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Baxter brings room temperature surgical patch to Europe

2 days ago | bioworld.com | Shani Alexander

Baxter brings room temperature surgical patch to EuropeBaxter International Inc. recently launched in Europe a new version of its surgical patch, the Hemopatch Sealing Hemostat, which can be stored at room temperature. The improved Hemopatch device eliminates the need for refrigeration, allowing surgeons to have the product on hand to quickly control bleeding or prevent leakage during surgery. BioWorld MedTech
Makary’s vision for slimmed-down US FDA somewhat reassuring

3 days ago | bioworld.com | Mari Serebrov

Makary’s vision for slimmed-down US FDA somewhat reassuringNearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda. BioWorld BioWorld MedTech Regulatory U.S. FDA Policy
‘Complement’-ary approaches? FcRn holds ground in myasthenia gravis

3 days ago | bioworld.com | Randy Osborne

Many US tariffs paused, pharma warned, EU put on noticeThe on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate...
Post-Pfizer dropout, Lilly Achieves GLP-1 win in phase III

1 week ago | bioworld.com | Randy Osborne

Post-Pfizer dropout, Lilly Achieves GLP-1 win in phase IIIDays after Pfizer Inc. pulled the plug on its oral GLP-1 candidate danuglipron, Eli Lilly and Co. aired positive top-line data from the phase III trial called Achieve-1 testing orforglipron vs. placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. BioWorld Clinical Diabetes Endocrine/metabolic Small molecule U.S.
Budget woes ahead for US life sciences sector?

1 week ago | bioworld.com | Mari Serebrov

Budget woes ahead for US life sciences sector? The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS. BioWorld BioWorld MedTech Regulatory U.S. FDA NIH Policy
NICE OKs conditional coverage of robotic surgery

1 week ago | bioworld.com | Mark McCarty

NICE OKs conditional coverage of robotic surgeryThe U.K. National Institute for Health and Care Excellence (NICE) gave the nod to a total of 11 robotic surgical systems for use in the U.K.’s trusts, but this is no free pass as the agency expects the manufacturers of these systems to gather data under this conditional coverage framework. BioWorld MedTech Regulatory Europe NICE
Brink’s recombinase enzymes offer new gene editing approach

1 week ago | bioworld.com | Nuala Moran

Home » Brink’s recombinase enzymes offer new gene editing approachBrink’s recombinase enzymes offer new gene editing approachNewco Brink Therapeutics SAS is poised to work on the next chapter in genome editing after raising €3.5 million (US$4 million) in seed funding to discover and develop programmable recombinase enzymes. BioWorld Financings Newco news Cancer CAR T Seed Europe
CMS suspends skin substitute local coverage determinations

1 week ago | bioworld.com | Mark McCarty

Home » CMS suspends skin substitute local coverage determinations BioWorld briefs for April 16, 2025. BioWorld MedTech briefs for April 17, 2025. In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate... The current treatment strategies for neurodegenerative diseases focus on targeting Aβ in Alzheimer’s disease (AD), α-synuclein aggregates in Parkinson’s disease...
Telix’s brain cancer radiotherapy shows phase II survival benefit

1 week ago | bioworld.com | Tamra Sami

Telix’s brain cancer radiotherapy shows phase II survival benefitTelix Pharmaceuticals Ltd.’s glioblastoma theranostic, TLX-101, is showing promising overall survival in a phase II trial in recurrent high-grade glioma. The targeted radiation therapy, combined with external beam radiation therapy, demonstrated a median overall survival of 12.4 months from treatment initiation and 32.2 months from initial diagnosis.
Predict4Health rebrands as Okeiro, raises €10M for transplantation predictive tool

1 week ago | bioworld.com | Shani Alexander

Predict4Health rebrands as Okeiro, raises €10M for transplantation predictive toolFrench startup Predict4Health SAS rebranded to Okeiro and raised €10 million (US$11.35 million). The series A funding round was led by Alven, Forepont Capital Partners and Red River West. Funds will be used to accelerate the deployment of the company’s AI-based technology which prevents organ failure. BioWorld MedTech Financings Urology Artificial intelligence Europe