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Research & Development

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ESMO: Evidence Piles Up For AZ’s Tagrisso With ADAURA CNS Data

A new analysis of the ADAURA study shows that Tagrisso’s disease-free survival benefits in early stage EGFRm NSCLC are replicated for brain metastases, a common complication with a poor prognosis. Filings and OS data await.

Cancer Clinical Trials Companies

Clinical Trials

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Latest From Clinical Trials

Nearly One Year Post-Celgene: BMS CMO On Pipeline Progress, Clinical Trial Diversity

Chief medical officer Samit Hirawat outlines R&D successes – though there have been some setbacks since it bought Celgene for $74bn last year – and the company’s commitment to clinical trial diversity.

Research and Development Strategies Clinical Trials

Akero Looks To Accelerate Path To Pivotal NASH Data With Phase IIb/III Protocol

Akero gets FDA’s ok to conduct Phase IIb/III study of FGF21 analog efruxifermin in biopsy-confirmed non-alcoholic steatohepatitis patients. With NASH leadership up in the air, Akero, 89bio and other FGF analog sponsors jockey for top spot.

Clinical Trials Drug Approval Standards

Anti-Tau For Alzheimer's In The Dock After Semorinemab Fail

Hopes that the Phase II TAURIEL trial could potentially validate the anti-tau antibody approach to treating Alzheimer's have been dashed as semorinemab did not meet its endpoints.

Neurology Clinical Trials

ESMO: Sanofi/Regeneron’s Latecomer Anti-PD-1 Libtayo Looking Likely In NSCLC

Sanofi/Regeneron’s anti-PD-1 product Libtayo may be late to the NSCLC party but strong data from EMPOWER-Lung 1 suggest it could gain traction in the space, especially in patients with high PD-L1 expression levels.

Clinical Trials Companies

Intrathecal Zolgensma Delay Could Allow Competitors To Shine

The rollercoaster ride continues for Novartis’s gene therapy Zolgensma, with the company committing to providing further clinical data on an intrathecal formulation for older spinal muscular atrophy patients.

Clinical Trials Gene Therapy

ESMO: Merck & Co Vibostolimab Data Are Another Validation Of TIGIT

A number of anti-TIGIT drugs are jockeying for position to provide benefit as monotherapies and in combinations for non-small cell lung cancer and Merck's offering is looking to challenge Roche's tiragolumab for the lead.

ImmunoOncology Clinical Trials
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Approvals

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Latest From Approvals

Pipeline Watch: Phase III Starts For CAEL-101, Etrasimod And NewGam

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Pipeline Watch: Phase III Starts For Fenebrutinib, Chikungunya Vaccine, Fruquintinib

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

GSK's Trelegy Ellipta Is First Triple Combination Approved For Asthma In the US

Trelegy, already approved for COPD, will be targeted to the roughly one-third of asthmatics not controlled on maintenance therapy.

Respiratory Approvals

Stockwatch: Winlevi And Aimmune Excitement Will Be Short-Lived

Apparently positive news for two unglamorous indications – acne and allergy – should be balanced against restrictive reimbursement and market fragmentation.

Stockwatch M & A

FDA OKs Blueprint/Roche's Gavreto As Rival To Lilly's Retevmo

Regulators in the US have approved Gavreto for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, setting the stage for a head-to-head battle for market share with Eli Lilly's Retevmo.

Approvals Cancer

Pipeline Watch: Liver Disease Candidates Dominate

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals
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