Joe Biden (AP Images)

Covid-19 roundup: Mod­er­na has filed for vac­cine use in chil­dren; Claim­ing lead­er­ship to com­bat Covid-19, US pledges to do­nate 500M dos­es of Pfiz­er/BioN­Tech vac­cines through CO­V­AX

Just days af­ter Mod­er­na’s vac­cine was sub­mit­ted for ap­proval for use in chil­dren in the EU and Cana­da, the com­pa­ny has an­nounced it has filed for emer­gency use au­tho­riza­tion with the FDA for the ad­min­is­tra­tion in teens be­tween 12 and 18.

Mod­er­na an­nounced in May that its Phase II/III study of the vac­cine in ado­les­cents met the pri­ma­ry end­points in near­ly 2,500 pa­tients, show­ing an ef­fi­ca­cy of 100% against se­vere symp­to­matic Covid-19. Be­cause chil­dren are less like­ly to de­vel­op se­ri­ous side ef­fects, the tri­al al­so looked at milder cas­es than ex­am­ined in the adult study. The study found that the vac­cine was 93% ef­fec­tive at stop­ping mild cas­es 14 days af­ter pa­tients were dosed.

The com­pa­ny ap­pears to be on sched­ule, as it pre­vi­ous­ly said it planned to ap­ply for au­tho­riza­tion in kids in June.

Right now, Pfiz­er-BioN­Tech’s vac­cine is the on­ly one avail­able for teens in the US. Pfiz­er an­nounced this week that it will be­gin tri­als of a re­duced dosage in chil­dren be­tween the ages of 6 months and 11 years old. — Josh Sul­li­van

Claim­ing lead­er­ship to com­bat Covid-19, US pledges to do­nate 500M dos­es of Pfiz­er/BioN­Tech vac­cines through CO­V­AX

Af­ter be­ing crit­i­cized for months for hoard­ing Covid-19 vac­cines, the Unit­ed States is mak­ing a grand ges­ture.

Pres­i­dent Joe Biden has an­nounced plans to buy 500 mil­lion dos­es of the Pfiz­er/BioN­Tech vac­cine and do­nate them to low­er-in­come coun­tries in what his ad­min­is­tra­tion brands as a his­toric move to help su­per­charge the glob­al fight against the pan­dem­ic.

The do­na­tion fol­lows a sep­a­rate ini­tia­tive to give away 80 mil­lion ex­cess vac­cine dos­es al­ready in the US stock­pile for re­dis­tri­b­u­tion through the CO­V­AX mech­a­nism, co­or­di­nat­ed by the WHO, Gavi and CEPI. That batch com­prised vac­cines from Mod­er­na, John­son & John­son, and Pfiz­er/BioN­Tech.

The new pur­chase for half a bil­lion dos­es will come en­tire­ly from Pfiz­er and, giv­en the two-shot reg­i­men, be enough to vac­ci­nate 250 mil­lion peo­ple. With ship­ments start­ing in Au­gust, 200 mil­lion dos­es are slat­ed to be de­liv­ered by the end of this year, while the rest will be de­liv­ered by June 2022.

While Pfiz­er had charged the US $19.50 per dose for do­mes­tic use, it will sell these new shots at a “not-for-prof­it” price, the Wash­ing­ton Post re­port­ed.

Fol­low­ing US al­lo­ca­tion, CO­V­AX will help de­liv­er these shots to the 92 low- and low­er-mid­dle in­come coun­tries around the world el­i­gi­ble for its fa­cil­i­ty, as well as the African Union.

On top of the vac­cine do­na­tion, the US has con­tributed $2 bil­lion to the ef­fort and pledged to sup­port lo­ca­tion pro­duc­tion of Covid-19 vac­cines.

As of Tues­day, CO­V­AX has fa­cil­i­tat­ed the dis­tri­b­u­tion of about 81 mil­lion shots world­wide.

“Thanks to the suc­cess of our vac­ci­na­tion pro­gram, the Unit­ed States is beat­ing COVID-19 here at home,” a White House fact sheet reads, with 64% of adult Amer­i­cans hav­ing re­ceived at least one shot.

Tedros Ad­hanom Ghe­breye­sus

That suc­cess, though, has ex­perts wor­ried about a dis­con­nect be­tween the de­vel­oped world and vul­ner­a­ble re­gions for whom the pan­dem­ic is far from over, with new records in dai­ly new cas­es and death tolls. Tedros Ad­hanom Ghe­breye­sus, the WHO di­rec­tor gen­er­al, ap­pealed to G7 just days ago to lever­age their pow­er in meet­ing the glob­al tar­get to vac­ci­nate at least 10% of the world’s pop­u­la­tion by Sep­tem­ber, which he said would re­quire an ad­di­tion­al 500 mil­lion dos­es.

“In­creas­ing­ly, we see a two-track pan­dem­ic: many coun­tries still face an ex­treme­ly dan­ger­ous sit­u­a­tion, while some of those with the high­est vac­ci­na­tion rates are start­ing to talk about end­ing re­stric­tions,” he told re­porters.

The dos­es, the White House was sure to add, will be pro­duced at Pfiz­er’s fa­cil­i­ties in Michi­gan, Kansas, Mis­souri and Mass­a­chu­setts. — Am­ber Tong

De­moc­rats take is­sue with Pfiz­er vac­cine price

High-pro­file De­moc­rats, in­clud­ing Sen. Eliz­a­beth War­ren (MA) and Rep. Katie Porter (CA), sent a let­ter to Pfiz­er CEO Al­bert Bourla on Tues­day, ques­tion­ing the com­pa­ny’s price tag for its Covid-19 vac­cine and its ex­pect­ed tens of bil­lions in rev­enue from the vac­cine.

With an eye to­ward fu­ture price es­ca­la­tions, the mem­bers of Con­gress note that Pfiz­er could end up caus­ing pri­vate in­sur­ers to raise pre­mi­ums and in­crease tax­pay­er costs for health care.

“Does the com­pa­ny in­tend to seek ‘a nor­mal price like [it] typ­i­cal­ly get[s] for a vac­cine—$150, $175 per dose.’? If so, when does the com­pa­ny plan to im­ple­ment these in­creas­es?” they asked Bourla, in ad­di­tion to ques­tions on how much the com­pa­ny in­vest­ed in the vac­cine. The De­moc­rats al­so asked how Pfiz­er will de­ter­mine its pric­ing for the vac­cine mov­ing for­ward. — Zachary Bren­nan

Ocu­gen to no longer pur­sue an EUA for its vac­cine

Penn­syl­va­nia-based Ocu­gen, which is look­ing to bring In­dia’s Covid-19 vac­cine from Bharat Biotech to the US, says it will no longer seek an emer­gency use au­tho­riza­tion and will in­stead seek a full ap­proval.

The com­pa­ny said FDA pro­vid­ed feed­back on the mas­ter file it had pre­vi­ous­ly sub­mit­ted and rec­om­mend­ed that Ocu­gen pur­sue a BLA sub­mis­sion in­stead of an EUA ap­pli­ca­tion for its vac­cine can­di­date and re­quest­ed ad­di­tion­al in­for­ma­tion and da­ta.

The news comes as the FDA said late last month that for the re­main­der of the pan­dem­ic, it may de­cline to re­view and process fur­ther EUA re­quests for Covid-19 vac­cines, as the coun­try still tries to ad­min­is­ter mil­lions of dos­es that it’s al­ready pur­chased of the three vac­cines that have al­ready won EUAs. — Zachary Bren­nan

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel, AP Images

Covid-19 roundup: Mod­er­na says vac­cine pro­duces 'strong' re­sponse in 5- to 11-year-olds; As­pen Phar­ma­care plans to up vac­cine pro­duc­tion in South Africa — re­port

After seeing a “robust” immune response in 6- to 11-year-olds dosed with its Covid-19 vaccine, Moderna says it’s headed to the FDA.

The results came from the Phase II/III KidCOVE study, which enrolled 4,753 participants between the ages of 6 and under 12 years old. The kids were given two half-doses of the Moderna vaccine (50 µg each), and showed “strong immune response” a month after the second dose.

AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.