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BioWorld - Tuesday, March 31, 2026
Home » Topics » Medical technology, BioWorld

Medical technology, BioWorld
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Gavel and scales

Drug, device makers could still be liable for terrorist attacks

Jan. 26, 2026
By Mari Serebrov
No Comments
In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.
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Decorative scales of justice in a courtroom

FY 2025 a banner year for US False Claims Act recoveries

Jan. 20, 2026
By Mark McCarty
The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from health care cases.
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PET imaging

Radiopharm Theranostics’ RAD-101 meets brain metastases endpoints

Dec. 16, 2025
By Tamra Sami
Radiopharm Theranostics Ltd.’s radiotracer RAD-101 met the primary endpoint in 92% of patients in the phase IIb imaging trial in brain metastases, according to interim results. To date, 11 of the 12 patients treated with RAD-101 (F18-Pivalate) achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. The results showed significant and selective tumor uptake, and images confirm metabolic activity in brain metastases compared to equivocal MRI findings.
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Lock on digital globe illustration

US Biosecure Act a vote away from law

Dec. 15, 2025
By Mari Serebrov
No Comments
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
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COVID-19 vaccine vials on conveyor belt

Petition claims FDA oops! means COVID-19 vaccines misbranded

Dec. 11, 2025
By Mari Serebrov
No Comments
Restricting the recommended use of COVID-19 vaccines in the U.S. wasn’t enough. Now the Children’s Health Defense (CHD) is trying to get the FDA to revoke the BLAs for all versions of the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines.
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RFK at Senate HELP meeting 5-14

US lawmakers demand that Kennedy be held accountable

Dec. 10, 2025
By Mari Serebrov
No Comments
As the systematic dismantling of the U.S. vaccine schedule escalates, the demands to hold Health and Human Services Secretary Robert Kennedy accountable are growing. Claiming that Kennedy has turned his back on science and is endangering public health, Rep. Haley Stevens, D-Mich., formally introduced articles of impeachment against him Dec. 10 for “high crimes and misdemeanors.” Under the Constitution, federal officials can only be impeached for treason, bribery and “other high crimes and misdemeanors.”
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HKEX on phone, digital stock chart

73 Chinese biotech, med-tech companies file for HK IPOs in 2025

Dec. 9, 2025
By Marian (YoonJee) Chu
No Comments
Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in the first half.
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Tracy Beth Høeg, acting CDER director

Høeg appointment as acting CDER director tied to vaccine strategy?

Dec. 5, 2025
By Karen Carey
No Comments
After a more than 13-year period of stability with Janet Woodcock as the head of CDER, with Patrizia Cavazzoni taking charge during the next four years of former U.S. President Joe Biden’s tenure, the FDA division has had no fewer than five different people in charge throughout 2025. Up to bat now as acting director is Tracy Beth Høeg, a physician and epidemiologist who co-authored a paper in 2022 with CBER Director Vinay Prasad, FDA Commissioner Marty Makary and others demonstrating that COVID-19 boosters and college vaccine mandates were harmful to young men due to myocarditis risks.
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Vial and syringe with blue hues

Hippocratic loath? ‘Harm’ threat from ACIP’s proposed HBV shift

Dec. 5, 2025
By Randy Osborne
No Comments
Individual liberty and choice vs. wider public health became one predictable hinge upon which swung the often-acerbic debates at the CDC’s Advisory Committee for Immunization Practices (ACIP) meeting, which took up – again – the matter of hepatitis B virus (HBV) vaccine scheduling, a day after the panel voted not to vote on such guidance.
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Infant receiving vaccine

ACIP votes on changes to hep B immunization delayed once again

Dec. 4, 2025
By Mari Serebrov
No Comments
Disorganization resulting from last-minute changes to voting questions involving new recommendations for hepatitis B virus vaccines created a moment of déjà vu Dec. 4 when the CDC’s Advisory Committee for Immunization Practices (ACIP) voted 6-3 to once again delay its votes on whether the current recommended birth dose should be pushed back.
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