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  • PSA Blood Test Found to Lower Prostate Cancer Deaths, Review Shows
    A new Cochrane review concludes that prostate-specific antigen (PSA) screening is likely to reduce deaths caused by prostate cancer. The analysis combined data from six trials involving roughly 80…
    STAT · 4mo agoPositive↗ source
  • Takeda to Pay $13.6 Million to Resolve DOJ Claims of Doctor Kickbacks for Antidepressant Trintellix
    Takeda Pharmaceuticals has agreed to pay $13.6 million to settle federal allegations that it provided illegal kickbacks to physicians to encourage prescriptions of its antidepressant, Trintellix. T…
    STAT · 4mo agoRegulatoryNegative↗ source
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  • Amgen tightens 340B program rules, expanding pharmacy claims data requirements
    Amgen announced it is expanding the data it requires from pharmacies that dispense its products under the federal 340B drug discount program. The new policy will obligate participating pharmacies…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Aardvark to unblind rare disease trial after FDA places full clinical hold; Alumis issues verdict on Acelyrin asset
    Aardvark's rare disease candidate is under a full clinical hold by the FDA, which has paused all dosing and data collection. The company says it intends to unblind the trial data despite the hold,…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Older adults warn that changing pill colors and shapes cause dangerous confusion
    Barbara Wolf, a 73‑year‑old from Birmingham, Alabama, takes six medications each day and relies on the color, shape and size of each pill to keep her regimen straight. She recently received a refi…
    STAT · 4mo agoNegative↗ source
  • Supreme Court Keeps Mail Delivery of Abortion Pill Mifepristone in Place
    The Supreme Court issued a ruling on Thursday that preserves the ability to ship the abortion medication mifepristone through the postal service. The decision leaves in place the existing safety r…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • US pushes Germany on drug pricing while FDA faces turmoil and biotech trials advance, says Pharmalittle roundup
    The newsletter notes that U.S. lawmakers are intensifying pressure on Germany to lower the prices of pharmaceuticals, a move that could reshape cross-border pricing negotiations. At the same time,…
    STAT · 4mo agoNeutral↗ source
  • AC Immune CEO Andrea Pfeifer Retires After 23 Years, Company Begins CEO Search
    AC Immune announced that its chief executive Andrea Pfeifer will step down after a 23‑year tenure. Pfeifer, who has guided the biotech through multiple development programs, said she will retire a…
    Endpoints · 4mo agoNeutral↗ source
  • Nonprofits launch Zillow-style marketplace to match abandoned gene and cell therapies with new developers
    Two nonprofit groups announced the launch of an online marketplace designed to give abandoned cell and gene therapy projects a chance for redevelopment. The platform, unveiled at the American Socie…
    Endpoints · 4mo agoPositive↗ source
  • Alcohol’s deadly toll is overlooked as a public-health crisis, STAT explores why
    STAT’s weekly video series highlighted that alcohol kills more Americans than any other drug, yet it is rarely framed as a public‑health emergency. The contrast between its mortality impact and pub…
    STAT · 4mo agoNeutral↗ source
  • Basking Biosciences appoints former Pulmocide chief medical officer Lance Berman
    Basking Biosciences announced the addition of Lance Berman as its new chief medical officer. The appointment was highlighted in a recent industry column that tracks personnel changes. Berman comes…
    STAT · 4mo agoNeutral↗ source
  • Remembering Craig Venter: The Complex Legacy Behind the Human Genome Race
    Former NIH archivist Zachary Utz reflects on the recent death of Craig Venter, a prominent figure in genomics known for challenging conventional scientific approaches. Venter’s private company Cel…
    STAT · 4mo agoNeutral↗ source
  • AstraZeneca reports Phase 3 trial shows Imfinzi-Padcev combo improves survival in bladder cancer
    AstraZeneca announced that its Phase 3 study of the immunotherapy Imfinzi combined with the antibody‑drug conjugate Padcev, developed with Pfizer and Astellas, extended overall survival for patient…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • BeOne secures FDA approval for lymphoma therapy
    BeOne received FDA approval for its lymphoma therapy, a notable achievement in a crowded therapeutic area. The agency’s review concluded that the treatment meets safety and efficacy standards, pla…
    STAT · 4mo agoApprovalPositive↗ source
  • Regenxbio reports key gene therapy results, moves toward FDA accelerated clearance for Duchenne
    Regenxbio said its experimental gene therapy RGX-202 met the primary endpoint in a pivotal Duchenne muscular dystrophy trial, positioning the company to file for accelerated FDA clearance. In the…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
  • Regenxbio reports successful Duchenne gene therapy trial, clearing path to FDA filing
    Regenxbio announced that its experimental gene therapy for Duchenne muscular dystrophy met its primary endpoints in a recent clinical trial, producing sufficient levels of a truncated muscle protei…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Supreme Court blocks restrictions, keeps mifepristone available through pharmacies and mail
    Supreme Court on Thursday issued an order that maintains women's ability to obtain the abortion medication mifepristone without requiring an in-person doctor visit. The decision overturns a lower-…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Biogen advances tau-targeting Alzheimer drug to Phase 3 despite mixed Phase 2 data
    Biogen reported results from a Phase 2 trial of its tau-targeting Alzheimer’s candidate diranersen (BIIB080). The study measured tau levels in cerebrospinal fluid and brain tissue of patients with…
    STAT · 4mo agoPositive readoutPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 4mo agoApprovalPositive↗ source
  • FDA commissioner Marty Makary exits, acting head Kyle Diamantas named as podcast discusses impact and Senate health race
    The Readout Loud podcast episode focused on health politics, featuring a discussion of FDA commissioner Marty Makary's departure. Hosts examined why Makary is leaving, which of his policies might…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Encoded Therapeutics gene therapy cuts seizures 76% in Dravet syndrome children
    Encoded Therapeutics presented data at the ASGCT26 meeting showing its gene therapy achieved a 76% reduction in seizures among children with Dravet syndrome. The result was observed in three patie…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Degron Therapeutics raises $40M in Series A extension, total $95M, as Cabaletta releases early CAR‑T data
    Degron Therapeutics, a US‑China biotech focused on molecular‑glue degrader technology, announced an additional $40 million in Series A extension funding, bringing its total capital raised to $95 mi…
    Endpoints · 4mo agoDealNeutral↗ source
  • Biogen reports mixed results in mid‑stage trial of tau‑targeting Alzheimer’s therapy
    Biogen disclosed data from a Phase 2 study of its experimental Alzheimer’s drug that targets the tau protein. The trial showed a combination of positive and negative signals, with some measures ind…
    STAT · 4mo agoNegative readoutNeutral↗ source
  • Biogen's anti-tau Alzheimer drug BIIB080 fails primary endpoint in Phase 2, but shows slower decline
    Biogen reported results of its Phase 2 trial of BIIB080, a tau-targeting therapy for Alzheimer’s disease. The study’s primary endpoint was not met, meaning the drug did not achieve the pre-specifi…
    Endpoints · 4mo agoNegative readoutNeutral↗ source