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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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Novo Nordisk and Eli Lilly presented data extolling the benefits of their relative weight loss therapies in obesity-linked indications, while analysts at BMO Capital Markets were “encouraged” by the strategy communicated by Novo management.
The acquisition gives Johnson & Johnson access to Firefly Bio’s next-gen platform designed to create degrader antibody conjugates that can crack the tricky KRAS cancer target.
Incyte is acquiring Vega Therapeutics, a subsidiary of Star Therapeutics, for a bleeding disorder program that analysts say has “pipeline-in-a-product” potential.
After Revolution Medicine’s groundbreaking data drop in April, its Tango-partnered combination approach has demonstrated what analysts called “unprecedented” results for 12 patients with pancreatic cancer, teeing up a late-stage study.
Roche and Nurix Therapeutics will advance their BTK degrader for chronic lymphocytic leukemia, as well as immunology and neurology indications.
While survodutide’s 16.6% overall weight loss was underwhelming, Boehringer Ingelheim and Zealand Pharma’s drug achieved “impressive” fat loss, according to BMO Capital Markets.
After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
Much work needs to be done for Pfizer to be able to catch up to the weight-loss frontrunners, according to Guggenheim Partners, but new data from Metsera’s lead asset could set the pharma apart from competitors with a monthly injection.
Over two years of treatment, Eli Lilly’s triple-G drug cut body weight by more than 30% in certain patients with obesity, cementing the pharma’s position as the frontrunner in the metabolic space.
The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.