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BioWorld - Thursday, June 12, 2025
Home » Topics » Regulatory

Regulatory
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Pharmaceutical manufacturing

As tariffs threaten US imports of APIs, companies reshore manufacturing

March 10, 2025
By Marian (YoonJee) Chu
While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.
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Pills arranged in dollar sign

Bill could have epic impact on drugs selected for negotiations

March 10, 2025
By Mari Serebrov
Several drugs already selected for Medicare price negotiations, including Novo Nordisk A/S’ mega-blockbuster diabetes/weight-loss franchise, could see up to a three-year reprieve if a bipartisan bill recently introduced in the U.S. House and Senate becomes law.
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Cancer

Mindrank’s dual WEE1 and YES1 kinase inhibitor cleared to enter clinic in US

March 10, 2025
Mindrank Ltd. has announced that the FDA has cleared the company’s IND application for MRANK-106, a potentially first-in-class, orally available dual inhibitor of WEE1 and YES1 kinases, for the treatment of pancreatic cancer, small-cell lung cancer, ovarian cancer, breast cancer and colorectal cancer.
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Researcher looking through a microscope

NIH changes set industry up for workforce, ideas drought

March 7, 2025
By Anette Breindl
On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.”
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NHS building

New AI fall prediction tool being rolled out across the NHS

March 7, 2025
By Shani Alexander
The U.K.’s national health service (NHS) is rolling out a new artificial intelligence (AI)-powered tool which can predict a patient’s risk of falling with a 97% accuracy rate. The AI software designed by Cera Care Ltd. is already in use in more than two-thirds of NHS integrated care systems across the country and NHS England hopes that the tool will prevent around 2,000 falls and hospital admissions each day.
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Map of Europe, Medical Device Regulation (MDR) text

EU MDR backlog could create an opportunity for Australia

March 7, 2025
By Tamra Sami
A slow-down in EU medical device audits due to the long-delayed transition to the EU Medical Device Regulation is leading to increased applications to Australia as small businesses bypass Europe altogether.
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Martin Makary, nominee for U.S. FDA commissioner

US FDA nominee HELPed on the way to confirmation

March 6, 2025
By Mari Serebrov
Martin Makary, President Donald Trump’s pick to head the U.S. FDA, took his turn before the Senate Health, Education, Labor and Pensions (HELP) Committee March 6, a week ahead of the committee’s confirmation votes on both him and Jay Bhattacharya as the next NIH director. The committee votes will set the stage for the full Senate to vote on confirming both nominees later this month.
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Neurotech ECT illustration

Neurotech’s CNTF implant approved for macular telangiectasia

March 6, 2025
By Jennifer Boggs
The first treatment for macular telangiectasia type 2 is set to enter the market following U.S. FDA approval of NT-501 (revakinagene taroretcel) from Neurotech Pharmaceuticals Inc., a privately held company that has been quietly advancing its encapsulated cell therapy platform for more than two decades.
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Cancer immunotherapy illustration
Immuno-oncology

CSPC’s bifunctional fusion protein cleared for trials in China

March 6, 2025
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with JMT-108 for advanced malignant tumors.
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Jay Bhattacharya, nominee for U.S. NIH director

Bhattacharya shares his vision for US NIH

March 5, 2025
By Mari Serebrov
Jay Bhattacharya will have his work cut out for him if he wins confirmation as the next director of the U.S. NIH. Besides getting NIH committees back on track to evaluate grant applications and calming the fears of researchers and other staff who have seen about 1,200 colleagues cut from their ranks in recent weeks, Bhattacharya will face the task of rebuilding public trust in the NIH itself.
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