U.S.-based Biomarin Pharmaceutical Inc.’s treatment for one of the most common forms of dwarfism received clearance from the European Commission, becoming the first therapy to get an approval in the region for achondroplasia.

Novartis

Novartis said the company’s Kymriah CAR-T therapy did not meet the drug’s primary endpoint of event-free survival in a phase III study in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment.

The Food and Drug Administration on Aug. 23 approved Cara Therapeutics’ drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making Korsuva the first therapy for the ailment in the United States.

Sanofi raised the company’s 2021 profit forecast on July 29 after its vaccines and star eczema treatment Dupixent helped the French drugmaker beat second-quarter results expectations.

Med Ad News talked to Wendbush Securities analysts David Nierengarten, Laura Chico, and Liana Moussatos about various new drug approvals and other recent news updates in the industry. 

Bristol Myers Squibb

The U.S. Food and Drug Administration approved Bristol Myers Squibb’s oral drug Zeposia to treat adults with ulcerative colitis, a chronic inflammatory bowel disease.

Amicus Therapeutics announced topline results from the Phase III PROPEL pivotal trial of AT-GAA (cipaglucosidase alfa and miglustat) for late-onset Pompe disease.

Moderna believes the company’s Covid-19 vaccine protects against new variants found in Britain and South Africa, although it will test a new booster shot aimed at the South Africa variant after concluding that the antibody response could be diminished.

Publicly traded companies that have been heavily involved in developing therapies and vaccines for Covid-19 have experienced significant spikes in their stock prices from March 2020 to January 2021, including Germany’s BioNTech, which surged 187% in one year.

Eli Lilly

A small trial of Eli Lilly’s donanemab showed the experimental Alzheimer’s drug slowed by about a third the rate of decline in a combined measure of cognition and function in patients at an early stage of the mind-wasting disease.