Unneeded, unscientific restrictions around access to abortion medication remain in place, perpetuating a two decade-long intrusion of politics where it does not belong.  The incoming Biden-Harris...

Following FDA’s first authorization of a COVID-19 vaccine, controversy over the Trump administration’s management of pandemic countermeasures will shift from FDA’s reviews to Operation Warp Speed’s procurement and deployment strategies. One of the most consequential...

President Donald Trump will sign an America First COVID-19 vaccines executive order at a White House event Tuesday, senior administration officials told reporters Monday. The order will commit the U.S. government to ensuring that all...

Pending legislation that would tighten disclosure requirements for foreign companies may push NASDAQ-listed Chinese biotechs to follow in the footsteps of BeiGene and Zai and seek out secondary listings in Hong Kong.  On Wednesday, the...

In selecting California Attorney General Xavier Becerra as his HHS secretary nominee, President-elect Joe Biden has signaled his intention to follow through on campaign commitments to extending the Affordable Care Act and giving Medicare the...

Senior Trump administration officials are spending their last weeks in office throwing sand into the gears of government, gumming up the operation of public health agencies and dismantling protections against political interference in the actions...

The U.S. Department of Commerce’s first biotech-focused definition of “emerging technology” suggests industry won’t have to wage the type of pushback campaigns that followed the Department of the Treasury’s initial definition of “sensitive data.” The...

The biopharmaceutical industry has filed legal challenges that it hopes will kill the Trump administration’s “Most Favored Nation” drug pricing policy, or at least delay implementation long enough for...

PhRMA, Partnership for Safe Medicines and the Council for Affordable Health Coverage filed a lawsuit against HHS and FDA requesting that a federal court block the implementation of a final rule that would permit states,...

The first problem area PhRMA seeks to address through its trial diversity guidelines, released last week, is the lack of trust among underserved communities when it comes to clinical studies.  The guidelines, which are voluntary...

If they withstand withering legal challenges from the biopharmaceutical industry, hospitals and medical groups, and overcome steep logistic obstacles, rules released by the Trump administration Friday...

Biopharma companies expect the Trump administration to release a “most favored nation” rule Friday that will create an international reference pricing scheme for Medicare drug prices, CEOs and lobbyists told BioCentury. The rule is likely...

In a move signaling that the Biden administration will not banish individuals with close ties to the pharmaceutical industry from its inner circle, President-elect Joe Biden Tuesday announced that Steve Ricchetti will serve as counselor...

Four former FDA officials and an oncologist are on a list of candidates President-elect Joe Biden’s team is considering as FDA commissioner, individuals who are advising the transition team told BioCentury....

On the cusp of a new era outside of Europe, the U.K. has an opportunity to create an innovative and interconnected regulatory and reimbursement system that can attract biopharma by accelerating patient...