A range of drugs critical to patient care are slipping into shortage. Source: Drug Industry Daily

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…

The FDA plans to resume unannounced onsite inspections in India and China shortly after the New Year. Source: Drug Industry Daily

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…

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…

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 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

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…

The European Medicines Agency’s (EMA) human medicines committee endorsed granting 13 marketing authorizations for drugs during its monthly meeting, held Dec. 13 to 16. Source: Drug Industry Daily

Regeneron and AstraZeneca both say their therapeutic antibody cocktails remain active against Omicron, but questions remain in light of a Chinese study concluding that the variant escapes 85 percent of…