Amgen's biologics license application for Aimovig, or erenumab, to prevent migraine in patients who experience at least four migraines a month, has been accepted for review by the FDA with an expected action date of May 17, 2018. Amgen and Novartis will jointly commercialize the drug.
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Independent pharmacies must evolve their business models and focus to be successful, according to Brian Nightengale, senior vice president for community and specialty pharmacy at AmerisourceBergen. Among the challenges is the ability to serve both customers, who most value convenience and speed, and patients, who appreciate the relationship and personal attention independent pharmacies can offer, he said.
Spark Therapeutics' Luxturna, or voretigene neparvovec, for treatment of patients with inherited retinal disease, received rare pediatric disease status from the FDA. The drug is under review with an action date of Jan. 12, 2018.
Senate Republican leaders are aiming for a Tuesday vote on starting debate on their health care overhaul legislation. GOP lawmakers are urging their colleagues to support the procedural measure and then force votes on amendments they feel are necessary.
Incyte said it has begun treating its first patient in a late-stage trial to assess the efficacy of its Janus kinase inhibitor 1 drug candidate itacitinib to treat acute graft-versus-host disease combined with corticosteroids. The study's primary endpoint is overall response rate 28 days after dosing begins, while the secondary goal is nonrelapse mortality at six months.
A study in the journal Scientific Reports found that an experimental selective HDAC3 inhibitor was able to delay the onset of Huntington's disease in mice. "While these results are preliminary, the data shows that the onset of Huntington's disease is delayed when HDAC3 (the enzyme) is blocked in this pre-clinical setting," said lead researcher Robert Lahue.
Roche has pulled out of a deal with Oryzon Genomics, a Spanish biotech developing the epigenetic drug candidate ORY-1001 for leukemia and lung cancer. The drug candidate is being assessed in early-stage trials.