Joe Biden, AP Images

Covid-19 roundup: White House push­es for IP waiv­er sup­port to WTO; Rare nerve dis­or­der list­ed as As­traZeneca side ef­fect in UK

In the mid­dle of a push to pro­duce more vac­cines for low­er- and mid­dle-in­come coun­tries, Pres­i­dent Joe Biden’s ad­min­is­tra­tion is call­ing on the mem­bers of the World Trade Or­ga­ni­za­tion to sup­port an in­tel­lec­tu­al prop­er­ty waiv­er for Covid-19 vac­cines.

This comes a year af­ter South Africa and In­dia in­tro­duced pro­pos­als to tem­porar­i­ly waive patent rights. Ne­go­ti­a­tions have led to lit­tle progress. More than 100 coun­tries have thrown sup­port be­hind the waiv­er, but the EU and an­oth­er sev­en coun­tries are op­posed. WTO Di­rec­tor-Gen­er­al Ngozi Okon­jo-Iweala said last week that ne­go­ti­a­tions were stuck.

“We … need every WTO mem­ber to step up as well and sup­port an in­tel­lec­tu­al prop­er­ty waiv­er, and every com­pa­ny must act am­bi­tious­ly and ur­gent­ly to ex­pand man­u­fac­tur­ing now,” White House spokesper­son Karine Jean-Pierre said in a press con­fer­ence.

The an­nounce­ment comes while Biden’s ad­min­is­tra­tion is in the mid­dle of a feud with Mod­er­na, among oth­er drug­mak­ers. Dur­ing an on­line pan­el mod­er­at­ed by Yale law pro­fes­sor Amy Kapczyn­s­ki last Wednes­day, Biden’s chief sci­ence of­fi­cer David Kessler said that the world doesn’t have months to wait for more dos­es. He al­so said that he didn’t have con­cerns with Pfiz­er pro­vid­ing enough dos­es on time.

“The gov­ern­ment played a very sub­stan­tial role in mak­ing it that com­pa­ny, and that does up the ante on Mod­er­na,” Kessler said. “They un­der­stand what we ex­pect to hap­pen. This gov­ern­ment hasn’t made a de­ci­sion yet on what it will do. But we are wait­ing.”

Guil­lain-Bar­ré syn­drome list­ed as As­traZeneca side ef­fect in UK

A nerve dis­or­der has been added as a rare side ef­fect of the As­traZeneca Covid-19 vac­cine in the UK.

Guil­lain-Bar­ré syn­drome was added to the UK reg­u­la­tor’s web­site Thurs­day. This comes a month af­ter the EU in­clud­ed the dis­ease as a pos­si­ble side ef­fect. The Eu­ro­pean Med­i­cines Agency said in Sep­tem­ber that a ca­su­al re­la­tion­ship be­tween the shot and the syn­drome was “at least a rea­son­able pos­si­bil­i­ty.” As of Sep­tem­ber 8, 833 cas­es were re­port­ed out of 592 mil­lion dos­es giv­en.

The FDA had al­ready pre­vi­ous­ly added a Guil­lain-Bar­ré side ef­fect warn­ing to the J&J shot. Both jabs use vi­ral vec­tor tech­nol­o­gy, and they’ve both al­so been linked to rare, but some­times fa­tal blood clots.

CDC OKs boost­ers

The Cen­ters for Dis­ease Con­trol gave Mod­er­na and J&J’s Covid-19 boost­er shots the OK for Amer­i­can Thurs­day, in a huge win for the White House.

Amer­i­cans can seek a boost­er shot as ear­ly as Fri­day. The en­dorse­ment comes a month af­ter the Pfiz­er-BioN­Tech shot was ap­proved.

A sin­gle boost­er dose has been ap­proved for peo­ple over the age of 65, 18 through 64 who are at high risk of se­vere Covid-19 and 18 through 64 with fre­quent ex­po­sure to the virus.

J&J’s boost­er can be ad­min­is­tered at least 2 months af­ter the first dose. The Pfiz­er-BioN­Tech and Mod­er­na jabs are both ap­proved for ad­min­is­tra­tion six months af­ter the orig­i­nal shot.

“To­day’s ac­tions demon­strate our com­mit­ment to pub­lic health in proac­tive­ly fight­ing against the COVID-19 pan­dem­ic,” act­ing FDA Com­mis­sion­er Janet Wood­cock said in a press re­lease. “As the pan­dem­ic con­tin­ues to im­pact the coun­try, sci­ence has shown that vac­ci­na­tion con­tin­ues to be the safest and most ef­fec­tive way to pre­vent COVID-19, in­clud­ing the most se­ri­ous con­se­quences of the dis­ease, such as hos­pi­tal­iza­tion and death.”

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.