LONDON – The UK has become the first country in the world to approve the use of mitochondria donation to prevent inherited mitochondrial diseases, with members of parliament (MPs) voting by 382 to 128 in favor in a free vote on Tuesday. Read More
Sales of Gilead Sciences Inc.'s top hepatitis C virus (HCV) drugs continued to boom in the fourth quarter amid new competition, totaling about $3.8 billion, and helping lead the company to a profit more than four times higher than the same quarter last year. Read More
Onconova Therapeutics Inc. delivered two pieces of information to the Street after Monday's market close, and neither sat particularly well with investors. The Newtown, Pa.-based biotech said it firmed up plans to conduct a phase III trial with the intravenous (I.V.) formulation of rigosertib in patients with higher-risk myelodysplastic syndrome (HR-MDS) who failed treatment with hypomethylating agents (HMAs). Read More
HONG KONG – Novartis AG faces a new series of challenges in Japan that stem from a failure to notify authorities of serious side effects associated with two dozen of its drugs. Read More
Chemically separating the antifungal efficacy of the amphotericin B scaffold from the mechanism that can lead to kidney damage – thus creating more potency without harm – is among the first projects of Revolution Medicines Inc., expected to disclose its $45 million round of series A financing Wednesday. Read More
SHANGHAI – The all-important CFDA looks set to welcome a new commissioner into the fold. Bi Jingquan comes to the top spot with a long resume of government service, the bulk of which was spent at China's economic planning agency, the National Development Reform Commission (NDRC), where he specialized in pricing. Read More
As widely expected, Pfizer Inc.'s cyclin-dependent kinase inhibitor palbociclib won a much-anticipated accelerated approval, with an FDA nod for use in advanced or metastatic breast cancer coming late Tuesday afternoon. Read More
DUBLIN – Quantum Genomics SA is seeking about €9.1 million (US$10 million) in a discounted share issue on the Alternext market in Paris to fund development of a first-in-class hypertension drug called QGC001. Read More
Ascendis Pharma A/S, of Copenhagen, closed its initial public offering of 6.9 million American depositary shares (ADSs) at a price of $18 each, which includes the exercise in full by the underwriters of their option to purchase additional ADSs. Read More
Celtaxsys Inc., of Atlanta, said the FDA granted orphan drug designation to its once-daily, oral leukotriene A4 hydrolase inhibitor (CTX-4430) for the treatment of cystic fibrosis (CF). Read More
CTI Biopharma Corp., of Seattle, said it was informed that the independent data monitoring committee recommended continuation of the GOG-0212 phase III study of Opaxio (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a second of four planned interim analyses for survival and futility. CTI remains blinded to the interim analysis results. Read More
Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review for the new drug application for Yondelis (trabectedin) to treat patients with advanced soft-tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy, including an anthracycline. Read More
Pierre Fabre Pharmaceuticals, of Castres, France, said it started a phase IIa program for F17464, a selective dopamine D3 receptor antagonist, in schizophrenia. Read More
