The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats.

As COVID-19 vaccinations continue to roll out, momentum builds with strong phase III data for what could become the fourth and fifth walls of defense in the U.S.

The Made in America Tax Plan President Joe Biden is proposing to pay for his $2 trillion U.S. American Jobs Plan could change the way multinational drug and device companies do business, as well as curb M&As that take advantage of global tax benefits.

The latest salvo in the debate over patents protecting COVID-19-related drugs, devices and vaccines came this week from U.S. industry organizations, including Advamed, the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America.

The continuing politicization of COVID-19 vaccines is undermining medical science and the international response to the pandemic. “Vaccine nationalism is very troubling,” Jeremy Levin, chair of the Biotechnology Innovation Organization’s (BIO) executive committee, told BioWorld.

A U.S. Senate committee met March 18 to review the federal government’s response to the COVID-19 pandemic, during which former FDA commissioner David Kessler said the Trump administration’s vaccine contracts were expensive, but effective in ensuring a robust supply. Nonetheless, Sen. Chris Murphy (D-Conn.) said one vaccine manufacturer had recently voiced an interest in charging more on a per-dose basis for its vaccine, and suggested that the cost of booster shots should perhaps be examined anew by the Biden administration.

Although U.S. President Joe Biden has yet to nominate his choice to lead the FDA, his nomination of Xavier Becerra as the next Health and Human Services (HHS) secretary – and Becerra’s Senate confirmation March 18 – could signal a shift to a more conservative approach at the FDA when it comes to approving new drugs and devices.

Combining research on emerging technologies with an accelerator program and a dedicated equity fund, the European Commission (EC) launched the European Innovation Council March 18 to invest in promising research and to scale up innovative startups and small- and medium-size businesses.

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.