AstraZeneca is spending $68 million to acquire LogicBio Therapeutics, a move that brings two innovative gene editing platforms to the pharma giant’s fold. Source: Drug Industry Daily
A European pharma group is calling on the EU to establish a mechanism comparable to the U.S.-based Priority Review voucher system to facilitate the development of new antimicrobial drugs. Source:…
The FDA has launched an external review to find out what the agency can do to better support the appropriate use of opioid analgesics in the U.S. Source: Drug Industry…
With reports that as many as 40 percent of Americans may have some difficulty swallowing tablets, the FDA released multiple guidances for sponsors of generic drugs on Monday, including a…
The European Medicines Agency’s (EMA) safety committee last week recommended adding a warning to the product information for three types of drug products: terlipressin, Imbruvica and combinations of codeine with…
Medicare and Medicaid have spent an estimated $23.8 billion on 18 FDA accelerated approval (AA) drugs with incomplete confirmatory trials that missed their planned completion dates, the HHS Office of…
Amylyx has received full approval for its amyotrophic lateral sclerosis (ALS) drug, now dubbed Relyvrio (AMX0035). Source: Drug Industry Daily
The House voted 230 to 201 on Friday to pass a continuing resolution (CR) — swiftly signed into law by President Biden — funding the federal government through Dec. 16…
German drug manufacturer System Kosmetik has drawn an FDA warning letter for lacking manufacturing process validation and other deficiencies observed during an FDA inspection of its facility in Bavaria in…
It’s been a long time coming, but the FDA has finally published a pair of proposed rules designed to sync the agency’s institutional review board (IRB) and informed consent requirements…