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Regulatory
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Boston Sci, Medtronic fare well in NICE review of remote monitoring

Oct. 24, 2024
By Mark McCarty
Remote monitoring for patients with implanted cardiac electrophysiology devices may finally be coming of age in the U.K. thanks to a review of these systems by the National Institute for Health and Care Excellence.
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Oncolytic virus concept illustration
Cancer

UP Oncolytics’ oncolytic virus-based therapy awarded US orphan drug designation to treat malignant glioma

Oct. 24, 2024
The FDA has awarded orphan drug designation to UP Oncolytics LLC’s oncolytic virus-based therapy (ZIKV-SJRP/2016) to treat malignant glioma.
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DBV making sure peanut-allergy patch plan sticks with FDA

Oct. 23, 2024
By Randy Osborne
DBV Technologies SA CEO Daniel Tasse said his firm will meet “very shortly” with the U.S. FDA for talks that will formalize an accelerated approval process for the Viaskin Peanut allergy patch. “Did this take longer than expected? Yes, it did,” Tasse said during a conference call update. “But this was a choice we made, and it was a necessary choice” in order to nail down precise requirements for the product.
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Green checkmark and red X

UK nod for Alzheimer’s drug Kisunla, but NICE says no coverage

Oct. 23, 2024
By Nuala Moran

The U.K. Medicines and Healthcare products Agency has become the third to approve Eli Lilly and Co.’s Kisunla (donanemab), but the drug’s spending watchdog has simultaneously ruled the Alzheimer’s disease treatment is not cost effective.


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UK's MHRA eyes new regs for point-of-care drug manufacturing

Oct. 23, 2024
By Mark McCarty
The U.K.'s Medicines and Health Care Products Regulatory Agency (MHRA) has posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K. However, the agency has also floated a regulation for the production of pharmaceuticals at the point of care, a proposal MHRA said is the first of its kind.
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EU flags in front of the Berlaymont building

European Parliament again presses for significant revisions to MDR

Oct. 23, 2024
By Mark McCarty
The EU's regulatory crisis continues to roil relations between Brussels and stakeholders in the health care sector, and the European Parliament reacted with a message to the European Commission to revise the Medical Device Regulation.
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FDA issues CRL: Inspection woes hold up Camurus’ acromegaly drug

Oct. 22, 2024
By Karen Carey
Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
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Mounjaro pen

NICE backs Mounjaro for obesity but UK’s NHS urges phased rollout

Oct. 22, 2024
By Nuala Moran
For once, the U.K.’s health technology assessment body, the National Institute of Health and Care Excellence (NICE), has no reservations about the cost effectiveness of a new drug and is recommending Eli Lilly and Co.’s obesity therapy, Mounjaro (tirzepatide), for use in the National Health Service (NHS).
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MHRA logo

UK MHRA posts series of stringent regulatory requirements

Oct. 22, 2024
By Mark McCarty
The U.K.'s Medicines and Health Care Products Regulatory Agency posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K.
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Michelle Tarver, FDA device center director

FDA confirms Tarver taking over at agency’s device center

Oct. 22, 2024
By Mark McCarty
The U.S. FDA declared that Michelle Tarver is the permanent replacement for Jeff Shuren as the director of the agency’s device center. The news is hardly a surprise as Shuren confirmed the appointment in an October 2024 public meeting.
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