→ Dana-Far­ber is lend­ing a hand to lit­tle On­coSec’s nascent ef­fort to de­vel­op CAR-T ther­a­pies for sol­id tu­mor can­cers. The San Diego biotech has worked out an ex­clu­sive li­cens­ing deal with Wayne Maras­co — an ex­pert in an­ti­body en­gi­neer­ing — to ap­ply his method of link­ing two sin­gle-chain vari­able frag­ment (scFv) in a bis­pe­cif­ic CAR-T such that the T cells are on­ly ac­ti­vat­ed when both tar­gets are en­gaged, there­by lim­it­ing off-tu­mor tox­i­c­i­ty. On­coSec’s fi­nan­cial con­tri­bu­tion in the re­search, which in­volves test­ing the ex­per­i­men­tal treat­ment so­lo and in com­bi­na­tion with Ta­vo in triple-neg­a­tive breast can­cer, will be “mod­est” and spread over sev­er­al years, CEO Daniel O’Con­nor said.

→ Af­ter win­ning the FDA nod for low blood platelet count (throm­bo­cy­tope­nia) in adults with chron­ic liv­er dis­ease (CLD) who are sched­uled to un­der­go a med­ical or den­tal pro­ce­dure, the la­bel of Do­va Phar­ma­ceu­ti­cal’s Doptelet on Thurs­day was ex­pand­ed to in­clude pa­tients with chron­ic im­mune throm­bo­cy­tope­nia (ITP) who have had an in­suf­fi­cient re­sponse to a pre­vi­ous treat­ment. The com­pa­ny’s shares $DO­VA leapt about 27.5% to $13.50 in morn­ing trad­ing. The FDA’s en­dorse­ment comes about a week af­ter Eu­ro­pean reg­u­la­tors al­so backed the drug for use in se­vere throm­bo­cy­tope­nia in adult pa­tients with CLD who are sched­uled to un­der­go an in­va­sive pro­ce­dure. Mean­while, late-stage da­ta from a study eval­u­at­ing the drug’s use in chemother­a­py-in­duced throm­bo­cy­tope­nia are ex­pect­ed in the first half of 2020.

→ The re­cent­ly-pub­lic Ver­ri­ca Phar­ma­ceu­ti­cals‘ $VR­CA ex­per­i­men­tal drug, VP-102, has cleared a mid-stage study in pa­tients with com­mon warts. The drug’s “ef­fi­ca­cy and tol­er­a­bil­i­ty has been fur­ther con­firmed with the pos­i­tive Phase II COVE-1 tri­al in com­mon warts, and is now de-risked in an ad­di­tion­al in­di­ca­tion. We be­lieve this pro­vides ad­di­tion­al (and not mod­eled) up­side for VR­CA as our val­u­a­tion tar­gets are based pure­ly on VP-102 in mol­lus­cum con­ta­gio­sum which re­mains on track for a po­ten­tial H2:2020 launch,” Cowen an­a­lysts wrote in a note. The com­pa­ny said it is on track to sub­mit an ap­pli­ca­tion to mar­ket the drug for pa­tients with mol­lus­cum con­ta­gio­sum — a vi­ral skin in­fec­tion some­times called wa­ter warts — lat­er this year.

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.”

The first potential gene therapy for hemophilia B has gotten one step closer to reaching patients as the FDA has accepted CSL Behring’s BLA for its uniQure-partnered one-time treatment. The therapy, dubbed etranacogene dezaparvovec, was accepted under “accelerated assessment” by the European Medicines Agency in March.

A priority review will be conducted for the gene therapy intended for patients with the hereditary bleeding disorder, CSL said Tuesday morning. The Pennsylvania biotech did not indicate the regulator’s decision date, but a priority review generally means the treatment’s fate will be handed down within six months rather than 10.

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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”