Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfiz­er and BioN­Tech said Tues­day they sub­mit­ted to FDA pos­i­tive da­ta from a Phase II/III tri­al of their Covid-19 vac­cine in chil­dren aged 5 to less than 12 years old.

A for­mal EUA sub­mis­sion for the vac­cine in these chil­dren is ex­pect­ed to fol­low “in the com­ing weeks,” the com­pa­nies said in a state­ment.

The tri­al of 2,268 healthy par­tic­i­pants aged 5 to less than 12 years old showed the vac­cine was safe and elicit­ed ro­bust neu­tral­iz­ing an­ti­body re­spons­es us­ing a two-dose reg­i­men of 10 μg dos­es, which is one-third the dose that’s ad­min­is­tered to adults.

“These re­sults – the first from a piv­otal tri­al of any COVID-19 vac­cine in this age group – were com­pa­ra­ble to those record­ed in a pre­vi­ous Pfiz­er-BioN­Tech study in peo­ple 16 to 25 years of age, who were im­mu­nized with 30 μg dos­es. The 10 μg dose was care­ful­ly se­lect­ed as the pre­ferred dose for safe­ty, tol­er­a­bil­i­ty and im­muno­genic­i­ty in chil­dren 5 to <12 years of age,” Pfiz­er said.

HCQ users tripled ear­ly on in the pan­dem­ic, a new study finds

Among com­mer­cial­ly in­sured and Medicare Ad­van­tage pa­tients, week­ly new users of hy­drox­y­chloro­quine tripled dur­ing the ear­ly surge in the Covid-19 pan­dem­ic, with the great­est in­creas­es in us­es of the drug com­ing from doc­tors with no pri­or ex­pe­ri­ence pre­scrib­ing the drug, ac­cord­ing to a new study in the Jour­nal of Gen­er­al In­ter­nal Med­i­cine.

And many of those pre­scrip­tions con­tin­ued even af­ter the drug proved in­ef­fec­tive. Al­though pre­scrip­tion rates fell be­low the ear­ly pan­dem­ic peak — when the num­ber of new hy­drox­y­chloro­quine pre­scrip­tions tripled — when the first rig­or­ous da­ta emerged, they re­mained well above pre-pan­dem­ic lev­el through from mid-June through De­cem­ber 2020.

The au­thors from Har­vard’s Pro­gram On Reg­u­la­tion, Ther­a­peu­tics, And Law found that those doc­tors with no pri­or doc­u­ment­ed hy­drox­y­chloro­quine pre­scrib­ing saw a rise in pre­scrib­ing hy­drox­y­chloro­quine from 2.3% of new users in a pre-pan­dem­ic pe­ri­od to 51.4% dur­ing the first pan­dem­ic pe­ri­od, a 65-fold change. Those were con­cen­trat­ed among non-rheuma­tol­ogy spe­cial­ists (10.6-fold) and pri­ma­ry care physi­cians (4.8-fold). Al­though tri­al da­ta proved the drug to be in­ef­fec­tive, and the FDA re­tract­ed its EUA, for­mer Pres­i­dent Trump and oth­er celebri­ties con­tin­ued to en­dorse the drug pub­licly.

Ben Rome, the pa­per’s lead au­thor, said in an in­ter­view that the da­ta un­der­scored the dan­gers of Trump’s rhetoric, while of­fer­ing a warn­ing for to­day, when a new an­ti-par­a­site drug, iver­mectin, has be­come a pop­u­lar Covid-19 drug, de­spite no ev­i­dence that it’s ef­fec­tive.

“What sur­prised us was that even through the end of the year, hy­drox­y­chloro­quine pre­scrip­tions re­mained above base­line, and that’s even af­ter stud­ies came out show­ing it’s not ef­fec­tive,” he said. “The wide­spread mis­in­for­ma­tion on hy­drox­y­chloro­quine at the be­gin­ning of the pan­dem­ic had long-last­ing im­pacts.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

David Kessler testifies during a Senate hearing in May (Jim Lo Scalzo/Pool via AP Images)

Biden's fight with Mod­er­na over pro­vid­ing vac­cines for the poor­est coun­tries in­ten­si­fies

With about $10 billion in taxpayer funds invested in Moderna so far, it would seem that the company would be more understanding of pleas from President Joe Biden and the federal government to provide more vaccine doses to low- and middle-income countries.

But the Biden-Moderna feud over supplying the world with doses of mRNA vaccines is now spilling into the public, with Biden’s chief science officer of the government’s Covid-19 response David Kessler explaining the details in an online panel discussion moderated by Yale law professor Amy Kapczynski on Wednesday.

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