Be­gin­ning in March 2023, CSL will have a new CEO and board ex­ec­u­tive di­rec­tor in Paul McKen­zie, who spent three years as COO af­ter jump­ing ship from Bio­gen.

Paul Per­reault

McKen­zie is tak­ing over from Paul Per­reault, a long­timer at CSL. Per­reault served as CEO for 10 years and over 25 years to­tal with the com­pa­ny. But March won’t be the end for Per­reault: He’ll stay on as an ad­vi­sor un­til of­fi­cial­ly re­tir­ing in Sep­tem­ber 2023.

McKen­zie is tak­ing over at CSL on the heels of a suc­cess af­ter the No­vem­ber ap­proval of Hem­genix, the world’s first gene ther­a­py for he­mo­phil­ia B. It’s al­so the US’ most ex­pen­sive sin­gle-use gene ther­a­py with the price list­ed at $3.5 mil­lion.

“I look for­ward to con­tin­u­ing our mo­men­tum and en­gag­ing close­ly with the Board, our lead­er­ship team, 30,000 col­leagues, and oth­er stake­hold­ers to serve pa­tients and pub­lic health around the world,” McKen­zie said in a state­ment. “We will con­tin­ue fo­cus­ing on ex­e­cut­ing our 2030 strat­e­gy, in­vest­ing in in­no­va­tion, and con­tin­ue achiev­ing sus­tain­able and prof­itable growth.”

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.