Adynxx Inc., of San Francisco, announced the completion of enrollment in a phase II study of its lead candidate, brivoligide, for reducing acute pain and preventing chronic pain following surgery. Read More
Novoclem Therapeutics Inc., of Durham, N.C., reported data from an in vitro study with BIOC-51, a nitric oxide-releasing biopolymer in development for Pseudomonas aeruginosa infections in cystic fibrosis patients. Read More
Inspyr Therapeutics Inc., of Westlake Village, Calif., said it initiated a new investigator-sponsored preclinical study of its compounds generated through its adenosine receptor modulator technology platform. Read More
Umecrine Cognition AB, of Stockholm, closed a financing round of SEK20 million (US$2.5 million) to fund a phase IIa study of its drug candidate, GR-3027, in idiopathic hypersomnia. Read More
Taking advantage of his opportunity to testify before a House subcommittee Tuesday, FDA Commissioner Scott Gottlieb devoted a few minutes of his time to provide an update on FDA activities in hurricane-ravaged Puerto Rico. Read More
Given the differences in disease patterns and medical practices in a country as large and diverse as India, pharmacovigilance can be quite a challenge. Read More
In a move that caught many by surprise, the FDA late Tuesday approved Mylan NV’s generic version of Copaxone (glatiramer acetate injection), both the 40-mg and 20-mg formulations, sending shares of Mylan (NASDAQ:MYL) up 16 percent. The Hertfordshire, U.K.-based firm said it planned to begin shipping its AP-rated – i.e. substitutable – versions of the relapsing multiple sclerosis drug “imminently.” Read More
DUBLIN – Immatics AG raised $58 million in a series E round that brought in Amgen Inc. as a new investor. The financing, among the top three private equity rounds closed this year by a European biotech, is confirmation that the Tuebingen, Germany-based company remains at the front rank of Europe’s immuno-oncology firms. Read More
T-cell checkpoint inhibitors, such as drugs targeting PD-1/PD-L1 and CTLA-4, have been successful at helping the immune system attack certain tumors, but the drugs fail to spur a response in many tumor types. Palleon Pharmaceuticals Inc. is taking a different approach, developing drugs to inhibit glycoimmune checkpoints that allow tumors to evade the innate immune system – dendritic cells, macrophages and NK cells – as well as T cells. Read More
As Catabasis Pharmaceuticals Inc. geared up for an FDA-blessed phase III trial, Wall Street already went to work handicapping the chances for later-stage success with the oral Duchenne muscular dystrophy (DMD) therapy edasalonexent. Read More
LONDON – Motif Bio plc reported positive results from the second phase III trial of iclaprim, in which the antibiotic again demonstrated noninferiority to vancomycin, and said it will file a new drug application to the FDA in the first quarter of 2018. Read More
The FDA process for determining whether a combination product will be regulated as a drug or a device has never failed to provoke comment, and the agency’s final guidance seems to sustain that trend with the inference that a regulated product is a drug until proven otherwise, because conceptually “all FDA-regulated medical products meet the definition of a drug.” Read More
