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…
The Centers for Medicare and Medicaid Services (CMS) has formally rescinded a Trump-era policy seeking to tie what Medicare pays for certain outpatient drugs to the lowest price paid by…
In the latest chapter in the 340B Drug Discount Program saga, HHS has appealed decisions issued in three federal courts that called into question the agency’s authority to punish drug…