Covid-19 roundup: Ques­tions re­main on US sup­plies of Pfiz­er, Mer­ck pills as UK ramps up; Is­rael to go for a fourth dose for those over 60

As the FDA is poised to au­tho­rize the new Pfiz­er and Mer­ck pills to treat those with Covid-19 who haven’t been hos­pi­tal­ized, Bloomberg re­ports that the US will on­ly have lim­it­ed sup­plies of each pill ini­tial­ly.

US of­fi­cials said Amer­i­cans should have near­ly 400,000 cours­es of Mer­ck’s pill avail­able up­on its au­tho­riza­tion and 65,000 cours­es of Pfiz­er’s pill. By the end of Jan­u­ary, the gov­ern­ment ex­pects 3 mil­lion Mer­ck cours­es — its en­tire or­der — and 250,000 Pfiz­er cours­es. Mer­ck’s pill has been shown to be less ef­fec­tive in ear­ly tri­als than Pfiz­er’s, al­though Mer­ck did not test its pill head-to-head against Pfiz­er.

Biden’s ad­min­is­tra­tion al­so ap­par­ent­ly of­fered Pfiz­er the sup­port of the US gov­ern­ment if it runs in­to any pro­duc­tion is­sues, in­clud­ing use of the De­fense Pro­duc­tion Act, but Pfiz­er “hasn’t need­ed any in­ter­ven­tion,” cit­ing the pill’s “lengthy, in­ten­sive man­u­fac­tur­ing process” to Bloomberg.

Mean­while, the UK on Wednes­day bought an ad­di­tion­al 2.5 mil­lion treat­ment cours­es (on top of 250,000 bought pre­vi­ous­ly) of Pfiz­er’s pill, and 1.75 mil­lion cours­es of Mer­ck’s pill.

Is­rael goes for a 4th dose of Pfiz­er’s vac­cine for those over 60

Is­rael said Wednes­day that it will ad­min­is­ter a fourth dose of coro­n­avirus vac­cine to peo­ple over the age of 60 and med­ical per­son­nel, be­com­ing the first na­tion in the world to do so, ac­cord­ing to Bloomberg.

Those el­i­gi­ble for the fourth dose can re­ceive it pro­vid­ed at least four months have passed since the third dose, the coun­try’s prime min­is­ter’s of­fice said, ac­cord­ing to CNN. In Is­rael, al­most all vac­ci­nat­ed cit­i­zens have re­ceived the Pfiz­er/BioN­Tech vac­cine.

As­traZeneca to make Omi­cron-spe­cif­ic vac­cine

As­traZeneca and Ox­ford Uni­ver­si­ty have teamed up to make a vac­cine spe­cif­ic to the Omi­cron vari­ant, join­ing Pfiz­er-BioN­Tech and Mod­er­na to do so.

The news comes fol­low­ing a study in The Lancet that pro­tec­tion of­fered by the As­traZeneca jab wanes three months af­ter vac­ci­na­tion, while oth­er ev­i­dence sug­gests that a two-dose shot course pro­vides few­er an­ti­bod­ies against Omi­cron, and that a third mR­NA shot can in­crease the num­ber of an­ti­bod­ies. As­traZeneca’s shot is ade­n­ovirus-based.

“Like with many pre­vi­ous vari­ants of con­cern, and to­geth­er with our part­ners As­traZeneca, we have tak­en pre­lim­i­nary steps in pro­duc­ing an up­dat­ed vac­cine in case it is need­ed,” Ox­ford re­search group leader Sandy Dou­glas said to the Fi­nan­cial Times.

As­traZeneca’s shot has not been ap­proved in the US, though it was used through­out the UK and Eu­rope be­fore ac­cess was re­strict­ed due to rare, but fa­tal blood clots be­ing linked as a side ef­fect.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.