The FDA has found a brand new di­rec­tor of the Dig­i­tal Health Cen­ter of Ex­cel­lence in Troy Tazbaz, a for­mer se­nior vice pres­i­dent at Or­a­cle.

Ac­cord­ing to Tazbaz’s LinkedIn, he took a five-month break af­ter leav­ing an 11-year ca­reer at Or­a­cle be­fore join­ing the FDA in Jan­u­ary. Stat News first re­port­ed the hire. Tazbaz al­so said on his LinkedIn that he biked all the way from Chesa­peake Bay to the San Fran­cis­co Bay over 58 days dur­ing his ca­reer break.

Tazbaz is the third leader of the de­part­ment since Bakul Pa­tel left nine months ago to join Google as se­nior di­rec­tor of the gi­ant’s dig­i­tal health strat­e­gy and reg­u­la­to­ry team. Deputy Di­rec­tor Bren­dan O’Leary then took over as act­ing di­rec­tor un­til Tazbaz joined.

In an emailed state­ment to End­points News, the FDA said Tazbaz will lead the pro­gram as dig­i­tal health tech­nolo­gies be­come more sig­nif­i­cant, and as Con­gress has called on the FDA to pro­vide more guid­ance in this space.

“In his role, Troy will lead the Dig­i­tal Health Cen­ter of Ex­cel­lence in its next phase, which is fo­cused on con­tin­ued growth and im­prove­ment of build­ing and sus­tain­ing ca­pac­i­ty for strate­gic part­ner­ships, in­no­vat­ing reg­u­la­to­ry frame­works for dig­i­tal health and con­tin­ued har­mo­niza­tion with oth­er reg­u­la­tors,” an FDA spokesper­son wrote.

At Or­a­cle, Tazbaz start­ed out as se­nior di­rec­tor of the com­pa­ny’s cloud da­ta cen­ter strat­e­gy and plan­ning, then moved to VP of cor­po­rate op­er­a­tions be­fore end­ing as SVP of the in­dus­tries busi­ness unit strat­e­gy and op­er­a­tions.

The Dig­i­tal Health Cen­ter of Ex­cel­lence opened its doors in 2020, housed with­in the Cen­ter for De­vices and Ra­di­o­log­i­cal Health as a way to ad­vance tech­nol­o­gy with­in health­care, via mo­bile health de­vices, soft­ware as a med­ical de­vice, wear­able med­ical de­vices and tech­nolo­gies used to study med­ical prod­ucts.

Tazbaz isn’t the on­ly one to flip-flop be­tween big tech and the FDA. Cur­rent FDA Com­mis­sion­er Robert Califf went to Al­pha­bet to take a full-time role as head of med­ical strat­e­gy and pol­i­cy across the Google Health and Ver­i­ly units in 2019 be­fore be­ing con­firmed again as com­mis­sion­er in 2022.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.