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1 week ago | 
medtechdive.com | Nick Paul Taylor
This audio is auto-generated. Please let us know if you have feedback. Q’Apel Medical has recalled a device for removing blood clots in the brain over an issue linked to two injuries, the Food and Drug Administration said Tuesday. The company asked customers to return Hippo 072 Aspiration Systems and Cheetah Delivery Tools after receiving a warning letter in which the FDA raised concerns about the device’s tip.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
PwC analysts have warned the speedy evolution of the Chinese biotech sector is creating “heightened risks related to IP security, regulatory compliance and strategic alignment.”China’s rise as a key source of molecules has gone up a gear in 2025. The pipeline of PD-1/L1xVEGF bispecifics, the hottest mechanism in immuno-oncology, is dominated by drug candidates discovered in China.
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1 week ago | 
biospace.com | Nick Paul Taylor
BioNTech’s $1.25 billion all-stock acquisition of CureVac brings together two German companies that have spent the past three years trading blows in the courts. Having painted CureVac as a failed rival that was trying to profit from its success, BioNTech now faces the task of integrating the biotech’s 1,000 employees into its operations.
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1 week ago | 
fiercepharma.com | Nick Paul Taylor
European marketers are feeling the squeeze, with a combination of shrinking budgets, rising targets and tightening compliance requirements piling on the pressure, according to a survey. M3, a medical communication company, surveyed 400 pharma marketers in the U.K., Germany, France and Switzerland to understand the current landscape. Around 90% of respondents said they have at least 12 areas of responsibility for budget allocation that they need to consider.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Immuneering has reported 94% overall survival (OS) at six months in first-line pancreatic cancer, emboldening the biotech to start planning a pivotal trial to support accelerated approval of its MEK inhibitor. The data come from a phase 2a trial that tested atebimetinib in 34 patients. Participants received the MEK inhibitor with a modified form of the gemcitabine–nab-paclitaxel chemotherapy combination that is currently used to treat pancreatic cancer.
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1 week ago | 
medtechdive.com | Nick Paul Taylor
Zyno Medical has recalled infusion pumps that shipped with software that had not undergone verification and validation testing, the Food and Drug Administration said Monday. The company released the Z-800 pumps with incorrect software versions. The software created a risk of incorrect air-in-line detection and audio alarms that could cause serious harm. Zyno has not reported any serious injuries or deaths.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Ventyx Biosciences has shared phase 2a data on a Parkinson’s disease prospect that has caught the eye of Sanofi. The readout shows the effect of VTX3232 on biomarkers, providing some of the data that will inform whether Sanofi takes up its right of first negotiation on the NLRP3 inhibitor. Sanofi secured the rights last year in conjunction with its $27 million investment in Ventyx.
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1 week ago | 
medtechdive.com | Nick Paul Taylor
This audio is auto-generated. Please let us know if you have feedback. Centerline Biomedical has recalled guidewires used in vascular procedures over a fault that could cause serious injury or death, the Food and Drug Administration said Friday. The company has asked customers to return devices from the affected lots because the coating can come off during the procedure and be left inside the patient. No customers have reported serious injuries or deaths associated with the fault.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Gilead is laying off 36 people as part of a rethink that saw the Big Pharma scrap plans to expand a biologics facility in California. At one point, the company had been planning to expand its facility in Oceanside, California. Gilead dropped that strategy early last year, choosing instead to move the team’s responsibilities more than 400 miles up the California coast to Foster City.
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1 week ago | 
fiercebiotech.com | Nick Paul Taylor
Eli Lilly has shared phase 1 data on amylin analog eloralintide, impressing analysts with results that point to the potential for the drug candidate to form part of a market-leading Zepbound combination. Amylin has emerged as the next hot target in obesity. AbbVie and Roche bought their way into the race with multi-billion dollar deals. The drugmakers are part of a pack led by Novo Nordisk, which combined an amylin analog with GLP-1 drug semaglutide to create CagriSema.
