Kathrin Jansen, Pfizer vaccine chief

Beat­ing Mer­ck, Pfiz­er gets pri­or­i­ty re­view as the first Pre­vnar fol­low-up heads to the FDA

It won’t get quite the work-on-Thanks­giv­ing wel­come that the Covid-19 jab re­ceived, but an­oth­er Pfiz­er vac­cine is head­ed to the FDA, where it will re­ceive a speedy re­view.

Pfiz­er an­nounced Wednes­day that an ap­pli­ca­tion for its new pneu­mo­coc­cal vac­cine, 20vP­nC, has been ac­cept­ed and grant­ed pri­or­i­ty re­view at the agency, set­ting up a de­ci­sion by June of next year.

With the ac­cep­tance, Pfiz­er re­mains a step ahead of Mer­ck in the race to de­vel­op a fol­low-on to one of the Big Phar­ma’s most im­por­tant prof­it gen­er­a­tors. While most vac­cines are slim mar­gin prod­uct, Pre­vnar col­lect­ed $6 bil­lion in rev­enue last year, more than any oth­er ful­ly owned Pfiz­er prod­uct.

With Pre­vnar near­ing patent ex­pi­ra­tion and ri­val vac­cines ad­vanc­ing in late-stage tri­als, though, Pfiz­er has pushed to get a next gen­er­a­tion pneu­mo­coc­cal shot ap­proved.

Un­like Pre­vnar, which pro­tects against 13 dif­fer­ent strains of path­o­gen­ic pneu­mo­coc­cal bac­te­ria, the new shot is de­signed to pro­tect against 20. Pfiz­er is tout­ing it as su­pe­ri­or to any pneu­mo­coc­cal shot on the mar­ket and any of the oth­er ones near­ing the mar­ket.

“If ap­proved, 20vP­nC will cov­er more serotypes re­spon­si­ble for the ma­jor­i­ty of pneu­mo­coc­cal dis­ease than any oth­er pneu­mo­coc­cal con­ju­gate vac­cine cur­rent­ly li­censed or cur­rent­ly in late-stage clin­i­cal de­vel­op­ment,” Kathrin Jansen, Pfiz­er’s vac­cine chief, said in a state­ment. “Im­por­tant­ly, 20vP­nC has shown to in­duce im­mune mem­o­ry, which pro­vides pro­tec­tion and ef­fi­ca­cy against non-bac­teremic pneu­mo­nia, par­tic­u­lar­ly in old­er adults.”

In a Phase III tri­al un­veiled in March, Pfiz­er an­nounced that the vac­cine suc­cess­ful­ly stim­u­lat­ed an­ti­bod­ies against 19 of the 20 strains in vol­un­teers over the age of 50, in­clud­ing all 13 of the strains in Pre­vnar 13. The 20th strain nar­row­ly missed, the com­pa­ny said.

Mer­ck, mean­while, an­nounced in Sep­tem­ber pos­i­tive Phase III da­ta for its vac­cine de­signed to de­fend against 15 dif­fer­ent strains. That in­clud­ed one strain where, the com­pa­ny claimed, they out­per­formed Pre­vnar.

Both Mer­ck and Pfiz­er’s can­di­dates have re­ceived break­through des­ig­na­tions from the FDA.

The two be­he­moths may soon al­so have to con­tend with an ad­di­tion­al play­er. The Cal­i­for­nia biotech Vax­cyte raised near­ly $300 mil­lion on pri­vate mar­kets and, this year, launched a $287.5 mil­lion IPO to de­vel­op its own pneu­mo­coc­cal vac­cine. The com­pa­ny ex­pects to file an IND un­til the sec­ond half of next year, with the first clin­i­cal da­ta com­ing in 2022.

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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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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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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Richard Pazdur (via AACR)

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

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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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.