Politics, Policy & Law

Latest executive order in spree to control biopharma centers on American-made drug products

An “America first” drug sourcing order signed Thursday is the latest in a series of attempts by President Donald Trump to bend the biopharma industry to his will in an effort to keep campaign promises...

China doubling size of centralized procurement program

Six months after the last round of price cuts for generics and off-patent originator drugs in China’s centralized procurement program, the Chinese government has outlined plans to nearly double the number of included drug formulations....

Alliance for Regenerative Medicine sees advanced therapies as pilot for EU's regular use of real-world evidence

As the European Commisson hammers out how best to incorporate real world evidence into the future of medicines regulation and reimbursement, the Alliance for Regenerative Medicine is calling for the EU bloc to use cell...

Senate Republicans release coronavirus relief bill with boosts for vaccine R&D, funding to restart NIH-funded labs

Senate Republicans Monday released proposed coronavirus relief legislation that includes $25 billion for COVID-19 testing, $26 billion for vaccine R&D and distribution, and big funding increases for BARDA and NIH. The funding is in line...

Biopharma industry accelerates attacks on Trump

Last week the White House invited Pfizer Chairman and CEO Albert Bourla to join a group of his peers at the White House Tuesday to discuss drug pricing with President Donald Trump. Instead of traveling...

Trump’s ultimatum, RADx & preclinical IPOs: a BioCentury podcast

President Donald Trump’s ultimatum to biopharma CEOs to work with him on drug pricing hit its first hurdle when the executives declined an offer to meet at the White House on Tuesday. On the latest...

Biopharma boycotts White House meeting

Biopharmaceutical industry CEOs informed the White House Monday that they would not attend a meeting that had been scheduled for Tuesday with President Donald Trump. As a result of the CEO boycott, the White House...

Trump issues drug pricing ultimatum to biopharma CEOs

President Donald Trump Friday gave biopharma CEOs a choice: accept an international reference pricing scheme for biologics or propose an alternative that achieves the same goals. The ultimatum was issued at a White House event...

FDA lays out right to try reporting requirements

Companies that provide an unapproved therapy to patients via the Right-to-Try Act would be required to report such instances to FDA, according to a rule proposed by the agency Thursday. Under the rule, manufacturers would...

Moderna says commercial path remains clear despite unfavorable patent ruling

Moderna isn’t aware of any IP barriers to its products, including its COVID-19 vaccine, after a PTAB decision on Thursday shaved more than $3 billion off its market cap. The Patent Trial and Appeal Board...

White House backs testing, vaccines boost in coronavirus bill, to unveil drug pricing orders Friday

Senate Republican leaders and the White House have agreed to include tens of billions of dollars for COVID-19 vaccines in a coronavirus relief bill, according to a draft of agreement obtained by BioCentury. The agreement...

White House drug pricing executive orders pushed back to August

The White House has again delayed the release of executive orders on drug pricing. The orders, which White House Chief of Staff Mark Meadows first publicly announced would be unveiled the week of July 6...

U.S. accuses Chinese government of cyber espionage against COVID-19 vaccine, drug developers

The U.S. Department of Justice Tuesday announced the indictments of two individuals in China for a number of cyber crimes, including stealing and attempting to steal confidential information from U.S. companies that are developing COVID-19...

PhRMA trying to water down White House drug pricing orders

The White House is finalizing executive orders on drug pricing and is expected to release them this week. PhRMA and its members are mobilizing to head-off or dilute plans for administrative steps that would seek...

Intelligence agencies warn of cyber espionage against COVID-19 R&D

Hackers working for Russian intelligence services are targeting COVID-19 vaccine R&D in the U.S., Canada and the U.K., according to a report released Thursday by the U.K.’s National Cyber Security Centre and Canada’s Communications Security...