A data-blocking rule set to go into effect in the U.S. April 5 could make it easier for sponsors to get the real-world data they need to demonstrate postmarket evidence of the safety and efficacy of their drugs and devices and to develop future products.
LONDON – The alchemy of induced pluripotent cells has broken another barrier, delivering a model of the earliest preimplantation stages of human development, when fertilized eggs form a blastocyst.
In the “The World for Asia, Asia for the World” panel discussion at the virtual Wuxi Healthcare Forum, investors and executives took note of the region’s digital capabilities for reducing R&D costs and timelines, while also calling for more harmonization on the regulatory front to empower R&D in Asia.
A new multilateral working group could bring deeper scrutiny to biopharma mergers, both past and future. The group, made up of competition experts from Canada, the EU, U.K. and U.S., is taking on the job of identifying fresh approaches to analyze and address the competitive concerns raised by biopharma M&As.
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit.
With the prevalence of central nervous system disorders such as Alzheimer’s disease, multiple sclerosis, epilepsy, Parkinson’s disease and stroke increasing annually, the need for novel therapeutics to treat neurologic and psychiatric disorders has never been greater. Unfortunately, even though there is a significant unmet medical need, because of the high risk and low approval rates of drugs targeting those devastating diseases, in the past decade big pharma companies have been dramatically reducing their R&D spending on CNS disorders, noted Naheed Kurji, president and CEO of Toronto-based Cyclica Inc.
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
The U.S. Senate Finance Committee hearing for the appointment of Xavier Becerra as Secretary of Health and Human Services ended in a tie vote, which not unexpectedly ran along party lines. The nomination of Becerra was controversial on several fronts, but the outcome nonetheless sends the nomination to the Senate floor, where Vice President Kamala Harris may cast the deciding vote in what is likely to be a literal 50-50 deadlock.
DUBLIN – Sofinnova Partners closed out its crossover fund at €445 million (US$535 million), a total, it said, that makes it Europe’s largest crossover investor in biotech. It’s almost three years since Paris-based Sofinnova Partners completed an initial close at €275 million. “We didn’t set a bar – we thought between €250 million and €400 million would be great,” Antoine Papiernik, chairman and managing partner at Sofinnova, told BioWorld.
LONDON – Oxular Ltd. has raised $37 million in a series B, enabling the company to take OXU-001, its long-acting treatment for diabetic macular edema (DME) into phase II development later this year.
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