The ball’s in HHS’s court as the Biden administration ramps up pressure on Congress to act on drug pricing. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the White House...
Answering critical scientific and medical questions about Aduhelm and other potential Alzheimer’s treatments will require cooperation among payers, FDA, drug companies and physicians, according to a discussion...
CMS is seeking public input as it undergoes a National Coverage Determination (NCD) analysis to decide whether Medicare will establish a coverage policy for Biogen’s aducanumab and future amyloid-targeting mAbs to treat Alzheimer’s disease. An NCD could...
The Biden administration has signaled that it may consider a policy change that would allow NIH to assert patent rights to reduce drug prices. A sweeping Executive Order on promoting competition released...
A day after House Speaker Nancy Pelosi (D-Calif.) said House Democrats are considering adding drug pricing legislation to a budget reconciliation bill, President Joe Biden released a 72-point executive order that seeks to promote competition among...
By requesting an independent investigation of FDA’s interactions with Biogen during the review of Aduhelm, Acting FDA Commissioner Janet Woodcock is trying to bolster public confidence in the agency’s integrity, and distance herself from a...
House Democrats are considering adding drug pricing legislation to a budget reconciliation bill that could be enacted using the filibuster-proof budget reconciliation process, House Speaker Nancy Pelosi...
HHS has sent a proposed rule to OMB that seeks to revive the Trump administration’s “most favored nation” drug pricing scheme. Details of the proposal have yet to be disclosed; however, it is possible that...
The U.K. government is looking to capitalize on the successes of the country’s pandemic response, such as the Vaccines Taskforce and RECOVERY study, and apply those same principles more broadly as part of a 10-year...
Political fallout from FDA’s decision to grant accelerated approval to Aduhelm is accumulating, with two house committees launching investigations, requests for a Senate hearing, and now a call from Rep. Katie Porter (D-Calif.) for an...
An old African proverb states that if you want to go fast, go alone. But if you want to go far, go together. As the WTO Trips Council convenes to discuss access and patents in...
FDA has commissioned Duke-Margolis Center to organize a private roundtable meeting in July with payers and other stakeholders to discuss challenges associated with covering and developing evidence for Alzheimer’s therapies such as aducanumab from Biogen...
Joining calls from the Senate to act on Biogen’s aducanumab, House committees on Oversight and Reform and Energy and Commerce announced Friday that they have launched an investigation into the approval and pricing of the...
Verily’s hiring of Amy Abernethy, who recently stepped down as FDA’s principal deputy commissioner, sheds some light on the company’s plans for its healthcare businesses, including conducting clinical trials for itself and for life sciences...
A day after Biogen and Eisai said in a statement that they are “committed to engaging with CMS on innovative price and access agreements” for aducanumab, Sens. Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) called...
