A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
Computational disease modeling company Cytoreason Ltd. is expanding its reach into Asia with a recent partnership with South Korean big data company Helixrus Inc., which is focused on biological big data and multiomics. The alliance will focus on leveraging Helixrus’ deep knowledge of the South Korean pharmaceutical market, and extensive network of relationships in Asian markets, to highlight Cytoreason’s capabilities in prioritizing new targets, finding biomarkers, profiling combinations, stratifying patients and other use cases within the drug lifecycle.
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
The flop that is Aduhelm (aducanumab) made itself felt in Biogen Inc.’s executive suite as CEO Michael Vounatsos is leaving the company. He had the job for five and a half years and for less than a year after the controversial Alzheimer’s treatment was approved. He will stick around until a successor is found.
Arecor Therapeutics plc has presented early stage clinical data from a novel concentrated insulin formulation, which it hopes will outperform marketed rivals by allowing lower volume and reduced frequency doses. Cambridge, U.K.-based Arecor presented data at the International Advanced Technologies and Treatments for Diabetes meeting from AT-278, an investigational meal-time concentrated (500 U/mL) novel formulation of insulin.
In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning.
After several delays due to COVID-19, Canada is on track to implement, within a few months, its first major changes to its Patented Medicines Regulations in more than 30 years. One change coming July 1 is a new basket of comparator countries that will be used to determine whether a drug’s Canadian price is excessive.
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
As part of a series of guidances addressing clinical trial diversity, the U.S. FDA issued a draft guidance April 13 focused on improving enrollment of participants from underrepresented racial and ethnic populations.
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