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.

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.

Many Nobel Prizes are awarded for conceptual advances that lead to new ways of looking at the world in a figurative sense.

Erythropoietin (EPO)-producing cells derived from human induced pluripotent stem (iPS) cells have been shown for the first time to be capable of successfully treating renal anemia in mice, Japanese researchers reported in the Sept. 27, 2017, edition of Science Translational Medicine.

Potentially a solution seeking a problem, two right-to-try bills considered by a House subcommittee Tuesday could result in more of the unintended consequences that are often a byproduct of U.S. congressional action.

It was a rough couple of weeks for Intercept Pharmaceuticals Inc.

Biocardia Inc. said an independent data safety monitoring board has found there are no safety concerns for the first 10 patients treated in the phase III Cardiamp cell therapy trial. The San Carlos, Calif.-based company’s ongoing multicenter, double-blind, randomized, sham-controlled trial is expected to enroll 260 patients at up to 40 centers across the U.S. and will continue as planned.