If approved, ALKS 5461 would be first opioid-containing product to carry indication for depression; Alkermes CEO Pops tells Pink Sheet that agency's safety and efficacy concerns are surmountable because "all depression drugs have mixed results."
Alkermes PLC's major depressive disorder (MDD) drug ALKS 5461 will need to clear a series of hurdles to win the backing of the US FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee at a Nov. 1 meeting, though it appears none will be higher than that for the product's efficacy.
Specifically designed as an adjunct to established antidepressant pharmacotherapy in the treatment of MDD, ALKS 5461 features a combination of...
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
