Af­ter about 17 years at Por­to­la Phar­ma­ceu­ti­cals, Pamela Con­ley was ready for her next ven­ture once help­ing tran­si­tion some of the drug­mak­er’s pro­grams in­to Alex­ion in mid-to-late 2020.

Since then, she’s been set­ting up shop at au­toim­mune-fo­cused Nu­vig Ther­a­peu­tics, which broke cov­er Wednes­day with $47 mil­lion from No­vo Hold­ings, Pla­tanus, Bris­tol My­ers Squibb, Dig­i­tal­is Ven­tures and Mis­sion Bio­Cap­i­tal.

A 30-year biotech and phar­ma vet­er­an, Con­ley is now at the helm of her first biotech start­up based on sci­ence li­censed out of the Rock­e­feller Uni­ver­si­ty lab of Jeff Ravetch, Con­ley told End­points News. The Rock­e­feller pro­fes­sor was a sci­en­tif­ic ad­vi­sor while Con­ley was at Por­to­la, where she con­clud­ed as an SVP.

Ravetch has long been a con­trib­u­tor to the drug de­vel­op­ment field, with his lab study­ing an­ti­body-Fc re­cep­tor in­ter­ac­tions in hopes of treat­ing in­flam­ma­to­ry and in­fec­tious dis­eases. He’s co-found­ed Vir­dante Phar­ma­ceu­ti­cals, ac­quired by Mo­men­ta in 2011, and is on the sci­en­tif­ic ad­vi­so­ry board of stem cell trans­plant biotech Jasper Ther­a­peu­tics and a sci­en­tif­ic ad­vi­sor to in­fec­tious dis­eases-fo­cused Vir Biotech­nol­o­gy.

Nu­vig closed the Se­ries A in No­vem­ber 2021 and set up its Red­wood City, CA of­fice in Feb­ru­ary, but is re­veal­ing it­self to­day at what ap­pears to be an ever-es­ca­lat­ing bear mar­ket for the biotech world. Con­ley co-found­ed the start­up with for­mer Por­to­la col­league Greg Cof­fey, now VP of im­munol­o­gy and trans­la­tion­al re­search.

The team is work­ing to bring its first mol­e­cule in­to the clin­ic at an undis­closed time. The pro­ceeds will bankroll pre­clin­i­cal and Phase I work through proof of con­cept, Con­ley said, as the biotech aims to use its pro­tein ther­a­pies to “tone down the im­mune re­sponse af­ter an in­flam­ma­to­ry event.”

“We’re de­vel­op­ing a se­ries of pro­tein ther­a­peu­tics that are ge­net­i­cal­ly en­gi­neered to en­gage a class of im­mune reg­u­la­to­ry re­cep­tors. These re­cep­tors nat­u­ral­ly func­tion to re-es­tab­lish home­osta­sis fol­low­ing in­flam­ma­tion,” Con­ley said.

The com­pa­ny’s drug is in­de­pen­dent of im­mune-sup­pres­sion tac­tics like steroids or “oth­er com­mon ther­a­pies in this space,” the CEO said.

“[T]his mech­a­nism re­al­ly has the po­ten­tial to be life-chang­ing for a lot of pa­tients who don’t have to wor­ry about their ther­a­pies mak­ing them im­muno­com­pro­mised, sus­cep­ti­ble to oth­er dis­eases or even at risk for can­cer, like some of the cur­rent ther­a­pies do,” Con­ley said.

The com­pa­ny’s board in­cludes Pla­tanus man­ag­ing di­rec­tor Han­nah Chang, No­vo Ven­tures part­ner Ken Har­ri­son and Es­pe­ri­on Ther­a­peu­tics CEO Shel­don Koenig.

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.”

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.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.