Behring Hemgenix News Today

Pfizer Inc.’s Beqvez (fidanacogene elaparvovec) won FDA approval for use in adults with hemophilia B, making it the second adeno-associated viral (AAV) vector-based gene therapy available for patients in the U.S., following the late 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec).

The agency greenlighted the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B. 

BioPharma

Teddi Shaw, a baby with extremely rare and fatal genetic disorder, becomes the first person in the UK to receive Libmeldy, a £2.8 million drug.

Synergie, a new independent company, aims to disrupt the specialty drug market by banding insurers together to negotiate prices for high-cost treatments such as gene therapy.

Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.

BioPharma

The FDA, which started 2022, on a slow note, has so far approved 30 novel drugs, compared to 47 that were approved during the same period last year. Now, lets take a look at the biotech stocks facing FDA decision in December.

(RTTNews) - As we wind down another month, lets take a look at some of the news stories that made headlines on the regulatory front in November. ...

CSL Behring’s Hemgenix is said to cut the number of bleeding events expected over the course of a year by 54%.