience has acquired an interest in Amplyx Pharmaceuticals – San Diego-based Amplyx is focused on developing novel, broad-spectrum antifungal agents for the treatment of life-threatening fungal infections – as part of an oversubscribed $67 million Series C financing round.