Covid-19 roundup: Mer­ck sub­mits mol­nupi­ravir for EUA; In­dia re­sumes vac­cine ex­ports af­ter Delta surge

Mer­ck’s oral an­tivi­ral drug for Covid-19 has been sub­mit­ted to the FDA for emer­gency use au­tho­riza­tion, the com­pa­ny an­nounced Mon­day morn­ing.

The com­pa­ny, which col­lab­o­rat­ed with Ridge­back Bio­ther­a­peu­tics, an­nounced last week that mol­nupi­ravir re­duced death and hos­pi­tal­iza­tions by 50%. The sub­mis­sion for EUA is based on pos­i­tive re­sults from the Phase III tri­al. Of 385 pa­tients in the tri­al, just 28 were hos­pi­tal­ized af­ter re­ceiv­ing mol­nupi­ravir, com­pared to 53 out of 337 pa­tients on the place­bo. No pa­tients who re­ceived mol­nupi­ravir died, com­pared with eight who were on the place­bo.

If au­tho­rized, it will be the first pill giv­en the go-ahead to treat Covid-19 and pro­vide doc­tors an eas­i­ly ad­min­is­tered tool to pre­vent new­ly di­ag­nosed pa­tients from pro­gress­ing in­to more se­ri­ous cas­es. Right now, the on­ly treat­ment au­tho­rized to keep pa­tients from be­ing hos­pi­tal­ized is mon­o­clon­al an­ti­bod­ies.

Sev­er­al coun­tries have al­ready inked sup­ply deals for the drug, in­clud­ing Thai­land, South Ko­rea, Malaysia and the US, with which Mer­ck agreed to sup­ply 1.7 mil­lion dos­es ear­li­er this year.

Be­fore it was li­censed out to Mer­ck and Ridge­back, a non-prof­it biotech at Emory Uni­ver­si­ty de­vel­oped the drug for the flu pan­dem­ic, but shift­ed when the coro­n­avirus broke out.

“The ex­tra­or­di­nary im­pact of this pan­dem­ic de­mands that we move with un­prece­dent­ed ur­gency, and that is what our teams have done by sub­mit­ting this ap­pli­ca­tion for mol­nupi­ravir to the FDA with­in 10 days of re­ceiv­ing the da­ta,” Robert Davis, Mer­ck’s CEO, said in a state­ment. “We are grate­ful to the pa­tients and in­ves­ti­ga­tors in our study, and of course to our own col­leagues who have ex­em­pli­fied Mer­ck’s high stan­dards of sci­en­tif­ic ex­cel­lence and our un­wa­ver­ing com­mit­ment to pa­tients.

In­dia re­sumes vac­cine ex­ports af­ter Delta surge

Af­ter a near­ly eight-month de­lay, the Serum In­sti­tute of In­dia has shipped an­oth­er batch of vac­cines. On Sat­ur­day, those vac­cines ar­rived in Bangladesh.

The Bangladesh gov­ern­ment, dis­trib­u­tor Bex­im­co Phar­ma­ceu­ti­cals and the Serum In­stitue have a deal for 30 mil­lion dos­es of the As­traZeneca jab. In­dia had stopped ex­ports while it ex­pe­ri­enced a bru­tal wave of the pan­dem­ic ear­li­er this year.

Dai­ly case num­bers sky­rock­et­ed from around 25,000 in mid-March to more than 400,000 a day by May. Since then, how­ev­er, the vac­cine out­put has more than dou­bled, and min­is­ter Man­sukh Man­daviya said that it was set to quadru­ple to more than 300 mil­lion dos­es in Oc­to­ber. The time­line has held strong. Al­most 50% of peo­ple in In­dia have re­ceived at least one shot of the vac­cine.

Com­pa­nies in In­dia have the ca­pac­i­ty to pro­duce al­most 3 bil­lion Covid-19 vac­cines a year, the Arab News re­port­ed. The coun­try sold or do­nat­ed near­ly 66 mil­lion dos­es be­fore the ex­port halt in April.

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.