News
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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As the yearslong litigation over ownership of CRISPR gene editing continues, investors have forged ahead with funding the technology’s development by biopharma.
Roche’s oral GLP-1 receptor agonist CT-996—obtained in the $2.7 billion acquisition of Carmot Therapeutics—reduced body weight by more than 6% at four weeks versus placebo in a Phase I trial.
As scrutiny of pharmacy benefit managers mounts, a House committee will hold a hearing on the alleged anticompetitive business practices of these middlemen.
AstraZeneca joins Johnson & Johnson and Bristol Myers Squibb in appealing a previous legal loss for its challenge to the government’s drug price-setting program.
Citing the need for another human factor study and more technical data for the final product, the FDA denied approval of Orexo’s nasal spray rescue medication for opioid overdose.
Pfizer selects its candidate for the oral GLP-1 race as Eli Lilly strives to overtake Novo Nordisk in the injectable weight-loss drug space. Meanwhile, pressure builds to reduce drug prices in the U.S.
Restructuring can invite lawsuits if companies aren’t careful. Following local, state and federal rules is critical, as is keeping the employee handbook current.
This week, Carina discusses how to transition into a career in biotech when you don’t have lab experience. Plus, handling difficult interviews and getting a “dry” promotion.
Backed by Bain Capital, Cardurion Pharmaceuticals will use the Series B funds to advance two assets for heart failure and other cardiovascular conditions.
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II.