Novartis AG is buying from Takeda Pharmaceutical Co. Ltd. the dry eye therapy Xiidra (lifitegrast ophthalmic solution) for a $3.4 billion up-front payment, with up to $1.9 billion more if milestones are met, and the Basel, Switzerland-based firm is bringing aboard about 400 employees – mostly based in the U.S. and Canada – associated with the drug, which was approved by the FDA in the summer of 2016.
Atara Biotherapeutics Inc.'s backers proved less than happy with the phase III delay for the T-cell immunotherapy tab-cel (tabelecleucel), but the company remained upbeat about prospects with the compound in patients with Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disease (PTLD, or lymphomas that develop after a transplant).
Goldfinch Bio Inc. CEO Anthony Johnson told BioWorld that his company's deal with Gilead Sciences Inc. represents "a phenomenal opportunity, because this [kidney disease patient registry] will be the biggest of its type, definitely for the kidney but arguably across other disease areas as well."
What could become the first nonsurgical therapy for ptosis, or droopy eyelid, inched closer to an NDA submission with upbeat top-line phase III efficacy results from Study 202, Osmotica Pharmaceuticals plc's test of RVL (oxymetazoline hydrochloride ophthalmic solution 0.1%), supplemented by new long-term phase III safety data, known as Study 203.
Almost nine years after its complete response letter (CRL) from the FDA for tafamidis, Pfizer Inc.'s approval of two forms of the drug well ahead of their PDUFA dates to treat wild-type or hereditary transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM) left investors in Pfizer and other firms speculating about what the win might mean.
Synthorx Inc. has rolled out intriguing data over the past couple of months and more is due ahead at the American Society of Clinical Oncology (ASCO) meeting in early June, when the San Diego-based firm unveils how synthetic biology can be used to reprogram the therapeutic activity of interleukin-2 (IL-2).
Exocrine pancreatic insufficiency (EPI) is one of the potential dreaded accompaniments of cystic fibrosis (CF) that patients must deal with, a condition that means downing as many as 40 pills per day if they take porcine-derived pancreatic enzymes (PPEs), the standard of care.
Saying he was "extraordinarily disappointed" by the complete response letter (CRL) from the FDA regarding HTX-011, Heron Therapeutics Inc. CEO Barry Quart called it "very discouraging" that the agency's objections could have been raised earlier during talks but were not.
Vividion Therapeutics Inc. CEO Diego Miralles told BioWorld that $82 million in new series B money will propel research to "clinical proof of concept in at least one of the three lead programs, if not more" as the company – just over a year after sealing a pact worth $101 million up front that brought Celgene Corp. aboard as a collaborator – pulled off an oversubscribed round with its partner on board.
