FDA to review Amgen's BLA for Aimovig | Independent pharmacy must adopt new business models | FDA grants rare pediatric disease status to Spark's retinal disease drug
July 21, 2017
Specialty Pharmacy SmartBrief
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Leading News
FDA to review Amgen's BLA for Aimovig
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.
Reuters (7/20),  Seeking Alpha (free registration) (7/20) 
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Specialty Pharmacy Update
Independent pharmacy must adopt new business models
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.
Drug Topics (7/20) 
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Legislation & Regulation
FDA grants rare pediatric disease status to Spark's retinal disease drug
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.
Seeking Alpha (free registration) (7/20) 
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GOP aims for Tuesday vote on health care
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.
ABC News/The Associated Press (7/20) 
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Patent lawsuit stands in way of Merck's biosimilar insulin
The FDA has tentatively approved Lusduna Nexvue, Merck & Co.'s biosimilar version of Sanofi's long-acting insulin Lantus, subject to the outcome of Sanofi's patent infringement lawsuit against Merck.
Reuters (7/20) 
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Clinical & Research News
First patient joins Incyte's Phase III trial of itacitinib to treat GVHD
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.
Genetic Engineering & Biotechnology News (7/20) 
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Irish study promising for potential Huntington's disease treatment
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.
Rare Disease Report (7/20) 
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Trends & Technology
Breast cancer drug price likely to top $10K/month
Puma Biotechnology's breast cancer drug Nerlynx is likely to be priced at $10,500 per month, according to Cowen Group analyst Chris Shibutani.
FiercePharma (7/20) 
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Roche withdraws from deal with Oryzon Genomics for cancer drug candidate
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.
Reuters (7/20) 
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ABL awarded contract to speed development of HIV vaccine
The National Institute of Allergy and Infectious Diseases' Division of AIDS awarded a seven-year contract of up to $318 million to ABL to support the development of an HIV vaccine and other biologics.
OutsourcingPharma (7/19) 
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