Mathai Mammen, Janssen global head of R&D (Rob Tannenbaum, Endpoints News)

Covid-19 roundup: J&J of­fers new da­ta to sup­port boost­ers — but some ex­perts are not im­pressed; Thai­land uni­ver­si­ty's ro­bot­ic arm max­i­mizes vac­cine vials

Amidst all the boost­er shot talk with Pfiz­er and Mod­er­na, J&J on Wednes­day of­fered new da­ta that may lead to its own sin­gle-shot boost­er.

New in­ter­im da­ta from Phase I/IIa tri­als showed that J&J’s boost­er gen­er­at­ed a lev­el of spike-bind­ing an­ti­bod­ies that was 9-fold high­er than 28 days af­ter the first sin­gle-dose shot.

“We have es­tab­lished that a sin­gle shot of our COVID-19 vac­cine gen­er­ates strong and ro­bust im­mune re­spons­es that are durable and per­sis­tent through eight months. With these new da­ta, we al­so see that a boost­er dose of the John­son & John­son COVID-19 vac­cine fur­ther in­creas­es an­ti­body re­spons­es among study par­tic­i­pants who had pre­vi­ous­ly re­ceived our vac­cine,” glob­al head of R&D Math­ai Mam­men said in a state­ment.

The study, how­ev­er, on­ly fea­tured 20 pa­tients, three of which end­ed up be­ing ex­clud­ed from the da­ta. Those three re­cip­i­ents had a sharp in­crease in an­ti­body re­spons­es dur­ing study, with one re­cip­i­ent hav­ing break­through in­fec­tion with mi­nor symp­toms and 2 who had re­ceived an mR­NA vac­cine. An­ti­bod­ies changed just a lit­tle, which led Er­ic Topol, the di­rec­tor of the Scripps Re­search In­sti­tute, to crit­i­cize the press re­lease from J&J on Twit­ter.

“Where are the re­sults from their 2-dose tri­al?” he tweet­ed.

Thai­land uni­ver­si­ty’s ro­bot­ic arm max­i­mizes vac­cine vials

In hopes of bat­ting down its worse Covid-19 out­break yet, Thai­land will in­tro­duce a ro­bot­ic arm called the “Au­to­Vacc” to help draw more ef­fi­cient dos­es of vac­cines and max­i­mize the coun­try’s low sup­ply.

The arm comes from Chu­la­longko­rn Uni­ver­si­ty, and sci­en­tists say that it can draw 12 dos­es of the vac­cine in four min­utes from a vial, an im­prove­ment from the 10 dos­es drawn man­u­al­ly. It’s been used at the uni­ver­si­ty’s vac­ci­na­tion cen­ter since Mon­day, and sole­ly deals with As­traZeneca vials, ac­cord­ing to Reuters, which says on the la­bel that it con­tains be­tween 10 and 11 dos­es. The pro­to­type cost $76,243, and the team plans to make sim­i­lar ma­chines to use with the Pfiz­er-BioN­Tech and Mod­er­na vac­cines as well.

Pre­vi­ous­ly, health work­ers used a cer­tain type of sy­ringe called a low dead space sy­ringe to re­duce the waste, but those re­quire skilled man­pow­er, some­thing that lead re­searcher Juthamas Ratanavara­porn says could drain en­er­gy, as they’d be at it for months.

Just about 9% of the Thai­land pop­u­la­tion has been ful­ly vac­ci­nat­ed, while 28% has re­ceived at least one dose.

British study finds wan­ing vac­cine pro­tec­tion

A study out of Eng­land has found that the pro­tec­tion of­fered by the Pfiz­er-BioN­Tech and the Ox­ford-As­traZeneca vac­cines fades with­in six months, re­it­er­at­ing the need for boost­er shots.

The ef­fi­ca­cy of the Pfiz­er-BioN­Tech jab fell from 88% to 74% af­ter five to six months, and As­traZeneca’s fell from 77% to 67% af­ter four to five months, Reuters re­ports. That study used da­ta from 1.2 mil­lion test re­sults.

Pro­tec­tion for the el­der­ly and health­care work­ers could drop by 50% by this win­ter, the study’s prin­ci­pal in­ves­ti­ga­tor Tim Spec­tor said. Britain has be­gun plans for a boost­er cam­paign lat­er this year, while in the US, Pres­i­dent Joe Biden’s ad­min­is­tra­tion an­nounced that boost­ers were rec­om­mend­ed for Amer­i­cans eight months af­ter their ini­tial vac­ci­na­tion.

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

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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.

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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.

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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.

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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.

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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.

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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.

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