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  • FDA urges Amgen to withdraw Tavneos after alleging data manipulation by former developer
    The FDA has sent a formal letter to Amgen recommending that the company pull its drug Tavneos from the market. The agency says new information shows the original approval filings from ChemoCentryx…
    BioPharma Dive · 6mo agoRegulatoryNegative↗ source
  • Eli Lilly partners with AI startup Profluent to develop next-generation gene editors
    Eli Lilly announced a collaboration with AI-focused biotech Profluent to create advanced gene-editing tools that could insert whole genes into patients. The partnership is intended to move beyond…
    STAT · 6mo agoDealPositive↗ source
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  • AbbVie eyes pan-RAS market with up to $1.45 B option to acquire Kestrel
    AbbVie announced it has signed an agreement that gives it the right to acquire Kestrel Therapeutics for up to $1.45 billion. The deal would give AbbVie access to Kestrel’s pipeline focused on pan-…
    Endpoints · 6mo agoDealPositive↗ source
  • FDA launches AI-driven pilot to review trial data in real time, aiming to speed clinical studies
    Washington officials said the Food and Drug Administration is starting a new program to speed clinical trials by reviewing data as it is generated. The first pilots will use real-time data from tr…
    STAT · 6mo agoRegulatoryPositive↗ source
  • FDA commissioner touts real-time trial monitoring to cut drug development dead time
    The Food and Drug Administration announced a new approach that will let regulators view clinical trial endpoints as they happen, using cloud‑based data streams. The move targets the long delays th…
    STAT · 6mo agoRegulatoryPositive↗ source
  • BeOne Medicines licenses trispecific antibody targeting PD-1, CTLA-4 and VEGF from Chinese biotech
    BeOne Medicines, formerly known as BeiGene, announced a licensing agreement with a Chinese biotechnology firm to obtain rights to an experimental trispecific antibody. The antibody is engineered t…
    Endpoints · 6mo agoDealPositive↗ source
  • STAT+: Boehringer’s obesity drug shows 16.6% weight loss; more data needed
    Eli Lilly's deal with Profluent, Erasca's RAS-targeting cancer pill, and more biotech news today
    STAT · 6mo agoDealNeutral↗ source
  • Health system CEOs face Congress on affordability, hearing shifts blame to opposing party's policies
    The House Ways and Means Committee held a hearing to examine the drivers of rising health‑care costs, calling CEOs of several large health systems to testify. CEOs from HCA Healthcare, CommonSpiri…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Experts warn brain-health initiatives overlook mental illness
    The authors – a professor at Oxford and Yale, the dean of Mount Sinai’s medical school, and a former U.S. congressman – argue that the surge in funding for neuroscience is being directed mainly tow…
    STAT · 6mo agoNegative↗ source
  • Former NIAID adviser David Morens indicted for hiding emails and falsifying records
    David Morens, a former senior adviser at the National Institute of Allergy and Infectious Diseases, was indicted on Tuesday for allegedly concealing emails and providing false responses to Freedom…
    STAT · 6mo agoRegulatoryNegative↗ source
  • New hepatitis B vaccine guidance prompts analysis of public trust and policy impacts
    The Morning Rounds newsletter examines how the latest recommendations for a hepatitis B vaccine could affect public health outcomes. It highlights recent surveys that show varying levels of confid…
    STAT · 6mo agoNeutral↗ source
  • New U.S. hepatitis B vaccine policy targeting only at-risk newborns could raise infant infections and costs, studies warn
    A new U.S. recommendation limits the birth‑dose hepatitis B vaccine to infants who are judged to be at risk of neonatal infection, rather than offering it universally to all newborns. One study co…
    STAT · 6mo agoRegulatoryNegative↗ source
  • Eli Lilly to acquire Ajax Therapeutics for up to $2.3 billion to develop improved JAK inhibitor
    Eli Lilly announced Monday it will purchase Ajax Therapeutics, a biotech based in New York and Cambridge, Massachusetts, in a deal valued at up to $2.3 billion. The transaction includes cash up fr…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Eli Lilly to pay up to $2.3B for Ajax's JAK inhibitor in cancer deal
    Eli Lilly announced a new agreement with Ajax Therapeutics to acquire rights to a JAK inhibitor called Kyle LaHucik for cancer treatment. The transaction could be worth up to $2.3 billion, reflect…
    Endpoints · 6mo agoDealPositive↗ source
  • Compass Therapeutics reports secondary endpoint data from pivotal biliary tract cancer trial, shares stock drop
    Compass Therapeutics announced new secondary‑endpoint results from its pivotal bispecific antibody trial in second‑line biliary tract cancer, a year after reporting a Phase 2/3 success. The additi…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • Supreme Court split on blocking thousands of Roundup cancer lawsuits
    The Supreme Court heard arguments on Monday about whether to block thousands of lawsuits claiming the weedkiller Roundup caused cancer, and the justices appeared divided. The dispute follows a wav…
    STAT · 6mo agoRegulatoryNegative↗ source
  • Erasca reports early trial shows tumor shrinkage in 40% of pancreatic and 62% of lung cancer patients
    Erasca announced that its experimental RAS-targeting oral drug, ERAS-0015, produced tumor reductions in a portion of patients with advanced pancreatic cancer and advanced non-small cell lung cancer…
    STAT · 6mo agoPositive readoutPositive↗ source
  • Erasca releases early-stage RAS drug data amid legal dispute with Revolution Medicines
    Erasca has released early-stage data on its RAS-targeting compound, doing so after receiving a legal threat from rival Revolution Medicines. Revolution recently announced a new drug that revived h…
    Endpoints · 6mo agoNeutral↗ source
  • Revolution Medicines threatens lawsuit against Erasca over RAS drug patent and efficacy claims
    Earlier this month a newly announced cancer therapy generated strong interest from patients and investors. The drug, which targets the RAS pathway, was highlighted for its potential impact on oncol…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • STAT+: Astellas retries XLMTM gene therapy after deaths
    Veradermics' hair loss pill late-stage trial success, FDA fast-tracks reviews for psychedelics, and more biotech news
    STAT · 6mo agoRegulatoryNeutral↗ source
  • CDC flu research pioneer Nancy Cox dies at 77
    Nancy Cox, a longtime CDC veteran, passed away at age 77 after battling glioblastoma, a form of brain cancer. Cox led the agency's influenza division for 22 years, expanding the team from a modest…
    STAT · 6mo agoNeutral↗ source
  • New Podcast 'Drug Story' Explores the Cultural Impact of Blockbuster Medications
    The First Opinion team has launched a new podcast called “Drug Story,” hosted by journalist and entrepreneur Thomas Goetz. The series aims to uncover the hidden narratives behind widely used medici…
    STAT · 6mo agoPositive↗ source
  • Eli Lilly to acquire cancer cell therapy startup Kelonia Therapeutics for $3.2 billion
    Eli Lilly announced it will buy privately held Kelonia Therapeutics, a biotech focused on cell therapies for cancer and autoimmune diseases, in a deal valued at $3.2 billion. Kelonia has operated…
    STAT · 6mo agoDealPositive↗ source
  • European regulators recommend Sanofi's MS drug tolebrutinib for approval after US rejection
    European Medicines Agency officials issued a positive recommendation for tolebrutinib, an experimental multiple sclerosis therapy from Sanofi, after the U.S. FDA rejected the drug earlier this year…
    BioPharma Dive · 6mo agoRegulatoryPositive↗ source
  • Utah medical board urges halt to AI-driven prescription renewal pilot
    Utah launched a pilot program that partners with AI startup Doctronic to let a chatbot conduct clinical evaluations and automatically renew prescriptions for roughly 200 medications, without direct…
    STAT · 6mo agoRegulatoryNegative↗ source