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BioWorld - Sunday, July 26, 2026
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
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China map/flag with silhouettes of business people

China deals highlight biopharma evolution, reports LEK

June 2, 2026
By Tamra Sami
No Comments
In 2025, China’s outbound life sciences and biopharma deals reached nearly $100 billion, about 12 times the level seen in 2021, underscoring how quickly global appetite for Chinese assets has accelerated, according to a recent report by L.E.K. Consulting.
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Gold dollar sign and gray question marks

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

June 1, 2026
By Mari Serebrov
No Comments
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.
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Cybersecurity data lock

China launches long-awaited drug data protection rules

May 29, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards.
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Skin exam

Replimune tries again with melanoma drug post FDA shakeup

May 29, 2026
By Jennifer Boggs
No Comments
Industry watchers will be tracking closely Replimune Group Inc.’s latest attempt to secure U.S. FDA approval of its advanced melanoma candidate, RP-1 (vusolimogene oderparepvec). The company announced Friday it had reached alignment for resubmitting the twice-rejected BLA with the agency, which it said has pledged to prioritize the review.
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Floating antibody drug conjugates

TROP2 ADCs progress into first-line for lung, breast cancers

May 28, 2026
By Marian (YoonJee) Chu
No Comments
Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics.
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COVID-19 vaccine vials on conveyor belt

FDA’s VRBPAC faces complex COVID-19 landscape

May 28, 2026
By Mari Serebrov
No Comments
Landing on the right COVID-19 vaccine formulation for the coming season is becoming more complicated against a backdrop of low vaccination rates, young children with little to no immunization, declining surveillance data and a new SARS-COV-2 lineage slowly emerging.
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Abbott Libre Duo sensor on patient

Abbott receives CE mark for dual glucose, ketone sensing systems

May 28, 2026
By Shani Alexander
No Comments
Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors that could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis.
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Blood cells and destruction of cancer cell

Elzonris this: FDA clears Abbvie’s Decnupaz in BPDCN

May 28, 2026
By Randy Osborne
No Comments
Payoff for the November 2023 buyout of Immunogen Inc. came for Abbvie Inc. in the form of U.S. FDA clearance for the CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare, aggressive and quick-killing hematologic malignancy.
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U.S. Capitol building

BMS-Hengrui deal strikes panic in Washington

May 27, 2026
By Tamra Sami
No Comments
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.
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Kennedy offers emergency immunity for use of MCM in hantavirus

May 26, 2026
No Comments
Acknowledging that the spread of the Andes virus and the resulting disease, hantavirus pulmonary syndrome, “constitutes a credible risk of a future public health emergency,” U.S. Health and Human Services Secretary Robert Kennedy is issuing a declaration to provide liability protection for manufacturers, distributors and providers using favipiravir as a medical countermeasure (MCM) against the virus.
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