Radar on Specialty Pharmacy

Recently Approved Evrysdi May Have Big Impact on SMA Class

The spinal muscular atrophy (SMA) therapeutic category continues to expand with the Aug. 7 FDA approval of Evrysdi (risdiplam) from Roche Group member Genentech, Inc. Industry experts maintain that the drug has the ...
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AllianceRx Walgreens Prime Unveils New Shipping Process

One common characteristic of specialty medications is that they require special handling. Quite often that means they need to remain refrigerated or frozen, which is critical while drugs are being transported to pat...
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New FDA Specialty Approvals

✦ Aug. 5: The FDA gave accelerated approval to GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, inclu...
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News Briefs

✦ Rep. Carolyn Maloney (D-N.Y.) said she plans to issue a subpoena to AbbVie Inc. for documents relating to Humira (adalimumab) and Imbruvica (ibrutinib). Maloney is the chairwoman of the Committee on Oversight an...
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Impact of Executive Orders on Drug Pricing Is Questioned

On July 24, President Donald Trump signed four executive orders aimed at lowering what Americans pay for prescription drugs. Industry experts questioned how much of an impact two of the orders — one on low price i...
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Banner Prepares to Launch Generic Novel Fumarate Bafiertam

A recent court decision put Mylan N.V. in the spotlight for its win over Biogen concerning the patent of the latter’s best-selling multiple sclerosis (MS) therapy Tecfidera (dimethyl fumarate). The decision to inv...
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Two PARP Inhibitors OK’d for New Prostate Cancer Indication

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the trea...
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Payers: Lynparza Coverage Will Be at Parity With Other Second-Line Prostate Cancer Drugs

AstraZeneca and Merck & Co., Inc. released positive results of Lynparza’s Phase III PROfound trial last August. Shortly thereafter, from Sept. 3, 2019, to Oct. 7, 2019, Zitter Insights polled 51 commercial pay...
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Anemia Due to CKD May See First-in-Class Drug This Year

Chronic kidney disease (CKD) affects almost 40 million people in the United States. The condition can cause a variety of health complications, including anemia. Treatments for anemia of CKD consist of erythropoiesis...
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New FDA Specialty Approvals

✦ July 7: The FDA approved Astex Pharmaceuticals, Inc., Taiho Oncology, Inc. and Otsuka Pharmaceutical Co., Ltd.’s Inqovi (decitabine and cedazuridine) for the treatment of adults with intermediate and high-risk...
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