Con­tract man­u­fac­tur­er Abzena has per­ma­nent­ly laid off 66 em­ploy­ees at one of its San Diego sites, mark­ing the lat­est in a string of lay­offs span­ning the biotech in­dus­try.

The lay­offs took ef­fect on Jan. 11 at the com­pa­ny’s 8810 Re­hco Road site, ac­cord­ing to a WARN no­tice filed with the Em­ploy­ment De­vel­op­ment De­part­ment of Cal­i­for­nia.

Abzena does have an­oth­er lo­ca­tion in the San Diego area, where the man­u­fac­tur­er in­vest­ed $60 mil­lion and added 50,000 square feet in 2020. End­points News reached out to Abzena but has not re­ceived a re­sponse as of press time.

Just last week, Pfiz­er an­nounced a deal to scoop up Abzena’s San­ford, NC man­u­fac­tur­ing plant for an undis­closed amount. Abzena net­ted a $65 mil­lion in­vest­ment last year to ex­pand its drug sub­stance and fill-fin­ish man­u­fac­tur­ing ca­pac­i­ty at the San­ford site, and Pfiz­er ex­pects the deal to close some­time this quar­ter.

The com­pa­ny al­so tapped a new CEO, Matthew Sto­ber, at the be­gin­ning of the month. Sto­ber pre­vi­ous­ly served as CEO of Castl­e­Vax and Is­tari On­col­o­gy and held ex­ec­u­tive po­si­tions at Mer­ck, No­var­tis and GSK. He was al­so “in­stru­men­tal in help­ing lead the op­er­a­tional turn-around of Hos­pi­ra,” re­sult­ing in its $17 bil­lion sale to Pfiz­er, ac­cord­ing to a news re­lease.

The lay­offs fol­low a string of cuts across the in­dus­try. Late last year, con­tract man­u­fac­tur­er Catal­ent an­nounced that it was ax­ing around 600 po­si­tions in Mary­land, Texas and In­di­ana. Catal­ent’s Bloom­ing­ton, IN lo­ca­tion, which has been a pro­duc­er of Covid-19 vac­cines, will have around 400 po­si­tions cut.

Ear­li­er in Jan­u­ary, the Mary­land-based man­u­fac­tur­er Emer­gent said that it will lay off 132 em­ploy­ees as part of its plan to com­bine its re­search, prod­uct de­vel­op­ment, and clin­i­cal teams in­to a sin­gle “Sci­ence & De­vel­op­ment” team. The lay­offs amount to around 5% of Emer­gent’s cur­rent work­force.

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.