Thanks to Myovant Sciences GmbH’s potential $4.2 billion deal with Pfizer Inc. for recently approved Orgovyx (relugolix) in prostate cancer (PC), more physicians are going to be learning about [the compound] faster,” said chief commercial officer Adele Gulfo. “This is going to create huge demand.” Read More
Shares of Aprea Therapeutics Inc. (NASDAQ:APRE), a company focused on developing therapies that reactivate the mutant tumor suppressor protein p53, fell 78.1% to $5.50 on Dec. 28, just north of its cash balance, after a pivotal trial of its lead candidate missed its endpoint, leaving the asset's future hazy and likely scuttling plans the company had for a first quarter 2021 NDA filing. Read More
HONG KONG and BEIJING – China’s Sinovac Biotech Ltd. delayed releasing trial data from its Coronavac COVID-19 vaccine while the National Medical Products Administration (NMPA) accepted an NDA from China National Biotec Group (CNBG) for its own vaccine, BBIBP-CorV. Read More
Although it held off on a proposed rule change addressing yet another gaming opportunity for drug manufacturers in the U.S., the Centers for Medicare & Medicaid Services (CMS) still is pressing its policy for including more 505(b)(2) drugs in multiple source reimbursement codes, which could force them to compete with generics on price. Read More
PERTH, Australia – Although Australians pay less for their drugs than patients in many other countries, Australia is falling behind when it comes to reimbursement for newer, targeted therapies, according to a report launched by Medicines Australia that assessed the timelines for registration and reimbursement of new medicines in Australia compared to 10 other Organisation for Economic Co-operation and Development (OECD) countries. Read More
As expected, the Centers for Medicare & Medicaid Services’ (CMS) interim final rule to implement a seven-year most favored nation (MFN) Medicare payment model for 50 drugs crashed into the brick wall of a U.S. court. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Algernon, Aprea, Gannex, Inovio, Lysogene, Novavax, Taiwan Liposome. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Aurobindo, Beigene, Biontech, Bridgebio, Chiesi, Cullinan, Elevar, IMV, Inceptua, Lifesci, Oasmia, Pfizer, Proteostasis, Recce, Soligenix, Tonix, United Biomedical, United Therapeutics, Vincera, Ymabs, Yumanity, Zai Lab. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Altimmune, Arctic Vision, Astrazeneca, Audentes, Bristol Myers Squibb, Cara, Innocare, Innovent Biologics, Inotrem, Janssen Biotech, Merck, Orphazyme, Verrica. Read More
