Roche's hemophilia A drug gets FDA nod | Specialty pharmacy pushes deeper into PBM market | Gazyva gains expanded indication
November 17, 2017
Specialty Pharmacy SmartBrief
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Leading News
Roche's hemophilia A drug gets FDA nod
Roche Holding was granted approval by the FDA for its Hemlibra, or emicizumab-kxwh, as a treatment for adult and pediatric patients with hemophilia A who have factor VIII inhibitors. The once-weekly administered drug, given via subcutaneous injection, is a preventive treatment for bleeding episodes in patients.
Seeking Alpha (free registration) (11/16) 
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Specialty Pharmacy Update
Specialty pharmacy pushes deeper into PBM market
Diplomat Pharmacy announced plans to buy LDI Integrated Pharmacy Services on the heels of an earlier announcement that the specialty pharmacy would acquire National Pharmaceutical Services.
Reuters (11/16) 
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Legislation & Regulation
Gazyva gains expanded indication
Roche's Gazyva was cleared by the FDA as a first-line treatment for patients with follicular lymphoma.
Reuters (11/16) 
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Treatment approved to lower recurrence of renal cell carcinoma
The FDA approved an additional indication for Pfizer's Stutent (or sunitinib malate) as an adjuvant therapy for patients at high risk of developing renal cell carcinoma
Rare Disease Report (11/16) 
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CMS considers Part D changes to address opioid abuse, out-of-pocket costs
CMS considers Part D changes to address opioid abuse, out-of-pocket costs
(Pixabay)
The CMS announced Thursday that it might allow Medicare drug plans to require that members get opioid prescriptions from selected prescribers and fill them only at certain pharmacies as part of measures to fight the opioid abuse epidemic. The agency is also considering requiring payers to pass on drug discounts to consumers, treating out-of-pocket costs for biosimilars like generic drugs and permitting midyear formulary changes after a lower-cost generic drug enters the market. The proposal is open for comments until Jan. 16.
Reuters (11/16),  Kaiser Health News (11/16) 
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FTC sees fewer pay-for-delay deals, chairman says
The Federal Trade Commission has seen a decline in the number of patent settlements between brand-name and generic-drug makers, acting FTC Chairman Maureen Ohlhausen says.
Reuters (11/16) 
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Trends & Technology
Litigation, regulation slow adoption of biosimilars
Biosimilars hold the promise of reducing drug costs, but regulatory and patent issues remain obstacles to their adoption. "Less than half the number of biosimilars that have been approved in the United States by the FDA are currently on the market, and the reason for that is the other ones are still tied up in litigation," said Chip Davis, CEO of the Association for Accessible Medicine.
Drug Store News (11/16) 
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Merck, Cue Biopharma to collaborate on autoimmune disease studies
Using Cue Biopharma's Cue Biologics platform, the company will work with Merck to develop treatments for autoimmune diseases. Under the terms of the collaboration, Cue will get an undisclosed upfront payment and is eligible for up to $374 million in milestones, plus royalties.
BioCentury (11/16) 
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A man may truly live in his dreams, his noblest dreams, but only, only if he is worthy of those dreams.
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