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Bristol-Myers Squibb cut short a Phase 3 study of Opdivo for the treatment of renal cell carcinoma after the immunotherapy drug met its primary endpoint versus everolimus, the current standard treatment. Read More
Beleaguered Indian generics maker Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers. Read More
A California appeals court has reinstated a $6.5 million jury award against Takeda in a case involving its diabetes drug Actos, which announced in April that it would pay up to $2.4 billion to settle the majority of U.S. lawsuits involving the therapy. Read More
The FDA is calling for increased focus on the underlying biology of diseases like Alzheimer’s and diabetes, noting that the discovery of biomarkers has led to important breakthroughs for cancer and HIV/AIDS. Read More
In a document released Friday, the Senate Appropriations Committee calls for fiscal year 2016 user fee amounts totaling nearly $1.2 billion for drugs and biologics — figures that are in line with those proposed by its counterpart in the House. Read More
Paris-based AB Science, a developer of tyrosine kinase inhibitors, received an FDA warning letter for failing to report adverse events promptly and lapses in clinical trial monitoring. Read More
A Montana compounder was hit with a 17-observation Form 483 due to issues with its sterile processing, contamination controls and other GMPs. Read More
Amgen is reporting a “clinically meaningful number” of patients showed complete remission in a Phase 2 study of its pricey drug to treat a rare strain of leukemia. Read More
In a bipartisan 28-2 vote, the Senate Appropriations Committee Thursday approved the fiscal year 2016 appropriations bill to fund the FDA, but at levels far below what President Barack Obama had requested. Read More