Politics, Policy & Law

Final reg reduces numbers of biopharma companies subject to CFIUS reviews

Final regulations implementing the Foreign Investment Risk Review Modernization Act of 2018 released on Jan. 14 represent a partial victory for the biopharma industry, but the process is still certain to cast a cloud over...

Trade deal elicits Chinese promises to align pharma IP with U.S. Hatch-Waxman paradigm

A combination of pressure from the U.S. government and admonitions from domestic and multinational innovative drug manufacturers have led the Chinese government to agree to align its pharmaceutical patent laws with those of developed countries....

Francis Collins’ 2020 vision for NIH

In his tenth year as NIH Director, Francis Collins is expanding the reach of marquee programs launched under his tenure, and growing the institutes’ footprint in artificial intelligence. In a conversation with BioCentury, Collins identified...

U.S.-China trade deal includes patent linkage, other pharma IP protections

China has agreed to implement patent linkage and patent term extension as part of the “phase one” trade deal signed Wednesday by President Donald Trump and Chinese Vice Premier Liu He. If China enforces the...

Treasury narrows definition of genetic data for CFIUS reviews

A final regulation implementing the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA) released Monday afternoon by the U.S. Treasury Department scales back the definition of genetic data that potentially trigger a review of...

Supreme Court declines to clean up its IP mess

Over the last decade the U.S. Supreme Court has issued a series of decisions on the patentability of diagnostics that have befuddled lower courts, stifled investment, and led former U.S. Patent and Trademark Director David...

2020 in Washington: another shot at drug pricing legislation, user fees and 21st Century Cures 2.0

The year ahead in Washington will start with an attempt to find middle ground on restructuring the way Medicare pays for medicines, and will end with politicians making plans to implement mandates to control drug...

Over 200 biopharma leaders endorse commitment to patients and the public

Dismayed by their industry’s abysmal reputation, leaders of small and medium-sized biotechs are taking rebuilding public trust into their own hands. Led by six CEOs, executives representing over 150 companies have signed an open letter...

Drug price hikes would have been impossible under pending bipartisan legislation backed by White House, Democrats

The latest round of increases in the list prices of drugs highlights how pending bipartisan legislation could force biopharma companies to rethink their business models. In what has become a predictable biannual event, manufacturers announced...

China’s expanded list of drugs for centralized procurement comes with new rules

Following the nationwide expansion of China’s pilot program for centralized procurement of generics and off-patent originator drugs, Beijing is adding a second group of 33 drugs and unveiling new rules that could increase the number...

Three-year sentence for Chinese gene editing researcher

A Chinese court sentenced researcher Jiankui He to three years in prison and ordered him to pay a RMB3 million ($429,314) fine for using CRISPR-based gene editing to modify single-cell embryos. The act resulted in...

Incentives added to support China’s rollout of centralized procurement

As China begins the nationwide rollout of its centralized procurement program for generics and off-patent originator drugs, the government has released additional guidelines that include incentives to encourage use of the drugs. In September, China’s...

U.S. drug industry hopes China deal ends stealth attack on IP

Innovator pharmaceutical manufacturers hope the new “phase one” U.S.-China trade deal will create a cease-fire in the stealth war on pharma IP in China. The deal, announced Dec. 13, comes at the end of a...

Hahn signals new messaging style as he commandeers FDA Twitter account, vaporizes Gottlieb

Stephen Hahn’s tenure as FDA commissioner has begun with a personal dispute with his predecessor over control of a Twitter account. Sworn in as commissioner on Tuesday, Hahn now has possession of an account previously...

Restrictions could dull impact of importation ‘pipeline’ from Canada

The political impact of a proposed rule by HHS that would allow importation of certain drugs by U.S. states from Canada could be immediate, but few therapies are likely to be imported through the pathway....