Covid-19 roundup: As­traZeneca touts boost­er as ef­fec­tive against Omi­cron; Africa CDC re­port­ed­ly in talks to buy Paxlovid

Though it still hasn’t re­ceived FDA au­tho­riza­tion for its Covid-19 vac­cine, As­traZeneca is chart­ing a course for boost­er shots.

On Thurs­day, the British-Swedish phar­ma com­pa­ny re­vealed new in­for­ma­tion for its Vaxzevria shot, say­ing a boost­er dose sig­nif­i­cant­ly raised an­ti­body lev­els against Omi­cron and oth­er vari­ants, in­clud­ing Delta, re­gard­less of whether an in­di­vid­u­als’ orig­i­nal vac­cine se­ries was As­traZeneca, an mR­NA shot or Sino­vac. As­traZeneca says it plans to sub­mit the da­ta to reg­u­la­to­ry bod­ies world­wide.

“These im­por­tant stud­ies show that a third dose of Vaxzevria af­ter two ini­tial dos­es of the same vac­cine, or af­ter mR­NA or in­ac­ti­vat­ed vac­cines, strong­ly boosts im­mu­ni­ty against COVID-19,” chief in­ves­ti­ga­tor and Ox­ford pro­fes­sor An­drew Pol­lard said in a state­ment. “The Ox­ford-As­traZeneca vac­cine is suit­able as an op­tion to en­hance im­mu­ni­ty in the pop­u­la­tion for coun­tries con­sid­er­ing boost­er pro­grams.”

As­traZeneca did not in­clude spe­cif­ic da­ta in its up­date, but it was the com­pa­ny’s first state­ment on how its Covid-19 vac­cine per­forms as a boost­er. As­traZeneca al­so point­ed to oth­er stud­ies that show its boost­er reg­i­men “in­duced sig­nif­i­cant­ly high­er im­mune re­spons­es” against Delta and the orig­i­nal strain than two-dose mR­NA or vi­ral vec­tor jabs.

Though As­traZeneca’s shot has been ap­proved in the UK and EU, it re­mains un­ap­proved and unau­tho­rized in the US. Af­ter be­ing beat­en to the mar­ket by Pfiz­er, Mod­er­na and J&J in the US, As­traZeneca said it would stop seek­ing an EUA from the FDA and in­stead go af­ter full ap­proval.

That goal hasn’t yet been reached, and it re­mains to be seen whether As­traZeneca can find a piece of the Amer­i­can mar­ket for its boost­er shots as well. The CDC has rub­ber-stamped the “mix and match” ap­proach for boost­er shots, how­ev­er, al­low­ing in­di­vid­u­als to re­ceive any boost­er re­gard­less of orig­i­nal vac­cine se­ries.

Africa CDC in talks to buy Paxlovid pills — re­port

The Africa CDC is re­port­ed­ly in dis­cus­sions with Pfiz­er to ac­quire ship­ments of its an­tivi­ral Covid-19 pill.

Paxlovid has shown to be 89% ef­fec­tive at re­duc­ing the risk of hos­pi­tal­iza­tion or death from Covid-19, Pfiz­er said pre­vi­ous­ly, and re­tains most of its ef­fi­ca­cy against the Omi­cron vari­ant. Gov­ern­ments around the world have scram­bled to buy up sup­plies, and now the Africa CDC is in the race as well, ac­cord­ing to a Reuters re­port.

“We are in re­al­ly close dis­cus­sions with Pfiz­er to see what can be done to make the drugs avail­able on the con­ti­nent and ac­ces­si­ble on the con­ti­nent, that is, the Paxlovid drugs,” Africa CDC di­rec­tor John Nken­ga­song told Reuters.

The Pfiz­er pill is one of two FDA-au­tho­rized an­tivi­rals to fight Covid-19, the oth­er be­ing Mer­ck’s mol­nupi­ravir. Fig­ures re­leased from Mer­ck, how­ev­er, are much low­er than Paxlovid, with an orig­i­nal 50% ef­fi­ca­cy rate falling to 30% in some cas­es and draw­ing con­cerns from an FDA ad­comm last month.

Much like last year with the vac­cine race, rich coun­tries have snapped up most avail­able Paxlovid sup­ply. The US con­tract for 10 mil­lion dos­es puts the price at $530 per five-day Paxlovid reg­i­men, a price that al­most cer­tain­ly re­mains out of reach for many poor na­tions.

Pfiz­er is work­ing with oth­er man­u­fac­tur­ers to pro­duce gener­ic ver­sions of Paxlovid for low- and mid­dle-in­come coun­tries, but it re­mains to be seen whether it will prove an ef­fec­tive strat­e­gy. Vac­cine up­take in Africa re­mains low, as on­ly 10% of Africans are ful­ly vac­ci­nat­ed, Nken­ga­song said.

Vir, Glax­o­SmithK­line seek EUA amend­ment for in­jectable an­ti­body

Vir and Glax­o­SmithK­line’s mon­o­clon­al an­ti­body re­mains the on­ly au­tho­rized treat­ment to re­duce the risk of hos­pi­tal­iza­tion and death against Omi­cron, and Thurs­day the pair re­quest­ed the FDA ex­pand its EUA.

The com­pa­nies are seek­ing an EUA amend­ment to in­clude in­tra­mus­cu­lar ad­min­is­tra­tion of the an­ti­body in ad­di­tion to the in­tra­venous method al­ready au­tho­rized, they said in a state­ment Thurs­day. Ac­cord­ing to a Phase III study, the in­jectable ver­sion proved non-in­fe­ri­or to the IV ver­sion and of­fered “sim­i­lar ef­fi­ca­cy” in mild-to-mod­er­ate, ear­ly Covid-19 cas­es.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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US to stop sup­ply­ing Lil­ly's mAb for Covid-19 this month as com­mer­cial mar­ket awaits

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.