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BIOSECURing the Future: What an American Cold War with China Could Mean for the Pharma Industry

 
• By Nielsen Hobbs

Whether the legislation aimed at discouraging use of Chinese contractors passes in its current form or not, industry will continue to face more pressure to decouple its operations.

Pharma could suffer some blows as conflict between the U.S. and China intensifies. (Shutterstock)

The pending US election brings much uncertainty for the biopharma industry, but one thing is certain: firms are still going to have to worry about the BIOSECURE Act even after the presidential contest is decided.

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More from Legislation

340B Not Designed To Pass Savings Directly To Patients, Hospitals Tell Senate Committee

 
• By Cathy Kelly

Respondents to a Senate investigation that could re-energize 340B reform efforts said hospitals offer patient assistance programs and use 340B revenue for “capital improvement projects” and “community benefit programs,” though they do not account for specific program revenue allocations.

Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
• By Eliza Slawther

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 
• By Francesca Bruce

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

More from North America

Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Political Influence And The US FDA: A New Era?

 
• By Michael McCaughan

FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting the agency in unprecedented ways about three weeks into his tenure.

If CMS Takes Over 340B, Will Government Allow Rebate Model Changes?

 
• By Cathy Kelly

Manufacturers have supported the proposed shift in oversight authority, which could create a more pharma-friendly environment in the drug discount program, but uncertainty remains.