https://www.biospace.com/policy Biopharma Policy News en-US Thu, 02 Jul 2026 14:54:36 GMT https://www.biospace.com/policy/biotechs-china-problem-an-issue-of-national-security-or-economic-value-for-the-us Jef Akst Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas' clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry. Thu, 02 Jul 2026 14:54:36 GMT https://www.biospace.com/policy/biotechs-china-problem-an-issue-of-national-security-or-economic-value-for-the-us https://www.biospace.com/fda/eli-lilly-and-regeneron-among-7-companies-picked-for-fda-precheck-pilot-program Nick Paul Taylor Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA. Wed, 01 Jul 2026 13:22:08 GMT https://www.biospace.com/fda/eli-lilly-and-regeneron-among-7-companies-picked-for-fda-precheck-pilot-program https://www.biospace.com/fda/bio-2026-fdas-ind-initiative-is-a-step-toward-normalization-after-slipshod-year Jef Akst Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy. Thu, 25 Jun 2026 14:52:57 GMT https://www.biospace.com/fda/bio-2026-fdas-ind-initiative-is-a-step-toward-normalization-after-slipshod-year https://www.biospace.com/drug-development/regenxbio-bets-on-fda-flexibility-with-filing-plans-for-duchenne-gene-therapy Gabrielle Masson A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy. Wed, 24 Jun 2026 14:53:11 GMT https://www.biospace.com/drug-development/regenxbio-bets-on-fda-flexibility-with-filing-plans-for-duchenne-gene-therapy https://www.biospace.com/policy/bio2026-us-public-health-as-we-know-it-is-gone-can-we-rebuild-a-better-system Jef Akst Former FDA, CDC and NIH leaders convene at the BIO International Convention to discuss the dismantling of the Department of Health and Human Services under the Trump administration—and where we go from here. Tue, 23 Jun 2026 11:44:18 GMT https://www.biospace.com/policy/bio2026-us-public-health-as-we-know-it-is-gone-can-we-rebuild-a-better-system https://www.biospace.com/business/with-onshoring-having-a-moment-aquestive-ceo-shares-lessons-from-20-years-of-us-manufacturing Nick Paul Taylor Having stuck with local production in the years when offshoring to lower-cost locations was in fashion, Aquestive’s CEO is well placed to explain what the recent reshoring drive means for manufacturers. Tue, 23 Jun 2026 11:08:34 GMT https://www.biospace.com/business/with-onshoring-having-a-moment-aquestive-ceo-shares-lessons-from-20-years-of-us-manufacturing https://www.biospace.com/business/us-launches-investigation-into-german-drug-pricing-citing-unfair-r-d-burden Gabrielle Masson The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts. Fri, 19 Jun 2026 14:07:38 GMT https://www.biospace.com/business/us-launches-investigation-into-german-drug-pricing-citing-unfair-r-d-burden https://www.biospace.com/policy/germany-rethinking-drug-price-reforms-after-lilly-boehringer-withdraw-investments-reuters Nick Paul Taylor Weeks after Boehringer Ingelheim and Eli Lilly retracted billions of dollar in German commitments, the nation’s government is reportedly changing a contentious element of its planned healthcare reforms. Mon, 15 Jun 2026 14:41:48 GMT https://www.biospace.com/policy/germany-rethinking-drug-price-reforms-after-lilly-boehringer-withdraw-investments-reuters https://www.biospace.com/drug-development/despite-fda-trial-clearance-ibogaine-metabolite-wont-receive-red-carpet-treatment Gabrielle Masson DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns. Mon, 15 Jun 2026 05:01:00 GMT https://www.biospace.com/drug-development/despite-fda-trial-clearance-ibogaine-metabolite-wont-receive-red-carpet-treatment https://www.biospace.com/fda/opinion-the-next-fda-commissioner-must-be-a-champion-for-gene-therapies Erik Paulsen The FDA must provide consistent and predictable regulatory frameworks if the U.S. is to maintain its leadership in gene therapy, one of the most consequential therapeutic fields of our generation. Fri, 05 Jun 2026 13:00:00 GMT https://www.biospace.com/fda/opinion-the-next-fda-commissioner-must-be-a-champion-for-gene-therapies