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Amgen's 'watershed' lung cancer drug nabs FDA nod in deadly, tough-to-treat form of the disease

Fierce Pharma

Seven months after Amgen’s chief medical officer referred to trial | Seven months after Amgen’s chief medical officer referred to trial results for the company's investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC). (..)

FDA 225
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China’s NMPA approves Henlius’ monoclonal antibody to treat ES-SCLC

Pharmaceutical Technology

The National Medical Products Administration (NMPA) of China has approved Shanghai Henlius Biotech ’s monoclonal antibody Hansizhuang (serplulimab injection) along with carboplatin and etoposide to treat extensive stage small cell lung cancer (ES-SCLC). Hansizhuang is the company’s first self-developed anti-PD-1 monoclonal antibody (mAb).

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Serplulimab increases survival in small cell lung cancer patients

European Pharmaceutical Review

A Phase III trial from Shanghai Henlius Biotech is the first study to suggest that the programmed cell death (PD) 1 receptor immune checkpoint inhibitor Hansizhuang (serplulimab) plus chemotherapy can markedly improve survival for extensive-stage small cell lung cancer (ES-SCLC) patients.

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FDA approves Amgen T-cell engager for small cell lung cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). FDA’s approval of Imdelltra was based on results from the Phase II DeLLphi-301 clinical trial.

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Lonza to acquire major biologics manufacturing facility

European Pharmaceutical Review

These include existing mammalian manufacturing facilities sited in Visp (CH), Slough (UK), Singapore (SG), Portsmouth (US) and Porriño (ES). More about the deal Upon closing of the deal, the US Vacaville site will be integrated into Lonza’s Biologics division.

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The Value of An Executive Sponsor with Tech Transfers

PharmaTech

The relationship you build with your executive sponsor (ES) is the most critical relationship you will build with your CDMO partner and will serve as the foundation for long-term commercial success.

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Trilaciclib Protects Against Chemotherapy-Induced Myelosuppression

Pharmacy Times

Treatment's approval marks exciting new development for patients with ES-SCLC to prevent CIM.