Radar on Specialty Pharmacy

New FDA Specialty Approvals

✦ Jan. 14: The FDA granted an additional indication to Pfizer Inc.’s Xalkori (crizotinib) to treat children at least 1 year old and young adults with relapsed or refractory, systemic anaplastic large cell lympho...
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News Briefs

✦ Implementation of the most- favored-nation (MFN) model continues to be stalled. Following court rulings in December that temporarily blocked its Jan. 1 enactment (RSP 1/21, p. 8), the U.S. District Court for the...
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Centene Boosts Specialty Drug Expertise With Pair of Deals

Centene Corp. celebrated the end of 2020 by closing on its acquisition of specialty pharmacy PANTHERx Rare, LLC on Dec. 30, then started 2021 with an agreement to acquire Magellan Health, Inc. The deals will strengt...
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Race for COVID Vaccines, Therapies Topped Past Year’s Trends

As we look back over the past year, the COVID-19 pandemic has been top of mind for many involved in pharma commercialization and coverage. Less than a year after scientists sequenced the COVID genome, the FDA grante...
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FDA Approves First Oral Therapy For Prevention of HAE Attacks

When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) last month, the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks. According to Zitt...
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Innovative Drugs Were Some Top 2020 Specialty Trends

While the COVID-19 pandemic and pharma’s efforts to counter it were the top pharma concerns in 2020, that wasn’t the only innovation within the specialty pharmacy arena. AIS Health spoke with a variety of indust...
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Court Rulings Temporarily Block MFN Model Implementation

As expected by some in the pharma industry, judges in two U.S. district courts have temporarily blocked implementation of the administration’s most-favored-nation (MFN) model that was set to take effect Jan. 1. Wh...
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New FDA Specialty Approvals

✦ Dec. 14: The FDA approved a new dosing time for Roche Group unit Genentech USA, Inc.’s Ocrevus (ocrelizumab) to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, ...
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News Briefs

✦ On Aug. 17, 2018, the FDA gave accelerated approval to Bristol-Myers Squibb Co.’s programmed death-1 (PD-1) inhibitor Opdivo (nivolumab) for the treatment of people with metastatic small cell lung cancer whose...
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MFN Rule Likely Will Have Broad Impact on Health Care System

More than two years after first proposing the idea of pricing drugs on the U.S. market based on their prices in certain countries, the administration on Nov. 20 moved ahead with an interim final rule that would requ...
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