A week af­ter Mod­er­na’s new CFO Jorge Gomez was oust­ed af­ter just one day on the job, the com­pa­ny con­tin­ues to stand be­hind its vet­ting process.

Flag­ship’s Noubar Afeyan — who co-found­ed Mod­er­na and is cur­rent­ly chair­man of the board — told the Fi­nan­cial Times on Wednes­day that le­gal con­straints pre­vent­ed Mod­er­na from find­ing out about an in­ter­nal in­ves­ti­ga­tion launched by Gomez’s last em­ploy­er, Dentsply, un­til last week.

“Both the process of re­cruit­ing and vet­ting, and the process with which we re­act­ed to the new facts that came out, were com­plete­ly ap­pro­pri­ate,” Afeyan told FT. “I can’t think of a dif­fer­ent ap­proach that we could have used un­der those cir­cum­stances.”

Afeyan de­clined a re­quest for com­ment made by End­points News. 

Just last week, Mod­er­na told End­points that it was un­aware of Dentsply’s in­ves­ti­ga­tion in­volv­ing Gomez un­til it was pub­licly dis­closed on May 10.

The den­tal equip­ment com­pa­ny ini­ti­at­ed an in­ves­ti­ga­tion back in March look­ing in­to the “use of in­cen­tives to sell prod­ucts to dis­trib­u­tors in the third and fourth quar­ters of 2021, and whether those in­cen­tives were ap­pro­pri­ate­ly ac­count­ed for and the im­pact of those sales was ad­e­quate­ly dis­closed in the Com­pa­ny’s pe­ri­od­ic re­ports filed with the Se­cu­ri­ties and Ex­change Com­mis­sion,” ac­cord­ing to a Dentsply SEC fil­ing.

It’s al­so as­sess­ing whether “cer­tain for­mer and cur­rent mem­bers of se­nior man­age­ment” used in­cen­tives and oth­er ac­tions to achieve ex­ec­u­tive com­pen­sa­tion tar­gets last year, the fil­ing said.

Mod­er­na an­nounced it was bring­ing Gomez on board the fol­low­ing month, hours af­ter its Covid-19 vac­cine ri­val Pfiz­er named its own new CFO.

Mod­er­na main­tains that it act­ed quick­ly af­ter learn­ing of Dentsply’s in­ves­ti­ga­tion, meet­ing with­in an hour to dis­cuss the sit­u­a­tion with ex­ecs and lat­er that day with the board of di­rec­tors. The board de­cid­ed “it was ap­pro­pri­ate to sep­a­rate Mr. Gomez from Mod­er­na,” a spokesper­son told End­points last week, and Gomez was im­me­di­ate­ly in­formed.

“The May 11, 2022 an­nounce­ment and de­par­ture of Jorge Gomez from Mod­er­na strong­ly re­flects the se­ri­ous­ness with which Mod­er­na takes cor­po­rate gov­er­nance,” the spokesper­son said. “We are con­fi­dent that Mod­er­na con­duct­ed all ap­pro­pri­ate due dili­gence on this mat­ter pri­or to the hir­ing of Mr. Gomez, based on avail­able in­for­ma­tion.”

Gomez land­ed $700,000 in sev­er­ance pay (equal to a year’s salary), but that could be tak­en away if he’s found guilty in the Dentsply in­ves­ti­ga­tion, Mod­er­na said in an SEC fil­ing.

The com­pa­ny did not re­spond to a re­quest for fur­ther com­ment on Thurs­day.

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Just this week, the Senate voted 51-50 along party lines (with tie breaker from VP Kamala Harris) to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission. And now that it is no longer split, a group of senators wants the commission to actually move forward on investigating pharmacy benefit managers.

Republican senators Chuck Grassley (IA) and Mike Braun (IN), alongside Democrat senator Ron Wyden (OR), submitted a letter to FTC chair Lina Khan earlier this week, after the commissioners remained deadlocked in a 2-2 vote in February to formally look into anti-competitive practices at the hands of PBMs.

At the beginning of the week, many people hadn’t ever heard of monkeypox. By Friday, that all changed — and now a handful of biotech companies are reaping the benefits.

Emergent Biosolutions’ $EBS stock jumped more than 10% on Friday, four days after the company plumped down $225 million for the rights to Chimerix’s smallpox vaccine. Chimerix’s stock $CMRX was up more than 3.8% on Friday. And Bavarian Nordic $BVNRY — which closed a $119 million deal with BARDA to provide the US government with freeze-dried doses of the Jynneos vaccine — was up nearly 2.5%.

GSK enlisted ’80s child star turned director, writer and mom Soleil Moon Frye, known for her “Punky Brewster” character, during the pandemic last year to spotlight meningitis B vaccinations for teens. At the time, the already low rate for MenB vaccinations was dipping even lower.

Frye, a mother of four whose oldest child turned 16 during the launch of the campaign, talked about the fact that she didn’t know there were different types of meningitis vaccinations. The campaign was well received with feedback from parents that it was “effective, simple and actionable,” said Stephanie Jen, GSK’s VP of marketing for US vaccines.

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The European Medicines Agency is recommending the suspension of about 100 drugs after finding data integrity issues at an India-based CRO that ran tests for the generic drugs.

The CRO in question, Synchron Research Services, isn’t the first to come under the microscope for data failings. The FDA and EMA have raised similar questions in the past regarding data findings from several India-based CROs, including Semler Research and GVK Biosciences. In the case of Semler, as in the case of Synchron, regulators are requiring the drug sponsors to repeat their bioequivalence/bioavailability studies at an acceptable alternate study site.

Pharma ad spending is concentrated at the top. A handful of health conditions – along with a handful of brands inside each condition – dominate industry advertising.

Five therapy areas accounted for almost half (43%) of all pharma DTC spending last year, according to deep dive research from MediaRadar. Diabetes led, followed by psoriasis, arthritis, HIV/AIDs and breast cancer. Diabetes took the top spot from arthritis, which was No. 1 in 2020.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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