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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
HONG KONG – Tensions have been building in India’s pharmaceutical sector as it tries to resolve a tricky dilemma. Stronger intellectual property (IP) protection is needed to sustain the country’s rapid economic growth, but that may come at the expense of affordable health care. Read More
With Insmed Inc.’s phase III Convert trial expected to read out any day, onlookers are busying themselves with guesswork about success for amikacin liposome inhalation suspension, formerly called Arikayce but now known by the acronym ALIS, in non-tuberculous mycobacterium (NTM) infection. Read More
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. Read More
