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#阿斯利康

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Oct 15Thu
  1. biospace.com69

    AstraZeneca bulks up MASH, cardio work in up to $1.5B AI partnership with insitro

    AstraZeneca will pay insitro up to $1.5 billion to discover drug targets for metabolic dysfunction-associated steatohepatitis and cardiomyopathies using insitro's Virtual Human AI platform. Insitro receives $40 million upfront and up to $1.46 billion in milestones plus royalties, while AstraZeneca advances any candidates through development. The deal adds to AstraZeneca's MASH work, which includes the Phase 1 anti-fibrotic asset AZD2389.

    Why it matters: A large pharma-AI target discovery deal in MASH and cardiomyopathies, indications where AstraZeneca has recent setbacks.

Oct 14Wed
  1. biospace.com48

    Alnylam bulls and bears fight it out after business-shaking guidance cut

    Alnylam cut full-year guidance by about $200 million after second-quarter sales of the TTR silencer Amvuttra in transthyretin-mediated amyloidosis fell short, and its stock has dropped from near $500 to around $250. Analysts at Guggenheim question whether the ATTR-CM opportunity is smaller than expected or whether stabilizers from Pfizer and BridgeBio are becoming preferred, while TD Cowen reiterated a $482 target and BMO argues the cut reflects second-line patient exhaustion. Alnylam is running Phase 3 trials of nucresiran in ATTR-CM and ATTR-PN, and a Phase 3 cardiovascular outcomes trial of zilebesiran in hypertension.

Oct 13Tue
  1. biopharmadive.com40

    Bausch + Lomb swaps CEOs; Merck reveals anticipated eye drug data

    Bausch + Lomb named board chair Thomas Appio interim CEO after he and Brent Saunders mutually agreed to Saunders' exit, and raised its 2026 earnings outlook. Merck disclosed that proliferative diabetic retinopathy adverse events occurred in 6.7% and 6.1% of remigromig patients versus 0.9% on Lucentis, with the drug not superior on secondary measures. Amgen and AstraZeneca reported nearly 70% of eosinophilic esophagitis patients on Tezspire's highest dose were in remission at 24 weeks; the FDA also approved Asahi Kasei's Hovilpri.

    Why it matters: CEO change at Bausch + Lomb plus pivotal safety and efficacy data on remigromig, Tezspire and a new HSV approval.

Oct 12Mon
  1. biopharmadive.com56

    Pharma’s $500B patent problem will come in waves — not as a cliff

    Evaluate forecasting data from Norstella show more than $500 billion in worldwide prescription drug sales at risk from generic competition between 2026 and 2032, with the largest single-year exposure of $158 billion in 2031. Merck is most exposed near term as Keytruda nears expiry in 2028, a year with $99 billion in sales at risk, while AbbVie faces roughly $50 billion of exposure in 2032 when Rinvoq and Skyrizi lose protection. Patent-exposed companies have responded with dealmaking since the start of 2024, led by Merck's six deals totalling $30.9 billion and Lilly's $27.2 billion across nine.

    Why it matters: Quantifies the multiyear patent-expiry risk facing major drugmakers and the dealmaking it is already driving.

Oct 5Mon
  1. nature.com75

    COPD trial wins spur broad respiratory hopes

    AstraZeneca's tozorakimab, an IL-33-targeted antibody, reduced COPD exacerbations by up to 30% in current and former smokers in two trials, with an FDA decision expected in the first quarter of 2027. Unlike dupilumab and mepolizumab, it worked across patients with all blood eosinophil counts, addressing non-eosinophilic COPD. The success, after mixed results for other IL-33 agents like itepekimab, is reviving industry interest in IL-33 and alarmin targets across respiratory disease.

    Why it matters: First IL-33 win in COPD works regardless of eosinophil count, reshaping the inflammatory biologic landscape.

Oct 2Fri
  1. biocentury.com44

    Trio of biotechs draw nine-figure fundings: Public Equity Report

    Immix Biopharma (NASDAQ:IMIX) raised $125 million in an offering underwritten by J.P. Morgan, announced minutes after an interim readout from the Phase II NEXICART-2 trial showed its BCMA-targeted CAR-T therapy NXC-201 achieved an 89% complete response rate among 45 patients with light-chain (AL) amyloidosis. Immix plans a BLA submission next year, when final data from the study are expected. Sagimet and Pyxis Oncology also raised nine-figure sums, alongside an AstraZeneca/Summit item.

Sep 30Wed
Sep 29Tue
  1. biospace.com52

    Summit snags $2B investment from AstraZeneca, clearing financial overhang

    AstraZeneca is investing $2 billion in Summit Therapeutics through a direct equity purchase of about 109,000 preferred shares, giving it roughly 12% of Summit's common shares at $18.36 per share, a 10% premium. The deal, expected to close within a week pending regulatory clearances, lifts Summit's cash to an estimated $2.5 billion and leaves it holding full rights to ivonescimab, the PD-1/VEGF bispecific, in its territories. The partners will also start trials pairing AstraZeneca's anti-CLDN18.2 ADC sonesitatug vedotin with ivonescimab in gastrointestinal cancers, while the FDA decides Summit's BLA for the NSCLC drug by Nov. 14.

    Why it matters: Large pharma is paying $2 billion for equity exposure to the PD-1/VEGF class without licensing ivonescimab.

  2. biopharmadive.com48

    AstraZeneca invests $2B in Summit, gaining ‘seat at the table’ for PD-1/VEGF drug push

    AstraZeneca will invest $2 billion in Summit Therapeutics by buying about 109,000 shares of convertible preferred stock, giving it roughly 12% ownership, or about 10.6% fully diluted. The companies will jointly test Summit's PD-1/VEGF drug ivonescimab with AstraZeneca medicines, starting with the ADC "Sone-Ve" in gastrointestinal tumors, and will share development costs while retaining rights to their own drugs. Ionescimab previously halved the risk of progression or death versus Keytruda in a Phase 3 lung cancer study, and the partnership may expand to further combinations.

Sep 17Thu
  1. STAT News57

    STAT+: England to cover AstraZeneca breast cancer drug, a result of U.K.-U.S. drug pricing deal

    English health authorities agreed to provide AstraZeneca's Enhertu through the NHS for women with metastatic breast cancer whose tumors have low levels of HER2, ending a years-long dispute. The decision extends the antibody-drug conjugate to an estimated 1,000 people in England and follows a U.S.-U.K. drug pricing deal under which a U.K. health agency raised cost-effectiveness thresholds. Scotland has covered the drug since 2023, as have 26 other European countries.

Sep 11Fri
  1. nature.com61

    Selective oestrogen receptor degrader class grows with new cancer approval

    The FDA has approved AstraZeneca's camizestrant (Etcamah), a selective oestrogen receptor degrader, as part of a combination therapy for a subset of breast cancer patients. The drug targets patients whose tumours have acquired resistance mutations to aromatase inhibitors. It expands the SERD class of therapies.

    Why it matters: FDA approval of a new SERD widens treatment options for aromatase inhibitor-resistant breast cancer.

Sep 8Tue
  1. N Engl J Med63

    Tozorakimab to Prevent COPD Exacerbations.

    Add-on tozorakimab, an interleukin-33 inhibitor, cut the annualized rate of moderate or severe COPD exacerbations by roughly 30% in two replicate phase 3 trials, OBERON and TITANIA, with no eosinophil-count eligibility criteria. Among former smokers, rates fell from 1.90 to 1.34 events per year (rate ratio 0.71) in OBERON and from 2.07 to 1.37 (rate ratio 0.66) in TITANIA. It offers a biologic option for exacerbation prevention independent of eosinophil status.

    Why it matters: Phase 3 data show an IL-33 biologic reduces COPD exacerbations regardless of eosinophil count.

Sep 5Sat
  1. fda.gov59

    FDA Grants Accelerated Approval to a New Breast Cancer Treatment

    The FDA granted accelerated approval to AstraZeneca's Etcamah (camizestrant), an oral tablet, combined with a CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer whose tumors show an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, detected by the FDA-authorized Guardant360 CDx companion diagnostic. In the pivotal trial, estimated median progression-free survival was 16 months versus 9.2 months for continuing an aromatase inhibitor plus a CDK4/6 inhibitor. The label carries a boxed warning for irregular heart rhythm, and confirmatory trials are required to verify clinical benefit.

    Why it matters: First FDA approval of a cancer therapy guided by ctDNA resistance-mutation detection before imaging shows progression.

Sep 1Tue
  1. N Engl J Med78

    Eplontersen for Transthyretin Amyloid Cardiomyopathy.

    Eplontersen, an antisense oligonucleotide that reduces hepatic transthyretin production, did not reduce cardiovascular death or recurrent cardiovascular events in transthyretin amyloid cardiomyopathy. In the phase 3 CARDIO-TTRansform trial, 1432 patients received subcutaneous eplontersen 45 mg or placebo every 4 weeks for 140 weeks; the primary composite occurred at a rate ratio of 0.89 (95% CI, 0.73 to 1.09; P = 0.28). The finding leaves no demonstrated outcome benefit for eplontersen on top of standard treatment in ATTR-CM.

    Why it matters: Negative phase 3 result for eplontersen in 1432 patients with ATTR-CM at 140 weeks.

Aug 30Sun
  1. nature.com59

    Eplontersen with and without background transthyretin stabilizers in transthyretin amyloid cardiomyopathy: secondary analysis of a phase 3, randomized controlled trial

    A secondary analysis of the CARDIOTTRansform phase 3 randomized controlled trial found that eplontersen, a transthyretin-targeting antisense oligonucleotide, benefited patients with transthyretin amyloid cardiomyopathy who were not on transthyretin stabilizers at baseline, but showed no such effect in those already taking stabilizers. The result separates responders from non-responders by background therapy. Findings were presented at the 2026 ESC Congress.

    Why it matters: It identifies baseline transthyretin stabilizer use as a factor determining which cardiomyopathy patients benefit from eplontersen.

Aug 24Mon
  1. FiercePharma56

    Merck, AZ lawsuits against Medicare price negotiations swatted down

    The U.S. Court of Appeals for the Third Circuit rejected Merck's claim that the CMS Medicare drug price negotiation program under the Inflation Reduction Act violates the First and Fifth Amendments, with Judge Colleen Kollar-Kotelly ruling companies can choose whether to participate. Five days earlier, a federal court in Maryland dismissed an AstraZeneca suit over how CMS grouped its drugs for eligibility. The rulings extend a string of losses for drugmakers since 2022, though Teva won a partial reversal last week when an appeals court sent its case back to District Court.

  2. fiercepharma.com47

    Daiichi Sankyo promotes Ken Keller to lead new commercialization unit

    Daiichi Sankyo has promoted Ken Keller, who has led its global oncology business for five years, to chief commercialization officer of a new globally integrated commercialization unit starting April 1. The restructured organization covers five regions, with internal appointments including Yuichi Yomasu in China, Markus Kosch in Europe, Marcelo Goncalves in Latin America, Kenji Shigeta in North America and Nobuo Murakami in Japan, Asia and the Pacific. The unit supports Daiichi Sankyo's plan to become a top-five oncology company by 2035 and to make five drugs available in 20 new indications by 2030.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org