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  • Novartis beats sales expectations as Q2 revenue rises to $14.4B, eyes upcoming study readouts
    Novartis reported a modest rise in second‑quarter sales, lifting its share price after the company posted a 1% increase in net sales to $14.4 billion, surpassing analyst forecasts for a decline. A…
    BioPharma Dive · 28d agoEarningsPositive↗ source
  • Dyne Therapeutics receives early 2027 FDA decision date for Duchenne therapy, analysts anticipate smooth review
    Dyne Therapeutics' investigational Duchenne muscular dystrophy therapy, zeleciment rostudirsen, has had its BLA accepted by the FDA with a target action date of Jan 21, 2027. Analysts at Oppenheim…
    BioSpace · 28d agoRegulatoryPositive↗ source
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  • Samsung Biologics proposes $1.8B acquisition of PolyPeptide to enter fast-growing obesity peptide market
    Samsung Biologics, a South Korean contract development and manufacturing organization, announced an offer to acquire Swiss CDMO PolyPeptide for CHF 1.46 billion (about $1.8 billion). PolyPeptide s…
    BioSpace · 28d agoDealPositive↗ source
  • Novo Nordisk sues Eli Lilly over alleged misleading obesity drug ads
    Novo Nordisk filed a lawsuit in a New Jersey federal court accusing Eli Lilly of deceptive advertising for its GLP-1 obesity medicines. The action follows a cease-and-desist request that asked Lil…
    BioPharma Dive · 28d agoRegulatoryNegative↗ source
  • Gilead and Merck to unveil detailed Phase 3 results of once‑weekly oral HIV regimen at AIDS 2026; Dimension Capital launches $800M fund
    Gilead Sciences and Merck announced that they will present detailed results from their Phase 3 trials of a once‑weekly oral HIV treatment regimen at the upcoming AIDS 2026 conference. The data wil…
    Endpoints · 28d agoNeutral↗ source
  • Novartis says it will keep seeking sub-$2 billion bolt-on deals worldwide, staying geography-agnostic
    Novartis CEO Vas Narasimhan told investors on the second‑quarter earnings call that the company will continue to pursue bolt‑on acquisitions below $2 billion and has no plans to overhaul its busine…
    BioSpace · 28d agoDealNeutral↗ source
  • FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study
    The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • FDA to appoint permanent heads of CBER and CDER alongside new commissioner
    The FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…
    Endpoints · 28d agoRegulatoryNeutral↗ source
  • Agios halts development of sickle cell drug tebapivat after mid-stage trial failure
    Agios announced it will stop developing tebapivat for sickle cell disease after a mid-stage trial did not meet expectations. The drug, a next-generation pyruvate kinase activator related to the ap…
    BioPharma Dive · 28d agoNegative readoutNegative↗ source
  • Agios halts development of next‑generation sickle‑cell drug tebapivat after disappointing mid‑stage trial
    Agios Therapeutics announced it will discontinue development of tebapivat, a next‑generation therapy for sickle cell disease, after the drug failed to demonstrate sufficient efficacy in a Phase 2 t…
    Endpoints · 28d agoNegative readoutNegative↗ source
  • Agios drops next-gen sickle cell drug after Phase 2 data show no advantage over Novo’s candidate
    Agios Pharmaceuticals said it is halting development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a mid‑stage trial failed to demonstrate a benefit ove…
    BioSpace · 28d agoNegative readoutNegative↗ source
  • Broad Institute, Boston Children’s Hospital and Jackson Laboratory launch nonprofit to advance affordable gene therapies for rare diseases
    The Broad Institute, Boston Children’s Hospital and Maine’s Jackson Laboratory announced a new collaboration to develop gene‑based treatments for rare genetic disorders. The three institutions will…
    STAT · 28d agoDealPositive↗ source
  • Anthropic expands rare disease collaborations as Novo sues Lilly and Agios halts sickle cell drug
    Anthropic, a biotech firm, announced it is expanding its partnership portfolio focused on rare disease therapeutics, deepening collaborations with several companies to advance pipeline candidates.…
    STAT · 28d agoDealNeutral↗ source
  • Novo Nordisk sues Eli Lilly over allegedly deceptive obesity and diabetes ads
    Novo Nordisk has filed a federal lawsuit against Eli Lilly, accusing the rival of running misleading advertisements for its obesity and diabetes medicines. The company claims Lilly's ads rely on ou…
    STAT · 28d agoRegulatoryNegative↗ source
  • FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gains
    The FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…
    BioSpace · 28d agoRegulatoryPositive↗ source
  • Broad Institute partners with Boston Children’s Hospital and Jackson Lab to launch Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard announced a partnership with Boston Children’s Hospital and the Jackson Laboratory to create a Center for Therapeutic Genetics focused on rare diseases. The…
    Endpoints · 28d agoPositive↗ source
  • Novo Nordisk sues Eli Lilly, alleging deceptive ads that misrepresent GLP-1 drug efficacy
    Novo Nordisk filed a lawsuit in federal court in New Jersey accusing Eli Lilly of running a deceptive advertising campaign. The complaint says Lilly’s ads compare the highest doses of its weight‑l…
    STAT · 28d agoRegulatoryNegative↗ source
  • Axiom Biosciences targets Hong Kong IPO to raise up to $200 million for regenerative therapy pipeline
    Axiom Biosciences, a San Diego‑based biotech, announced plans to list on the Hong Kong Stock Exchange rather than the traditional U.S. exchanges. The company aims to use the offering to secure new…
    BioSpace · 28d agoDealPositive↗ source
  • Rare-disease biotech coalition urges Trump admin to carve out orphan drugs from Medicare price-cut pilots
    Biotech firms formed the Rare Disease Company Coalition and met with the White House Office of Management and Budget to discuss excluding orphan drugs from two Medicare price‑cut pilot programs. T…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Novo Nordisk files lawsuit against Eli Lilly over allegedly deceptive GLP-1 dose ads
    Novo Nordisk has initiated legal action against Eli Lilly in a U.S. court, alleging that Lilly's recent advertisements misrepresent the dosing of GLP-1 obesity treatments. The company says the ads…
    Endpoints · 28d agoNegative↗ source
  • Rare disease drugmakers brace for potential Trump administration price cuts amid GOP push on health‑care fraud
    Rare disease drugmakers are watching the Trump administration closely as proposals emerge that could force lower prices for their specialty therapies. The companies are exploring strategies to miti…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Novartis CEO says China partnerships driven by science, not market strategy
    Novartis chief executive Vas Narasimhan told reporters during the second quarter earnings call that the company’s recent agreements in China are motivated by scientific opportunities rather than a…
    Endpoints · 28d agoDealNeutral↗ source
  • Dimension raises $800 million for third fund to boost AI-driven biotech ventures
    Dimension, a venture capital firm focused on the intersection of technology and biotech, announced the closing of its largest fund to date, raising $800 million for its third fund, called Dimension…
    BioPharma Dive · 28d agoDealPositive↗ source
  • Advocates warn federal HIV prevention funding cuts could force community groups to close
    Community-based organizations that deliver HIV testing and prevention tools are urging federal health officials to restore a key funding program that recently expired. Advocates say the lapse thre…
    STAT · 28d agoRegulatoryNegative↗ source
  • A-Alpha Bio launches AI antibody data consortium with GSK, Boltz and partners
    A-Alpha Bio, a spin‑out founded by David Baker, announced the creation of a new consortium focused on sharing antibody design data. The group aims to address a shortage of high‑quality data that b…
    Endpoints · 28d agoDealPositive↗ source