Van­da Phar­ma­ceu­ti­cals is mak­ing a name for it­self, at least in terms of su­ing the FDA.

The DC-head­quar­tered firm on Mon­day filed its lat­est suit against the agency, with the com­pa­ny rais­ing con­cerns over the FDA’s fail­ure to grant a fast track des­ig­na­tion for Van­da’s po­ten­tial chron­ic di­ges­tive dis­or­der drug tradip­i­tant, which is a neu­rokinin 1 re­cep­tor an­tag­o­nist.

Specif­i­cal­ly, Van­da said FDA’s “es­sen­tial point” in its one-page de­nial let­ter on the des­ig­na­tion point­ed to “the lack of nec­es­sary safe­ty da­ta,” which was “in­con­sis­tent with the cri­te­ria for … Fast Track des­ig­na­tion.”

But Van­da says that tradip­i­tant, which it’s hop­ing to treat short-term nau­sea in gas­tro­pare­sis pa­tients, “has been stud­ied ex­ten­sive­ly in an­i­mals and hu­mans for mul­ti­ple in­di­ca­tions, be­gin­ning in 2003. No rel­e­vant hu­man safe­ty sig­nals have emerged.”

In De­cem­ber 2018, how­ev­er, FDA im­posed a par­tial clin­i­cal hold on tradip­i­tant, pre­vent­ing Van­da from study­ing the drug in hu­mans for longer than 3 months un­til the com­pa­ny could con­duct a 9-month tox­i­c­i­ty study in non-ro­dent an­i­mals (dogs, mon­keys, or pigs).

“Van­da de­clined to con­duct such a study,” the com­pa­ny said in its law­suit. “Long-term tox­i­c­i­ty stud­ies al­ways con­clude in the killing of the test-sub­ject dogs, typ­i­cal­ly young bea­gles. And it would have di­vert­ed Van­da’s lim­it­ed re­sources from drug re­search and de­vel­op­ment ef­forts to un­help­ful an­i­mal tests.”

And while the FDA paved some­what of a path for Van­da to move for­ward, the agency said in its fast-track de­nial let­ter that based on the cur­rent tradip­i­tant de­vel­op­ment plan as FDA un­der­stood it, “Van­da might not be able to ob­tain safe­ty and ef­fi­ca­cy da­ta to achieve mar­ket­ing ap­proval.”

Van­da’s de­ci­sion to sue the FDA might seem like an odd move, but the com­pa­ny has sued the agency mul­ti­ple times and lost at least one case re­cent­ly con­cern­ing that clin­i­cal hold from FDA on tradip­i­tant.

The FDA is­sued the hold af­ter con­clud­ing that “ex­ist­ing tradip­i­tant stud­ies in non­ro­dents con­tain suf­fi­cient trou­bling in­di­ca­tions of tox­i­c­i­ty such that—while short­er-term hu­man stud­ies may be safe enough to pro­ceed—FDA needs to see if those tox­i­c­i­ty mark­ers in­crease dur­ing long-term non­ro­dent stud­ies be­fore al­low­ing long-term hu­man stud­ies.”

Van­da Phar­ma­ceu­ti­cals al­so the agency again in the same DC dis­trict court in April, al­leg­ing this time that the agency is wrong­ful­ly with­hold­ing parts of a re­jec­tion let­ter for a new in­di­ca­tion for its sleep drug Het­lioz (tasimelteon) for jet lag.

Sales of the com­pa­ny’s mela­tonin re­cep­tor ag­o­nist Het­lioz, ap­proved in 2020 for non-24-hour sleep-wake dis­or­der and night­time sleep dis­tur­bances in Smith-Ma­ge­nis syn­drome, in­creased by $12.9 mil­lion, or 8%, to $173.5 mil­lion for 2021, com­pared to $160.7 mil­lion for 2020.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.