The U.S. Food and Drug Administration on July 6 declined to approve Provention Bio Inc.’s experimental diabetes drug, citing insufficient data, sending the company’s shares down about 28 percent
The U.S. drug regulator on June 29 declined to approve MediWound Ltd.’s topical burn treatment NexoBrid, sending the company’s shares tumbling in trading.
In a flurry of activity, multiple biopharma companies made their first appearance on the Nasdaq Stock Exchange on June 25, raising hundreds of millions of dollars to advance the development of next-generation therapeutics and scale their businesses.
Eli Lilly will apply for U.S. health regulator’s accelerated approval during 2021 for the company’s experimental Alzheimer’s drug, weeks after Biogen Inc.’s controversial drug for the disease was approved.
Calling herself a “change agent,” GlaxoSmithKline Chief Executive Officer Emma Walmsley outlined plans to transform the pharmaceuticals business of GSK following the expected spin-off of the company’s consumer health division during an investor conference.
GlaxoSmithKline will lay out plans to boost the spending power of the company’s research-focused pharmaceuticals business at an investor day on June 23, as analysts call on the British drugmaker to boost drug development prospects with takeovers or alliances.
The U.S. Food and Drug Administration rejected Orphazyme’s key drug candidate for Niemann-Pick disease type C (NPC), causing the Denmark-based biopharmaceutical company’s “meme stock” to decline in trading.
Sage Therapeutics’ experimental depression drug showed significant improvement in symptoms compared to placebo in a late-stage study.
Avenue Therapeutics Inc. said on June 14 the U.S. Food and Drug Administration had once again declined to approve the company’s non-opioid painkiller tramadol, sending the drugmaker’s shares lower in trading.
Celltrion Inc. on June 14 announced positive results for the company’s experimental antibody Covid-19 treatment that the South Korean drugmaker said was safe and reduced the treatment period by nearly five days in Phase 3 global clinical trials.
