AbbVie office

The full approval makes Elahere the “first and only antibody-drug conjugate (ADC) approved in the U.S. for” ovarian cancer, a “difficult-to-treat malignancy,” AbbVie CMO of global therapeutics Roopal Thakkar, said in a statement.

BioNTech

The U.S. National Institutes of Health has sent a notice to the German company regarding default on the payment of royalties and other amounts related to its COVID-19 vaccine.

Novo Nordisk

Cardior is a leader in the discovery and development of therapies that target RNA as a means to prevent, repair and reverse diseases of the heart. The company’s therapeutic approach targets distinctive non-coding RNAs as a platform for addressing root causes of cardiac dysfunctions with an aim to achieve lasting patient impact.

A recent study carried out by researchers at Tulane University and published in the American Journal of Respiratory and Critical Care Medicine unveiled a novel diagnostic tool that can identify Mycobacterium avium complex (MAC) nontuberculous mycobacterial (NTM) infections in as little as two hours.

Roche logo

Despite meeting its primary endpoint in a late-stage generalized myasthenia gravis trial, Roche and Chugai Pharmaceutical’s Enspryng did not demonstrate clinical benefit as expected, the companies announced Thursday.

Following its label expansion earlier this month, Medicare on Thursday said it will now cover the use of Novo Nordisk’s Wegovy in patients with overweight or obesity who have preexisting cardiovascular disease.

Leqembi

The European Union’s medicines regulator has delayed it decision on Eisai and partner Biogen’s Alzheimer’s disease drug that was expected this week, the Japanese company said today.

The oral drug, to be sold under the brand name Duvyzat, is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD, according to the FDA.

FDA

Yesterday the agency classified the recall of privately held Vyaire Medical’s respiratory support devices as most serious and said their use could cause major injuries or death.

Bayer

As part of a sweeping reorganization, Bayer Pharmaceuticals on Wednesday shuffled its leadership roster, which included the creation of a new unit and role changes.