As Celgene Corp. made ready to unveil second-quarter earnings Thursday, onlookers were disappointed but not hugely surprised by the firm's disclosure that it would not seek approval in diffuse large B-cell lymphoma (DLBCL) with Revlimid (lenalidomide), due to a miss on the key secondary endpoint of overall survival (OS) in interim results from a phase III trial called REMARC.
Justifying the $1.53 billion price tag for Relypsa Inc., Galenica Group executive chairman Etienne Jornod compared the plan to moves made by his firm in 2008 and 2010, saying "very few people understood the strategic reach of these two deals [then], but I am convinced that this time it will be different."
Saying "the time is right to bring all the various pieces together," Fulcrum Therapeutics Inc. CEO Robert Gould told BioWorld Today that his firm, funded by a $55 million series A round from Third Rock Ventures LLC, will combine recent findings in the biology of gene regulation to develop small-molecule therapies.
The FDA switcheroo that's holding up Elite Pharmaceuticals Inc.'s Sequestox (oxycodone hydrochloride and naltrexone hydrochloride), the firm's abuse-deterrent opioid for pain "should not take that long" to resolve, CEO Nasrat Hakim said during a conference call intended to explain "why the FDA made that decision and how we're going to overcome it and get [the drug] approved."
Five Prime Therapeutics Inc.'s respiratory diseases pact with Glaxosmithkline plc (GSK) bore fruit, putting $1.5 million in the pocket of the former by way of a license option fee, with the promise of more if the protein on the table hits milestones.
A simplified way of making BRCA mutation testing available for women with ovarian cancer (OC) – a handier procedure that makes results available quicker, pioneered by researchers at the Institute of Cancer Research in London – comes just as competition heats up among drug developers.
Bellicum Pharmaceuticals Inc. CEO Thomas Farrell told BioWorld Today that the snag, albeit short-term, met by Juno Therapeutics Inc. jolted some out of "perhaps a good deal of denial about safety as an issue" in chimeric antigen receptor (CAR) T-cell therapy.
Calling Sage Therapeutics Inc.'s drug candidate for postpartum depression (PPD) "completely unlike anything we see in psychiatry currently," principal investigator Samantha Meltzer-Brody told BioWorld Today that the resoundingly successful phase II trial with SAGE-547 showed safety and efficacy that researchers need to investigate further but offers great hope for patients. "Obviously, this study has to lead to the next study," she said. "All of these are stepwise increments."
Daniel Levitt, Cytrx Corp.'s chief medical officer, told BioWorld Today that a two-month clinical hold placed on the trial in late 2014 apparently skewed the much-awaited data from Cytrx's phase III experiment comparing aldoxorubicin to investigator's-choice therapy in patients with relapsed or refractory soft tissue sarcomas (STS), and the results available so far show a miss on the primary endpoint of progression-free survival (PFS).
