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The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne muscular dystrophy.
FEATURED STORIES
Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible.
Leading companies spent $1.4 billion upfront on licensing deals and embarked on vast R&D programs. Clinical setbacks mean many companies are unlikely to ever recoup their investments.
Drug pricing, budget cuts, tariffs and other shifts under the Trump administration undermine the biopharma and healthcare ecosystem.
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Shanghai-based LaNova Medicines—which has captured the attention of some of the biggest Western pharmas—will be folded into fellow Chinese company Sino Biopharmaceutical in a deal worth up to $951 million.
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
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.
Seven biotech unicorns are advancing AI-powered drug discovery and development—but must contend with a difficult investing environment where competition is steep and the usual roads to exit are uncertain.
More than thirty years since its 1993 founding, Catherine Owen Adams and Elizabeth Thompson—the R&D combo that has led Acadia since last year—are managing two products on the market and a pipeline estimated to be worth an additional $12 billion in sales.
Despite the FDA commissioner’s promises of partnership and collaboration, personnel changes and continued federal cuts create uncertainty for an industry already struggling with nearly half a decade of investment scarcity.
The deal, which involves a $700 million upfront payment, gives AbbVie access to ISB 2001, a clinical-stage first-in-class trispecific antibody currently being tested for certain kinds of multiple myeloma as well as autoimmune indications.
The Global Fund to Fight AIDS, Tuberculosis and Malaria will work with Gilead and other private backers to ensure the HIV preventive Yeztugo, approved last month by the FDA, is available in low- and middle-income countries, concurrent with high-income nations.
Nuclidium’s radiopharmaceutical platform is unique in its use of copper-based payloads, which the biotech claims can deliver higher doses while also being safer.