RESEARCH

Gilead gets WHO cold shoulder for remdesivir in COVID-19, launches speedy defense

Gilead | November 21, 2020

Gilead Sciences’ Veklury, better known as remdesivir, is so far the only COVID-19 therapy officially approved by the FDA, but the World Health Organization has some other ideas about the drug’s worth.

At clear odds with the FDA’s approval, the WHO has for now recommended against the use of remdesivir in any hospitalized patients—regardless of disease severity—after an expert panel said it had found no evidence that remdesivir has any meaningful effect on saving lives and other important outcomes for patients, the international body said Thursday.

A “disappointed” Gilead immediately fought back. It pointed to remdesivir’s inclusion in several other organizations’ guidelines based on data from a phase 3 trial by the National Institute of Allergy and Infectious Diseases (NIAID), which showed the drug’s use could lead to faster recovery.

Spotlight

The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.

Spotlight

The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.

Related News

Cannabis Industry Giant WayofLeaf.com Expands Health-Specific Content, Introduces Medical Review Team

Prnewswire | September 30, 2020

In a bid to improve the quality and availability of information on health-specific cannabis use, industry giant WayofLeaf.com has introduced a team of doctors and health experts to review thousands of topics relating to the use of medical cannabis and CBD for specific health conditions. The website, which for years has provided a reliable informational resource for medical cannabis patients, believes it is time for cannabis users of all types to have access to trustworthy, research-backed content on specific conditions and ailments. "There's no shortage of information out there in terms of using cannabis medicinally," says WayofLeaf Medical Director Dr. Lynn Marie Morski. "However there is a need for more trustworthy, research-backed information that medical cannabis and CBD users can rely on."

Read More

Intec Pharma Announces New Research Collaboration Agreement with MSD

Intec Pharma | October 08, 2020

Intec Pharma Ltd. ("Intec" or "the Company") today announces it has entered into a new research collaboration agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. Details of the agreement are confidential. "We are very excited to continue to work with MSD," said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "This new agreement builds upon the relationship we have enjoyed in prior research and allows the companies to leverage their combined experience in delivery."

Read More

PHARMACY MARKET

BC Platforms Adds Japans Mitsubishi Space Software to its Global Data Network

BC Platforms | February 21, 2022

BC Platforms (BCP), a global leader in healthcare data management and analytics, announced a new data partnership with Japan's Mitsubishi Space Software Co. Ltd. (Mitsubishi), one of the country's oldest bioinformatics companies. The collaboration, which provides secure access to Mitsubishi's cancer specific cohort of 8,000 patients, will accelerate the provision of cancer genetic data analysis services to medical institutions for cancer research. As part of the collaboration, Mitsubishi joins BCP's BCRQUEST network, which is revolutionizing drug development & personalizing care. This global, federated data partner network enables analytics and deeper insights. BCP has built this network, which reaches over 22 million patient lives in the catchment area, and data partners across Europe, North America, and Asia-Pacific to enable the realization of the full potential of real-world data. "At BCP, our mission is to accelerate the translation of research into global clinical practice through the faster generation of translatable, actionable, research insights. We encourage health systems to invest in consenting and data infrastructure as it provides strong foundations underpinning personalized medicine and ultimately improve outcomes for patients. Through our partnership with Mitsubishi, a long-standing leader in the field of bioinformatics, we expect patient lives will be directly, positively, impacted. This collaboration also adds significant data from millions of Asian patients to fuel research with connections to 30 hospitals in Japan. Such achievements are part of our continued efforts to scale our vision to build the world's leading analytics platform for healthcare and the life sciences industry." Nino da Silva, Deputy Managing Director, BCP Mitsubishi Space Software Co., Ltd., commented, "At Mitsubishi, we have long been supporting patients by utilizing and researching genomic research and providing cancer genetic data analysis services to medical institutions for cancer research. We are looking forward to working with BC Partners, and its BCRQUEST network, to enhance Japan's provision of clinical and genomic datasets to benefit research, patient care and personalized medicine." This latest data partnership builds on recent successes of delivering industry-leading interpretation services on genomics related insights, including pharmacogenomics in clinical practice in Asia and around the world. In October 2021, BCP announced its partnership with Bumrungrad International Hospital (BIH), in Bangkok, Thailand, one of the largest private hospitals in Southeast Asia and a world leader in healthcare delivery and pioneering clinical research. BCP is supporting BIH on its transition from single-gene tests to multi-gene panels for clinical pharmacogenetics, providing data interpretation support on single nucleotide variations. About BC Platforms BC Platforms is a global leader in providing a powerful data and technology platform for personalized medicine, accelerating the translation of insights into clinical practice. Our technology drives the infinite loop between personalized care and research discoveries, leveraging latest science, deep technical expertise, strategic partnerships, and harmonized, diverse data collections. Our high performing genomic data discovery and analytics platform enables flexible data integration, secure analysis, and interpretation of molecular and clinical information. Additionally, BC Platforms has developed a Global Data Partner Network BCRQUEST.com, which allows us to access real-world data equivalent to approximately 22 million patient lives, including longitudinal clinical data in addition to 500k patients' genetic data, across 14 countries in Europe, North and South America, Asia and Africa, providing rich data for pharmaceutical and medical research and development. About Mitsubishi Space Software Mitsubishi Space Software was established in 1962 as a system engineering company. Our cooperate mission is "We support future society with high-quality and highly reliable solutions based on advanced science and technology which are cultivated by space system development."

Read More