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  • FDA advisory committee meetings sow confusion, threaten trust with rare disease developers
    The Food and Drug Administration has been working to repair its relationship with rare-disease drug makers and patient groups since former commissioner Marty Makary left three months ago. Last wee…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Gilead pushes into inflammation and oncology as it seeks to diversify beyond HIV franchise
    Gilead reported that HIV remained its strongest franchise in the second quarter, but the company is actively building a pipeline outside virology. CEO Daniel O’Day told investors that diversificat…
    BioSpace · 1mo agoNeutral↗ source
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  • Amgen drops Phase 1 obesity drug AMG 513, leaving MariTide as its only weight-loss candidate and eyes early-stage deals
    Amgen announced it is halting development of AMG 513, a Phase 1 obesity therapy, leaving MariTide as its sole weight‑loss asset. The company said its late‑stage pipeline is largely full, so future…
    BioSpace · 1mo agoDealNeutral↗ source
  • Novo Nordisk CEO says innovation is essential as pipeline faces setbacks
    During Novo Nordisk's second-quarter earnings call, CEO Maziar Mike Doustdar said that failure is a normal part of drug development and emphasized that the company's survival depends on continual i…
    BioSpace · 1mo agoEarningsNeutral↗ source
  • Expedition Therapeutics raises $115M Series B for China-sourced COPD candidate
    Expedition Therapeutics, a US biotech, announced a $115 million Series B financing round. The capital will be used to advance its COPD drug candidate that is being developed from a China-sourced p…
    Endpoints · 1mo agoDealPositive↗ source
  • Expedition Therapeutics secures $115M Series B to advance China-origin COPD drug
    Expedition Therapeutics, a biotech that licenses drugs from Chinese firms, announced a $115 million Series B financing that will fund mid-stage testing of its experimental COPD candidate. The fund…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Merger talks between Bristol Myers Squibb and AstraZeneca fade as Q2 earnings roll out and FDA advisory meetings heat up
    Talks of a possible merger between Bristol Myers Squibb and AstraZeneca have receded after analysts highlighted antitrust hurdles. Both companies, each valued over $130 billion, were rumored to con…
    BioSpace · 1mo agoDealNeutral↗ source
  • Five BioSpace NextGen companies debut on US markets in 2026, four actively hiring
    BioSpace NextGen honorees accounted for about one third of the 14 U.S. biotech companies that went public in 2026. The five companies together raised roughly $1.5 billion in IPO proceeds, includin…
    BioSpace · 1mo agoPositive↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 1mo agoCRLNegative↗ source
  • WuXi AppTec posts six-month revenue higher than Lonza for first time
    WuXi AppTec, a Chinese contract manufacturing organization, has reported that its revenue over the most recent six-month period exceeded that of Swiss CDMO Lonza for the first time. The increase c…
    Endpoints · 1mo agoPositive↗ source
  • Gilead reports modest sales rise but analysts question future growth beyond HIV drugs
    Gilead's second‑quarter results showed total product revenue of $7.6 billion, up 8% year‑over‑year. The company's two leading HIV treatments, Biktarvy and Descovy, together generated about $5.7 bi…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • AstraZeneca and Bristol Myers Squibb abandon merger talks
    Reuters reported that AstraZeneca and Bristol Myers Squibb have ended discussions about a possible merger and will not pursue a deal. The collapse of the talks removes a potential consolidation th…
    Endpoints · 1mo agoDealNegative↗ source
  • Senate confirms Erica Schwartz as new CDC director
    The U.S. Senate voted 51 to 44 on Wednesday to confirm Erica Schwartz as the next director of the Centers for Disease Control and Prevention. Schwartz, a former deputy surgeon general and a vetera…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Atossa Therapeutics CEO Steven Quay likely to become NIAID director
    Steven Quay, founder and CEO of Atossa Therapeutics, is reported to be the likely choice for director of NIH's National Institute of Allergy and Infectious Diseases. The report notes his backgroun…
    Endpoints · 1mo agoNeutral↗ source
  • Aurora Therapeutics drops PKU program and trims staff
    Aurora Therapeutics, a gene-editing startup founded by Jennifer Doudna, announced it is abandoning its lead phenylketonuria (PKU) program. The decision follows growing competition in the PKU field…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • Fujifilm Biotechnologies appoints COO Maja Pedersen as new president after Lars Petersen steps down
    Fujifilm Biotechnologies announced that its chief executive officer and president, Lars Petersen, has stepped down effective immediately. The company said the transition will be seamless as the cur…
    Endpoints · 1mo agoNeutral↗ source
  • Alphabet reshuffles AI leadership as DeepMind CEO steps down to become chief scientist
    Alphabet announced a reorganization of its artificial intelligence leadership. Demis Hassabis will leave his role as chief executive of Google DeepMind and take on the position of chief scientist f…
    Endpoints · 1mo agoNeutral↗ source
  • Novo Nordisk shares slide 6% after Wegovy pill sales miss despite earnings beat
    Novo Nordisk reported second‑quarter results that beat both revenue and profit forecasts, posting a profit of $5.15 billion. The company’s oral Wegovy obesity pill generated $496 million in sales,…
    BioSpace · 1mo agoEarningsNegative↗ source
  • Vertex posts strong Q2 earnings, but upcoming Sionna cystic fibrosis data casts a shadow
    Vertex reported Q2 revenue from its cystic fibrosis portfolio exceeding $3.2 billion, beating estimates and prompting an upward revision of full‑year revenue guidance to $13.1‑$13.2 billion. Analy…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • BioNTech trims full-year COVID-19 vaccine sales outlook by up to 20% amid weak demand
    BioNTech announced it is lowering its full-year sales guidance for its COVID-19 vaccine. The company cut the midpoint of its outlook by almost 20%, moving the range to €1.6-1.9 billion from the pr…
    BioSpace · 1mo agoEarningsNegative↗ source
  • Otsuka's Voyxact hits key secondary endpoint in Phase 3 IgA nephropathy trial as BioNTech cuts revenue outlook
    Otsuka announced that its experimental kidney drug Voyxact met a key secondary endpoint in the Phase 3 VISIONARY study of patients with IgA nephropathy. The positive result suggests the therapy ha…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Pathos AI signs two cancer deals, including $2 bn contract with China's Alphamab and partnership with AstraZeneca
    Pathos AI announced two new collaborations to expand its oncology pipeline, one with AstraZeneca and another with a subsidiary of China's Alphamab Oncology. The deal with Jiangsu Alphamab Biopharm…
    BioSpace · 1mo agoDealPositive↗ source
  • Pathos AI signs major ADC partnership with Chinese biotech Alphamab and targets up to $300M Series E raise
    Pathos AI, a technology and drug development company, announced a major antibody‑drug conjugate (ADC) collaboration with Chinese biotech Alphamab. The firm also disclosed a partnership with AstraZ…
    Endpoints · 1mo agoDealPositive↗ source
  • Hinge Health to acquire Cylinder Health for $105 million, expanding into digestive care
    Hinge Health, known for virtual physical therapy, announced it will purchase digestive health startup Cylinder Health. The transaction is a cash deal valued at $105 million, marking Hinge's latest…
    Endpoints · 1mo agoDealPositive↗ source
  • Pfizer CEO says $7 billion cash ready for bolt‑on acquisitions and dividend will stay intact
    During its second‑quarter earnings call, analysts asked Pfizer if the company would increase M&A spending as rivals rush to buy biotech assets. CEO Albert Bourla replied that Pfizer currently has…
    BioSpace · 1mo agoDealPositive↗ source