Politics, Policy & Law

New technology add-on payments by the numbers: Data Byte

CMS is receiving more applications for the new technology add-on payment than ever before, but it seems less willing to award them.  The NTAP is an extra payment, available on successful application...

Three Democrats erect speed bump for Medicare drug price control

Three House Democrats Wednesday made good on vows to vote against Medicare drug price control legislation, erecting a procedural speed bump that they hope to turn into a stop sign. Reps. Scott Peters (D-Calif.), Kathleen...

Clinical trials capacity should be considered strategic asset

The U.S. government should consider creating a strategic national stockpile of capacity for clinical research. Government could also fund and help create a standing network of clinical trial sites that...

Three Democrats balk at H.R. 3, jeopardizing drug pricing bill

The defections of three Democrats who serve on the Energy & Commerce Committee has complicated the path for the House of Representatives to pass drug pricing legislation. The public renunciations of Elijah E. Cummings Lower...

Disputes at FDA over COVID boosters put spotlight on Friday panel

Intra-agency disputes over pandemic policy played out in public Monday as FDA’s top vaccine regulators, Marion Gruber and Phil Krause, advocated against authorizing booster doses for most Americans at this time, while the Director of...

Commentary: Attack on the future

As part of a package commemorating the twentieth anniversary of 9/11, BioCentury is republishing this commentary, which was originally published on Sept. 17, 2001. BioCentury is also republishing its September...

Lisa Raines: An appreciation

As part of a package commemorating the twentieth anniversary of 9/11, BioCentury pays tribute to Lisa Raines, who helped build the biopharma industry’s regulatory and policy framework. BioCentury’s Sept....

Biden hints at executive actions on drug pricing

The White House drug pricing plan released Thursday reiterates the administration’s enthusiasm for legislation empowering the government to negotiate drug prices, but the most important news is buried in sections describing options for executive action....

Investors, biopharma companies sound alarms on drug pricing legislation

As Democrats in the U.S. House and Senate race to finalize a spending bill, investors are combining forces with drug developers and some patient advocates in a battle to block or blunt attempts to include...

COVID-19 antivirals could be ‘game-changers,’ Kessler says

David Kessler has maintained a low profile in the nine months since President Joe Biden named him chief science officer for the administration’s COVID-19 response. The initiative, started under President...

Aduhelm investigations could spur changes at FDA

Congress is ratcheting up the pressure on FDA to disclose details about and provide justifications for its accelerated approval of Aduhelm for Alzheimer’s, setting in motion processes that could alter career paths of FDA officials...

Biden administration restores FDA authority revoked by Trump

The Biden administration has reversed a Trump administration policy that attenuated FDA’s independence. In a Federal Register notice, HHS Secretary Xavier Becerra rescinded former HHS Secretary Alex Azar’s decision to strip FDA commissioners and senior...

Congress relying on flawed model to set drug pricing policy

The Congressional Budget Office’s model for analyzing how legislative proposals may affect new drug development disregards impacts on early-stage biotech companies, and as result dramatically underestimates...

BMS to seek review of CAFC’s reversal of $1.2B judgment against Gilead

BMS will challenge a ruling by a federal appeals court that has overturned a $1.2 billion judgement against Gilead. The U.S. Court of Appeals for the Federal Circuit ruled that a jury erred in when...

China’s new economic plan sets stage for future reforms affecting biopharma

China’s new five-year economic plan likely means many investors in the country’s biotechs may have to get used to the volatility that has tortured biotech and tech shares recently as new policies affecting the sector take...