Tetraphase Pharmaceuticals Inc. is closer to filing for FDA and EMA approval of eravacycline – the drug could become only the second tetracycline antibiotic cleared in more than 30 years – after reporting positive top-line data from the phase III IGNITE 1 study in complicated intra-abdominal infections (cIAIs) testing eravacycline against ertapenem.
Adding to its roster of big pharma partners, Halozyme Therapeutics Inc. inked a deal with Johnson & Johnson unit Janssen Biotech Inc. for use of its Enhanze technology, even as the San Diego firm looks at growing royalties from earlier partnered programs and advancing a promising internal program in cancer.
A little more than a year after completing the sale of his company to Amgen Inc. in a $10.4 billion deal, the former CEO of Onyx Pharmaceuticals Inc., Tony Coles, is back in the biotech game, this time heading start-up Yumanity Therapeutics, which is aimed at neurodegenerative diseases and already boasts a potential new target for Parkinson's disease.
Ending the year in a much better position than it started, Chemocentryx Inc. reported positive data from its 52-week phase II study of CCR2 inhibitor CCX140 in diabetic nephropathy (DN), positioning the drug for phase III development and, hopefully, a partnership.
Acorda wasted no time getting down to business following its buyout of Civitas Therapeutics Inc. in October, enrolling the first patient in the pivotal study of CVT-301, an inhaled version of levodopa designed specifically to reduce motor fluctuation – i.e., “off” episodes – in Parkinson’s disease patients.
Though it still has aims of securing a partner for phase III-ready diabetes drug sotagliflozin, Lexicon Pharmaceuticals Inc. is bolstering its balance sheet with a $50 million public offering and a concurrent $80 million convertible note offering ahead of a planned pivotal program set to start next year.
Taking advantage of a flurry of promising data for its lead immune disease candidate, RPC1063, including a late-October stock surge on positive ulcerative colitis data, Receptos Inc. priced a whopping $360 million public offering.
Poised to move its first two compounds for genomically defined cancers into the clinic next year, while teasing out further opportunities from its kinase-specific discovery platform, Blueprint Medicines Corp. drew further investor interest to the tune of $50 million.
Amid the rising rate of multidrug-resistant infections, The Medicines Co. launched a pivotal program testing Carbavance, a combination anti-infective, against carbapenem-resistant Enterobacteriaceae (CRE), which the Centers for Disease Control and Prevention has called one of the most deadly gram-negative pathogens.
Cara Therapeutics Inc.'s opioid candidate CR845 passed with flying colors a critical test, demonstrating significantly lower abuse potential compared to a comparator schedule IV narcotic, results that could give it an edge in the multibillion-dollar analgesic market as the first opioid with a schedule V – perhaps even nonscheduled – labeling.