BioSpace News Archive

The U.S. Food and Drug Administration (FDA) approved Novartis’ Kesimpta (ofatumumab) for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Boehringer Ingelheim’s Animal Health USA division will reimburse $379,089 in back pay and interest to 75 female employees to resolve alleged wage discrimination at its St. Joseph, Missouri, facility.

Following approval of its coronavirus vaccine, the first in the world, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute the drug to patients in that country, as well as to patients in countries it has struck deals with.

It was a relatively quiet week for clinical trial news. Here’s a look.

Today’s data describes key safety and immunogenicity data from the U.S. Phase I study for BNT162b.

August has been a busy month for the U.S. Food and Drug Administration. The final two weeks are marked by a number of PDUFA dates, although a few of those drugs have already been approved.

The trial remains on clinical hold and continues to indefinitely delay the company’s plans to seek regulatory approval for the treatment.

The process, auxotrophy, uses the engineered inability of an organism to synthesize a compound required for its survival to allow physicians to turn off a gene therapy if serious side effects develop.

Audentes Therapeutics, Inc., an Astellas company, announced that a third study patient has passed away in the ASPIRO clinical trial evaluating AT132 in patients with X-linked Myotubular Myopathy, which is a serious, life-threatening neuromuscular disease characterized by extreme muscle weakness, respiratory failure, and early death.

Tiziana Life Sciences plc announces that the United States Patent and Trademark Office has granted a patent on use of Milciclib in combination with tyrosine kinase inhibitors such as Sorafenib, Regorafenib and Lenvatinib for the treatment of hepatocellular carcinoma and other cancers in humans.