Politics, Policy & Law

Drug pricing pressure; plus European deal trends

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...

Why FDA is meeting with payers about Aduhelm, other Alzheimer’s mAbs

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 seeks public input as it launches NCD analysis for amyloid-targeting mAbs

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...

Biden signals interest in using NIH IP to reduce drug prices

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...

Pressure to tackle drug pricing mounts as Biden releases executive order

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...

Woodcock acts to bolster confidence in FDA, distance herself from Aduhelm controversy

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...

Democrats may put drug pricing provisions in reconciliation bill, Pelosi says

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...

Revival of ‘most favored nation’ could give Biden alternative if Congress fails to act on drug pricing

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...

U.K. to apply COVID response strategy to other diseases through Life Sciences Vision

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...

Aduhelm fallout accumulates

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...

A path forward on access & IP for COVID vaccines and beyond: Guest Commentary

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 scheduled Alzheimer’s drug coverage meeting with payers before aducanumab approval

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...

Pressure on aducanumab price from lawmakers grows as House begins investigation

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...

Abernethy’s appointment sheds light on Verily’s plans

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...

Bipartisan concern over cost of aducanumab could prompt CMS, Congress to act

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...