A European approval for Alzheimer’s drug aducanumab by year-end looks even more in doubt. A week after being called in before the EMA’s Committee for Medicinal Products for Human Use (CHMP) for an oral explanation of the trial data, Biogen Inc. said it received a “negative trend vote” on the marketing authorization application. A formal opinion by the CHMP is expected at its December meeting, but analysts are not optimistic.
Technically speaking, the scientific community as a whole cannot say for sure whether and how well Aduhelm (aducanumab, Biogen Inc./Eisai, Co., Ltd.) works. After all, two years after the initial report of the Engage and Emerge data at the 2019 Clinical Trials in Alzheimer’s Disease (CTAD), the full trial data have still not been published in a peer-reviewed publication. Which, of course, is one of the problems with Aduhelm.
European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA.
PERTH, Australia – Australian researchers have debunked previous research that suggests autism spectrum disorder behavior may be caused by differences in the composition of the gut microbiota.
Vaxxinity Inc. priced its IPO below the targeted range, selling 6 million shares (NASDAQ:VAXX) at $13 each for proceeds of $78 million, but came out of the gate impressively, closing at $16.55, up $3.55, or 27%, after reaching $22.77 during the day.
Investors were thrilled when Roche Holding AG subsidiary Genentech Inc. and AC Immune SA reported top-line results from the Lauriet trial on Aug. 31, giving a positive jolt to AC Immune’s stock on the day of the announcement. At the Clinical Trials in Alzheimer’s Disease 2021 meeting, the reaction of the medical community was more skeptical.
Yumanity Therapeutics Inc. CEO Richard Peters said his firm is “in the driver’s seat” with regard to partnering options or going it alone, after YTX-7739 hit the primary endpoints in a phase Ib Parkinson’s disease (PD) study. Wall Street seemed less than certain about the success, knocking shares (NASDAQ: YMTX) down $2.83, or 33.4%, to close at $5.65.
After signing a potential $1.2 billion cell therapy deal with Vertex Pharmaceuticals Inc. in August, Arbor Biotechnologies Inc. has raised $215 million in series B financing to advance next-generation precision gene editing therapeutics.
Zai Lab Ltd. and Blueprint Medicines Corp. have inked an exclusive collaboration and license agreement for the development and commercialization of two candidates for the potential treatment of patients with EGFR-driven non-small-cell lung cancer (NSCLC) in greater China, where Clarivate forecasts total NSCLC market sales are poised to grow from $3.2 billion in 2020 to $9.5 billion in 2030.
Shares of Alkermes plc slipped 15% Nov. 9 on news that longtime partner Janssen Pharmaceutica NV plans to partially terminate two license agreements related to know-how royalties on U.S. sales of paliperidone products using Alkermes’ nanoparticulate technology. While the move is expected to result in only a modest near-term impact on the Dublin-based firm’s bottom line, it took both company management and investors by surprise.
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