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Patient groups happy Virginia won't have a PDAB. Plus, seeking clarity about onshoring agreements. (789 words, 3 minutes, 10 seconds)
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Patient groups praise Virginia PDAB veto |
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Patient advocates praised Virginia Gov. Abigail Spanberger’s veto of Prescription Drug Affordability Board (PDAB) legislation, saying PDABs in other states failed to lower patient costs and threatened access to medicine.
The veto on May 19 blocked legislation to create a body that would seek to impose arbitary price controls on prescription drug prices in Virginia.
Why it matters: “We already know these boards don’t work. We've seen them fail,” said Maimah Karmo, Founder & CEO of Tigerlily Foundation, which works to advocate for and empower women before, during, and after cancer. “We're deeply grateful to Gov. Spanberger for putting patients first and protecting access.”
To really lower patient costs we must address prescription drug middlemen, like pharmacy benefit managers (PBMs), Gov. Spanberger said when explaining her veto. Karmo agreed, saying: “We’re glad that Gov. Spanberger is identifying PBM reform as an important policy.”
BIO’S view: “The Governor's action recognized an important point: even well-intentioned healthcare policies must be carefully designed to avoid unintended consequences for patients, providers, employers, and Virginia’s innovation economy,” said Patrick Plues, SVP of State Government Affairs & Affiliate Relations at BIO.
Read more on Bio.News.
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BIO: Information lacking to apply for onshoring agreements |
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As the deadline passed for onshoring agreements to determine whether companies face high tariffs on certain pharmaceutical imports, the Department of Commerce offered insufficient guidance on compliance, BIO says.
The opportunity: Commerce released a May 13 Federal Register Notice for manufacturers seeking to apply for “onshoring agreements” to reduce tariff burdens under a Presidential Proclamation on “adjusting imports of pharmaceuticals and pharmaceutical ingredients.” Onshoring plan applications were due June 12.
But to submit plans, companies needed to know more: - Which products would be exempt?
- How would tariffs apply to complex supply chains? What if patented and non-patented products share the same manufacturing inputs, or imported ingredients include multiple products with different tariff classifications?
- How would pre‑commercial biotech products impacted? Would pre‑commercial products—or the ingredients used to develop them—be subject to tariffs?
- What would count as an onshoring commitment? Commerce did not define this term clearly.
- Can companies realistically meet the timeline? Shifting contract manufacturing facilities—relied upon by nearly 90% of biotechnology companies—can take up to eight years. How could companies submit detailed onshoring plans within 30 days—with major implementation questions unanswered?
BIO’s view: “U.S. biotechnology companies are facing major business, investment, and supply chain decisions,” according to BIO, “and ongoing uncertainty isn’t conducive to innovation.”
Read more on Bio.News.
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BIO International Convention: Attendees fill their meeting schedule. “We have 35,000 scheduled meetings as of June 8. We’re expecting to end with a record of 70,000 or above,” said Mackensie Vernetti, BIO SVP of Partnering. The meetings are being arranged through the BIO PartneringTM system, which allows those attending the June 22-25 BIO International Convention in San Diego to prearrange meetings in one of the 2,000 meeting locations available onsite. “BIO is just an amazing opportunity to meet so many investors, partners, clients,” said Ram May-Ron, an attendee of several BIO International Conventions. Read more on Bio.News.
FDA grants priority review for Genentech’s treatment for a certain type of stage III colon cancer. Genentech announced June 10 the U.S. Food and Drug Administration (FDA) granted priority review for adjuvant Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy in stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer, a type of tumor characterized by high mutation rates. The FDA is expected to make a decision on approval by October 9, 2026, Genentech said. Read more here. |
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Phyllis Arthur, BIO EVP, Chief of Global Health, told journalists about the importance and challenges of reporting on vaccines as a panelist in a webinar for the media co-organized by BIO and the National Press Foundation. Entitled “Vaccines and Government: From D.C. to the States to Your Provider's Office,” the June 10 webinar covered topics like the need for scientific advice from the Advisory Committee on Immunization Practices (ACIP) and the challenges of varying rates of vaccination among states. Watch the webinar recording here. |
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The Senate Health, Education, Labor and Pensions (HELP) Committee has scheduled a June 17 executive session to consider several bills: S. 1782, Charlotte Woodward Organ Transplant Discrimination Protection Act; S. 3799, Healthy Start Reauthorization Act of 2026; S. 4109, Stem Cell Therapeutic and Research Reauthorization Act; S. 2339, EARLY Act Reauthorization of 2025; S. 4472, Accelerating Access to Critical Therapies for ALS Act of 2026; S. 2658, Medication Affordability and Patent Integrity Act; S. 3014, Ensuring Timely Access to Generics Act of 2025; S. 1954, Biosimilar Red Tape Elimination Act. |
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