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Regulatory
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Lab chip skin wound healing with electricity

Industry wary of CMS’s view of skin substitutes in doc fee draft

Sep. 20, 2024
By Mark McCarty
The draft Medicare physician fee schedule for calendar year 2025 provoked a strong backlash from physician societies due to a net cut in physician pay. Device makers have their own concerns, including the latest in a series of controversies over coverage of skin substitutes.
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Art concept for tumor
Immuno-oncology

FDA clears Chengdian (Suzhou) Biopharmaceutical’s IND for CD-001

Sep. 20, 2024
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
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Astellas patent survives ‘natural law’ decision

Sep. 19, 2024
By Mari Serebrov
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
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Cost of using a priority review voucher going up, way up

Sep. 19, 2024
By Mari Serebrov
What comes down must go up seems to be the rule of thumb these days, even for U.S. FDA fees. The cost of using a priority review voucher (PRV) to shave four months off an FDA standard 10-month drug review has dropped drastically over the past several years. But come Oct. 1, biopharma companies will have to pay nearly 89% more than on the previous day to use a PRV.
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Laptop displaying FDA logo

US FDA issues CRL for Vanda’s tradipitant for gastroparesis

Sep. 19, 2024
By Karen Carey
Clearly frustrated by the U.S. FDA’s rejection of tradipitant to treat gastroparesis, Vanda Pharmaceuticals Inc. CEO Mihael Polymeropoulos said the agency is discouraging drug development for the serious gastric emptying condition for which there has been no new treatment in 40 years. The complete response letter (CRL) issued on the Sept. 18 PDUFA date for the neurokinin-1 receptor antagonist, which Vanda licensed from Eli Lilly and Co. in 2012, requested additional studies that the company said are not in line with the advice of experts in the field.
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3D illustration of transparent human torso with close up of spinal cord

FDA clears Avicenna algorithm to detect cervical spine fractures

Sep. 19, 2024
By Annette Boyle
Avicenna.ai SAS received U.S. FDA clearance for its Cina-Cspine algorithm, which uses machine learning technology to detect and triage cervical spine fractures from computed tomography images. The tool automatically flags imaging findings that are compatible with acute cervical spine fractures, which can cause serious neurological damage or paralysis.
Read More
Gears with regulatory words

MDMA urges CMS to craft separate outpatient payments for RDN devices

Sep. 19, 2024
By Mark McCarty
The U.S. CMS believes it has a quandary on its hands with regard to transitional pass-through payment for renal denervation devices, but the Medical Device Manufacturers Association urged the agency to provide separate payment mechanisms for these devices as seen in the inpatient final rule.
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No adcom needed for Applied Therapeutics’ galactosemia therapy

Sep. 18, 2024
By Jennifer Boggs
Investors reading into the U.S. FDA’s decision to skip an advisory committee meeting to discuss the NDA for Applied Therapeutics Inc.’s govorestat, seeking approval as the first therapy for treating classic galactosemia, clearly saw reasons for optimism, as shares of Applied (NASDAQ:APLT) jumped 69% to close Sept. 18 at $7.85.
Read More
Australia flag with microscope, test tubes

Australia’s HTA consultation wraps up with 50 recommendations

Sep. 18, 2024
By Tamra Sami
Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate.
Read More
Rebound arrows
Med-tech financings 2Q24

Q2 sees med-tech financings rise 16.5% as sector builds momentum

Sep. 18, 2024
By Amanda Lanier
The med-tech sector maintained its momentum in the second quarter, with total financings climbing 16.5% to $7.47 billion, compared to $6.41 billion in Q1.
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