Genedx Holding Corp. launched Genomedx Prenatal, its whole genome sequencing test, to provide more definitive diagnoses of the causes of fetal abnormalities identified by ultrasound. By combining the company’s decade of experience in prenatal exome testing and its massive Genedx Infinity rare disease dataset, the test can determine not just whether a pregnancy has a risk of a genetic disorder but whether the fetus actually has a genetic disorder.
The U.S. FDA’s September 2022 final guidance for clinical decision support (CDS) systems set a dismal record for pushback, but the new administration at the FDA has reissued the guidance with provisions that industry will undoubtedly find encouraging.
Securing a second major partnership with Sanofi SA – this time worth a potential $2.56 billion – Earendil Labs will provide its AI-driven discovery platform to find new therapeutics for autoimmune and inflammatory diseases.
Securing a second major partnership with Sanofi SA – this time worth a potential $2.56 billion – Earendil Labs will provide its AI-driven discovery platform to find new therapeutics for autoimmune and inflammatory diseases.
Abbvie Inc. signed a $1.1 billion New Year’s Eve deal with China’s Zelgen Biopharmaceuticals Co. Ltd., gaining ex-China rights to Zelgen’s lead oncology asset, alveltamig (ZG-006), a trispecific T-cell engager targeting delta-like ligand 3. Under terms of the deal, Abbvie will pay Zelgen an up-front fee of $100 million, and Zelgen is eligible to receive $60 million in near-term milestones and could receive up to $1.075 billion in additional development, regulatory and commercial milestones, alongside tiered royalties on net sales outside China. Zelgen retains full rights in China.
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
The newly released 2026 edition of Clarivate’s Drugs to Watch report highlights 11 potential blockbusters that could change treatment paradigms for patients.
Eye disease specialist Oculis SA is laying plans to branch out into multiple sclerosis (MS) after the phase II trials of its acute optic neuritis (AON) drug, privosegtor, showed it reduced levels of neurofilament release, a key biomarker of neuronal damage and neurodegeneration.
It doesn’t take a meteorologist to predict another stormy year for the biopharma sector, not just in the U.S., but also in Europe. Lurking within those storms, though, could be a few silver linings.
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