UK won’t order Grail’s cancer test for 1M people this year, a setback for...
The UK’s National Health Service will wait until 2026 before deciding whether to roll out Grail’s cancer test to one million people, a setback for Illumina and its plan to divest the diagnostics...
View ArticleFDA to begin restructuring its inspection office in October
The FDA received an official go-ahead from HHS on Thursday, setting into motion its planned reorganization of its inspection operations around the globe, with an extra focus on facility inspections,...
View ArticleBristol Myers' CAR-T therapy Breyanzi adds new approval in mantle cell lymphoma
Bristol Myers Squibb’s CAR-T therapy Breyanzi scored its third approval over the last several months, this time in the third-line setting for adults with relapsed or refractory mantle cell lymphoma, a...
View ArticleLab group sues FDA over final rule regulating laboratory-developed tests
The American Clinical Laboratory Association is arguing in a new lawsuit that the FDA has overstepped its authority by bringing laboratory-developed tests (LDTs) under its purview, the first major...
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Novo Nordisk mounts legal campaign against companies marketing compounded...
Novo Nordisk is ramping up its legal campaign against medical spas, pharmacies and clinics marketing compounded versions of its popular weight loss and diabetes drugs. The Danish pharma filed nine new...
View ArticleSummit Therapeutics' stock soars as biotech says its cancer drug beat...
Hours before America’s biggest cancer conference starts in Chicago, a small biotech may have stolen the show, touting late-stage results in a Thursday afternoon press release that added over $5 billion...
View ArticleGilead’s blockbuster ADC Trodelvy fails bladder cancer confirmatory study
Gilead on Thursday disclosed that Trodelvy, the antibody-drug conjugate that is a key part of the drugmaker’s oncology business, failed a Phase 3 study after it didn’t show an improvement in patient...
View ArticleFDA delays decision on Sanofi and Regeneron's Dupixent in COPD, EMA...
Sanofi and Regeneron will have to wait three more months for a major FDA decision on expanding Dupixent’s label, the companies disclosed Friday morning. Meanwhile, European authorities have recommended...
View ArticleUltragenyx touts Phase 3 win for gene therapy in rare glycogen storage disorder
Ultragenyx’s one-time gene therapy has hit the primary endpoint in a registrational test in a rare glycogen storage disorder, triggering company plans to file with regulatory authorities next year. The...
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Neurocrine CEO Kevin Gorman to retire after 32-year run; Bluebird picks up...
Kevin Gorman After more than three decades at Neurocrine, CEO Kevin Gorman will retire later this year, handing the reins of the $13 billion neuroscience drugmaker over to Kyle Gano, a longtime...
View ArticleIonis outlines Phase 3 data for rare disease drug, preps for another...
Ionis outlined full Phase 3 results for its rare disease drug donidalorsen on Friday, prepping for a potential FDA submission by the end of the year. The study is Ionis’ third Phase 3 win in the last...
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Adaptimmune taps Galapagos to decentralize manufacturing of solid tumor T...
Adaptimmune Therapeutics and Galapagos have formed an alliance to manufacture a clinical-stage solid cancer asset in a decentralized way. Thad Huston At the center of the deal is Adamtimmune’s T cell...
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#ASCO24: Gilead presents more data on failed Trodelvy lung cancer study
CHICAGO — Researchers on Friday afternoon pulled back the curtain on Gilead’s previously announced Phase 3 failure in certain forms of non-small cell lung cancer. Gilead’s TROP2 antibody-drug conjugate...
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#ASCO24: Novartis' new CML treatment tops older drugs, including Gleevec, in...
CHICAGO — Novartis said its chronic myeloid leukemia drug Scemblix was better than its own first-generation blockbuster medicine and an investigator’s choice of second-generation treatments made by...
View ArticleNovartis shares updated data for BTK inhibitor; Astellas resubmits BLA for...
Plus, news about Valar Labs, Pharming Group and Day One Pharmaceuticals: Novartis outlines one-year data for BTK inhibitor: The drug, called remibrutinib, demonstrated symptom improvements up to one...
View ArticleFDA approves Moderna's RSV vaccine, marking its second commercial product
Moderna on Friday secured a long-awaited but expected approval for its RSV vaccine, giving the biotech its first FDA approval for a non-Covid-19 product and kickstarting what’s now a three-way race...
View ArticleJoe Jimenez and Mark Fishman target $400M for third fund after leaving Novartis
Former Novartis CEO Joe Jimenez and research leader Mark Fishman are fundraising again for their life sciences firm Aditum Bio, which in-licenses translational-stage drugs and sets up individual...
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'Invisible hand' of inherited genetics can drive cancer risk, new study suggests
For almost as long as scientists have understood how genetic mutations can drive the growth of cancers, they’ve also believed that most of those mutations are acquired over the course of a person’s...
View ArticleDrugmakers to Maryland affordability board: Capping list prices may not help...
Drugmakers are pushing back against Maryland’s Prescription Drug Affordability Board and its list of six medicines that will be reviewed for potential price caps. The board is conducting studies of six...
View ArticleCHMP recommends 14 new approvals, seven label expansions
The European Medicines Agency’s human medicines committee recommended 14 new drugs for approval this week, including Pfizer’s gene therapy for hemophilia B. The approval recommendations include: →...
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