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577 stories matching this filter · ← front page

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  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, expanding siRNA portfolio
    Merck KGaA, the German science and technology conglomerate, announced an agreement to purchase UK‑based Silence Therapeutics. The deal is valued at about $1.3 billion and gives Merck access to Sil…
    Endpoints · 16h agoDealPositive↗ source
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    Fierce Biotech · 22h agoApprovalPositive↗ source
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Nephrology627
  • Disc Medicine's rare sun-sensitivity drug meets all endpoints in Phase 3 trial
    Disc Medicine announced that its experimental therapy for a rare condition that makes sun exposure painful has completed a Phase 3 study. The trial reported success on every primary and secondary…
    Endpoints · 19h agoPositive readoutPositive↗ source
  • Merck KGaA buys Silence in $1.3B deal after siRNA drug's phase 2 blood cancer win
    Germany’s Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech’s mid-stage success for its challenger to Takeda’s Mimrylo.
    Fierce Biotech · 21h agoDealNeutral↗ source
  • Editor shares personal loss and calls for assisted suicide options for severe mental illness
    Torie Bosch, an editor at STAT, recounts the repeated suicide attempts of her mother, culminating in her death in 2016. She describes the ongoing cycle of crises, hospitalizations and the emotional…
    STAT · 21h agoNegative↗ source
  • Theranos whistleblower says new film ‘You Can See Everything’ is art, not a documentary
    Tyler Shultz, a former Theranos scientist who became a whistleblower, wrote an opinion piece criticizing Nathan Fielder’s recent film about Elizabeth Holmes. He argues the movie, titled “You Can S…
    STAT · 12h agoNegative↗ source
  • Jury deliberates conflicting accounts in David Sabatini misconduct trial at Whitehead Institute
    A Boston jury is hearing a civil case that pits two very different narratives about the conduct of renowned molecular biologist David Sabatini. The three‑week trial has focused on accusations that…
    STAT · 3d agoNegative↗ source
  • Merck and Moderna plan to seek approval for personalized mRNA melanoma vaccine after Phase 3 shows delayed recurrence
    At the 2026 STAT Summit, Merck and Moderna outlined their partnership to combine Keytruda with a personalized mRNA cancer vaccine aimed at melanoma patients. In a large Phase 3 trial, the vaccine…
    STAT · 4d agoRegulatoryPositive↗ source
  • Former FDA chiefs slam Trump administration, label DOGE a disaster and warn of staff loss, while AstraZeneca announces AI partnership
    Three former FDA commissioners publicly rebuked the Trump administration, saying its actions have harmed the agency. They said the administration’s handling of a large staff departure stripped the…
    STAT · 4d agoRegulatoryNegative↗ source
  • Oxford biotech OMass Therapeutics secures $310 million to advance genetic adrenal disorder program
    Oxford-based OMass Therapeutics announced a $310 million private financing round, one of the largest recent fundraises for a UK biotech. The capital will fund the development of therapies targetin…
    Endpoints · 5d agoDealNeutral↗ source
  • Melanoma patient shares hope after receiving Merck-Moderna mRNA cancer vaccine in trial
    A schoolteacher diagnosed with melanoma in 2019 participated in a late‑stage trial testing an mRNA cancer vaccine developed by Merck and Moderna. The trial added the vaccine to standard immunothera…
    STAT · 4d agoPositive↗ source
  • Compass Pathways CEO says company will proceed cautiously as it readies psychedelic therapy for FDA review
    Compass Pathways chief executive Kabir Nath told reporters at the STAT Summit that the company will "go slow before we go fast," emphasizing that early negative experiences could hurt the emerging…
    STAT · 5d agoRegulatoryNeutral↗ source
  • Verastem reports encouraging early data for KRAS G12D inhibitor in pancreatic cancer
    Verastem Oncology disclosed early clinical results for its KRAS G12D inhibitor, which is being evaluated in more than 200 patients with advanced solid tumors, including metastatic pancreatic ductal…
    STAT · 4d agoPositive readoutPositive↗ source
  • Patients struggle to opt out of MyChart data sharing, facing notary and endless hurdles
    An opinion piece highlights how MyChart users who want to stop sharing their health information encounter a maze of requirements. The author describes needing a notary, multiple phone calls, unansw…
    STAT · 4d agoNegative↗ source
  • FDA proposes new framework prioritizing consistency over flexibility for rare disease drug reviews
    The FDA announced a shift in its approach to evaluating rare disease therapies, emphasizing a more uniform assessment process. Agency officials explained that the flexibility shown over the summer…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Ultragenyx sells second priority review voucher as Biomea shares tumble after oral GLP-1 data
    Ultragenyx Pharmaceutical, a commercial-stage rare disease company, completed its second sale of a priority review voucher this month. The voucher sale reflects the company's strategy of monetizin…
    Endpoints · 5d agoDealNeutral↗ source
  • Study finds almost 40% of FDA advisory committee meetings in past two decades included members with active industry ties
    Researchers examined FDA advisory committee meetings spanning the last 20 years and discovered that nearly 40% of those sessions featured a patient or consumer representative who had active ties to…
    STAT · 5d agoRegulatoryNeutral↗ source
  • FTC and states seek contempt order against Martin Shkreli for breaching pharma work ban
    The U.S. Federal Trade Commission, joined by seven states, asked a federal court to hold former biotech executive Martin Shkreli in contempt. The request cites repeated violations of a court order…
    STAT · 5d agoRegulatoryNegative↗ source
  • States could counter potential Trump administration vaccine shortages by producing vaccines themselves
    Joel Dodge, director of industrial policy at Vanderbilt Policy Accelerator, warns that the Trump administration is considering changes to the Vaccine Injury Compensation Program, a policy that has…
    STAT · 5d agoRegulatoryNegative↗ source
  • Former FDA leaders denounce agency layoffs as historic disaster
    Three former Food and Drug Administration commissioners publicly condemned the recent staffing reductions at the agency, calling the moves a major failure of policy. Rob Califf, who served as FDA…
    STAT · 5d agoLayoffsNegative↗ source
  • Trump administration delays rule that could curb imported prescription drugs
    The Trump administration announced a 90‑day postponement of a federal rule that would have limited Americans’ ability to purchase prescription medicines from licensed pharmacies abroad. The rule w…
    STAT · 5d agoRegulatoryPositive↗ source
  • Sanofi avoids fine as EU ends antitrust probe over alleged disparagement of rival flu vaccine
    EU antitrust regulators have closed a probe into Sanofi after the company offered concessions, allowing it to avoid a monetary penalty. The investigation centered on a campaign that allegedly port…
    STAT · 5d agoRegulatoryNeutral↗ source
  • Study finds nearly 40% of FDA advisory panels include reps linked to pharma-funded advocacy groups
    A new analysis published in Health Affairs Scholar examined FDA advisory committee meetings over the past 20 years and found that almost 40% featured a patient or consumer representative with activ…
    STAT · 6d agoRegulatoryNegative↗ source
  • iOnctura’s roginolisib shows encouraging phase 1 results in metastatic uveal melanoma
    iOnctura, a spinout of Merck KGaA, reported data from a two‑part phase 1 trial of its PI3K delta inhibitor roginolisib in patients with advanced solid and hematologic cancers, including a cohort of…
    Fierce Biotech · 6d agoPositive readoutPositive↗ source
  • Beam Therapeutics reports early Phase 1/2 data for base editing therapy in GSD Ia, partners with Pfizer and Enodia
    Beam Therapeutics disclosed early results from a Phase 1/2 study evaluating a base editing approach aimed at correcting the genetic defect that causes glycogen storage disease type Ia, a rare metab…
    Endpoints · 6d agoPositive readoutNeutral↗ source