Many Drugs Critical to Patient Care are Slipping Into Shortage Due to Prioritization of COVID-19 Products, Says Report
A range of drugs critical to patient care are slipping into shortage. Source: Drug Industry Daily
Biogen Cuts Aduhelm Cost by 50 Percent, Hoping to Secure Insurance Coverage
In an unusual bid to trim costs and win prescriber and payer support, Biogen has cut the price of Aduhelm in half. Source: Drug Industry Daily
AbbVie Presses Trade Commission to Ban Alvotech's Humira Biosimilar in the U.S.
AbbVie is pushing the International Trade Commission (ITC) to prevent Iceland-based biosimilar developer Alvotech from marketing its biosimilar candidate to AbbVie's blockbuster Humira (adalimumab). Source: Drug Industry Daily
FDA Puts Another Hold on Bluebird’s Sickle Cell Gene Therapy
The FDA has placed a partial clinical hold on Bluebird Bio’s gene therapy for sickle cell disease (SCD), lovotibeglogene autotemcel (lovo-cel), for trial participants under the age of 18 after…
FDA to Resume Unannounced Foreign Inspections Shortly, Says FDA Official
The FDA plans to resume unannounced onsite inspections in India and China shortly after the New Year. Source: Drug Industry Daily
Moderna Pauses Acrimonious Bid for Patent on mRNA Sequence, Says More Time is Needed for Discussions with NIH
Amid an ongoing dispute with the National Institutes of Health (NIH) over who exactly invented the mRNA sequence of Moderna’s COVID-19 vaccine, the company is hitting the pause button on…
Novartis Gets A Miss and a Hit in Urticaria Space
Ligelizumab, Novartis’ investigational anti-IgE antibody, didn’t stand up to the company’s established blockbuster omalizumab in a pair of phase 3 studies in patients with chronic spontaneous urticaria (CSU). Source: Drug…
Federal Judge Overturns Purdue Pharma’s $4.5 Billion Bankruptcy Settlement Over Sackler Family Immunity Provision
A federal judge has overturned a $4.5 billion settlement that protected members of the Sackler family, owners of Purdue Pharma, the maker of OxyContin. Source: Drug Industry Daily
FDA’s Fall Regulatory Agenda Adds Several New Proposed and Final Rules
The FDA’s fall 2021 regulatory agenda includes several new proposed and final rules. Source: Drug Industry Daily
Aduhelm Gets Thumbs Down From EMA as Biogen Plans U.S. Confirmatory Study
In another huge blow to Biogen’s controversial Alzheimer’s blockbuster, the European Medicines Agency (EMA) has declined to approve Aduhelm (aducanumab), saying the data don’t support a strong clinical benefit and…
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