Abstracts from the 2016 annual meeting of the American Academy of Neurology (AAN) drew swift reaction from analysts, who zeroed in on prospects for success in Bluebird Bio Inc.’s ongoing phase II STARBEAM trial of Lenti-D in childhood cerebral adrenoleukodystrophy (CCALD), an ultra-rare and ultimately fatal disorder.
Syndax Pharmaceuticals Inc. managed to squeak through the IPO window but not before slashing its price to $12, below its proposed range of $14 to $16, to collect $52.8 million – well below its initial target raise of approximately $81 million.
Exelixis Inc. selected Ipsen SA as its traveling partner outside the U.S., Canada and Japan in an exclusive licensing deal to commercialize and develop lead oncology drug cabozantinib (cabo) in all indications.
Tremelimumab flopped, again, as monotherapy, this time with Astrazeneca plc. The drug failed to demonstrate effectiveness in overall survival (OS) compared to placebo in a randomized, double-blind phase IIb study in second- or third-line treatment of patients with unresectable pleural or peritoneal malignant mesothelioma.
Peregrine Pharmaceuticals Inc. turned out the lights on its lead candidate, bavituximab (bavi), in the lead program in non-small-cell lung cancer (NSCLC). The company said it is halting the phase III SUNRISE trial evaluating bavi plus docetaxel in patients with previously treated locally advanced or metastatic nonsquamous NSCLC compared to docetaxel alone after the study's independent data monitoring committee concluded the bavi group showed insufficient improvement in overall survival (OS) to warrant continuation of SUNRISE.
ATLANTA – Speakers at the second day of the Accelerating Osteoarthritis (OA) Clinical Trials Workshop co-sponsored by the Arthritis Foundation and the FDA pointed to a wealth of trials examining drug, surgical and other interventions to treat the disease, citing more than 500 studies in the U.S. and five dozen in Europe under the sponsorship of dozens of biopharmas and academic institutions.
ATLANTA – "It takes a village" to develop biomarkers in osteoarthritis (OA), Chris Leptak, medical officer in the FDA Office of New Drugs, Guidance and Policy Team told participants at the Accelerating Osteoarthritis Clinical Trials Workshop co-sponsored by the Arthritis Foundation and the FDA.
Oncbiomune Pharmaceuticals Inc. is pressing ahead with a phase II trial of Proscavax, its therapeutic vaccine to treat prostate cancer, after preliminary data from a small phase I trial showed the treatment was safe and suggested initial indications of efficacy.