Ugur Sahin, BioNTech CEO (Frank Rumpenhorst/dpa via AP Images)

'Don't freak out': Ugur Sahin takes a dif­fer­ent tone on Omi­cron than his mR­NA coun­ter­part — re­ports

Where­as some pub­lic health of­fi­cials and bio­phar­ma lead­ers — in­clud­ing Mod­er­na CEO Stéphane Ban­cel — are sound­ing the alarm over the new Omi­cron coro­n­avirus vari­ant, BioN­Tech chief Ugur Sahin is press­ing a more cau­tious ap­proach.

In in­ter­views Tues­day with the Wall Street Jour­nal and Reuters, Sahin cau­tioned that lit­tle is yet known of the vari­ant’s abil­i­ty to cause se­vere Covid-19, and T cell re­spons­es among the vac­ci­nat­ed would like­ly re­main strong. Though the biotech is still con­duct­ing lab tests to de­ter­mine whether an­ti­body pro­tec­tion will be di­min­ished, Sahin isn’t press­ing the pan­ic but­ton.

“Our mes­sage is: Don’t freak out, the plan re­mains the same: Speed up the ad­min­is­tra­tion of a third boost­er shot,” Sahin told WSJ on Tues­day.

The com­ments stand in stark con­trast to an in­ter­view Ban­cel gave to the Fi­nan­cial Times ear­li­er this week, in which he pre­dict­ed a sig­nif­i­cant drop in vac­cine ef­fec­tive­ness against Omi­cron. Ban­cel hedged, not­ing he didn’t know how steep the drop would be, but stressed that “all the sci­en­tists I’ve talked to … are like, ‘This is not go­ing to be good.’”

Omi­cron has shak­en glob­al mar­kets since South African sci­en­tists first de­tect­ed the vari­ant last week, and coun­tries around the world are is­su­ing new trav­el bans in the hopes of stem­ming the tide. The vari­ant has been par­tic­u­lar­ly no­table for its high num­ber of mu­ta­tions, lead­ing to fears it may be more con­ta­gious than the Al­pha or Delta strains and in­fect vac­ci­nat­ed peo­ple more eas­i­ly.

But Sahin told WSJ he thinks those who re­ceived their shots — es­pe­cial­ly those that got a boost­er — would still be pro­tect­ed against se­vere dis­ease re­sult­ing in hos­pi­tal­iza­tion or death. The CEO high­light­ed that the shot pro­duced by BioN­Tech and Pfiz­er has large­ly low­ered se­vere dis­ease risk from oth­er vari­ants and said most Delta break­through in­fec­tions are mild.

He said the same would like­ly hold true for Omi­cron, as T cells con­tin­ue to of­fer pro­tec­tion even if the virus evades an­ti­bod­ies. The re­duc­tion in an­ti­body pro­tec­tion against Omi­cron is yet to be de­ter­mined, he told Reuters, but he is ex­pect­ing some loss against mild and mod­er­ate dis­ease.

Even so, Sahin is stay­ing calm.

“To my mind there’s no rea­son to be par­tic­u­lar­ly wor­ried. The on­ly thing that wor­ries me at the mo­ment is the fact that there are peo­ple that have not been vac­ci­nat­ed at all,” Sahin told Reuters.

While re­searchers await an­swers on on­go­ing lab tests, the virus and emerg­ing vari­ants aren’t go­ing away any time soon. The pan­dem­ic has al­ready cre­at­ed a boon for Pfiz­er and Mod­er­na, with the for­mer al­so de­vel­op­ing an an­tivi­ral pill it says is 89% ef­fec­tive in re­duc­ing se­vere dis­ease in in­fect­ed in­di­vid­u­als.

Pfiz­er al­so like­ly has a leg up on Mer­ck, an­oth­er com­pa­ny work­ing on an oral treat­ment. In an ad­comm yes­ter­day, ad­vis­ers nar­row­ly vot­ed to rec­om­mend au­tho­riz­ing the Mer­ck pill de­spite ques­tions about ef­fi­ca­cy and con­cerns over us­ing the ther­a­py in preg­nant women.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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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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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.

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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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.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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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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