Merck’s HIV drug Idvynso could become a drug choice for patients who need to switch from Gilead Sciences’ Biktarvy for safety or tolerability reasons. The Merck combination drug pairs two molecules that bring different mechanisms of action to suppressing HIV.
Travere Therapeutics’ Filspari is now the first FDA-approved drug for focal segmental glomerulosclerosis (FSGS), a rare kidney disease. Analysts project the pill will become a blockbuster seller.
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FDA approval for Eli Lilly’s oral GLP-1 drug, Foundayo, comes about three months after Novo Nordisk launched its Wegovy pill. While clinical trial results for both daily pills showed comparable weight reduction, Lilly’s pill offers patients a slight dosing advantage.
March has seen a slew of executive hires, exits and layoffs across the healthcare industry. For instance, Flare Capital Partners, SCAN Group and Advocate Health named new executives. There were also layoffs at organizations including Oracle, Takeda and Blue Shield of California.
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Denali Therapeutics’ Avlayah received FDA approval for treating Hunter syndrome, a rare neurological disorder. The biologic medicine uses Denali’s proprietary drug delivery technology to cross the protective blood-brain barrier.
Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but there is a "lack of substantial evidence" that warrants exploration about the reasons for trial failures to identify the appropriate patients for the eye drop. AbbVie holds an option to collaborate on reproxalab's commercialization.
Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.
The FDA said consolidating safety reporting into a single platform, the Adverse Event Monitoring System (AEMS), will increase transparency and reduce costs. But like the legacy systems it replaces, AEMS reports are unverified so causation and frequency of events cannot be determined.
Povetacicept, a Vertex Pharmaceuticals immunology drug designed to block two targets, met the main goal of a Phase 3 clinical trial in the rare kidney disease immunoglobulin A nephropathy. The fusion protein came from Vertex’s acquisition of Alpine Immune Sciences, and analysts say the drug has best-in-class potential.
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Ampreloxetine’s Phase 3 failure in multiple system atrophy is the third disappointing clinical trial outcome for the Theravance Biopharma drug. The biotech will now wind down all R&D and explore options that could include the sale of the company.
The label expansion for Boehringer Ingelheim’s Hernexeos was made under an FDA pilot program that accelerates regulatory review of products with national interest. The daily pill is now approved as a first-line treatment for HER2-positive non-small lung cancer, an indication with few treatment options.
Despite missing statistical significance, Grail said the observation of trending improvement suggests potential for better results with more time, so the company is extending follow up by up to a year. More detailed trial results will be submitted for presentation at the annual meeting of the American Society of Clinical Oncology.
The FDA asked for more data to determine whether Disc Medicine’s bitopertin is benefiting patients with erythropoietic protoporphyria, a rare blood disorder. Analysts say it’s a surprising delay considering bitopertin is one of the first drugs in a new FDA pilot program that speeds up regulatory review of medicines deemed critical for national security or public health.
PTC Therapeutics said it cannot resolve differences it has with the FDA in interpreting clinical trial data for Translarna, a drug it developed for Duchenne muscular dystrophy. The rare disease drug developer’s decision to withdraw Translarna’s FDA submission comes nearly a year after a negative European regulatory decision for the drug.