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.

Covagen AG, of Zurich, Switzerland, said it secured CHF42 million (US$47.1 million) in a tranched Series B financing with an option to obtain an additional CHF14 million to increase the round to CHF56 million.

Coronado Biosciences Inc., of Burlington, Mass., submitted an investigational new drug application to the FDA to start a Phase II trial with Trichuris suis ova, or eggs of the porcine whipworm, for the treatment of moderate to severe chronic plaque psoriasis.

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...

Scientists from Emory University have shown that the yellow fever vaccine, one of the most successful vaccines of all time that has been used by more than half a billion people, works partly by stimulating a nutrient sensor that activates autophagy. The authors used a systems biology approach to look at changes in gene expression following vaccine administration.

Genmab A/S, of Copenhagen, said it reached a new milestone in its Duobody technology collaboration with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, triggering a $4 million milestone.

Moberg Pharma AB, of Stockholm, signed a deal to acquire three over-the-counter brands in the U.S. from Bayer Healthcare LLC, of Deerfield, Ill.

Shire plc, of London, reported top-line Phase III results with its lifitegrast dry-eye treatment.

Sangamo Biosciences Inc., of Richmond, Calif., presented data from all dose cohorts in ongoing clinical trials (SB-728-1101 and SB-728-902 Cohort 5) of SB-728-T, which is being developed for the functional control of HIV/AIDS.