Paul Burton, Moderna CMO

Covid-19 roundup: Mod­er­na notes high­er my­ocardi­tis risk for young males when com­pared to Pfiz­er's vac­cine; EMA signs off on Roche, Cell­tri­on mAb treat­ments

Mod­er­na’s new CMO Paul Bur­ton spoke to re­porters Thurs­day morn­ing, at­tempt­ing to de­fend his com­pa­ny’s vac­cine against ques­tions around heart-re­lat­ed risks that ap­pear to be crop­ping up in very rare in­stances among younger men.

The me­dia push comes as the Mod­er­na vac­cine has proven to be over­whelm­ing­ly safe in more than 155 mil­lion in­di­vid­u­als. But coun­tries like Fin­land, Swe­den, Nor­way and Den­mark have lim­it­ed use of the Mod­er­na vac­cine to men over the age of 30, as it found the younger men who re­ceived the vac­cine, known as Spike­vax, had a slight­ly high­er risk of de­vel­op­ing my­ocardi­tis when com­pared to oth­er vac­cines.

“Some health au­thor­i­ties have not­ed a slight­ly in­creased risk of my­ocardi­tis when com­pared to the Pfiz­er-BioN­Tech vac­cine and that equates to about 10 ad­di­tion­al cas­es in every 100,000 peo­ple who would be vac­ci­nat­ed,” Bur­ton said.

But he al­so not­ed that when my­ocardi­tis does ap­pear, typ­i­cal­ly af­ter the sec­ond dose with males, for the most part it re­solves on its own. He al­so said the rea­son why men get my­ocardi­tis while women do not may be linked to testos­terone.

Mod­er­na did not re­spond to a ques­tion about fur­ther de­tails for why the FDA has pushed back its re­view of the com­pa­ny’s vac­cine for younger pop­u­la­tions. The com­pa­ny pre­vi­ous­ly said the FDA needs ad­di­tion­al time to com­plete its as­sess­ment for the vac­cine among ado­les­cents 12 to 17 years old be­cause the agency wants to “eval­u­ate re­cent in­ter­na­tion­al analy­ses of the risk of my­ocardi­tis af­ter vac­ci­na­tion,” Mod­er­na said. The re­view could take un­til Jan­u­ary.

EMA en­dors­es first 2 mAb treat­ments from Roche and Cell­tri­on

As Covid-19 cas­es con­tin­ue to in­crease across Eu­rope, the Eu­ro­pean Med­i­cines Agency on Thurs­day signed off on two new mon­o­clon­al an­ti­body treat­ments sub­mit­ted by Roche (Re­gen­eron de­vel­oped the mAb) and Cell­tri­on.

Al­though the US has au­tho­rized and dis­trib­utes three mAb treat­ments to states (de­vel­oped by Re­gen­eron, Eli Lil­ly and GSK/Vir), these are the first two OKs from the EMA for mAb treat­ments.

EMA’s hu­man med­i­cines com­mit­tee rec­om­mend­ed au­tho­riz­ing Roche and Re­gen­eron’s mAb treat­ment, known in the EU as Ron­apreve, for treat­ing Covid-19 in those who are 12 years of age and old­er, weigh at least 40 kilo­grams (88 pounds), and who are at in­creased risk of their dis­ease be­com­ing se­vere but do not yet re­quire sup­ple­men­tal oxy­gen.

Ron­apreve al­so won a nod as a pro­phy­lac­tic in the same pop­u­la­tion.

With re­gard to Cell­tri­on’s Regkirona, the com­mit­tee rec­om­mend­ed au­tho­riz­ing the treat­ment for adults with Covid-19 who do not re­quire sup­ple­men­tal oxy­gen and who are al­so at in­creased risk of their dis­ease be­com­ing se­vere.

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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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