The drug that had so far mounted a strong defense for Roche Holdings AG's CD20-targeting franchise against the encroachment of biosimilars stumbled in a late-stage trial reported over the weekend.
With the bulk of Galena Biopharma Inc.'s value riding on cancer vaccine Neuvax (nelipepimut-S), the firm's shares predictably plunged to a new 52-week low Wednesday as an independent data monitoring committee (IDMC) recommended the PRESENT phase III study in breast cancer be stopped for futility following a planned interim analysis.
Long-awaited data from a confirmatory phase III study aimed at convincing regulators of the efficacy of twice-rejected Kiacta (eprodisate) in AA amyloidosis, ended up dealing a crushing blow to Bellus Health Inc., with top-line results Monday showing the five-year, event-driven trial missed the primary endpoint of slowing renal function decline in patients with the orphan disease.
As investors await top-line phase III data later this summer for AM-101, its lead program in tinnitus, Auris Medical Holding AG continued advancing its other late-stage candidate, AM-111, launching as planned a second phase III study in hearing loss. Both indications represent potential first-mover opportunities for the Swiss-based biopharma.
The team at Marinus Pharmaceuticals Inc. will be digging into results from the missed phase III study in drug-resistant focal onset seizures, hoping to determine why ganaxolone failed to mirror the reduction in seizure rate observed in earlier trials.
SAN FRANCISCO – If there were any doubts that the drug pricing debate – exacerbated by recent political volleys – was a hot topic coming into this year BIO International Convention, they were surely dashed Tuesday afternoon during an increasingly animated fireside chat between recently named Celgene Corp. CEO Mark Alles and Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood.
SAN FRANCISCO – With last week's European nod for Fabry disease drug Galafold (migalastat), Amicus Therapeutics Inc. has performed a feat few biopharmas get to experience: Completing the transition from start-up to commercialization.
Shares of Innocoll Holdings plc jumped 47.8 percent Wednesday on word that two phase III trials testing Xaracoll, its long-acting bupivacaine implant, solidly hit their primary endpoints in a postoperative pain study, findings that bode well for the company’s overall collagen-matrix platform technology, even if analysts await greater clarity to gauge the product’s potential in the non-opioid analgesic market.
