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592 stories matching this filter · ← front page

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  • FDA staff raise concerns over data for Moderna’s mFlusiva flu vaccine ahead of advisory panel
    FDA staff have examined the evidence for Moderna's mFlusiva, an mRNA flu vaccine, and highlighted shortcomings in the data submitted to the agency. The Food and Drug Administration will convene an…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • Covid vaccine linked to 24% drop in overall cardiac events, study of 1 million veterans shows
    A new analysis of more than one million U.S. veterans indicates that receiving a Covid‑19 vaccine is associated with a substantial reduction in heart‑related problems. Researchers observed a roughl…
    STAT · 4mo agoPositive readoutPositive↗ source
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  • Summit Therapeutics cancels $500 million secondary share offering citing market conditions
    Summit Therapeutics announced it would pull a planned $500 million secondary share sale just one day after the announcement, saying market conditions were unfavorable. The offering had been slated…
    BioPharma Dive · 4mo agoDealNegative↗ source
  • Nonprofit Blood Cancer United purchases remaining Luvelta supplies to keep compassionate access for children
    Blood Cancer United, formerly the Leukemia & Lymphoma Society, announced it will purchase the remaining inventory of Luvelta, an investigational antibody‑drug conjugate that had been discontinued.…
    STAT · 4mo agoDealPositive↗ source
  • ACOG issues new pregnancy vaccine schedule that diverges from CDC guidance
    The American College of Obstetricians and Gynecologists (ACOG) released a new vaccine schedule for pregnant individuals that differs from the current CDC guidance. ACOG recommends four vaccines be…
    STAT · 4mo agoNeutral↗ source
  • GSK to buy Nuvalent for $10.6B, gaining two lung-cancer drugs under FDA review
    GSK announced it will acquire Nuvalent, a biotech focused on lung cancer, in a transaction valued at about $10.6 billion. The deal gives GSK control of Nuvalent’s two experimental lung-cancer ther…
    Endpoints · 4mo agoDealPositive↗ source
  • GSK to acquire cancer-focused biotech Nuvalent for $10.6 billion
    GSK announced it will acquire Nuvalent, a biotech that develops targeted cancer therapies, in a transaction valued at $10.6 billion. The purchase price translates to $124 per Nuvalent share, a 26%…
    STAT · 4mo agoDealPositive↗ source
  • GSK to acquire Nuvalent for $11 billion, adding two lung-cancer drugs under FDA review
    GSK announced a deal to buy Massachusetts‑based biotech Nuvalent for $11 billion. The acquisition brings two experimental lung‑cancer medicines that are currently under review by the U.S. Food and…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • GSK to acquire Nuvalent for $10.6 billion, expanding its lung-cancer pipeline
    GSK announced it will buy Cambridge-based biotech Nuvalent for $10.6 billion, paying $124 per share, a 26% premium to the biotech's recent average share price. Nuvalent has two lung‑cancer drugs u…
    STAT · 4mo agoDealNeutral↗ source
  • Gilead reports positive Phase 3 HIV results while Merck's Trodelvy fails in lung cancer trial
    Gilead Sciences announced that its Phase 3 HIV trial met its primary efficacy endpoint, delivering a positive readout for the experimental therapy. In a separate study, Merck reported that its Pha…
    Endpoints · 4mo agoNeutral↗ source
  • GSK to acquire cancer drug developer Nuvalent for $10.6 billion
    GSK announced an agreement to purchase Nuvalent, a company focused on cancer therapies, in a transaction valued at $10.6 billion. The acquisition is intended to broaden GSK’s oncology portfolio an…
    STAT · 4mo agoDealNeutral↗ source
  • Merck, Gilead report mixed outcomes in key lung cancer, HIV studies
    Trodelvy's latest setback carries implications for a newly important Merck drug, while the success of a once-weekly HIV tablet could boost Gilead's main business.
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • J&J to acquire Firefly Bio for $1 billion, adding degrader-antibody conjugate technology
    J&J announced it will acquire biotech startup Firefly Bio in an all‑cash transaction valued at $1 billion. The deal gives J&J access to Firefly’s degrader‑antibody conjugate platform, which blends…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • City Therapeutics secures $99.5 million to advance RNAi drugs targeting clotting disorder and Stargardt disease
    City Therapeutics, a young biotech focused on RNA interference therapies, announced it has raised $99.5 million to support further development of its pipeline. The funding will back its lead candid…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Tango Therapeutics reports strong early response with vopimetostat plus daraxonrasib in pancreatic cancer trial
    Tango Therapeutics announced that its experimental epigenetic drug vopimetostat, when combined with Revolution Medicines' KRAS inhibitor daraxonrasib, produced high response rates in a small pancre…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Analysts warn that PD-1/VEGF bispecific drugs may be better suited for liver cancer than lung cancer
    Many drugmakers have poured billions into PD-1/VEGF bispecific antibodies after ivonescimab beat Keytruda in a 2024 lung‑cancer trial, sparking a wave of deals and development programs. A recent C…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Grail’s Galleri multi-cancer early detection trial misses primary endpoint, but oncologists note promising signals
    The first randomized trial of a multi-cancer early detection test enrolled about 143,000 English adults aged 50 to 77. Participants were randomly assigned to receive either standard care or the Gal…
    STAT · 4mo agoNegative readoutNeutral↗ source
  • Eli Lilly cuts German weight-loss syringe investment by half amid new cost-cutting law
    Eli Lilly said it will cut its planned investment in Germany for the production of weight‑loss syringes. The company had originally earmarked $2.67 billion, but will now invest roughly half that a…
    STAT · 4mo agoDealNegative↗ source
  • Revolution Medicines eyes broader use of daraxonrasib pending FDA submission
    Revolution Medicines' daraxonrasib has not yet been approved for metastatic pancreatic cancer after chemotherapy, but a recent ASCO plenary presentation generated strong interest. Analysts expect…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Cigna to End Coverage of GLP-1 Weight-Loss Drugs Wegovy and Zepbound for Employees Starting July 1
    Cigna announced it will stop covering GLP-1 weight-loss medications for its employee health plan, effective July 1. The decision affects drugs such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepboun…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Rising AI battle between hospitals and insurers drives soaring medical bills, says pediatric cardiologist
    Darshak Sanghavi, a pediatric cardiologist and chief medical officer of Machinify, writes an opinion piece about an emerging AI conflict between health providers and insurers over patient records a…
    STAT · 4mo agoNegative↗ source
  • Eli Lilly warns 340B hospitals to submit claims data within five days or lose price discounts
    Eli Lilly has given roughly 50 hospitals that participate in the federal 340B drug discount program a five‑day deadline to provide comprehensive claims data. The company says that if the data are n…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Revolution Medicines reports pancreatic cancer drug daraxonrasib extends median survival to 13.2 months in second-line study
    Revolution Medicines released detailed data confirming that its experimental pancreatic cancer therapy, daraxonrasib, improved overall survival for patients with advanced disease. In the second‑lin…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Daraxonrasib shows promising pancreatic cancer results as Chinese lung therapy exceeds expectations
    The latest ASCO updates highlighted detailed data on daraxonrasib, a drug targeting pancreatic cancer, indicating encouraging efficacy signals for patients. In parallel, a lung cancer treatment de…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Servier to acquire Edgewise Therapeutics' muscular dystrophy program for up to $2.65 billion
    French pharma group Servier announced it will purchase Edgewise Therapeutics' muscular dystrophy business. The transaction is valued at up to $2.65 billion, comprising a $1.55 billion upfront cash…
    STAT · 4mo agoDealPositive↗ source