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Home » Topics » Regulatory

Regulatory
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Immuno-oncology

IND clearance for Fibrogen’s Gal9-targeting monoclonal antibody for solid tumors

June 4, 2024
Fibrogen Inc. has received IND clearance from the FDA allowing the company to initiate a phase I trial of FG-3165, a galectin-9 (Gal9)-targeted monoclonal antibody under development for treatment of solid tumors characterized by high levels of Gal9 expression.
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No ecstasy for adcom in considering heavy issues for psychedelic

June 3, 2024
By Mari Serebrov
Unblinding, zealous therapists, severity of harms, abuse potential and actual benefit could all be part of the conversation June 4 when the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee meets in person for the first time since the COVID-19 lockdowns to consider the use of a psychedelic drug, guided by psychotherapy, to treat post-traumatic stress disorder, or PTSD.
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CHMP: Re-eval for Translarna; recommendation for Ixchiq, Cejemly

June 3, 2024
By Nuala Moran
The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn.
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Therasphere Y-90 glass microspheres

NICE: Radioembolization treatment for neuroendocrine liver cancer

June 3, 2024
By Shani Alexander
The U.K.’s National Institute for Health and Care Excellence recent recommendation that selective internal radiation therapy could be used to treat neuroendocrine tumors that have metastasized to the liver is a boon for patients suffering from the disease. However, there is not yet a clear pathway for these patients to receive the therapy via the national health service.
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Cholesterol plaque in artery

Cleerly seeks US Medicare coverage of AI-enabled plaque analysis

June 3, 2024
By Mark McCarty
New York-based Cleerly Labs Inc., petitioned several U.S. Medicare administrative contractors for coverage of the use of the company’s artificial intelligence product for analysis of CT coronary arteries to evaluate the disease burden of plaque.
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Ribbons of digital data

Dissolution of UK Parliament leaves AI bill in limbo

June 3, 2024
By Mark McCarty
The Parliament of the U.K. has dissolved right on schedule, leaving the members of the House of Commons with a raft of policy issues to deal with in the next assembly. One of these issues is a bill originating in the House of Lords, the Artificial Intelligence Bill, which seems technologically agnostic and thus may represent a risk of duplicative oversight of AI for health care purposes.
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ASCO roars to life in Chicago as CEOs talk innovation

May 31, 2024
By Lee Landenberger
The American Society of Clinical Oncology (ASCO) meeting opened at the McCormick Place convention center in Chicago with after-lunchtime sessions on breast cancer, melanoma, sarcoma and advancements on adjuvant cancer vaccines. As ASCO revved up, the CEOs of Merck & Co. Inc., Gilead Sciences Inc. and Eli Lilly and Co. vented their frustrations about the impact of the Inflation Reduction Act on innovation.
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Vaccine vial and syringe

Moderna’s Mresvia approved as first mRNA-based RSV vaccine

May 31, 2024
By Karen Carey
Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S.
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U.S. flag on columned building

Innovasis, two execs hit with $12M fine over FCA allegations

May 31, 2024
By Mark McCarty
The U.S. Department of Justice announced May 29 that Innovasis Inc., of Salt Lake City and two of the company’s executives have agreed to pay $12 million over allegations of payment of kickbacks to surgeons.
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Stereotaxis robotic magnetic navigation (RMN) system

Stereotaxis receives CE mark certification for devices in Europe

May 31, 2024
By Shani Alexander
Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies.
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