The FDA is clear­ly keep­ing up with the Kar­dashi­ans as its Of­fice of Pre­scrip­tion Drug Pro­mo­tion (OPDP) raised con­cerns that Khloé Kar­dashi­an’s pro­mo­tion­al video for a Bio­haven Phar­ma­ceu­ti­cals mi­graine drug made false claims about quick re­lief in as lit­tle as 15 min­utes.

In re­al­i­ty, OPDP said in its first un­ti­tled let­ter of the year, clin­i­cal work to sup­port the drug, known as Nurtec ODT, be­gan mea­sur­ing how it works two hours af­ter dos­ing.

“Claims that Nurtec ODT pro­vides re­lief in 15-30 min­utes are not sup­port­ed by the clin­i­cal tri­al da­ta,” the FDA said in its let­ter re­leased Tues­day.

The video, which orig­i­nal­ly aired on ABC’s “The View” last sum­mer, al­so claims that Nurtec ODT is more ef­fec­tive than oth­er mi­graine drugs and a “gamechang­er.”

Again, the FDA makes clear that these com­par­a­tive claims are mis­lead­ing be­cause Bio­haven has not demon­strat­ed that Nurtec ODT is clin­i­cal­ly su­pe­ri­or to or more ef­fec­tive than oth­er pre­scrip­tion and over-the-counter drugs. The com­pa­ny has 15 work­ing days to re­spond to the FDA.

“Bio­haven is work­ing close­ly with the FDA to eval­u­ate their com­ments and re­spond,” the com­pa­ny said in an SEC fil­ing on Tues­day.

This isn’t the first run-in be­tween the FDA and the Kar­dashi­ans over their pro­mo­tion of drugs. Khloé’s sis­ter Kim pro­mot­ed Duch­es­nay’s morn­ing sick­ness drug Di­clegis on In­sta­gram back in 2015 and the FDA slammed the com­pa­ny with a warn­ing let­ter for not dis­clos­ing enough risk in­for­ma­tion in the post.

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.