House passes SBIR/STTR reauthorization

House passes SBIR/STTR extension

On Sept. 15, the House gave bipartisan approval to a bill granting a one-year reauthorization of Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding programs, a BIO priority.

What happened: Backing from both parties enabled an expedited vote through suspension of the rules to advance H.R. 5100, which would reauthorize the SBIR and STTR through FY2026. The current authorization is due to expire at the end of this month.

Why it matters: SBIR and STTR funding enables the launch of innovative biotech startups. The programs provide $4 billion for thousands of small- and medium-sized companies each year, driving 12% of all FDA-approved drugs.

BIO’s view: “For years, Congress has reauthorized the SBIR program with bipartisan support due to its proven track record of helping innovators,” according to NewYorkBIO CEO Jennifer Hawks Bland, who leads the Council of State Bioscience Associations' SBIR working group. “For the sake of our (national) innovation economy and the patients who depend on continued progress, we urge Congress to get this done.”

What’s next: The legislation must pass the full Senate, but awaits some political hurdles with competing bills.

BIO on the American Road tours big biotech ecosystem in Texas

Biotech in Texas was in the spotlight as BIO President & CEO John F. Crowley led a BIO on the American Road tour through Houston and Dallas on Sept. 15-16.

Big biotech ecosystem: Texas has the most Tier 1 research universities in the U.S., the world’s largest medical center, Texas Medical Center (TMC), and UT’s M.D. Anderson Cancer Center, which handles 1.6 million cancer patient visits annually and runs one of the world’s largest clinical trial programs.

“You're looking at more than 100,000 jobs in biotechnology,” with “industry growing here in Texas at more than 20%,” Crowley told WBAP’s Morning News in Dallas. Listen to his interview.

Workshop in Houston: After touring MD Anderson, Crowley participated in a workshop at Rice University spotlighting Houston’s growing capacity in translational research, cell and gene therapy, and biomanufacturing.

iC3 Summit: At BioNTX’s annual summit in Dallas, Crowley received the Dennis K. Stone Award and joined panels on Texas’ biotech ecosystem and biosecurity.

BIO’s view: “Texas has all of the ingredients necessary to become a global leader in biotechnology: the people, the passion, the persistence, and the policies.” Crowley said. “With world-class academic and clinical institutions, visionary policymakers, and strategic entrepreneurs, leaders in Houston and throughout the state have put Texas at the forefront of the biotechnology revolution, and patients in the U.S. and around the world stand to benefit.”

Read more on Bio.News.

What Else to Read

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) met last week. The advisory committee voted to change a recommendation on the combined measles, mumps, rubella and varicella (MMRV) vaccine, supporting separate, not combined, MMR and varicella shots for those under the age of 4. Currently, most children receive separate vaccines, and the change does not impact this process. For COVID-19 vaccines, the panel voted in favor of the following recommendations: Adults 65 and older: Vaccination based on individual-based decision-making, also known as shared clinical decision making. Individuals 6 months to 64 years: Vaccination based on individual-based decision-making — with an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors.

FDA-approved Moderna COVID vaccine shows strong data against COVID LP.8.1 variant. Data from an ongoing Phase 4 clinical trial of the 2025-2026 formula of Moderna’s Spikevax COVID vaccine showed, on average, an increase of more than eightfold in neutralizing antibodies against the COVID LP.8.1 variant. The FDA approved this formulation for 2025-2026 for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID, and all adults 65 and older.

Patient groups join letter urging congressional leaders to reauthorize the PPRV program. “On behalf of the 30 million Americans living with a rare disease, the undersigned 192 organizations write to express strong support for the Give Kids a Chance Act of 2025 (H.R. 1262/ S.932) and urge its swift passage by Congress,” the letter begins. (Read the letter.) The legislation includes reauthorization of the Pediatric Priority Review Voucher (PPRV) program to incentivize rare disease research and it advanced in the house last week. (see Beltway, below).

Online discussion to cover “Advancing Rare Disease Healthcare: Spotlighting the Economic and Health System Burden of Disease.” Academic experts will discuss the economic impact of rare disease and patient advocates will share practical experiences in seeking to advance patient needs. The meeting seeks to “drive change in practice and better health outcomes for people living with rare diseases.” Two sessions will be held on Sept. 23., one at 7 am EDT and one at 11:30 am EDT. Learn more and register.

Above: The Council of State Bioscience Associations (CSBA) cohosted a briefing on NIH and SBIR on Capitol Hill. Biotech industry experts, academic leaders, and life sciences startups discussed the importance of the National Institutes of Health (NIH) and the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs for the bioscience sector. “Robust, predictable NIH funding helps U.S. institutions recruit and retain top-level talent, ensuring America remains the destination of choice for the world’s best scientists,” said Mike Guerra, President and CEO of California Life Sciences. “As other nations rapidly increase research investment, the U.S. must maintain global leadership in biomedical research, which is critical to patients at home and abroad. A lapse in NIH and SBIR/STTR funding would be a serious blow to American biomedical innovation and patients holding out hope for a solution—patients are waiting for treatments, technologies, and cures that don’t yet exist. And across the country, our life sciences ecosystem is working to deliver them."

Beltway Report

H.R. 1262, which includes reauthorization of the Pediatric Priority Review Voucher (PPRV) program to incentivize rare disease research, was approved unanimously by the House Committee on Energy and Commerce on Sept. 17 and sent to the full House for review. BIO has listed reauthorization of the PPRV as a top priority for congressional action.