FDA
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Devices & Diagnostics, BioPharma
Rigorous Data Are Key to Convince Payers, Investors in the World of Digital Therapeutics
Pear Therapeutics was once regarded as a digital therapeutics pioneer, but its spiral into bankruptcy has the industry searching for the best path forward. While some favor going direct to consumers, others say the solution is in generating more robust clinical trial data to persuade hesitant payers.
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FDA Approval of RSV Drug Gives Infants and Toddlers Long-Lasting Protection
AstraZeneca and Sanofi drug Beyfortus is now FDA approved for preventing respiratory problems from RSV infection in infants and toddlers. Antibody engineering enables the drug to last longer in the body, providing protective effects for potentially the entire RSV season.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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Eli Lilly Strengthens the Case for Going Early in Alzheimer’s Treatment
Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference.
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FDA Nod Makes Perrigo’s Opill the First Oral Contraceptive to Switch to OTC Use
FDA approval of Opill makes it the first oral contraceptive that may be used without a prescription. Clinicians say over-the-counter availability will lower barriers to access to a key component of reproductive healthcare.
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Devices & Diagnostics, BioPharma
FDA Authorizes Better Therapeutics Mobile App for Treating Type 2 Diabetes
Better Therapeutics prescription digital therapeutic, AspyreRx, received De Novo FDA authorization for type 2 diabetes. The mobile app digitizes and personalizes cognitive behavioral therapy.
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FDA Lifts Partial Hold on Curis Drug, Clearing Way for Phase 2 Leukemia Study
A partial clinical trial hold has been lifted from cancer drug emavusertib and Curis has selected a dose to use in Phase 2 testing. The small molecule is being developed as a potential treatment for blood cancers.
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Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert
Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.
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A Startup Wins the First FDA Approval of a Cell Therapy for Type 1 Diabetes
CellTrans’s Lantidra is now the first FDA-approved cell therapy for type 1 diabetes. The therapy is made from islet cells sourced from deceased donors.
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FDA Approves BioMarin Pharma’s Gene Therapy, the First for Hemophilia A
The FDA approved Roctavian for treating hemophilia A. The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Pfizer Growth Hormone Drug Measures Up at FDA With O.K. for Weekly Dosing
Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.
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UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval
The FDA approved UCB’s Rystiggo for treating generalized myasthenia gravis. Drugs are already available for the rare neuromuscular disorder, but Rystiggo’s approval includes treatment of a subset of patients not addressed by other products.
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FDA Approval of Pfizer Alopecia Drug Brings New Competition to Eli Lilly Med
Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.
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After Second FDA Rejection, Intercept Abandons NASH Drug and Restructures
The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.
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FDA Approves First Gene Therapy for Duchenne Muscular Dystrophy
Sarepta Therapeutics’ Elevidys is now the first FDA-approved gene therapy for Duchenne muscular dystrophy. Elevidys is an engineered version of a gene intended to restore function lost to the mutation at the root of the inherited muscle disease.
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FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death
Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
