The tone of the briefing document posted by the FDA for Wednesday’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting suggested sponsor Amylin Pharmaceutics LLC, a wholly owned subsidiary of Bristol-Myers Squibb Co. (BMS), may have a skeptical panel on its hands reviewing the biologics license application (BLA) for metreleptin (recombinant methionyl human leptin) in metabolic disorders associated with lipodystrophy.
Who needs Black Friday and Cyber Monday, anyway? True biotech aficionados know they can find the perfect gift for everyone on their holiday list in BioWorld’s 7th Annual Biotech Holiday Gift Guide. Shoppers, start your engines. Personal Health Last year, biotech holiday lists – including ours – featured genomic testing. Thanks to the FDA, the popular 23andMe genotyping service has suspended health-related genetic tests. However, BioWorld Managing Editor Jennifer Boggs pointed out that you can still get your microbiome sequenced at ubiome, learning what bacteria reside in your body, comparing your microbiome to those of other individuals and visualizing yourself...
Receptos Inc. moved one step closer to its goal of setting a safer standard in oral therapy for multiple sclerosis (MS), reporting positive data from a planned interim analysis of the Phase II portion of RADIANCE, the company’s Phase II/III trial of RPC1063 in relapsing MS. (See BioWorld Insight, Nov. 4, 2013.)
In perhaps the biggest U.S. biotech launch ever, Seattle’s Fred Hutchinson Cancer Research Center (Fred Hutch), New York’s Memorial Sloan-Kettering Cancer Center (MSKCC) and Seattle Children’s Research Institute joined forces to establish Juno Therapeutics Inc. Arch Venture Partners and the Alaska Permanent Fund led the initial round – a whopping $120 million – through a partnership managed by Crestline Investors.
Ignyta Inc. capped its recent reverse merger with two private placements totaling $54 million, surpassing the company’s original target raise of $35 million.
Cardiome Pharma Corp. and privately held specialty pharma Correvio LLC consummated a marriage of convenience that may create a company stronger than the sum of the two partners.
Chanrx Corp. moved a step closer to the goal line for lead candidate vanoxerine (GBR-12909), reporting Phase IIb data at the American Heart Association (AHA) 2013 Scientific Sessions suggesting the drug’s efficacy approached that of direct current (DC) cardioversion for patients with atrial fibrillation.
After reducing its initial public offering (IPO) from a range of $16 to $19 down to $12, Relypsa Inc. dropped the price again, to $11 , before the company’s shares began trading Friday on Nasdaq under the ticker “RLYP.” But that move seemed to sit well with investors, with the stock opening at $12.47.
Lightstone Ventures led a $32.4 million Series B round for Catabasis Pharmaceuticals Inc., designed to complete a Phase II study of lead compound CAT-2003, currently under way in hypertriglyceridemia and in combination with statins in hypercholesterolemia.
The FDA gave drug developers a shot of good news Wednesday afternoon with the approval of Imbruvica (ibrutinib), the oral Bruton’s tyrosine kinase (BTK) inhibitor developed by Pharmacyclics Inc. and Johnson & Johnson unit Janssen Biotech Inc., as a single agent to treat patients with mantle cell lymphoma (MCL) who received at least one prior therapy.
