Covid-19 roundup: Duke de­mands Covid vac­cine — or else; FDA re­sumes Eli Lil­ly's mAb use in 22 states af­ter pause for vari­ant uptick

Duke Uni­ver­si­ty has come up with one of the most se­vere vac­cine man­dates in the books. Their mes­sage to more than 22,000 fac­ul­ty and staff: Get a jab of ei­ther the J&J, Mod­er­na or Pfiz­er/BioN­Tech vac­cines, or get fired. And don’t come back look­ing for a job lat­er.

Ex­emp­tions for med­ical and re­li­gious rea­sons will be con­sid­ered, but any­one al­lowed to take that route will al­so be sub­ject­ed to dai­ly mon­i­tor­ing for symp­toms and week­ly tests, ac­cord­ing to their state­ment to staff, sent to End­points News.

The bot­tom line from provost Sal­ly Ko­rn­bluth and ad­min­is­tra­tion VP Kyle Ca­vanaugh:

Vac­ci­na­tion is the best way to pro­tect your­self and your loved ones from se­ri­ous ill­ness re­lat­ed to COVID-19, and it is (the) on­ly way we will bring an end to this pan­dem­ic.

Duke is al­ready close to its goal, with 91% of staff and fac­ul­ty vac­ci­nat­ed.

News of the Duke de­mand spread fast on Mon­day morn­ing, com­ing as a whole host of busi­ness­es — in­clud­ing a wide swathe of bio­phar­ma — have been man­dat­ing a Covid-19 vac­cine. Now that Pfiz­er/BioN­Tech has a full ap­proval, the hope among many ex­perts is that more man­dates can push wider adop­tion at a time the Delta vari­ant has been rack­ing up a surg­ing wave of new in­fec­tions.

Hous­ton Methodist was one of the first health cen­ters to man­date a vac­cine, fir­ing or ac­cept­ing res­ig­na­tions from dozens of work­ers. And oth­er com­pa­nies have been ratch­et­ing up the pain for non­com­pli­ance. That in­cludes Delta, where health in­sur­ance will now cost more for the unin­sured. — John Car­roll

Eli Lil­ly gets a green light to re­sume an­ti­body sales

In Eli Lil­ly’s Q2 call, their ex­ecs re­vealed that sales of its mon­o­clon­al an­ti­bod­ies for Covid-19 treat­ment were slashed af­ter dis­tri­b­u­tion was halt­ed na­tion­wide. Now, two months since the ship­ments were paused, the FDA is re­sum­ing its use in a lit­tle less than half of the US.

The FDA has now spec­i­fied that Eli Lil­ly’s mAb com­bo of bam­lanivimab and ete­se­vimab is al­lowed for use in states and ter­ri­to­ries in which the com­bined fre­quen­cy of vari­ants that are re­sis­tant to the drug are less than 5%, the agency an­nounced.

While the an­ti­bod­ies were deemed in­ef­fec­tive against the Be­ta and Gam­ma vari­ants — which were trend­ing up­ward when dis­tri­b­u­tion was first halt­ed — the cock­tail can still neu­tral­ize the Delta and Al­pha vari­ants. Giv­en the dom­i­nance of Delta (and rel­a­tive fall of Be­ta and Gam­ma), it ap­pears Lil­ly’s drugs can once again play a role in the pan­dem­ic.

There are 22 states in which that ap­plies: Col­orado, Con­necti­cut, Illi­nois, In­di­ana, Iowa, Kansas, Maine, Mass­a­chu­setts, New Hamp­shire, Michi­gan, Min­neso­ta, Mis­souri, Mon­tana, Ne­bras­ka, North Dako­ta, Ohio, Rhode Is­land, South Dako­ta, Utah, Ver­mont, Wis­con­sin, and Wyoming. On Fri­day, the FDA and the HHS’ As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse start­ed dis­tri­b­u­tion of both bam­lanivimab and ete­se­vimab to­geth­er and ete­se­vimab alone.

The two mAbs were first au­tho­rized for emer­gency use by the FDA on Feb. 9 for use in pa­tients ages 12 years and old­er, Covid-19 pos­i­tive and at risk of hos­pi­tal­iza­tion. But as the Be­ta and Gam­ma vari­ants be­came more fre­quent, the dis­tri­b­u­tion of the com­bo was halt­ed, first in nine states — in­clud­ing Ore­gon, Mass­a­chu­setts and Flori­da — where the fre­quen­cy of vari­ants was high­er than 10%, then through the en­tire coun­try.

The list of places where the use of the mAb is not al­lowed in­cludes Wash­ing­ton DC, Amer­i­can Samoa, Guam and Puer­to Ri­co, among a num­ber of states.

Sales of the mAb were $148 mil­lion in the sec­ond quar­ter — a far cry from the $809 mil­lion the drugs post­ed in Q1 — af­ter the US halt­ed dis­tri­b­u­tion of the com­bo amid a rise in vari­ants. The pause is es­ti­mat­ed to cost Eli Lil­ly about $375 mil­lion, ac­cord­ing to one biotech an­a­lyst.

The Delta vari­ant has be­come the dom­i­nant vari­ant of the virus in the US, ac­cord­ing to the CDC. Based on as­says, bam­lanivimab and ete­se­vimab are ex­pect­ed to be ef­fec­tive against the Delta and Al­pha vari­ants, but not the Gam­ma, Be­ta or Delta-plus vari­ants.

States and ter­ri­to­ries that al­ready have re­ceived sup­ply but aren’t cur­rent­ly per­mit­ted to ad­min­is­ter the treat­ment are al­lowed to hold on to it for fu­ture use, the FDA said. Bam­lanivimab and ete­se­vimab are just one of three mAb treat­ments au­tho­rized to treat Covid-19. Re­gen­eron’s Re­gen-Cov and Glax­o­SmithK­line/Vir’s sotro­vimab are still able to be used with­out any re­stric­tions.

FDA al­so re­voked the EUA for bam­lanivimab alone in April be­cause it was no longer as ef­fec­tive as the com­bo ther­a­py. — Josh Sul­li­van

White House stick­ing with 8-month boost­er shot rec­om­men­da­tion

NI­AID’s An­tho­ny Fau­ci said Sun­day that the Biden ad­min­is­tra­tion is “stick­ing with” its rec­om­men­da­tion for a third dose of the coro­n­avirus vac­cine eight months af­ter re­ceiv­ing the orig­i­nal shots, ac­cord­ing to Ax­ios. The Biden ad­min­is­tra­tion re­cent­ly an­nounced it would be­gin of­fer­ing boost­er shots to stay ahead of de­clin­ing vac­cine ef­fec­tive­ness.

His com­ments were in di­rect con­tra­dic­tion to re­ports that the White House planned to call for boost­er shots six months fol­low­ing the sec­ond mR­NA jab in­stead.

“If the da­ta tells us dif­fer­ent­ly, we’ll make ad­just­ments ac­cord­ing­ly,” Fau­ci said on ABC’s “This Week”.

Fau­ci’s state­ments come as the US sees an in­crease in Covid cas­es — most­ly due to the in­fec­tious Delta vari­ant. In the last 28 days, Johns Hop­kins Uni­ver­si­ty da­ta show that the US re­port­ed al­most 3.8 mil­lion con­firmed cas­es. — Paul Schloess­er

Got­tlieb ex­pects Pfiz­er Covid-19 vac­cine ap­proval for kids un­der 12 by ear­ly win­ter

For­mer FDA Com­mis­sion­er Scott Got­tlieb said on CBS’s “Face the Na­tion” Sun­day that the Pfiz­er vac­cine could be ap­proved for kids ages 5-12 by late No­vem­ber or ear­ly De­cem­ber of this year.

Got­tlieb, who is on the board of di­rec­tors of Pfiz­er, said that Pfiz­er “is go­ing to be in a po­si­tion… to file da­ta with the FDA at some point in Sep­tem­ber and then file the ap­pli­ca­tion po­ten­tial­ly as ear­ly as Oc­to­ber. So that’ll put us on a time frame where the vac­cine could be avail­able at some point, late fall, more like­ly ear­ly win­ter, de­pend­ing on how long FDA takes to re­view the ap­pli­ca­tion.”

Da­ta on the vac­cine in chil­dren be­tween the ages of 2 and 5 will be avail­able by No­vem­ber, Got­tlieb said. — Paul Schloess­er

Pfiz­er bol­sters mar­ket­ing team to ap­proach vac­ci­na­tion push

Fol­low­ing its full FDA ap­proval, Pfiz­er has made it a pri­or­i­ty to mar­ket its Covid-19 vac­cine, and it’s hir­ing more team mem­bers to pro­mote it.

The drug­mak­er has post­ed sev­er­al po­si­tions on LinkedIn, The Fi­nan­cial Times first re­port­ed, in­clud­ing a se­nior di­rec­tor for its US Covid launch and a se­nior man­ag­er for US Covid con­sumer mar­ket­ing. The jobs are be­ing cre­at­ed among a flur­ry of com­pe­ti­tion from vac­cine mak­ers for boost­er shots.

Boost­ers will be­come avail­able in the US on Sept. 20 for those who are im­muno­com­pro­mised, and have re­ceived ei­ther the Mod­er­na or Pfiz­er-BioN­Tech jab. Pfiz­er de­clined to talk to the FT about the depth or du­ties of the new team, but it’s ex­pect­ed to mar­ket the vac­cine through on­line so­cial me­dia, TV ads and bill­boards. It’s been work­ing with New York-based ad agency Ogilvy. — Josh Sul­li­van

So­cial: Shut­ter­stock

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

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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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