A Bloomberg-backed can­cer drug sum­mit aims to thaw US-Chi­na re­la­tions

Next week, a new coali­tion will be launched in Sin­ga­pore in an ef­fort to speed can­cer drug de­vel­op­ment and en­hance re­search co­op­er­a­tion be­tween the US and Chi­na, de­spite ris­ing ten­sions.

Launched by bil­lion­aire Michael Bloomberg’s eco­nom­ic fo­rum, dubbed the Bloomberg In­ter­na­tion­al Can­cer Coali­tion, the sum­mit will bring drug ex­ecs to­geth­er from the coun­tries with the two largest can­cer pop­u­la­tions in the world. The coali­tion will aim to cre­ate new can­cer drug stan­dards and cool tem­per­a­tures that have risen dur­ing the Covid-19 pan­dem­ic.

Rep­re­sen­ta­tives from sev­er­al high-pro­file drug­mak­ers will be in at­ten­dance, in­clud­ing J&J, Bay­er, Roche, No­var­tis, BeiGene, Zai Lab and aca­d­e­m­ic in­sti­tu­tions from Chi­na, the US and Eu­rope.

Some cur­rent and for­mer diplo­mats will al­so be in at­ten­dance, but rep­re­sen­ta­tives from Chi­na and its health reg­u­la­tor have not yet said whether they’ll be in Sin­ga­pore, the Fi­nan­cial Times re­port­ed Sun­day.

One diplo­mat, for­mer Aus­tralian Prime Min­is­ter and Asia So­ci­ety chief Kevin Rudd, told FT the ef­fort to lessen the pan­dem­ic-in­duced saber-rat­tling is akin to the 1970s dé­tente be­tween the US and Chi­na, which saw the coun­tries use ta­ble ten­nis as a way to thaw Cold War an­i­mosi­ties.

“The US-Chi­na re­la­tion­ship has got so bad that we at the Asia So­ci­ety have formed a view that can­cer treat­ment tri­als may well be­come the next it­er­a­tion of ping-pong diplo­ma­cy, to get this re­la­tion­ship back on the rails,” he told FT.

Rudd added that dis­agree­ments over in­tel­lec­tu­al prop­er­ty will like­ly be dis­cussed at the sum­mit.

The re­port al­so not­ed the group will at­tempt to use the FDA’s Pro­ject Or­bis as a mod­el to stream­line new drug sub­mis­sions out­side the US. Am­gen’s can­cer drug Lumakras won ap­proval in sev­er­al coun­tries in May un­der the project, and reg­u­la­tors from the US, Aus­tralia, Brazil, Cana­da and the UK re­viewed Am­gen’s sub­mis­sion si­mul­ta­ne­ous­ly.

Sev­er­al is­sues have emerged as flash points dur­ing the pan­dem­ic, caus­ing the re­la­tion­ship be­tween the US and Chi­na to head south. Chief among US con­cerns has been Chi­na’s re­luc­tance to al­low a full in­ves­ti­ga­tion in­to the ori­gins of the nov­el coro­n­avirus, with Chi­nese au­thor­i­ties block­ing WHO re­searchers ear­li­er this year from ac­cess­ing cer­tain da­ta.

Af­ter that group made its re­port in Feb­ru­ary, the WHO an­nounced a sec­ond at­tempt to look in­to the pan­dem­ic’s ori­gins in Ju­ly. But Chi­na said it couldn’t ac­cept the new terms be­cause it in­clud­ed a new pro­vi­sion to in­ves­ti­gate whether the coro­n­avirus might have leaked from a Chi­nese lab­o­ra­to­ry, NPR re­port­ed at the time.

A sci­en­tif­ic con­sen­sus emerged ear­ly in the pan­dem­ic that the SARS-CoV-2 virus jumped from an­i­mals to hu­mans, but one US in­tel­li­gence agency has not ruled out the “lab leak the­o­ry,” ac­cord­ing to a re­port. Four oth­er agen­cies dis­agreed while an­oth­er three couldn’t say for cer­tain one way or an­oth­er.

The WHO es­tab­lished a new sci­en­tif­ic ad­vi­so­ry group to look in­to Covid-19 ori­gins last month.

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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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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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Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

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