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.”

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.