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259409 items
7:44 AM, Oct 17, 2018  |  BC Extra | Company News

Priority Review for Imbruvica-Gazyva combo to treat CLL, SLL

AbbVie Inc. (NYSE:ABBV) said FDA accepted and granted Priority Review to an sNDA for Imbruvica ibrutinib plus Gazyva obinutuzumab to treat chronic lymphocytic leukemia or small lymphocytic leukemia in the first-line setting. AbbVie said the...
4:44 PM, Oct 16, 2018  |  BC Extra | Company News

Changsheng fined $1.3B after vaccine scandal

China's National Medical Products Administration (NMPA) fined Changsheng Bio-Technology Co. Ltd. (SZSE:002680) RMB7.2 billion ($1 billion) for eight counts of manufacturing violations, falsification of records and destruction of evidence associated with the illegal production of...
4:13 PM, Oct 16, 2018  |  BC Extra | Politics & Policy

FDA mandates pediatric trials for 200 cancer targets

In a move to spur development of drugs for pediatric populations and require more studies of pediatric cancers, FDA published Tuesday a list of 200 molecular targets for which companies developing directed compounds must conduct...
3:50 PM, Oct 16, 2018  |  BC Extra | Company News

After two deals, FDA approval talazoparib joins PARP party

FDA approved Talzenna talazoparib from Pfizer Inc. (NYSE:PFE) to treat germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, making it the second PARP inhibitor approved for the indication. The approval comes well ahead of...
3:17 PM, Oct 16, 2018  |  BC Extra | Company News

Revolution acquiring fellow Third Rock company Warp Drive

Revolution Medicines Inc. (Redwood City, Calif.) is expanding its cancer pipeline with the acquisition of another Third Rock Ventures portfolio company, Warp Drive Bio Inc. (Cambridge, Mass.). The financial terms of the deal are undisclosed beyond...
2:43 PM, Oct 16, 2018  |  BC Extra | Company News

J&J stalls development of antiviral from Alios deal

Johnson & Johnson (NYSE:JNJ) has stalled development of lumicitabine (AL-8176), an antiviral candidate that was a key to its $1.75 billion acquisition of Alios BioPharma Inc. in 2014, and revealed a resulting impairment charge of...
1:55 PM, Oct 16, 2018  |  BC Extra | Financial News

Taiho Ventures ups investments to $300M, to focus on oncology

Taiho Ventures LLC increased its investment pool to $300 million from $50 million. Taiho Ventures said it will focus the additional funds on oncology startups with drug discovery capabilities or unique platform technologies. Taiho Pharmaceutical Co....
10:31 PM, Oct 15, 2018  |  BC Extra | Clinical News

Pharnext planning U.S., EU submissions for Charcot-Marie-Tooth therapy on Phase III data

Pharnext S.A. (Euronext:ALPHA) plans to submit regulatory applications to FDA and EMA in 2H19 for PXT3003 to treat mild to moderate Charcot-Marie-Tooth 1A (CMT1A) disease after a high dose of the compound met the primary...
4:48 PM, Oct 15, 2018  |  BC Extra | Company News

Management tracks: Rhythm, Redpin

Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) hired Murray Stewart as CMO of the metabolic disorder company. Stewart was CMO of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) until 2017 when he became head of R&D at Novelion Therapeutics Inc. (NASDAQ:NVLN)....
4:20 PM, Oct 15, 2018  |  BC Extra | Politics & Policy

ICER weighing issuing advice on trial design

The Institute for Clinical and Economic Review is evaluating whether to collaborate earlier than it now does with drug companies by offering advice on clinical trial designs. ICER spokesperson David Whitrap said the institute is considering...