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The Bayh-Dole Act was meant to encourage innovative research. However, some lawmakers are trying to change the intent of the law using the “march-in […]
‘Backdoor’ drug price controls will limit access to medicines, says expert Read More »
The FDA’s Accelerated Approval pathway has assisted America’s biotech industry in making remarkable advances over the last 30 years—but it has come under political
Accelerated Approval is under political attack, experts say Read More »
On April 13, the U.S. Food and Drug Administration (FDA) released new draft guidance for industry on “creating strategies to recruit additional participants from underrepresented
BIO recommends improvements to FDA’s clinical trial diversity guidance Read More »
In a letter to the leaders of the Senate Agricultural Committee, the Biotechnology Innovation Organization (BIO) and dozens of other food and agriculture groups
BIO, ag industry groups support Alexis Taylor for USDA Under Secretary Read More »
On June 22, the Senate Commerce Committee approved BIO-supported legislation intended to increase transparency of the business practices of pharmacy benefit managers (PBMs), which
Senate Committee advances PBM transparency legislation Read More »
While some US federal regulators believe the ongoing intensification of mergers and acquisitions in various sectors could jeopardize market competition, M&As can be beneficial
M&As in biotech can help patients, says AskBio Read More »
“Another pandemic is upon us, and policymakers are once again proving slow to respond, to the detriment of global health,” writes Henry B. Skinner,
AMR: ‘We’re already ignoring the next pandemic’ Read More »
On Day 4 – the final episode of Good Day BIO Live – we have interviews with BIO leadership and policy experts on Accelerated
Good Day BIO LIVE! from San Diego – watch Thursday’s episode Read More »
Accelerated Approval, growing misinformation and declining life expectancy, and the need for more resources on the food side of the agency were among the
FDA Commissioner on Accelerated Approval, misinformation, and food Read More »
The Senate Health, Education, Labor and Pensions (HELP) Committee marked up its legislation to reauthorize the Food and Drug Administration (FDA) user fee agreements,
FDA user fee bill marked up by Senate HELP Committee Read More »
