Policy

Policy, aka politics, to have bigger role in US grants?

Mon, 01 Jun 2026 12:00:00 -0400

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.

BMS-Hengrui deal strikes panic in Washington

Fri, 29 May 2026 09:00:00 -0400

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.

BMS-Hengrui deal strikes panic in Washington

Wed, 27 May 2026 12:00:00 -0400

SEC settlements to take on a new look going forward

Wed, 20 May 2026 12:00:00 -0400

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.

Life sciences ‘sweet’ opportunity in US-China talks

Tue, 19 May 2026 12:00:00 -0400

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.

Sen. Cassidy’s primary loss increases uncertainty

Mon, 18 May 2026 12:00:00 -0400

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.

USPTO doubles down on inconsistencies in dual IPR-court action

Thu, 14 May 2026 12:00:00 -0400

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.

Life sciences ‘sweet’ opportunity in US-China talks

Wed, 13 May 2026 12:00:00 -0400

Multiple appearances on Priority Watch List leading to action?

Tue, 12 May 2026 12:00:00 -0400

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.

Makary out at the FDA

Tue, 12 May 2026 12:00:00 -0400

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.

Multiple appearances on Priority Watch List leading to action?

Wed, 06 May 2026 12:00:00 -0400

Bio Korea 2026: US policy risks shift to execution framework

Tue, 05 May 2026 12:00:00 -0400

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.

White House looks to expand MFN pricing for $530B-plus in savings

Tue, 05 May 2026 12:00:00 -0400

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.

Bio Korea 2026: US policy risks shift to execution framework

Mon, 04 May 2026 12:00:00 -0400

US legislative reforms needed to make biosimilars competitive

Mon, 27 Apr 2026 12:00:00 -0400

Now that the FDA is on board with doing away with the U.S.’ unique two-tier biosimilar pathway, the biosimilar industry is urging Congress to pass the bipartisan Biosimilar Red Tape Elimination Act, which would recognize that biosimilars and interchangeables are one and the same.

A free gene therapy? Regeneron’s Otarmeni approved for hearing loss

Thu, 23 Apr 2026 12:00:00 -0400

Children and adults with a type of congenital hearing loss now have a free treatment option, with the U.S. FDA’s accelerated approval of Regeneron Pharmaceuticals Inc.’s DB-OTO, an AAV-mediated gene therapy. Branded Otarmeni (lunsotogene parvec), it is cleared specifically for hearing loss caused by variants in the otoferlin gene.

FDA, CMS partner to deliver RAPIDly for innovative devices

Thu, 23 Apr 2026 12:00:00 -0400

The U.S. FDA and CMS are teaming up to give Medicare beneficiaries quicker access to breakthrough medical devices and provide manufacturers with certainty of reimbursement.

CMS to Bridge coverage for obesity drugs as BALANCE teeters

Wed, 22 Apr 2026 12:00:00 -0400

When the U.S. CMS didn’t get takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced late April 21 that it will indefinitely delay the BALANCE model in Medicare but extend its temporary Medicare GLP-1 Bridge demonstration model through the end of 2027. (The Medicaid BALANCE model will still kick in this year in states that choose to participate in it.)

Psychedelic space expanding on Trump’s EO

Mon, 20 Apr 2026 12:00:00 -0400

Timothy Leary is dead, but he could be on the outside looking in with a smile on his face as U.S. President Donald Trump’s latest executive order (EO) fuels a surge in investment in companies researching and developing psychedelic drugs to treat mental health issues. The EO, Accelerating medical treatments for serious mental illness, is intended to address the increasing burden of suicide and serious mental illness, which impacts more than 14 million Americans.

New nominee may need a charm at the CDC

Fri, 17 Apr 2026 12:00:00 -0400

As U.S. President Donald Trump’s third nominee for CDC director, Erica Schwartz will soon find out if three times really is a charm. Trump announced the nomination on social media April 16, touting Schwartz’s credentials for the job. Calling her “incredibly talented,” Trump cited her “distinguished career” as a military doctor, in the Navy and Coast Guard, and her service as deputy surgeon general during his first term in office.

HHS budget hearing not so much about budget

Thu, 16 Apr 2026 12:00:00 -0400

U.S. Health and Human Services (HHS) Secretary Robert Kennedy made his first stop April 16 on a congressional tour in support of President Donald Trump’s proposed fiscal 2027 budget, which would reduce discretional spending for HHS and its agencies by about 12%.

Flow of Trump EOs slowing way down

Wed, 15 Apr 2026 12:00:00 -0400

Despite key vacancies, ongoing staffing challenges and policy issues at the U.S. CDC, FDA and NIH, some of the regulatory churn that roiled those agencies in the first year of the second Trump administration is settling a bit, at least in terms of the number of executive orders (EOs) coming out of the Oval Office.

Kennedy expands ACIP function, membership criteria

Fri, 10 Apr 2026 12:00:00 -0400

Amending his previous two-year-renewal of the standard charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), Health and Human Services Secretary Robert Kennedy made monitoring adverse vaccine events a primary function of the committee and expanded its liaison membership to include organizations that have challenged vaccine safety.>

UK formalizes zero tariffs deal with US, will pay more for drugs

Wed, 08 Apr 2026 12:00:00 -0400

The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.

Kennedy sidestepping court order sidelining ACIP?

Tue, 07 Apr 2026 12:00:00 -0400

Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP).

Sector tariff now more than a threat – for some Rx companies

Tue, 07 Apr 2026 11:00:00 -0400

Sector tariff now more than a threat – for some Rx companies

Mon, 06 Apr 2026 12:00:00 -0400

After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for large manufacturers and six months for smaller companies. However, depending on the drug, where it’s made and whether a manufacturer has reached onshoring and pricing agreements with the Department of Health and Human Services, the actual tariff could be as low as 0%.

Drama encases ACIP, CDC amid lawsuit, deadline

Wed, 25 Mar 2026 12:00:00 -0400

Chaos continues at the U.S. CDC and its Advisory Committee on Immunization Practices (ACIP) with the resignation of ACIP member Robert Malone and the impending deadline for the president to nominate a new CDC director following the dramatic exit last year of Susan Monarez and months of acting directors.

Australia’s R&D reset puts biotech translation in focus

Tue, 24 Mar 2026 12:00:00 -0400

Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.

China’s pharma rise rattles US policymakers

Tue, 24 Mar 2026 12:00:00 -0400

U.S. lawmakers and industry experts are raising alarm over China’s expanding dominance across the pharmaceutical supply chain, warning that reliance on Chinese inputs poses a growing national security and public health risk.