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A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
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Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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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.
As the FDA tries to clarify its intent for former FDA Commissioner Marty Makary’s plausible mechanism framework for bespoke therapies, experts emphasize the importance of expanding its scope to encompass rare diseases that affect more than just one or a few individuals.
Eli Lilly sauntered into the American Diabetes Association meeting with a commanding lead in the metabolic space and put down more evidence for its pipeline, including new pill Foundayo and next-gen asset retatrutide, in new indications.