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.
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.
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.
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.
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.
Given the differences in disease patterns and medical practices in a country as large and diverse as India, pharmacovigilance can be quite a challenge.
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.”
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.
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.
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