Covid-19 roundup: WHO looks to boost pro­duc­tion of an­ti­body tests in low­er-in­come coun­tries; US gov­ern­ment fights to up­hold work­place vac­cine man­date

In an ef­fort to com­bat ris­ing Covid-19 cas­es world­wide, the World Health Or­ga­ni­za­tion has struck a deal to li­cense sero­log­i­cal tech­nol­o­gy for an­ti­body test­ing and pro­vide it roy­al­ty-free to low- and mid­dle-in­come coun­tries in the hopes of boost­ing pro­duc­tion.

The WHO’s Covid-19 Tech­nol­o­gy Ac­cess Pool (C-TAP) and the Med­i­cines Patent Pool (MPP) fi­nal­ized the deal with the Span­ish Na­tion­al Re­search Coun­cil (CSIC), a pub­lic re­search in­sti­tute, on Tues­day. It’s the first test li­cense signed by the MPP, a Unit­ed Na­tions-backed pub­lic health or­ga­ni­za­tion, and in­clud­ed in the WHO pool, ac­cord­ing to the or­ga­ni­za­tions. It cov­ers all re­lat­ed patents and bi­o­log­i­cal ma­te­r­i­al nec­es­sary for man­u­fac­tur­ing the tests, and CSIC has agreed to pro­vide know-how and train­ing.

So far, CSIC’s tech­nol­o­gy has re­sult­ed in four an­ti­body tests, in­clud­ing one that can dis­tin­guish the im­mune re­sponse of Covid-in­fect­ed in­di­vid­u­als from vac­ci­nat­ed in­di­vid­u­als.

“This is the kind of open and trans­par­ent li­cense we need to move the nee­dle on ac­cess dur­ing and af­ter the pan­dem­ic,” WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said in a state­ment. “I urge de­vel­op­ers of COVID-19 vac­cines, treat­ments and di­ag­nos­tics to fol­low this ex­am­ple and turn the tide on the pan­dem­ic and on the dev­as­tat­ing glob­al in­equity this pan­dem­ic has spot­light­ed.”

The move marks the lat­est in a string of ef­forts to con­tain the pan­dem­ic in low­er in­come coun­tries, where vac­cines are sore­ly need­ed. Back in Sep­tem­ber, the US gov­ern­ment said it would buy 500 mil­lion more dos­es of Pfiz­er’s vac­cine to do­nate to coun­tries in need. It al­so dumped more $200 mil­lion over the sum­mer in­to a South African man­u­fac­tur­ing plant to boost ac­cess to J&J’s vac­cine. How­ev­er, the New York Times re­port­ed in Au­gust that many of those dos­es had been ex­port­ed back to Eu­rope.

CSIC pres­i­dent Rosa Menén­dez em­pha­sized that tech­nol­o­gy re­lat­ed to Covid-19 should reach all coun­tries, adding: “In this sense, we would like this ac­tion by CSIC, of tak­ing part in the in­ter­na­tion­al ini­tia­tives of MPP and WHO, to be­come an ex­am­ple and a ref­er­ence for oth­er re­search or­ga­ni­za­tions in the world.”

US gov­ern­ment fights to up­hold work­place vac­cine man­date

The US gov­ern­ment is fight­ing to keep an Oc­cu­pa­tion­al Safe­ty and Health Ad­min­is­tra­tion (OS­HA) rule in place that re­quires work­ers to be vac­ci­nat­ed for Covid-19 or test­ed week­ly, ac­cord­ing to court doc­u­ments.

The OS­HA rule, which was is­sued Nov. 5 and re­quires busi­ness­es with at least 100 em­ploy­ees to com­ply by ear­ly next year, was ini­tial­ly shot down in the US 5th Cir­cuit Court of Ap­peals in New Or­leans. OS­HA es­ti­mat­ed that the rule would save a min­i­mum of 6,500 lives and pre­vent over 250,000 hos­pi­tal­iza­tions over the next six months. But chal­lengers called the stan­dard “stag­ger­ing­ly over­board,” Reuters re­port­ed.

Now, the US gov­ern­ment is ask­ing a Sixth Cir­cuit fed­er­al ap­peals court to “im­me­di­ate­ly” lift the 5th Cir­cuit’s stay, ac­cord­ing to court doc­u­ments filed Tues­day.

“A court or­der block­ing the Stan­dard is a far greater af­front to sov­er­eign pre­rog­a­tives. Such an or­der would al­so threat­en deaths and hos­pi­tal­iza­tions that em­ploy­ers wish to pre­vent. Those in­ter­ests, and the gov­ern­ment’s in­ter­ests in pro­tect­ing em­ploy­ees and em­ploy­ers while this case pro­ceeds, vast­ly out­weigh pe­ti­tion­ers’ as­sert­ed harm,” the mo­tion states.

The news comes as Covid-19 cas­es rise in the US, de­spite more than 82% of adults hav­ing got­ten at least one dose of a vac­cine. Last Fri­day, the FDA an­nounced that all adults who re­ceived two dos­es of an mR­NA Covid-19 vac­cine are now el­i­gi­ble for a boost­er shot.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.