Te­va set­tles with Louisiana for $18M over opi­oid claims; Video game treat­ment churns out PhII re­sults

Te­va Phar­ma­ceu­ti­cals is pay­ing the state of Louisiana $15 mil­lion in cash over the next 18 years, in ex­change for be­ing re­leased from law­suits over the state’s opi­oid claims.

As part of the agree­ment, Te­va will al­so do­nate $3 mil­lion in opi­oid ad­dic­tion re­cov­ery drugs — con­tin­gent up­on be­ing re­leased from all Louisiana law­suits by Nov. 2.

As the US-based sub­sidiary for Is­rael’s Te­va Phar­ma­ceu­ti­cal In­dus­tries, Te­va has been fac­ing le­gal pro­ceed­ings in a num­ber of US states, in­clud­ing New York and Cal­i­for­nia, amid claims that the com­pa­ny en­gaged in mis­lead­ing mar­ket­ing of opi­oids and down­played the risks of opi­oid ad­dic­tion.

Puretech sub­sidiary shows PhII re­sults for video-game AD­HD ther­a­peu­tic

Puretech sub­sidiary Ak­ili In­ter­ac­tive re­vealed Phase II study re­sults to­day of SDT-001, a video game ther­a­peu­tic de­signed to im­prove at­ten­tion in chil­dren di­ag­nosed with AD­HD.

The study, con­duct­ed by Ak­ili part­ner Sh­iono­gi in Japan, will in­form de­sign­ing a po­ten­tial piv­otal study. Re­sults show the treat­ment was well-re­ceived by pa­tients and showed im­prove­ments in AD­HD inat­ten­tion symp­toms. Sh­iono­gi plans to ap­proach Japan­ese reg­u­la­tors about a Phase III study for SDT-001.

“This study marks the first time a clin­i­cal tri­al of Ak­ili’s tech­nol­o­gy has been con­duct­ed out­side of the U.S., and we thank our part­ners at Sh­iono­gi who are help­ing us to de­vel­op this new treat­ment op­tion for fam­i­lies of chil­dren with AD­HD in Japan,” said Ak­ili CMO Anil Ji­na.

Pep­ti­log­ics shows PhI da­ta from PJI in­ves­ti­ga­tion­al drug tri­al

Pitts­burgh biotech Pep­ti­log­ics re­vealed Phase I da­ta on PJI an­tibac­te­r­i­al can­di­date PLG0206 to­day. The first in-hu­man tri­al showed that in­tra­venous PLG0206 was well tol­er­at­ed in healthy vol­un­teers.

The in­ves­ti­ga­tion­al an­tibac­te­r­i­al pep­tide was grant­ed FDA or­phan drug des­ig­na­tion and qual­i­fied in­fec­tious dis­ease prod­uct des­ig­na­tion for treat­ing PJI. The Phase I study en­rolled 47 sub­jects re­ceiv­ing es­ca­lat­ing sin­gle IV in­fu­sions of the pep­tide or place­bo.

“We re­main on track to ini­ti­ate a first-in-pa­tient clin­i­cal study for the treat­ment of PJI in the first quar­ter of 2022,” said Pep­ti­log­ics CMO David Huang in a pre­pared state­ment.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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