Covid-19 man­u­fac­tur­ing roundup: In­di­an man­u­fac­tur­er waives vac­cine pro­tec­tions for mi­grants; EMA gives go-ahead for French J&J pro­duc­tion site

Amid fears that mil­lions of mi­grants may not have ac­cess to Covid-19 vac­cines from Co­v­ax fol­low­ing li­a­bil­i­ty fears, the Serum In­sti­tute of In­dia has an­nounced that it will waive its pro­tec­tion from le­gal li­a­bil­i­ties for any As­traZeneca-Ox­ford dos­es it pro­vides to the pro­gram, Reuters re­port­ed Wednes­day.

Co­v­ishield can now be al­lo­cat­ed to the Co­v­ax Hu­man­i­tar­i­an Buffer, a pro­gram de­signed to en­sure that the most vul­ner­a­ble por­tions of pop­u­la­tions, such as con­flict zones or hu­man­i­tar­i­an set­tings that are not able to be reached by gov­ern­ment vac­ci­na­tion cam­paigns, are not left be­hind. Gavi sees it most ef­fec­tive in ar­eas that have been im­pact­ed by state fail­ure or ar­eas con­trolled by groups that are not the gov­ern­ment. Asy­lum seek­ers, refugees, de­tainees, and peo­ple who are state­less are all el­i­gi­ble.

Many man­u­fac­tur­ers re­quire pro­tec­tion from any side ef­fects. That is not able to be guar­an­teed if there is no gov­ern­ment.

The As­traZeneca shot is right now the main vac­cine sup­plied to Co­v­ax. If all goes ac­cord­ing to plan, the Pfiz­er-BioN­Tech jabs will take over that crown in 2022, Reuters said.

EMA ap­proves new French site for J&J vac­cine, ap­proves Spain scale-up

A site in Mar­cy-l’Étoile, France has been giv­en the OK by the EMA’s hu­man med­i­cines com­mit­tee to man­u­fac­ture the J&J Covid-19 vac­cine.

The site, owned by Sanofi, will man­u­fac­ture the fin­ished prod­uct. It will sup­port the con­tin­ued sup­ply of the vac­cine, the agency said.

An An­dover, MA site op­er­at­ed by Wyeth Bio­Phar­ma has al­so been giv­en the OK to up the pro­duc­tion of the ac­tive sub­stance for Pfiz­er-BioN­Tech’s Comir­naty. That will help sup­port the sup­ply for the EU. A Madrid, Spain site op­er­at­ed by Rovi will al­so be per­mit­ted a 50% scale-up of batch size for the fin­ished prod­uct of Mod­er­na’s Spike­vax, and is al­lowed a sec­ond fill-fin­ish line. These changes are ex­pect­ed to al­low the pro­duc­tion of an­oth­er 25 mil­lion dos­es each month to the EU, and Co­v­ax.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

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.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

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.

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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.

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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.

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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.

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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.