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...
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...
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...
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...
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, ...
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...
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...
Biosimilars May Be at Risk Depending on Court’s ACA Ruling
As the Supreme Court decides on the fate of the Affordable Care Act (ACA), much of the focus understandably has been on the millions of people who would lose health insurance coverage and protections for pre-existin...
Keytruda Brings New Option To Treatment of PD-L1+ TNBC
The FDA has approved only a few drugs to treat triple-negative breast cancer (TNBC), and last month saw Merck & Co., Inc’s Keytruda (pembrolizumab) gain accelerated approval for the condition. Commercial payer...
With Oxlumo Approval, Alnylam Unveils Value-Based Program
With its third FDA approval in less than two-and-a-half years, Alnylam Pharmaceuticals, Inc. is bringing another orphan drug for a rare condition to the U.S. market. And similar to the first two, Oxlumo (lumasiran) ...