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2,395 stories matching this filter · ← front page

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  • 2026 Nobel Chemistry Prize honors research on chiral molecules with implications for drug development
    Henri B. Kagan, 95, and Kenso Soai, 76, received the 2026 Nobel Prize in chemistry for their work on asymmetric organic synthesis. Their research uncovered how certain reactions can act as their o…
    STAT · 14d agoPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 14d agoRegulatoryNeutral↗ source
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  • Trump administration proposes $70,000 fee for OPT program, raising concerns for biotech talent pipeline
    The Department of Homeland Security announced a proposal to charge $70,000 for the Optional Practical Training (OPT) program, which allows international students on F-1 visas to work in the United…
    STAT · 14d agoRegulatoryNegative↗ source
  • PhRMA sues Trump administration over Medicare GLOBE price pilot
    PhRMA filed a lawsuit in the U.S. District Court for the District of Columbia challenging the Trump administration's GLOBE pilot that would tie Medicare Part B drug prices to those in peer nations.…
    STAT · 14d agoRegulatoryNegative↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda in several European markets
    A Dutch court has ruled that Merck infringed a patent covering a subcutaneous formulation of its cancer drug Keytruda. The decision requires the company to stop manufacturing and marketing that ver…
    STAT · 14d agoRegulatoryNegative↗ source
  • Forbion secures $2.6 billion in its biggest European venture fund to date
    Forbion, a leading European venture capital firm, announced it has closed a $2.6 billion fund, the largest it has raised and among the biggest recent funds in the region. The new capital will be d…
    STAT · 14d agoDealPositive↗ source
  • Biotech VC Forbion raises record €2.3 bn ($2.6 bn) to back 30 high-potential life-science companies
    Forbion announced a record fundraising of €2.3 bn ($2.6 bn) across two new funds, bringing its assets under management to about €7.5 bn ($8.4 bn). The capital will be allocated through the Forbion…
    BioSpace · 14d agoDealPositive↗ source
  • DOJ expands fraud enforcement to include drug and device makers under FD&C Act
    The Justice Department's National Fraud Enforcement Division released a new directive aimed at combating white-collar fraud, highlighting violations of the Federal Food, Drug, and Cosmetic Act. In…
    STAT · 14d agoRegulatoryNegative↗ source
  • Bayer invests $2.2 billion in Ohio to build pharma manufacturing plant
    Bayer announced a $2.2 billion investment to construct a new pharmaceutical manufacturing complex in New Albany, Ohio. The plant will produce drug substances and finished products for oncology, ca…
    BioSpace · 14d agoDealNeutral↗ source
  • Experimental exon-skipping drug from Avidity Biosciences shows early improvement in a Duchenne patient
    A recent story follows two teenage boys living with Duchenne muscular dystrophy, a rare and fatal muscle‑wasting condition. While one boy’s health continues to decline, the other, a 12‑year‑old nam…
    STAT · 14d agoPositive↗ source
  • Caribou Biosciences shuts down after failing to fund late-stage CAR-T lymphoma trial
    Caribou Biosciences, a biotech co-founded by Nobel laureate Jennifer Doudna, announced it is shutting down. The closure follows the company's inability to raise the funding required for a Phase 3…
    STAT · 14d agoNegative↗ source
  • Venture capital continues to flow into biopharma in Q3 2026, favoring later-stage and AI-driven companies
    Venture capital funding into biopharma topped $16 billion in the first half of 2026 and kept rising in the third quarter, according to industry sources. Investors remain selective, directing money…
    BioSpace · 14d agoDealNeutral↗ source
  • Utah health AI pilots face regulatory uncertainty as FDA scrutiny looms
    Utah has launched an AI sandbox that allows health-focused artificial-intelligence projects to be tested in real-world settings. The initiative aims to accelerate innovation while monitoring safety…
    STAT · 14d agoRegulatoryNeutral↗ source
  • WHO issues first global guidelines on childhood and adolescent obesity
    The World Health Organization has released its inaugural set of guidelines aimed at tackling the rapid increase in obesity among children and adolescents. The agency notes that in 2024, about 170 m…
    STAT · 14d agoRegulatoryNeutral↗ source
  • Executive candidates need full truth, not a sales pitch, to address company challenges
    The article argues that candidates for senior roles must be given an honest picture of the company's problems rather than a polished sales narrative. It notes that during executive searches, infor…
    BioSpace · 14d agoNeutral↗ source
  • ER visits by foreign-born patients fall sharply after increased ICE raids in Los Angeles
    A new study of three Los Angeles emergency rooms found that visits by people born outside the United States dropped sharply after a rise in ICE immigration raids last year. The researchers linked…
    STAT · 14d agoNegative↗ source
  • Democrats court new Make America Healthy Again voters with food and environmental proposals
    Democrats are reaching out to a new constituency called the Make America Healthy Again (MAHA) voters as the 2026 midterm elections approach. Party leaders have met with MAHA activists, discussed c…
    STAT · 14d agoNeutral↗ source
  • Life insurers deem active-surveillance prostate cancer 'untreated' and deny term coverage, says patient
    Howard Wolinsky, a medical journalist, recounts that after his term life policy expired, eight insurers rejected his application because they considered his prostate cancer, managed by active surve…
    STAT · 14d agoNegative↗ source
  • Epkinly shows 51% PFS boost in frontline DLBCL, may become new standard of care
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a substantial gain in progression‑free survival when added to the standard R‑CHOP regimen in newly diagnosed diffuse large…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • AstraZeneca launches $1 billion R&D hub in Boston’s Kendall Square
    AstraZeneca opened a new research and development site in Kendall Square, Boston, marking a $1 billion investment in the U.S. biotech corridor. The Boston location underscores the company’s commit…
    STAT · 15d agoNeutral↗ source
  • U.S. government launches first federally funded ibogaine trials for opioid addiction and PTSD
    The Trump administration announced the start of the United States' first government‑funded clinical trials of ibogaine, a psychedelic compound being investigated for its potential to treat opioid u…
    STAT · 15d agoRegulatoryPositive↗ source
  • Compliance worries keep AI adoption in drug manufacturing low, survey finds
    A new survey of more than 400 research and manufacturing professionals shows that over 90% of drugmakers have not committed to expanding AI use in regulated drug production. While AI is widely em…
    BioSpace · 15d agoRegulatoryNegative↗ source
  • Experts warn FDA against approving Grail’s ineffective multicancer blood test
    Physician and cancer‑screening researcher H. Gilbert Welch argues that the FDA should not greenlight Grail’s multicancer blood test, noting the company’s trial of 140,000 participants used a weak s…
    STAT · 15d agoRegulatoryNegative↗ source
  • BioSpace honors 40 emerging leaders shaping biopharma with breakthroughs in mRNA, gene and cell therapies
    BioSpace announced its latest 40 Under 40 cohort, recognizing young professionals who have made notable contributions across biopharma. The honorees span a range of roles, from scientific innovator…
    BioSpace · 15d agoPositive↗ source
  • UK regulator adopts AI framework for medical devices and launches third AI Airlock phase
    The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK government has adopted a set of recommendations on the use of artificial intelligence in medical devices. These…
    raps · 15d agoRegulatoryNeutral↗ source