Merck's Keytruda, passing Opdivo, bags double head and neck cancer OK

fiercepharma | June 11, 2019

Tuesday was a twofer for Merck & Co., which notched two new FDA approvals for blockbuster Keytruda in previously untreated head and neck cancer patients. Regulators green-lighted the immuno-oncology star as monotherapy in patients whose tumors bear the biomarker PD-L1 and in combination with a commonly used chemo regimen in patients regardless of PD-L1 status. The regulatory wins follow a quick review from the agency, which bestowed its priority designation on Keytruda back in February. FDA staffers based the speed-up on data showing that that, when facing off against a standard-of-care regimen commonly referred to by the name “Extreme,” Keytruda could lower the risk of death by 22% in PD-L1 positive patients. And when paired with chemo, Keytruda slashed the risk of death by 23% regardless of patients’ PD-L1 status.

Spotlight

Recent reports of intrinsic contamination of drug products, including skin antiseptics in the United States have focused attention on the importance of strict adherence to established good manufacturing processes and the application of quality assurance measures in the manufacture of drug products. FDA investigations and recallsi, ii associated with these events have prompted concern from the Canadian scientific community and healthcare workers regarding the need for sterile antiseptic products.

Spotlight

Recent reports of intrinsic contamination of drug products, including skin antiseptics in the United States have focused attention on the importance of strict adherence to established good manufacturing processes and the application of quality assurance measures in the manufacture of drug products. FDA investigations and recallsi, ii associated with these events have prompted concern from the Canadian scientific community and healthcare workers regarding the need for sterile antiseptic products.

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BUSINESS INSIGHTS

Ginkgo Bioworks and Novo Nordisk to Collaborate on Expression Systems for Pharmaceutical Products

Ginkgo Bioworks and Novo Nordisk, | June 08, 2022

Ginkgo Bioworks the leading horizontal platform for cell programming, announced a collaboration with Novo Nordisk, a leading global healthcare company, to create novel expression hosts for pharmaceutical products. hundreds of millions of people are living with diabetes, obesity, and other serious chronic diseases, putting a strain on individuals, families, and healthcare systems. More effective medicines could improve treatment options for these people. Using synthetic biology, Ginkgo and Novo Nordisk will collaborate to unlock the potential of expression systems, which may accelerate and enhance the discovery and development of Novo Nordisk's biological medicines. "Novo Nordisk is constantly pushing the boundaries for innovative tools to bring new treatments to people living with diabetes and other serious chronic diseases. Using synthetic biology and the reprogramming of expression system genomes, we have the potential to engineer biological systems that will expand the chemical space of biological medicines." Brian Vandahl, Senior Vice President, Global Research Technologies, Novo Nordisk "It's an honor to work with partners like Novo Nordisk that not only have an incredible range of critically important products, but that also provide us with the opportunity to do meaningful work that could help so many patients," said Jason Kelly, CEO and cofounder of Ginkgo Bioworks. "At Ginkgo, we are always on the lookout for projects that will have an outsized impact on people's lives and well-being. We're excited to be working with Novo Nordisk in our efforts to use biology to create better medicines for patients with chronic diseases." Under the terms of the partnership, Ginkgo and Novo Nordisk will launch a multi-year collaboration. Ginkgo will receive an upfront R&D fee and is eligible to receive milestone payments as the parties advance in the collaboration. About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery.

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PHARMA TECH

Aidoc and Subtle Medical Partner to Bring End-to-End AI Solutions to Medical Imaging

Aidoc | September 15, 2021

Aidoc, leading provider of AI for medical imaging, announced today a partnership with Subtle Medical, developer of leading AI-based image enhancement bringing best-of-breed AI to both image acquisition and post-acquisition clinical workflows. Aidoc has developed the industry's most robust AI platform, delivering a unified and seamless cross-specialty AI experience for physicians in over 500 medical centers, including the largest clinical deployment of AI in healthcare at Radiology Partners. "Mainstream healthcare adoption of AI requires both a comprehensive package of premier AI solutions and an ability to deliver their results in a reliable and seamless manner across physician workflow, Through this partnership, we will provide health systems and imaging centers with Subtle Medical's optimal solution, now seamlessly delivered through a unified AI architecture. Our platform's ability to deliver interoperable AI solutions is a game changer for AI adoption." - Tom Valent, VP of Business Development at Aidoc. A pioneer in healthcare AI, Aidoc's FDA-cleared solutions analyze medical images for critical conditions and trigger actionable alerts directly in the imaging workflow supporting medical specialists in reducing turnaround time and improving quality of care. Subtle Medical's AI-powered software solutions, SubtlePET™ and SubtleMR™ are image enhancement tools that increase the efficiency of image capture by improving the quality of accelerated scans. This enables optimized scan times and can potentially increase the number of patients scanned per day. Subtle's solutions are compatible with all scanner brands, models and field strengths so institutions can see the benefit across their entire scanner fleet. "This agreement will provide our customers with a multimodality solution that includes acquisition workflow efficiencies and image quality improvements together with Aidoc's post-acquisition clinical workflow solutions, We believe that the integration of Subtle's AI-based software tools with the Aidoc platform will dramatically change the medical imaging equation." - Josh Gurewitz, Chief Commercial Officer at Subtle Medical. About Subtle Medical Subtle Medical, Inc. is a leading healthcare technology company making medical imaging faster, safer, and smarter. For more information, visit subtlemedical.com. About Aidoc Aidoc is the leading provider of artificial intelligence solutions that support and enhance the impact of physician diagnostic power - helping them expedite patient treatment and improve quality of care.

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RESEARCH

Pfizer and Biontech Nab Covid-19 Vaccine Authorization from U.K. For First-ever Marketed mRNA shot

Pfizer | December 03, 2020

The two organizations' BNT162b2 has become the primary COVID-19 immunization permitted in the Western world as medication controllers in the U.K. given out a crisis use approval on Wednesday, in front of choices by the U.S. also, Europe, which are normal soon. For the more extensive immunization world, the Medicines and Healthcare items Regulatory Agency's choice methods the world currently has the principal mRNA shot approved for far reaching use, opening up a fresh out of the box new part for antibody advancement. The principal portions will be conveyed to the U.K. quickly, the organizations said. A representative at the U.K's. Department of Health and Social Care said the antibody will be made accessible the nation over from one week from now. The U.K. has requested 40 million portions of the antibody—enough to immunize 20 million individuals—through an arrangement endorsed in July and extended in October. "As we envision further approvals and endorsements, we are centered around moving with a similar degree of criticalness to securely flexibly an excellent immunization around the globe. With a great many individuals turning out to be tainted, each day matters in the aggregate competition to end this staggering pandemic," Pfizer CEO Albert Bourla, Ph.D., said in an explanation, calling the U.K. gesture a "noteworthy second." Pfizer has appointed COVID-19 antibody assembling to three destinations in the U.S. also, one in Belgium. BioNTech has offices in Mainz and Idar-Oberstein in Germany, which have been delivering dosages for clinical preliminaries. The German biotech as of late purchased a Novartis plant in Marburg, Germany, to quicken business assembling of the COVID-19 immunization. In general, the two organizations have said they can create up to 50 million dosages in 2020 and up to 1.3 billion portions in 2021.

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