Recognizing that the future is now, drug and device companies are joining with health care providers and software/IT manufacturers in clamoring for a new kind of FDA guidance to clarify the regulatory path for treatment systems that combine digital health products with drugs. Read More
Nearly six months after downsizing, in part to focus on gaining regulatory approvals for its anaplastic lymphoma kinase (ALK) inhibitor brigatinib, Ariad Pharmaceuticals Inc. has completed a rolling submission of a new drug application for the candidate. Read More
NEW DELHI – Indian drug manufacturing plants were under the scanner again in August, with the U.S. FDA issuing warning letters to Pfizer Inc. and Frontida Biopharm Inc. for regulatory lapses observed during inspections in plants operating in India. Read More
As investors look ahead to results later this year from the second phase III trial with Rigel Pharmaceuticals Inc.'s fostamatinib, principal investigator James Bussel said "the fact that, at least so far, the results in this [first] phase III trial mimic and are very similar to the first phase II trial gives all of us on the Rigel team a lot of confidence." Read More
While Sarepta Therapeutics Inc. waits for the FDA's decision on its DMD candidate, eteplirsen, Marathon Pharmaceuticals LLC is quickening its pace in the race to approval in the field. Read More
Last year, Synageva Biopharma Corp. went to Alexion Pharmaceuticals Inc. in one of the year's biggest buyouts – an $8.4 billion cash and stock deal notable for its whopping 140 percent premium. With the ink barely dry on that deal, the former execs of the rare disease firm decided they were ready for another round, regrouping to create new startup Kiniksa Pharmaceuticals. Read More
Bioasis Technologies Inc., of Vancouver, British Columbia, said the results of an in vivo study of the treatment of metastatic HER2+ breast cancer brain tumors in an animal model using BT2111, their trastuzumab-melanotransferrin (Transcend) conjugate, have been published in Pharmaceutical Research. Read More
Daiichi Sankyo Co. Ltd., of Tokyo, reported results from the global phase IIIb ENSURE-AF study of 2,199 patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion, or low-energy shocks to trigger normal heart rhythm). Read More
