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Home » Topics » Regulatory

Regulatory
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US prices of asthma, COPD inhalers under HELP microscope

Jan. 9, 2024
By Mari Serebrov
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
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US FDA issues complete response for Astellas’ zolbetuximab BLA

Jan. 9, 2024
By Tamra Sami
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch.
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FDA icons and doctor

CG Bio gains FDA breakthrough designation for spine implant device

Jan. 9, 2024
By Marian (YoonJee) Chu
The U.S. FDA granted breakthrough device designation to CG Bio Co. Ltd.’s spine implantation device, Novosis putty, making it the first bone substitute material developed in South Korea to gain the agency’s priority support. Novosis putty, successor to CG Bio’s first generation Novosis Ortho, combines a bone-forming protein called recombinant human bone morphogenetic protein 2 (rhBMP-2; Nebotermin) with ceramic scaffolds to accelerate bone growth.
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UK’s MHRA emphasizes harmonization in new regulatory roadmap

Jan. 9, 2024
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency finalized its plans for an overhaul of its med-tech regulatory system in a comprehensive approach that captures both in vitro diagnostics and artificial intelligence.
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US FDA importation approval: Worth the wait?

Jan. 8, 2024
By Mari Serebrov
With its approval Jan. 5 of Florida’s drug importation program, the U.S. FDA ended a 23-year wait for the government to implement a 2000 provision allowing certain prescription drug imports from Canada.
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medtronic micra vr2

Medtronic receives CE mark for latest leadless pacemakers and CGM

Jan. 8, 2024
By Shani Alexander
Medtronic plc received CE mark for its latest miniature, leadless pacemakers, the Micra AV2 and Micra VR2. According to the company, they are the world's smallest pacemakers, provide a longer battery life, and are easier to program than previous Micra pacemakers, while maintaining the benefits of their predecessors such as reduced complications compared to traditional pacemakers.
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Swissmedic overhauls postmarket surveillance functions

Jan. 8, 2024
By Mark McCarty
Switzerland’s regulatory authority for devices and drugs, Swissmedic, decided to revamp how it organizes its postmarket surveillance work, and is also seeking to stand up its medical product surveillance database.
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3D illustration demonstrating CAR T therapy
Immuno-oncology

Sana’s hypoimmune CD22-directed allogeneic CAR T-cell therapy gains IND clearance

Jan. 8, 2024
Sana Biotechnology Inc. has obtained FDA clearance of its IND application to conduct a study of SC-262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed chimeric antigen receptor (CAR) T therapy.
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’23 in review

FDA scrambled in 2023 to keep up with industry on AI

Jan. 5, 2024
By Mark McCarty
The U.S. FDA might still be seen as the premier med tech regulatory entity in the world, but the agency is badly outnumbered by companies in the life sciences, which are pumping out artificial intelligence algorithms at a breathtaking pace. Further, the FDA must also avoid being lapped by industry in connection with the regulatory novelty known as the predetermined change control plan, a challenge that put the agency’s device center in scramble mode for essentially the entirety of calendar year 2023.
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Skin, tissue layer illustration
Dermatologic

OQL-025 cleared to enter clinic for EGFR inhibitor-induced rash

Jan. 5, 2024
Onquality Pharmaceuticals LLC has obtained IND clearance from the FDA for OQL-025 to treat epidermal growth factor receptor (EGFR) inhibitor-induced acneiform rash, a common toxicity affecting patients treated with EGFR inhibitor therapy for various cancers.
Read More
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