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Investors had been “holding out hope” that there remained a regulatory path forward for RP1, but results of Replimune’s Type A meeting with the FDA do not appear to support this, according to BMO Capital Markets.
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Participants in trials of BrainStorm Cell Therapeutics’ NurOwn filed a Citizens’ Petition with the FDA earlier this month seeking a new review of the stem cell therapy that was rejected in 2022 based on real-world data and 90% survival in an expanded access program.
From Wall Street to real estate to a “big, ugly” pharma building, Mayo Venture Partner Audrey Greenberg reflects on a career defined by taking a leap at just the right moment.
Some of the most high-profile acquisitions in recent years have involved women-fronted biotechs. BioSpace reviews five of the most notable here.
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Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented late-breaking data from the NOTUS Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy (nearly all on triple therapy) and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL).
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Read our takes on the biggest stories happening in the industry.
Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
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The CDC director—the first to be confirmed by the Senate under new legislation—has been ousted after less than a month following internal unrest regarding new, more restrictive approvals for updated COVID-19 vaccines, according to multiple sources.
Looking for a biopharma job in San Francisco or South San Francisco? Check out the BioSpace list of eight companies hiring life sciences professionals like you.
Massachusetts biopharma workforce growth was fairly flat last year, and R&D and manufacturing employment declined, according to a new MassBio report. BioSpace data further highlight challenges facing the state, showing roughly 2,300 people out of work in 2025 and jobs live on the website falling.
Scott Gottlieb, who served as FDA commissioner during the first Trump administration, wrote in a JAMA editorial that China is speeding drugs to market and could potentially surpass the U.S. in the innovation game.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
AMX0035—approved as Relyvrio in 2022 for amyotrophic lateral sclerosis but voluntarily pulled from the market last year—was unable to distinguish itself from placebo in a mid-to-late-stage trial of progressive supranuclear palsy.
Novartis has bet up to $772 million to gain access to BioArctic’s BrainTransporter platform, which was leveraged in a partnership with Eisai to produce Leqembi.
Regeneron’s cemdisiran, used alone or in combination with its complement inhibitor Veopoz, significantly improved activities of daily living in patients with generalized myasthenia gravis.
The layoffs will affect employees at Pfizer’s Bothell, Washington site, which previously served as the headquarters for Seagen before being acquired by the pharma for $43 billion.
Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development.