BioMérieux's BioFire Diagnostics got an FDA OK for its rapid meningitis and encephalitis test, a feather in the company's cap as it diversifies its portfolio and ramps up business in an increasingly competitive market.
Hong Kong-listed Luye Pharma's New Drug Application to the U.S. FDA for candidate LY03004 (risperidone), aimed at treating schizophrenia and bipolar disorders, is under way without the agency requesting further clinical trials, Barron's reported, sending shares higher on Friday.
An extramarital affair has cost GVK Biosciences millions of dollars in lost opportunity and brought unwanted scrutiny of its testing procedures and a ban on the marketing of about 700 generic drugs tested at a facility where the affair began, according to a report in The Hindu newspaper.
Eli Lilly's would-be rival to Pfizer's Ibrance (palbociclib) just gained an inside track at the FDA. Regulators handed Lilly the coveted "breakthrough therapy" designation for abemaciclib, another CDK 4/6 inhibitor with big plans for carving out a niche among patients with advanced breast cancer.
The ink's not even dry yet on the Trans-Pacific Partnership announced this past Monday in Atlanta (and the specific details on many sections remain undisclosed), but the fight to get the 12-nation pact approved by the countries' respective legislatures and parliaments is already heating up.
Dilip Shah, secretary-general of the Indian Pharmaceutical Alliance, said this week's decision by the Delhi High Court against homegrown Glenmark Pharmaceuticals showed "due process was followed" and that Indian companies could not count on Indian courts for special treatment, according to a report in the Wall Street Journal.
U.S.-based biotech Myriad Genetics lost a closely watched court appeal case in Australia over a patent for a BRCA1 and BRCA2 cancer gene diagnostic that was brought by a grandmother who survived cancer twice.
Singapore-based TauRx Pharmaceuticals has pulled in $135 million in a fundraising program launched in March, setting the stage for ongoing Phase III trials for a unique Alzheimer's candidate focused on inhibiting the aggregation of tau tangles in the brain.
A nonprofit plans to address drug shortages in the U.S. by making its own products under a model that seeks to break a chain of manufacturing quality and price concerns that also have the sharp attention of regulators and policymakers.
The FDA has signed off on Israeli devicemaker InSightec's ultrasound technology to treat women with uterine fibroids who want to conceive, a win for the company as it pushes for new indications of its product and reels in funding to spur R&D.