After months of speculation about Gilead Sciences Inc.'s need to accelerate its business development activities to augment its antiviral products portfolio, it finally pulled the trigger on a major acquisition last week. The proposed $11.9 billion acquisition of Kite Pharma Inc., a leader in chimeric antigen receptor (CAR) and engineered T-cell receptor development (TCR), will vault the company into the white-hot immuno-oncology (I-O) space.

Just weeks ahead of the planned resubmission of the FDA new drug application for a pain pill tailored to reduce opioid-induced nausea and vomiting (OINV), one-time backer Daiichi Sankyo Co. Ltd. is handing rights to the drug back to Charleston Laboratories Inc. and booking a ¥27.8 billion (US$252.7 million) loss on the project as it reevaluates its U.S. pain drug strategy.

BioWorld's offices will be closed Monday, Sept. 4, in observance of the Labor Day holiday in the U.S.

The U.S. Court of Appeals for the Federal Circuit agreed Thursday to reconsider, en banc, whether patent applicants that appeal a Patent and Trademark Office (PTO) decision to the federal courts have to pay all of the PTO’s legal costs, win or lose.

Dimension Therapeutics Inc., the Cambridge, Mass.-based company that Regenxbio Inc., of Rockville, Md., moved to acquire on Monday, said it has started dosing participants in the company’s global, multicenter phase I/II study of DTX-301, one of its two lead candidates, for the treatment of patients with ornithine transcarbamylase (OTC) deficiency.

Steadymed Ltd., of San Ramon, Calif., said it received a refuse-to-file letter from the FDA relating to the NDA for its pulmonary arterial hypertension treatment Trevyent (treprostinil). The FDA requested more information on certain device specifications and performance testing for the Patchpump infusion system used in Trevyent. The FDA also wants additional design verification and validation testing on the final, to-be-marketed Trevyent product. Steadymed plans to request a type A meeting with the FDA in the next 30 days to further clarify what information the FDA needs to resubmit its NDA.

Vistagen Therapeutics Inc., of South San Francisco, priced an underwritten public offering of about 1.3 million shares of its common stock and warrants to purchase up to about 1.9 shares of common stock at an offering price of $1.75 per share and related warrants.

PERTH, Australia – Australian biotech company Clinical Genomics Pty Ltd., based in Sydney, will be able to dramatically expand the U.S. footprint of its liquid biopsy diagnostic to detect recurrent colon cancer following a new pact with the Netherlands-based Qiagen NV for its Paxgene blood collection system.