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AstraZeneca is spending $68 million to acquire LogicBio Therapeutics, a move that brings two innovative gene editing platforms to the pharma giant’s fold. Read More
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. Read More
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 final guidance on how the physical attributes of generics may affect patients’ compliance with their drug regimens. Read More
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. Read More
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 ibuprofen. Read More
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 Inspector General (OIG) said in a new report released Friday, adding that the drugs have been “staying on the market — and being administered to patients — for years without the predicted clinical benefit being verified.” Read More
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 and reauthorizing the FDA’s user fee agreements. Read More