Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfiz­er and BioN­Tech will sell 500 mil­lion dos­es of their Comir­naty Covid-19 vac­cine to the US at cost as part of an ex­pand­ed agree­ment to dri­ve do­na­tions to low- and mid­dle-in­come na­tions, the drug­mak­er said Wednes­day.

The ex­pand­ed pact dou­bles Pfiz­er/BioN­Tech’s com­mit­ment to the US ef­fort, which will ship do­na­tions to CO­V­AX, a glob­al clear­ing­house for up to 92 tar­get na­tions, as well as the 55 mem­ber states of the African Union, Pfiz­er said. De­liv­er­ies start­ed in Au­gust and are ex­pect­ed to run through Sep­tem­ber 2022.

Pfiz­er ex­pects to cen­ter pro­duc­tion for this or­der at its sites in Kala­ma­zoo, MI, An­dover, MA, Chester­field, MO, and McPher­son, KS, the drug­mak­er said.

Ugur Sahin

“In the short term, we have pledged to de­liv­er at least one bil­lion dos­es this year and at least one bil­lion dos­es next year to low- and mid­dle-in­come coun­tries,” BioN­Tech CEO Ugur Sahin said in a state­ment. “In par­al­lel, we are ex­plor­ing how to build a sus­tain­able mR­NA pro­duc­tion in­fra­struc­ture in low-in­come coun­tries to de­moc­ra­tize ac­cess to vac­cines in the mid- and long-term. This ap­plies to both in­di­vid­ual pro­duc­tion steps and com­plete man­u­fac­tur­ing.”

Pfiz­er says it has com­mit­ted 2 bil­lion dos­es of its vac­cine to low- and mid­dle-in­come coun­tries through 2022, much of that com­ing through its US agree­ment. The drug­mak­er, mean­while, has inked di­rect sup­ply agree­ments with in­di­vid­ual coun­try gov­ern­ments and sep­a­rate­ly with CO­V­AX for 40 mil­lion dos­es in 2021.

Gilead’s remde­sivir helps pre­vent hos­pi­tal­iza­tions with ear­ly use — study

Remde­sivir has shown mixed re­sults over the course of the pan­dem­ic in hos­pi­tal­ized Covid-19 pa­tients, but Gilead could have a case for the an­tivi­ral’s use in the out­pa­tient set­ting, new da­ta show.

A three-day course of remde­sivir cut the risk of Covid-19 hos­pi­tal­iza­tion or all-cause death by 87% com­pared with place­bo (p=0.008) at the 28-day mark in non-hos­pi­tal­ized, high-risk pa­tients, ac­cord­ing to re­sults from a 562-pa­tient Phase III study un­veiled Wednes­day. On a sec­ondary end­point re­duc­ing the risk of med­ical vis­its or all-cause death, remde­sivir beat out place­bo by 81% (p=0.002). There were no deaths re­port­ed in ei­ther arm of the study dur­ing the 28-day pe­ri­od.

It’s a big win for remde­sivir, but it’s worth con­sid­er­ing one big grain of salt: The study stopped en­rolling pa­tients in April, well be­low its tar­get goal of 1,264, “re­flect­ing the chang­ing epi­demi­ol­o­gy and adop­tion of ad­di­tion­al treat­ment op­tions at the time,” Gilead said.

With that point in mind, remde­sivir’s po­ten­tial in the out­pa­tient set­ting could be lim­it­ed giv­en the rapid­ly chang­ing stan­dard of care, the rise in vac­ci­na­tion rates and the emer­gence of the Delta vari­ant. But Gilead is still tout­ing the da­ta as a win and a po­ten­tial path for­ward for out­pa­tient EUA.

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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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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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.

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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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.

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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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

Covid-19 roundup: Ugur Sahin says new shots like­ly need­ed for Omi­cron; UK ful­ly ap­proves Vir/Glax­o­SmithK­line an­ti­body

Despite Ugur Sahin’s calls for calm over the Omicron variant — making a much more measured appeal than Moderna CEO Stéphane Bancel — the BioNTech chief is already predicting the potential need for new Covid-19 vaccines.

In comments made at a conference hosted Friday morning by Reuters, Sahin said that even though vaccinated individuals would likely still be protected from severe disease, Omicron could see greater numbers of breakthrough infections than other variants. The mutations mean Covid shots will probably become necessary every year, similar to the flu.