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A Delaware court ruled Wednesday that Takeda Pharmaceutical is liable for damages to AbbVie for failing to supply its hormone therapy Lupron Depot (leuprolide acetate for depot suspension) according to the contract. Read More
The Health Resources and Services Administration (HRSA) has sent letters to six pharmaceutical companies — AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics — letting them know their failure to comply with the 340B drug discount program has been referred to the Office of Inspector General at HHS. And several of the companies are pushing back. Read More
A federal court has ruled that the FDA must do more work on its regulation of compounding pharmacies before it can enforce a final standard issued last year. Read More
The White House Office of Management and Budget (OMB) has instructed all federal agencies, including the FDA, to prepare contingency plans in case government funding expires on Sept. 30. Read More
One of the most important obligations for researchers seeking UK clinical trial approval is to determine from the start how they will disseminate their study results publicly. Read More
A short-term funding measure to keep federal agencies, including the FDA, running at the start of the next fiscal year, which begins Oct 1, faces an uphill battle in the Senate. Read More
The FDA yesterday authorized booster shots of the Pfizer-BioNTech COVID-19 vaccine for people over 65 who have been vaccinated at least six months earlier with the two-dose shot. Read More
Incyte has received the FDA’s approval for its Opzelura (ruxolitinib) cream for treatment of mild-to-moderate atopic dermatitis, making it the first topical JAK inhibitor to receive the agency’s blessing. Read More
In the wake of the FDA’s controversial Aduhelm approval, public and private groups are calling on the agency to amend its accelerated approval pathway, including forcing companies to complete the required confirmatory studies in a timely manner and getting rid of drugs that fail the postmarket test. Read More