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#Biotech #BiosecureAct #USDefenseBill #ChinaBiotech #Biopharma The Biosecure Act, aimed at restricting U.S. pharmaceutical companies from collaborating with certain Chinese firms, has faced significant legislative challenges recently. The latest update on the legislative move regarding the inclusion of the BIOSECURE Act in the National Defense Authorization Act (NDAA) for fiscal year 2025 indicates that the BIOSECURE Act was NOT INCLUDED in the final version of the NDAA compromise. Negotiators decided against adding the BIOSECURE Act to the defense bill, which has effectively dealt a significant blow to its chances of enactment this year. Legislative Status : House Approval: The Biosecure Act was passed by the U.S. House of Representatives in September 2024, gaining substantial bipartisan support Senate Developments: Despite its passage in the House, the Act was notably excluded from the National Defense Authorization Act (NDAA) for fiscal year 2025 during recent negotiations, which has raised concerns about its future2411. This exclusion indicates a potential softening of the U.S. stance towards Chinese biotech firms, as it would have imposed restrictions on five specific companies linked to China Future Prospects : Alternative Strategies: Representative Brad Wenstrup, a key sponsor of the bill, indicated that there are alternative strategies for advancing the legislation, such as introducing it as a standalone measure in future sessions. However, analysts suggest that this route may be less favorable given the current political climate Support and Opposition: While there remains strong bipartisan support for some form of the Biosecure Act, opposition from certain Democratic lawmakers has complicated its path forward. Concerns have been raised regarding the potential negative impact on U.S. pharmaceutical research and development due to reliance on Chinese companies in supply chains. Currently, the Biosecure Act is not included in any major legislative package and its future remains uncertain. While there is a possibility for it to be reintroduced or attached to other legislation, significant obstacles exist that could hinder its passage in the near term. Thanks to Perplexity and Grok for the information. https://lnkd.in/gx8PJ6cF

Thoughts on this? >> Lawyers predict Biosecure passage in Congress' lame duck session >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #healthcare #biotech #pharmaceutical #pharma

BIG PHARMA DECOUPLING FROM CHINA MANUFACTURING ALREADY UNDERWAY With less than 4 months to the US Presidential and Congressional elections, any vote in the House of Representatives will likely be symbolic because all will await a new Congress in January. However, US (West in general) decoupling from China regarding strategic supply lines is assured. While key ingredient-to-API, will take more time, future contracts will be dead in the water because the belligerence of CCP geopolitics have made urgency of such actions indisputable.  Political recalcitrance has consequences! #china #pharmaceuticals #drug #manufacturing #cdmo #cmo #cro #decoupling #biosecureact #wuxiapptec #wuxibiologics #lekconsulting #uscongress #fda #phrma #bio #efpia #firecepharma https://lnkd.in/erMGVwMF

Explore the investigation into financial ties between past FDA chiefs and the drug industry, raising questions about conflicts of interest and regulatory integrity. https://lnkd.in/ds6WmVFx . . . . #FDA #DrugIndustry #ConflictOfInterest #RegulatoryIntegrity #Transparency #GovernmentEthics #MedicalRegulation #Investigation #BMJ #HealthcareNews #EthicalObligations #PublicTrust #Accountability #RegulatoryAgency

Hurry up and take advantage of the early bird pricing for 𝐑𝐄𝐂𝐎𝐍 2025! Join us at the University of Maryland, Baltimore, on January 27 & 28, 2025. 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐭𝐨𝐝𝐚𝐲!🎉 ➡ https://lnkd.in/g84STPHx Get ready to navigate the fast-changing regulatory landscape and explore key industry topics. Our goal is to prepare, motivate, and advance you and your organization for growth. Join us for four tracks and engaging panel discussions with industry experts. Over the course of the two-day conference, we will delve into: 1. 𝐁𝐢𝐨𝐦𝐚𝐫𝐤𝐞𝐫 𝐭𝐨 𝐄𝐧𝐝𝐩𝐨𝐢𝐧𝐭 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐨𝐧 - Establishing reasonable surrogate endpoints. 2. 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 - Towards a streamlined global regulatory assessment. 3. 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐎𝐩𝐭𝐢𝐦𝐮𝐬 - R&D strategies, practicality, and collaboration between FDA and sponsors. 4. 𝐃𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 - Strategies and implications for enhancing clinical trial diversity. Spread the word among your colleagues- we can't wait to welcome you all there! #RECON #UniversityOfMarylandBaltimore #DrugDevelopment #Pharma #BioTech #FDA #ProjectOptimus #ClinicalTrials #RegulatoryStrategy #Biomarkers #Endpoints #RegulatoryHarmonization #VivproCorp #MorePowerToYou

Registration is now open for 📅 𝐑𝐄𝐂𝐎𝐍 2025 at the University of Maryland, Baltimore, on January 27 & 28, 2025. 𝐓𝐚𝐤𝐞 𝐚𝐝𝐯𝐚𝐧𝐭𝐚𝐠𝐞 𝐨𝐟 𝐄𝐚𝐫𝐥𝐲 𝐛𝐢𝐫𝐝 𝐩𝐫𝐢𝐜𝐢𝐧𝐠🎉 ➡ https://lnkd.in/g84STPHx Join us at 𝐑𝐄𝐂𝐎𝐍 as we explore the rapidly changing regulatory landscape and the most relevant topics in the industry. Our goal is to prepare, motivate, and advance you and your organization for growth. We will cover four tracks and host engaging panel discussions, providing you with the opportunity to engage with experts in an intimate setting. Over the course of the two-day conference, we will delve into: 1. 𝐁𝐢𝐨𝐦𝐚𝐫𝐤𝐞𝐫 𝐭𝐨 𝐄𝐧𝐝𝐩𝐨𝐢𝐧𝐭 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐨𝐧 - Establishing reasonable surrogate endpoints. 2. 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 - Towards a streamlined global regulatory assessment. 3. 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐎𝐩𝐭𝐢𝐦𝐮𝐬 - R&D strategies, practicality, and collaboration between FDA and sponsors. 4. 𝐃𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 - Strategies and implications for enhancing clinical trial diversity. We can't wait to see you there! #RECON2025 #UniversityofMaryland #DrugDevelopment #Pharma #ProjectOptimus #ClinicalTrials #RegulatoryStrategy #FDA #Biomarkers #Endpoints #RegulatoryHarmonization #VivproCorp #MorePowerToYou

To help life sciences, medtech, and diagnostic companies and investors navigate the complicated web of evolving legal and regulatory requirements, our Goodwin Life Sciences Regulatory & Compliance team’s quarterly overview of key developments has been released for Q4 2024. Sharing with you all below. #regulatorycompliance #privacy #lifesciences #medtech #diagnostics #Goodwinlaw #legaltrends

The most consequential piece of health care policy legislation since the Inflation Reduction Act is barreling toward passage. From the lemons of supply-chain shocks and slowed development on new drug development -- to the lemonade of thousands of good, high-paying, clean manufacturing jobs in the US... "Since the bill was first introduced in January 2024, it has had a chilling effect on the industry, pressuring an already strained U.S. supply chain and threatening continued R&D. A recent GlobalData report found the legislation could affect more than 120 U.S. drugs partnered with companies named in the BIOSECURE Act, of which about half are in clinical trials and a third are in early-stage preclinical studies and discovery." The BIOSECURE Act -- independent of the national security necessity argued by it supporters, or the industry-styming downsides associated with it over-correction argued by its detractors -- does have the potential to create good jobs all over the US, if Congress is honest about the lemons and amends the legislation with provisions for making the lemonade.\

To help life sciences, medtech, and diagnostic companies and investors navigate the complicated web of evolving legal and regulatory requirements, our Life Sciences Regulatory & Compliance team’s quarterly overview of key developments has been released for Q4 2024. Check it out! #regulatorycompliance #privacy #lifesciences #medtech #diagnostics #Goodwinlaw

#News: Some of the most widely used #CROs and #CDMOs among U.S. #pharma and #biotech companies are based in China. But the industry may soon be forced to cut ties with these partners if the Biosecure Act, which was passed in the House last week, is ultimately signed into law. The act would effectively prohibit U.S. companies from doing business with five Chinese firms — including WuXi AppTec, Complete Genomics and MGI Tech — and, in the House version, companies are given eight years to sever ties. The bill also allows Congress to add more companies to its list as it weighs perceived connections between the Chinese government and #biopharma industry, as well as cybersecurity and intellectual property concerns. Despite strong support, the bill’s passage was not smooth sailing, garnering more “nay” votes than expected, with a final house count of 306-81 in favour of the legislation. The downturn in support could signal similar sentiments in the Senate, which has its own version of the act. “It did not pass as overwhelmingly as it had passed out of committee,” said Nielsen Hobbs, an analyst with Citeline. “It’s both an indication of some softness of support, as well as an invitation for folks [who] want to make modifications to try and do so.” It’s unclear if the Senate intends to vote on the issue or if there’s enough time left in the year for either version of the bill to make its way into law. And a lame duck Congress is unlikely to push through such a substantial change this fall. “This is probably not going to pass before the election,” Hobbs predicted. Even with a murky future, U.S. #biotechs are preparing for a potential disentanglement from some of their largest Chinese contractors. Read more from Amy Baxter at PharmaVoice 👇🏼