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Pfizer and BioNTech announced Thursday that their COVID-19 vaccine is effective against the Delta variant after two doses and that a third dose will boost the protection even more. Read More
The European Parliament has voted to expand the European Medicines Agency’s (EMA) authority to monitor the supply chain for drugs and medical devices. Read More
The FDA has granted a Priority Review to AstraZeneca and Amgen’s investigational asthma treatment tezepelumab — setting a target decision date for the Biologics License Application (BLA) in the first quarter of 2022. Read More
Biogen and FDA have narrowed the treatment indications for Aduhelm (aducanumab), now recommending the antiamyloid antibody only for patients with mild cognitive impairment (MCI) and early Alzheimer’s disease (AD). Read More
OxyContin maker Purdue Pharma filed a restructuring plan that includes its owners, the Sackler family, paying $4.2 billion toward the settlement of opioids lawsuits, dissolves Purdue following its bankruptcy, and has the Sackler family and Purdue agreeing to disclose about 30 million internal documents related to the company and the family’s roles in igniting and fueling the opioid crisis over the past 20 years. Read More
The FDA sent a warning letter to Round Rock, Texas-based Davati Medical Supply instructing it to stop marketing an unapproved quadrivalent influenza vaccine. Read More
The World Health Organization (WHO) has recommended the use of interleukin-6 receptor blockers — including Roche’s Actemra (tocilizumab) and Sanofi’s Kevzara (sarilumab) — plus corticosteroids for the treatment of severe COVID-19. Read More