https://www.bioworld.com/rss en-us Scientists in Europe have added their voices to the many thousands of objections made against proposed changes to the oversight of U.S. federal research grants, under which political appointees and not peer review experts would have the final say on who and what gets funding. The concern is that awarding grants, based on the principle that research proposals must be in keeping with President Donald Trump’s policy priorities, poses a threat to open scientific inquiry and academic freedom, and also will undermine international research collaboration. http://www.bioworld.com/articles/732748 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732748-europe-voices-concerns-on-changes-to-us-federal-grant-rules Blocks displaying microscopes and money bags Signs of recovery are emerging in the biotechnology investment sector, although investors across Asia say that capital is flowing selectively to companies that can demonstrate clinical differentiation, strong management teams and a clear path to commercialization. http://www.bioworld.com/articles/732842 Tue, 21 Jul 2026 11:00:00 -0400 https://www.bioworld.com/articles/732842-capital-remains-selective-in-barbell-biotech-market International currency symbols Signs of recovery are emerging in the biotechnology investment sector, although investors across Asia say that capital is flowing selectively to companies that can demonstrate clinical differentiation, strong management teams and a clear path to commercialization. http://www.bioworld.com/articles/732692 Thu, 16 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732692-capital-remains-selective-in-barbell-biotech-market International currency symbols There have been plenty of complaints about U.S. Health and Human Services Secretary Robert Kennedy interfering with science. Now he’s facing allegations of a different kind of interference. Sen. Ron Wyden, D-Ore., the ranking member of the Senate Finance Committee, asked the U.S. Office of Special Counsel to immediately open an investigation into election interference claims against the secretary. http://www.bioworld.com/articles/732613 Wed, 15 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732613-senator-calls-for-investigation-of-kennedys-election-interference U.S. Health and Human Services Secretary Robert Kennedy was the 800-pound gorilla that couldn’t be ignored as the Senate Health, Education, Labor and Pensions Committee held a joint confirmation hearing July 15 for President Donald Trump’s nominees for CDC director and the head of the Administration for Strategic Preparedness and Response. http://www.bioworld.com/articles/732609 Wed, 15 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732609-cdc-nominees-qualifications-shadowed-by-kennedy-agenda Erica Schwartz, CDC director nominee Erica Schwartz, nominee for CDC director, speaks at the Senate Health, Education, Labor and Pensions Committee joint confirmation hearing held July 15. Credit: help.senate.gov South Korea is moving ahead with its biggest reform of drug review and pricing in more than a decade, reflecting a wider shift across Asian markets to reward innovation and tighten controls on generics. http://www.bioworld.com/articles/732668 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732668-korea-targets-generics-innovation-in-drug-pricing-overhaul Generic drugs and bottle More than 52,000 individuals, lawmakers, institutions and other organizations have submitted comments on the White House Office of Management and Budget’s (OMB) proposal to revise its Guidance for Federal Financial Assistance, which serves as a government-wide framework for administering grants, cooperative agreements and other forms of assistance. http://www.bioworld.com/articles/732599 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732599-omb-flooded-with-comments-on-proposed-rule-impacting-grants Speech bubbles South Korea is moving ahead with its biggest reform of drug review and pricing in more than a decade, reflecting a wider shift across Asian markets to reward innovation and tighten controls on generics. http://www.bioworld.com/articles/732585 Mon, 13 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732585-korea-targets-generics-innovation-in-drug-pricing-overhaul Generic drugs and bottle What appears to be a routine item on a routine list of the U.S. Department of Health and Human Services’ (HHS) proposed rulemakings for the next fiscal year is being seen as anything but routine, given HHS Secretary Robert Kennedy’s stance on vaccines and several commonly used drugs. http://www.bioworld.com/articles/732516 Thu, 09 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732516-covid-19-injuries-posting-of-crls-on-hhs-2027-rulemaking-agenda US flag and HHS logo Credit: mehaniq41 Of all the U.S. SEC’s recent proposed rules to make going, and staying, public more attractive, perhaps the most beneficial for biopharma and med-tech startups is the amendment that would give public companies the flexibility to file semi-annual rather than quarterly reports, Ben Bradford, head of external affairs at Massbio, told BioWorld. BioWorld.]]> http://www.bioworld.com/articles/732433 Wed, 08 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732433-sec-reform-good-for-life-sciences-startups-but-getting-pushback Gears with regulatory words Ready or not, the future has arrived. Novel AI and brain-computer interface (BCI) systems are no longer confined to the realm of science fiction. As an increasingly intertwined human-machine model moves closer to adoption in real-world clinical and military practice, technological advances are sparking concerns over public health, ethics and national security. http://www.bioworld.com/articles/732225 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732225-ascending-bci-systems-deepen-national-security-ethical-concerns Brain made of chip and circuits For the second time this year, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) canceled a scheduled meeting due to a federal judge’s stay that keeps the panel from meeting with its current membership. Typically, ACIP meets three times a year – in February, June and October. The 2026 June meeting was slated for June 23-25. Whether the adcom meets in October will be up to the courts and how far Health and Human Services Secretary Robert Kennedy digs in his heels to maintain a hand-picked committee tilted toward his view of vaccines. http://www.bioworld.com/articles/732159 Thu, 25 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732159-uncertainty-reigns-as-acip-remains-on-court-hold Empty meeting room In a little more than a month, 17 big biopharma companies will be subject to U.S. President Donald Trump’s long-promised section 232 global biopharma sector tariff. But instead of paying the 100% duty on imported patented drugs and their key ingredients, most of those companies, if not all, will pay much reduced rates or no tariff at all, based on where the imports are coming from, what type of drug is being imported, and whether the companies have signed onshoring and most-favored-nation pricing agreements with the administration. http://www.bioworld.com/articles/731904 Wed, 17 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731904-rx-tariff-just-around-the-corner Prescription bottle with dollar sign shadow The Centers for Medicare & Medicaid Services (CMS) proposed a rule June 12 that would codify the Inflation Reduction Act of 2022’s Medicare Drug Price Negotiation Program, establish new negotiation and drug benefit policies, and modify the fixed combination drug policy – the latter of which would negatively impact biopharmas attempting to extend lifecycles of blockbuster products. http://www.bioworld.com/articles/731879 Mon, 15 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731879-proposed-cms-rule-aims-to-close-fixed-combo-drug-loophole The U.S. FDA’s year-old Commissioner’s National Priority Voucher (CNPV) pilot program played to mixed reviews at the agency’s June 4 listening session intended to get various stakeholders’ perspective on the ultra-accelerated review process being offered to qualifying drugs. http://www.bioworld.com/articles/731633 Fri, 05 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731633-fda-gets-earful-on-cnpv-pilot FDA website and logo Credit: Postmodern Studio - stock.adobe.com Nearly a year after Health and Human Services Secretary Robert Kennedy announced the U.S. was cutting off funding for Gavi, a global vaccine alliance, Secretary of State Marco Rubio said his department is reengaging with the organization in light of the ongoing Ebola outbreak in central Africa. In testifying before a June 2 Senate Foreign Relations Committee hearing, Rubio said the State Department made the decision to reengage a few weeks earlier with Gavi. He provided no detail of what that engagement looks like. http://www.bioworld.com/articles/731543 Wed, 03 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731543-rubio-reopening-door-with-gavi Smartphone with webpage of Gavi, The Vaccine Alliance Credit: Timon - stock.adobe.com On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025. http://www.bioworld.com/articles/731649 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731649-bms-hengrui-deal-strikes-panic-in-washington U.S. Capitol building The Trump administration’s efforts to ensure U.S. federal grants align with its policies may soon be coming to fruition. The White House Office of Management and Budget released a proposed rulemaking to revise its Guidance for Federal Financial Assistance. http://www.bioworld.com/articles/731514 Mon, 01 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731514-policy-aka-politics-to-have-bigger-role-in-us-grants Gold dollar sign and gray question marks On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025. http://www.bioworld.com/articles/731574 Fri, 29 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731574-bms-hengrui-deal-strikes-panic-in-washington U.S. Capitol building On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025. http://www.bioworld.com/articles/731422 Wed, 27 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731422-bms-hengrui-deal-strikes-panic-in-washington U.S. Capitol building As of May 21, the U.S. SEC’s “no-deny” settlement policy is dead. For the past 50 years, the agency has required settling defendants to sign an agreement stating that they neither admit nor deny the SEC’s allegations. And beyond that, the standard settlement prohibits, under threat of court action, the defendants from ever denying the allegations publicly. According to an SEC notice to be published in the May 21 Federal Register, the agency has reconsidered the issue and is now rescinding the no-deny rule. Federal Register, the agency has reconsidered the issue and is now rescinding the no-deny rule.]]> http://www.bioworld.com/articles/731346 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731346-sec-settlements-to-take-on-a-new-look-going-forward Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14. http://www.bioworld.com/articles/731365 Tue, 19 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731365-life-sciences-sweet-opportunity-in-us-china-talks China and U.S. flags On the heels of the ouster of Marty Makary as the U.S. FDA commissioner and the serial leadership vacancies at the CDC and the FDA’s drugs and biologics centers, the government’s adherence to science took another blow May 16 when Sen. Bill Cassidy, R-La., lost the Louisiana primary, ending his bid for re-election. http://www.bioworld.com/articles/731313 Mon, 18 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731313-sen-cassidys-primary-loss-increases-uncertainty Health care and politics illustration The U.S. Patent and Trademark Office (USPTO) is driving home its message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting “inconsistent positions” as a litigation strategy. http://www.bioworld.com/articles/731197 Thu, 14 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731197-uspto-doubles-down-on-inconsistencies-in-dual-ipr-court-action Patent gears Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14. http://www.bioworld.com/articles/731060 Wed, 13 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731060-life-sciences-sweet-opportunity-in-us-china-talks China and U.S. flags It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception. http://www.bioworld.com/articles/731225 Tue, 12 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731225-multiple-appearances-on-priority-watch-list-leading-to-action Magnifying glass on wooden table U.S. President Donald Trump ended days of rumors and speculation when he confirmed May 12 that Marty Makary is resigning as FDA commissioner. Speaking with reporters before heading off to China for a two-day summit, Trump wouldn’t comment on whether he or someone else asked Makary to step down. However, while calling Makary a “wonderful man” and a “great guy, who’s a friend of mine,” the president acknowledged that “he was having some difficulty” at the FDA. http://www.bioworld.com/articles/731051 Tue, 12 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731051-makary-out-at-the-fda Martin Makary, former FDA-commissioner Marty Makary at his confirmation hearing in March 2025. Makary resigned as U.S. FDA commissioner on May 12, 2026. Credit: www.help.senate.gov It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception. http://www.bioworld.com/articles/730867 Wed, 06 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730867-multiple-appearances-on-priority-watch-list-leading-to-action Magnifying glass on wooden table Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle. http://www.bioworld.com/articles/730926 Tue, 05 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730926-bio-korea-2026-us-policy-risks-shift-to-execution-framework Strategy compass Amid calls for transparency on the most-favored nation (MFN) pricing deals U.S. President Donald Trump has reached with 17 biopharma companies, the White House Council of Economic Advisers released a report May 5 detailing how the volunteer MFN policy works and touting the $530 billion-plus in savings it’s projected to deliver over the next 10 years. http://www.bioworld.com/articles/730850 Tue, 05 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730850-white-house-looks-to-expand-mfn-pricing-for-530b-plus-in-savings Prescription drug bottle, pills shaped in $ sign