CRISPR-based cell therapies continued to gain steam Sept. 27 with the announcements of a potentially valuable big pharma collaboration and an ambitious global regulatory push.
An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.
An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.
Five months after winning its first approval in Japan, Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), earned a U.S. FDA nod for use in pediatric and adult patients with acid sphingomyelinase deficiency (ASMD), becoming the first medication designed to treat symptoms not related to the central nervous system.
If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC, it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that’s still an if. Whether the patent infringement case involving a so-called “skinny label” makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts.
The race to develop an oral selective estrogen receptor degrader (SERD) is under fresh scrutiny in light of Sanofi SA’s decision to axe development of its late-stage compound amcenestrant on Aug. 17, citing lack of efficacy in breast cancer trials. While there are concerns about the new class after Sanofi’s decision, a clear signal about its future could be growing nearer. The driver? Menarini Group and its development partner, Radius Health Inc., are advancing elacestrant, an oral SERD into regulatory reviews on both sides of the Atlantic.
Sanofi SA has terminated development of amcenestrant, an oral selective estrogen receptor degrader (SERD), following an interim analysis of data from a phase III trial in estrogen-receptor-positive advanced breast cancer patients. The company has also halted all other studies of the drug, including a phase III study in patients with early stage breast cancer.
Innovent Biologics Inc. has formed a partnership with Sanofi SA to jointly develop and commercialize two of Sanofi’s oncology candidates in combination with sintilimab in China, namely SAR-408701 (tusamitamab ravtansine) and SAR-444245.
Pfizer Inc. plans to pay about $5.8 billion – total equity value – for Global Blood Therapeutics Inc. (GBT) and its oral sickle cell disease (SCD) treatment Oxbryta (voxelotor). The company reported the enterprise value as $5.4 billion, which includes debt and net cash. If completed, the GBT buy would be the second largest M&A in 2022 after Pfizer’s $6.7 billion buyout of Arena Pharmaceuticals Inc. Oxbryta, which netted about $195 million in sales in 2021, gained U.S. FDA approval in November 2019 for the treatment of SCD in adults and pediatric patients ages 12 and up. The FDA later expanded Oxbryta’s approved uses to SCD patients 4 years of age and older in December 2021.
It’s a delicate time in Europe, where the recovery from the pandemic has been stifled by the war on its doorstep in Ukraine. Although the crisis caused by the Russian invasion is dominating the short-term political agenda, there are serious concerns about Europe’s long-term economic prospects and whether its research-led industries are falling by the wayside.
