Ugur Sahin, AP Images

Covid-19 man­u­fac­tur­ing roundup: BioN­Tech an­nounces plans to pro­duce mR­NA vac­cines in Africa; As­traZeneca de­liv­er­ies from Thai­land de­layed

BioN­Tech, Pfiz­er’s part­ner on its Covid-19 vac­cine, will look to es­tab­lish mR­NA vac­cine pro­duc­tion fa­cil­i­ties in Africa, the Fi­nan­cial Times re­port­ed Wednes­day.

The move is a part of a larg­er push to tack­le dis­eases be­yond Covid-19, and as the EU looks to up its man­u­fac­tur­ing ca­pac­i­ty on the con­ti­nent. Right now, Africa im­ports over 99% of the vac­cines it us­es, the FT re­ports. The plan was out­lined in a call be­tween CEO Ugur Sahin and Eu­ro­pean Com­mis­sion Pres­i­dent Ur­su­la von der Leyen be­fore the G7 sum­mit.

Africa has of­ten been ne­glect­ed by the phar­ma­ceu­ti­cal in­dus­try. Sen­ti­ments of that were echoed in a Mon­day sto­ry from Sci­ence Mag­a­zine that re­port­ed that health of­fi­cials in Africa are pre­pared for a tri­al to test the ef­fi­ca­cy of mR­NA vac­cines in preg­nant women and pa­tients who have HIV, yet Pfiz­er and Mod­er­na have yet to pro­vide any vac­cines for the tri­al.

Just 39 mil­lion vac­cine dos­es have been ad­min­is­tered in Africa so far. The con­ti­nent ac­counts for 2% of all vac­ci­na­tions.

Venezuela to buy an­oth­er Russ­ian vac­cine

Venezuela and Rus­sia have an­nounced an­oth­er Covid-19 vac­cine deal, this time for the Russ­ian Epi­Vac­Coro­na vac­cine, Reuters has re­port­ed.

So far, the coun­try has re­ceived 3 mil­lion dos­es of Sput­nik V and Sinopharm shots from Rus­sia and Chi­na. Now, it has an­nounced plans to not on­ly pur­chase dos­es of Epi­Vac­Coro­na, but man­u­fac­ture them with­in the coun­try, Vice Pres­i­dent Del­cy Ro­driguez said Fri­day. Right now, it’s not clear how many dos­es would be sent, or when man­u­fac­tur­ing will be­gin. The coun­try re­ceived a thou­sand dos­es of the vac­cine ear­li­er this year to be used in tri­als, Reuters re­ports.

Venezuela launched a vac­ci­na­tion cam­paign last week, as the coun­try has lagged be­hind in ad­min­is­ter­ing shots to its pop­u­la­tion.

As­traZeneca de­liv­er­ies from Thai­land de­layed

Near­ly 200 mil­lion dos­es of As­traZeneca’s Covid-19 vac­cine are ex­pect­ed to be de­layed to Malaysia and Tai­wan this week, due to a holdup from a Thai plant.

As­traZeneca’s dis­tri­b­u­tion plans re­ly on Siam Bio­science, a com­pa­ny owned by Thai­land’s king Ma­ha Va­ji­ra­longko­rn. It is the com­pa­ny’s first time mak­ing a vac­cine, and ques­tions sur­round­ing the pro­duc­tion tar­gets are sen­si­tive, be­cause in­sult­ing the Thai­land monar­chy is a crime pun­ish­able by up to 15 years in prison, Reuters re­ports.

As­traZeneca gave 1.8 mil­lion dos­es to the Thai gov­ern­ment last week, but said that de­liv­er­ies to oth­er coun­tries could take as long as Ju­ly to be shipped. The first de­liv­ery to the Phillip­pines, which was set to be 17 mil­lion dos­es, was both re­duced and post­poned, Reuters was told by an ad­vi­sor to the pres­i­dent. Tai­wan’s Health Min­is­ter Chen Shih-chung told law­mak­ers that his coun­try’s or­der would be de­layed by a month. Tai­wan has or­dered 10 mil­lion shots, but on­ly has re­ceived 100,000 dos­es so far.

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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.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

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.