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The FDA is reaching out to states that have filed applications with the agency seeking approval to directly import prescription medicines from Canada. Read More
Alzheimer’s disease drug Aduhelm and other investigational anti-amyloid antibodies similar to Aduhelm will only be covered by Medicare and Medicaid if they’re used in the setting of a federally approved study, the Centers for Medicare and Medicaid Services (CMS) announced yesterday. Read More
Generics and biosimilars will slow the overall pace of drug spending growth this year, even though U.S. prescription drug spending is slated to rise by 4 to 6 percent year-over-year in 2022. Read More
The UK’s National Institute for Clinical Excellence (NICE) voted down a recommendation for Gilead Sciences’ chemotherapy drug aimed at triple-negative breast cancer, but approved Merck KGaA’s Bavencio (avelumab), which fought its way back into the agency’s good graces after stakeholders launched a letter-writing campaign and the company lowered its cost. Read More
Pfizer announced yesterday that it would acquire ReViral in a $525 million deal that will give the company ownership of ReViral’s experimental treatments for respiratory syncytial virus (RSV) infections. Read More
Despite the disappointing results, Theravance is still investigating the drug as a potential treatment for patients with multiple system atrophy. Read More
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted this week by the Alliance for a Stronger FDA. Read More