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

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

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…

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…