FDA
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Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy
NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.
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Contamination Risk Sparks a Recall of GSK, Scynexis Antifungal Drug
Scynexis said no adverse events or contamination problems have been reported for Brexafemme, an antifungal approved for treating vaginal yeast infections. The biotech said the risk of cross-contamination stems from the processes of the small molecule’s third-party manufacturer.
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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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Once a Blockbuster Prospect, Is Travere’s Kidney Drug on Track to Become a Bust?
Seven months after Travere Therapeutics’ flagship drug received accelerated FDA approval in a rare kidney disease, the molecule has fallen short of the key goal of its confirmatory test. It’s the small molecule’s second Phase 3 failure this year.
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FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine
ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.
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FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class
FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.
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FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants
The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.
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Twice Rejected Diabetes Drug/Device Product Gets New Chance at Startup i2o
Intarcia Therapeutics’ GLP-1 agonist product candidate for type 2 diabetes now belongs to i2o Therapeutics, which will make the treatment’s case for approval at an upcoming FDA advisory committee meeting. The startup’s $46 million Series A financing is one of several recently announced funding rounds.
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Senate Bill Proposes Slashing ‘Red Tape’ Around Biosimilar Interchangeability
Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.
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BMS Cancer Drug’s New FDA Nod Puts It on Path to Reach Blockbuster Status
Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.
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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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J&J Broadens Scope in Multiple Myeloma, Winning FDA Approval for New Drug
Johnson & Johnson’s stable of multiple myeloma drugs has grown to five products with the FDA approval of Talvey. The bispecific antibody is the first in a new class of new drugs designed to go after the novel multiple myeloma target GPRC5D.
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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder
Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.
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Sage, Biogen Drug Is Now the First Approved Oral Med for Postpartum Depression
Sage Therapeutics’ Zurzuvae is the biotech’s second FDA approved product for postpartum depression, following the 2019 nod for IV-infused Zulresso. But in a blow to the multi-billion dollar partnership between Sage and Biogen, Zurzuvae did not win an additional approval in major depressive disorder.
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A Nonprofit Pharma Nabs FDA Nod for Nonprescription Naloxone Nasal Spray
The FDA approved RiVive, an over-the-counter version of naloxone nasal spray from Harm Reduction Therapeutics. It’s the second such approval from the FDA this year, following an affirmative decision in March for OTC Narcan.
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FDA Refuses to Review Biohaven Drug for Rare Neuromuscular Disease With No Treatments
Biohaven’s bid to bring to market the first drug for rare neuromuscular disorder spinocerebellar ataxia has hit a setback. The FDA is refusing to review the drug’s application, a decision that could indicate the agency wants another clinical trial.
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FDA Approves Blood Thinner Reversal Drug, But Requires More Tests to Assess Serious Risk
While Octapharma drug Balfaxar met the goal of its pivotal clinical trial, more deaths and blood clot problems were reported in the study drug arm versus the comparator group. The FDA is requiring a post-marketing study to further assess the drug’s risks.
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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.
