|Healthcare Review: Novartis, Pfizer, Halozyme, AbbVie, Catalyst Pharmaceutical|
|By Staff and Wire Reports|
|Tuesday, 25 March 2014 13:57|
FDA staff have recommended that the agency not approve Novartis' ($NVS) Serelaxin heart treatment. In a briefing document for an advisory committee that's due to meet on Thursday to discuss the therapy, the FDA says "there is insufficient evidence to support the proposed indication: to 'improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.'"
Pfizer's ($PFE) Xalkori (Crizotinib) treatment met the main goal of a Phase III trial of untreated patients with a certain form of lung cancer by "significantly prolonging progression-free survival (PFS)" when compared with standard chemotherapy. The study, called Profile 1014, is the second positive global Phase III test that evaluated Xalkori against chemotherapy. Xalkori has already been authorized to treat previously treated patients.
Halozyme's ($HALO) HTI-501 significantly improved the appearance of cellulite on patients' skin in a Phase I/II trial, thereby meeting the main goal of the study. Halozyme's effect was compared with a control vehicle and with the skin prior to treatment. The effect was maintained at three and six months.
Cannabis taken in pill or oral spray form may help reduce stiffness and involuntary spasms, pain from these symptoms and frequent urination according to a recent study. The findings form the basis for new alternative therapy guidelines for MS from the American Academy of Neurology. No studies have been done to determine if smoking pot delivers the same benefits. Chicago-based AbbVie ($ABBV) sells a synthetic cannabinoid in pill form called Marinol for chemo-associated nausea. GW Pharma ($GWPH) sells a spray called Sativex ex-US.
The independent Data Monitoring Committee ($DMC) supervising the Phase III trial of Catalyst Pharmaceutical's ($CPRX) Firdapse therapy for Lambert-Eaton Myasthenic Syndrome (LEMS) has recommended that the study continue. The DMC based its decision on a review of safety and clinical data from the trial.