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New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Biopharma and life sciences organizations strengthen their leadership teams and boards with these Movers & Shakers.
Boston-based Kelonia Therapeutics launched after a successful $50 million Series A round of financing, which will push its research efforts in genetic medicines for immunology and oncology.
Eli Lilly had a lucrative first quarter, with revenue growth rising 15% driven by sales of its diabetes drug Trulicity and its COVID-19 antibodies.
Moderna has made the official request to the FDA to approve its COVID-19 for use in children ages 6 months to 5 years. Moderna also announced the location of its first non-U.S. mRNA manufacturing facility.
Pfizer says it will open the first U.S. sites in its Phase III study evaluating its investigational mini-dystrophin gene therapy in ambulatory patients with Duchenne muscular dystrophy (DMD).
In its 2022 Q1 earnings report, Sanofi reported major wins in the first quarter of 2022, driven mostly by the success of consumer healthcare (CHC) and Dupixent.
Alexion shared the news that Ultomiris (ravulizumab-cwvz) has been approved by the FDA for commercialization, adding another indication for the precedent-setting drug.
Chimera’s research comes largely from its GOLD platform, a technology that reprograms RNA gene regulation circuits to alter chimeric antigen receptors (CAR) on T cells.
Sio Gene has terminated its licensing deal with the UMass to develop and commercialize two gene therapy product candidates to focus on more potentially profitable projects.
Amgen held its earnings conference call on Wednesday for Q1 of 2022. Most notably, the company provided updates on its ongoing litigation with the Internal Revenue Service.