Fri.Mar 29, 2024

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EC approves Merck’s KEYTRUDA regimen for NSCLC treatment

Pharmaceutical Technology

The EC has approved Merck’s KEYTRUDA regimen for adult patients with resectable non-small cell lung cancer at increased recurrence risk.

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The Rising Tide of Biopharma Manufacturing Costs

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses the specific factors contributing to rising manufacturing costs.

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Intravacc, Primrose to advance conjugate vaccine development

Pharmaceutical Technology

Intravacc and Primrose Bio have announced a strategic collaboration aimed at bolstering the conjugate vaccine development and supply.

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GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law Blog

By John W.M. Claud & Kalie E. Richardson — While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. Inspections went down—way down—during the pandemic. In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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China NMPA accepts Astellas’ sBLA for urothelial cancer treatment

Pharmaceutical Technology

The CDE of the China NMPA has accepted Astellas Pharma’s sBLA for enfortumab vedotin plus KEYTRUDA to treat urothelial cancer.

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Too Good To Go: Providing Hope in the Fight Against Food Waste

XTalks

Andrea Li, head of Canadian operations at Too Good To Go In the fight against food waste, Too Good To Go stands out with their commitment to innovation and sustainability. This pioneering company has quickly become an industry leader, leveraging technology to bridge the gap between surplus food and hungry consumers. Xtalks spoke to Andrea Li, head of Canadian operations at Too Good To Go, to learn valuable insights into how the company is changing the landscape of food sustainability.

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Japan becomes first country to approve Astellas’ gastric cancer mAb

Drug Discovery World

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Vyloy (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. Vyloy is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world. Gastric cancer is the third deadliest cancer in Japan, with 126,724 cases diagnosed in 2022.

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A Further Examination of Pharmacy Benefit Managers

Pharmaceutical Commerce

Brandon Newman joins The Pharmaceutical Commerce Podcast to discuss the evolving role of PBMs, including the importance of drug price transparency.

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Disappointment for BMS as Zeposia fails Crohn’s study

pharmaphorum

Bristol-Myers Squibb's Zeposia has failed to outperform placebo in its first phase 3 test in Crohn's disease

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Pharma Pulse 3/29/24: Social Media Users Turn to Twitter for Guidance on Birth Control, Wider Availability of Oral Contraceptives & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.