In a collaboration potentially valued at $1.9 billion, Amgen is teaming up with Cambridge, Mass.-based Generate Biomedicines to develop protein therapeutics for up to five clinical targets. Source: Drug Industry…

Bristol Myers Squibb’s potentially groundbreaking monoclonal antibody for advanced melanoma could win FDA approval in the next few months. Source: Drug Industry Daily

Sales of Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab) have been exceedingly low. Source: Drug Industry Daily

The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2021 — slightly fewer than 53 approved in 2020. Source: Drug Industry Daily

The FDA has issued nasal-spray maker Amcyte Pharma of Kirkland, Wash., a warning letter for marketing an unapproved and misbranded product related to COVID-19. Source: Drug Industry Daily

An appraisal committee for the UK’s National Institute for Health and Care Evidence (NICE) has recommended against National Health Service (NHS) use of Lynparza (olaparib), AstraZeneca’s blockbuster cancer drug, for…

Sen. Joe Manchin (D-W.Va.) reiterated his opposition yesterday to President Biden’s nearly $2 trillion social spending package, saying there are currently no negotiations underway — further sinking the Build Back…

The FDA has announced that due to the fast-spreading Omicron variant of COVID-19, it will postpone the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in…

Already, pharmaceutical companies have increased prices for 456 brand name drugs for 2022, with the median increase coming in at a relatively modest 4.9 percent. Source: Drug Industry Daily

A Senate committee will vote whether to approve Robert Califf’s nomination to become FDA commissioner on Wednesday, Jan. 12 — a critical step before the full chamber can hold a…