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Home » Topics » Regulatory

Regulatory
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Antibodies illustration

Tracon quits work on anti-PD-L1 envafolimab after phase III flop

July 2, 2024
By Tamra Sami
Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma.
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Unwinding of Chevron could bring down HHS, FDA, CMS policies

July 2, 2024
By Mari Serebrov
The U.S. Department of Health and Human Services (HHS) and the FDA already are getting a glimpse of the post-Chevron world and how the Supreme Court’s June 28 unwinding of the 40-year-old Chevron deference could rein in agency policies that defy Congress’ expressed intent.
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Red wooden approved stamp

China approves first cetuximab biosimilar

July 2, 2024
By Tamra Sami
China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.).
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Drug vials

FDA grants approvals to Stelara, Neupogen, Eylea biosimilars

July 2, 2024
By Marian (YoonJee) Chu
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
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1-10-abbott-heartmate3.png

Heartmate recall underscores systemic issues with VADs

July 2, 2024
By Mark McCarty
The U.S. FDA posted notice of a recall of the system monitor for the Heartmate left ventricular assist device by Abbott Laboratories, an action necessitated by reports of a series of malfunctions that may lead to inadvertent operator error.
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Edwards EVOQUE

Edwards urges CMS to mimic TMVR coverage for Evoque

July 2, 2024
By Mark McCarty
After snaring the U.S. FDA’s approval for the Evoque tricuspid valve device, Edwards Lifesciences Corp. petitioned the Centers for Medicare & Medicaid Services for a national coverage determination for transcatheter tricuspid valve replacement devices.
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Clinical data illustration
Endocrine/metabolic

Medipal and JCR move JR-446 toward clinic in Japan for mucopolysaccharidosis type IIIB

July 2, 2024
Medipal Holdings Corp. and JCR Pharmaceuticals Co. Ltd. have announced the completion of the clinical trial notification review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for a phase I/II study of JR-446 for the treatment of mucopolysaccharidosis type IIIB (MPS IIIB; Sanfilippo syndrome type B).
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Gastric cancer
Cancer

Signet’s SIGX-1094 receives US IND clearance for diffuse gastric cancer

July 2, 2024
Signet Therapeutics Inc. has received IND clearance from the FDA for SIGX-1094 as a potential treatment for diffuse gastric cancer. A phase I trial is planned in patients with diffuse gastric cancer and other advanced solid tumors.
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Daiichi, Merck’s HER3-DXd gets CRL for lung cancer

July 2, 2024
By Karen Carey
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
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EMA icons

EMA takes negative view on masitinib; Ocaliva, Translarna out

July 1, 2024
By Nuala Moran
Two drugs were pushed back by the EMA last week, with a recommendation that Ocaliva, currently the only second line standard of care for treating primary biliary cholangitis, be withdrawn from the market, and a refusal to grant conditional approval for masitinib in the treatment of amyotrophic lateral sclerosis.
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