Sanofi has been for­mal­ly charged over De­pakine — a decades-old ther­a­py for epilep­sy that caus­es birth de­fects and im­pedes neu­ro­log­i­cal de­vel­op­ment when tak­en dur­ing preg­nan­cy.

Ev­i­dence that the com­pound — sodi­um val­proate — was as­so­ci­at­ed with neu­rode­vel­op­men­tal risks emerged in the lat­ter half of the 20th cen­tu­ry. In 2014, the EMA re-eval­u­at­ed the drug, and a year lat­er rec­om­men­da­tions that prac­ti­tion­ers should no longer pre­scribe the treat­ment for women of child­bear­ing age or preg­nant women were en­forced.

In 2015, the French so­cial af­fairs in­spec­tion agency (IGAS) chid­ed French health au­thor­i­ties and Sanofi over their re­sponse to the risks re­lat­ed to the drug and its de­riv­a­tives. Soon af­ter, the French pros­e­cu­tor kicked off a pre­lim­i­nary in­ves­ti­ga­tion in­to the ap­proval and sale of De­pakine in Oc­to­ber 2016, Reuters re­port­ed.

The com­pound — which is on the WHO list of “es­sen­tial med­i­cines” — has been on the mar­ket since 1967 to treat epilep­sy and bipo­lar dis­or­der. Sanofi learned of the risk of fe­tus mal­for­ma­tion in the 1980s. In 2003, the com­pa­ny be­came aware of the drug’s im­pact on the neu­ro­log­i­cal de­vel­op­ment of the fe­tus, with a risk of autism or learn­ing dif­fi­cul­ties, ac­cord­ing to the wire agency.

“It’s fi­nal­ly a great vic­to­ry!” tweet­ed Ma­rine Mar­tin, pres­i­dent of the As­so­ci­a­tion for the as­sis­tance of par­ents of chil­dren suf­fer­ing from an­ti-con­vul­sant syn­drome (APE­SAC), which was set up in 2011. “My de­ter­mi­na­tion paid off, we will have our big crim­i­nal tri­al !!!”

Ca y est en­fin GRANDE VIC­TOIRE ✌️ SANOFI MIS EN EX­A­M­EN au PE­NAL ⛓dans le dossier de la DE­PAKINE 💊
Ma déter­mi­na­tion a payé on au­ra notre grand procès pé­nal !!!
Com­mu­niqué de Presse pic.twit­ter.com/Ptf­S­lzd­NYw

— Ma­rine Mar­tin (@_Marine­Martin) Feb­ru­ary 3, 2020

The crim­i­nal in­ves­ti­ga­tion was ini­ti­at­ed by APE­SAC, and forms of part of the process of the pend­ing crim­i­nal in­ves­ti­ga­tion on De­pakine be­fore the Ju­di­cial Tri­bunal of Paris, a Sanofi spokesper­son told End­points News.

“This (in­dict­ment) sta­tus will al­low us to as­sert all of our means of de­fence and demon­strate that the com­pa­ny has com­plied with its no­ti­fi­ca­tion oblig­a­tion,” the spokesper­son said.

IGAS has es­ti­mat­ed that be­tween 425 to 450 ba­bies suf­fered con­gen­i­tal birth de­fects or were still­born fol­low­ing ex­po­sure to De­pakine from 2006 to 2014, ac­cord­ing to es­ti­mates cit­ed by Reuters.

Af­ter par­ents of suf­fer­ers crit­i­cized the French state and Sanofi for be­ing too slow to warn about the side ef­fects of the drug — in 2017, a com­pen­sa­tion scheme for vic­tims was set up. Rough­ly 6.5 mil­lion eu­ros has been pro­vid­ed in com­pen­sa­tion to 31 vic­tims, al­though near­ly 2,000 claims have been filed, ac­cord­ing to the French me­dia group fran­ce­in­fo.

Sanofi is not par­tic­i­pat­ing in this fund, the spokesper­son told End­points.

In a 2016 in­ter­view with Reuters, Sanofi said it would ac­cept any blame at­trib­uted by a court over the drug.

On Tues­day, Sanofi in a state­ment that it will “prove it has al­ways com­plied with its du­ty to in­form and been trans­par­ent.”

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.