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AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ. Read More
Boehringer Ingelheim is aiming to broaden its research into diabetes and other cardiometabolic diseases via a partnership with Circuit Therapeutics to develop novel drugs to treat obesity. Read More
Eli Lilly Thursday scored its second court victory in less than a week and third overall in lawsuits against its blockbuster antidepressant Cymbalta. Read More
India’s prime minister has approved a $270 million plan to strengthen the country’s drug regulatory system, including establishing new drug testing laboratories and a training academy for regulatory and drug testing officials. Read More
The FDA has extended until Nov. 27 its deadline for deciding whether to approve Bristol-Myers Squibb’s sBLA for Opdivo in previously untreated advanced melanoma to allow the company to present additional data from a Phase 3 clinical trial. Read More
AbbVie said it will seek FDA approval later this year for its investigational leukemia treatment venetoclax, after the drug met its primary goal in a Phase 2 trial. Read More
A Houston, Texas, API and finished drugmaker received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year: 18 sites were cited for QMS issues and 13 for problems with AE reporting. Read More
Drugmakers are seeking clarification on the use of in vitro studies to assess the effects of active pharmaceutical ingredients taken by men on their potential offspring. Read More
GlaxoSmithKline has temporarily closed its Zebulon, N.C., facility after routine testing found the bacteria that causes deadly Legionnaire’s disease inside two of the building’s external cooling towers. Read More