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Home » Topics » Regulatory

Regulatory
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Cancer

HLX-42 is EGFR-targeting ADC with activity in several cancer models

Oct. 31, 2023
Researchers from Shanghai Henlius Biotech Inc. presented the discovery and preclinical characterization of HLX-42, a next-generation EGFR-targeting antibody-drug conjugate (ADC) being developed for the treatment of cancer.
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US FDA greenlights Loqtorzi for nasopharyngeal carcinoma

Oct. 30, 2023
By Tamra Sami
Patients living with aggressive nasopharyngeal carcinoma (NPC) now have a new treatment option with the U.S. FDA approval of Junshi Biosciences Co. Ltd./Coherus Biosciences Inc.’s PD-1 inhibitor antibody Loqtorzi (toripalimab), which will likely become the new standard of care for NPC.
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Money and pills

Patients warn US CMS of unintended consequences of Rx negotiations

Oct. 30, 2023
By Mari Serebrov

Most of the patients and advocacy groups speaking at the first of 10 public listening sessions questioned the Biden administration’s talking points that U.S. Medicare’s prescription drug price negotiation will be good for beneficiaries because it will improve access to costly drugs by lowering prices.


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Telehealth credited with boosting effectiveness of care for opioid-use disorder

Oct. 30, 2023
By Mark McCarty
Advocates of expanded use of telehealth in the U.S. may believe they have an unfairly high evidentiary bar to meet to bring payers on board, but that evidentiary requirement just received support from the National Institutes of Health (NIH).
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Regulatory actions for Oct. 30, 2023

Oct. 30, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivedx, Neurotrigger.
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Loqtorzi becomes first FDA-approved treatment for NPC

Oct. 27, 2023
Sickle cell disease 3D illustration

No red flags flying ahead of adcom on Vertex’s SCD therapy

Oct. 27, 2023
By Lee Landenberger
It’s just a discussion next week of Vertex Pharmaceuticals Inc. and Crispr Therapeutics AG’s sickle cell disease (SCD) therapy, with no vote expected from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. The FDA isn’t questioning the drug’s efficacy as much as it is concerned about the effects of off-target editing.
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US FDA clears Santhera’s improved steroid, Agamree, for DMD

Oct. 27, 2023
By Jennifer Boggs and Karen Carey
Less than two weeks after getting a thumbs-up from the EMA’s Committee for Medicinal Products for Human Use, Santhera Pharmaceutical AG’s vamorolone secured U.S. FDA approval for use in patients, 2 and older, with Duchenne muscular dystrophy (DMD). A first-in-class drug, vamorolone, branded Agamree, is expected to offer a safer alternative to the steroid therapy, which the company has said will remain a foundational treatment of DMD, even with the introduction of gene therapies.
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Regulatory actions for Oct. 27, 2023

Oct. 27, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cordance, Exatech.
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Green approved stamp

Lilly gains FDA nod for Omvoh in ulcerative colitis; Stelara era ending in EU?

Oct. 27, 2023
By Randy Osborne
After a delay caused by the April complete response letter from the U.S. FDA for Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz), regulators cleared the drug for moderately to severely active ulcerative colitis (UC) in adults. Given by infusion (300 mg/15 mL)/injection (100 mg/mL), Omvoh stands as the first and only interleukin (IL)-23p19 antagonist for the treatment of moderately to severely active UC in adults – as well as the pharma giant’s first drug approval in the space.
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