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Home » Topics » Regulatory

Regulatory
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Australia’s anti-trust watchdog clears Cohlear-Oticon revised deal

April 4, 2024
By Tamra Sami
Australia’s Competition and Consumer Commission said it will not oppose Cochlear Ltd.’s proposed acquisition of the cochlear implants business of Denmark’s Oticon A/S after the bone conduction businesses was removed from the deal.
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Non-Hodgkin lymphoma cells in the blood flow
Immuno-oncology

Verismo submits IND application for Synkir-310 for relapsed or refractory B-cell NHL

April 4, 2024
Verismo Therapeutics Inc. has submitted an IND application to the FDA seeking to initiate a phase I trial this year of Synkir-310 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas (B-cell NHL), including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma.
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Dollar sign dropper and test tube

US NIH under fresh scrutiny for questionable research funding

April 3, 2024
By Mari Serebrov
Does the NIH have the ability to screen for U.S. security issues in its award of research grants? That question is at the heart of an April 2 letter the Republican leadership of the House Energy and Commerce Committee sent to the Government Accountability Office in which it asked the government watchdog to examine the extent to which the NIH “adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.”
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FDA accepts Daiichi/Astrazeneca’s BLA for Trop2 breast cancer drug

April 3, 2024
By Tamra Sami
The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan to treat adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
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Cyber security padlock

US cybersecurity rule may increase device reporting requirements

April 3, 2024
By Mark McCarty
Makers of medical devices already have a substantial series of requirements related to cybersecurity, but those requirements may increase per a draft rule released by the U.S. Cybersecurity and Infrastructure Security Agency.
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Obesity and heart disease illustration

Coreline Soft wins FDA approval, raises ₩18B in private placement

April 3, 2024
By Marian (YoonJee) Chu
South Korean medical software firm Coreline Soft Co. Ltd. said it gained U.S. FDA 510(k) clearance for its artificial intelligence-based coronary artery calcification assessing solution, Aview CAC, while raising ₩18 billion (US$13.33 million) in a private placement.
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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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