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Regulatory
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Eko Health Low EF Stethoscope

Eko grabs a nod from US FDA for AI-enabled ejection fraction detector

April 3, 2024
By Mark McCarty
Artificial intelligence (AI) is steadily making inroads into the world of health care, and San Francisco-based Eko Health Inc. has taken up the AI call with a stethoscope developed in conjunction with the Mayo Clinic that can detect low ejection fraction of the heart.
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Doctor examining child's leg

China accepts Sperogenix NDA filed for rare muscle disorder drug

April 2, 2024
By Marian (YoonJee) Chu
Beijing- and Shanghai-based Sperogenix Therapeutics Ltd. said that China’s regulatory agency accepted the NDA filing and granted priority review of Agamree (vamorolone) for Duchenne muscular dystrophy on March 26.
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Green approved stamp

Astellas wins first approval of Vyloy in gastric cancer in Japan

April 2, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
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Teva, Janssen to continue squabble over schizophrenia drug patent

April 2, 2024
By Mari Serebrov
Yes, even a phase III protocol for a “failed” trial can constitute prior art, the U.S. Court of Appeals for the Federal Circuit told a lower court April 1 when it returned Janssen Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.’s patent squabble for a do-over.
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Gears with regulatory words

MHRA’s regulatory update adds a rule for stand-alone device software

April 2, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency is in the thick of its proposed regulatory overhaul for medical technology, which the agency promises will hew closely to the regulations still in deployment in the European Union.
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4-9-Abbott-Triclip.png

Abbott wins approval for Triclip tricuspid valve repair system

April 2, 2024
By Holland Johnson
Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.
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Bispecific antibodies with heavy chain in green and pink, light chain in blue and yellow
Immuno-oncology

Context Therapeutics files IND application for CTIM-76 for CLDN6-positive gynecologic and testicular cancers

April 2, 2024
Context Therapeutics Inc. has submitted an IND application to the FDA to begin a first-in-human phase I study of CTIM-76 in patients with claudin 6 (CLDN6)-positive gynecologic and testicular cancers.
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Doctor examining child's leg

China accepts Sperogenix NDA filed for rare muscle disorder drug

April 1, 2024
By Marian (YoonJee) Chu
Beijing- and Shanghai-based Sperogenix Therapeutics Ltd. said that China’s regulatory agency accepted the NDA filing and granted priority review of Agamree (vamorolone) for Duchenne muscular dystrophy on March 26.
Read More

Rx, med-tech industry groups warn of impact of Gilead R&D suits

April 1, 2024
By Mari Serebrov
The U.S. biopharma and med-tech industries are adding their voice to that of Gilead Sciences Inc. in urging the California Supreme Court to review the Gilead Tenofovir Cases, which seek to hold the drug company liable for how and when it developed its pipeline of HIV drugs.
Read More
Image from pilot animal study

​US FDA wary of predicate devices in draft guidance for jawbone grafts​

April 1, 2024
By Mark McCarty
The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.
Read More
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