Covid-19 man­u­fac­tur­ing roundup: Kenya will add man­u­fac­tur­ing plant, up vac­ci­na­tion sites; South Ko­rea left wait­ing on Rus­sia vac­cine ex­ports

A fill-and-fin­ish man­u­fac­tur­ing site is pop­ping up in Kenya to help as­sure Covid-19 vac­cine sup­ply, the min­istry of health an­nounced Wednes­day.

The site will help third-par­ty drug­mak­ers put vac­cines in­to vials. As a re­sult, Kenya’s vac­ci­na­tion sites will more than triple — to 3,000 from 800 — lead­ing to the dou­bling of vac­cines in arms by De­cem­ber, Bloomberg re­port­ed.

Africa has been fo­cused on self-sus­tain­abil­i­ty on the Covid-19 vac­ci­na­tion front. In ear­ly Sep­tem­ber, BioN­Tech an­nounced it is con­sid­er­ing putting vac­cine man­u­fac­tur­ing sites in Rwan­da and Sene­gal to help beef up the con­ti­nent’s sup­ply.

That an­nounce­ment came af­ter it was learned that a South African plant that was giv­en $200 mil­lion from the US gov­ern­ment to pro­duce J&J’s shot was forced to send those jabs back to Eu­rope, de­spite an uptick in cas­es do­mes­ti­cal­ly.

With mil­lions of dos­es in stor­age, GL awaits Russ­ian man­u­fac­tur­ing ap­proval

A South Ko­re­an biotech is an­tic­i­pat­ing ap­proval from Rus­sia to ex­port the coun­try’s one-shot ver­sion of its Covid-19 vac­cine, Reuters re­port­ed Tues­day.

The Russ­ian Di­rect In­vest­ment Fund plans to pro­duce 700 mil­lion dos­es this year alone, and GL Rapha ex­pects to be the first man­u­fac­tur­er to gain ap­proval. Chair­man Whang Jae-gan said in an in­ter­view that every­thing on GL’s side is good to go, and the com­pa­ny just awaits val­i­da­tion of the process from Rus­sia. The com­pa­ny has 10 mil­lion dos­es of Sput­nik Light in stor­age, ready to be shipped in its Chun­cheon fa­cil­i­ty, east of Seoul, Reuters re­port­ed.

Sput­nik V and Sput­nik Light both await emer­gency use au­tho­riza­tion from the World Health Or­ga­ni­za­tion af­ter an Oc­to­ber 2020 sub­mis­sion.

In Au­gust, re­ports not­ed that Kaza­khstan might jump in­to the man­u­fac­tur­ing of Sput­nik Light in-coun­try, as it has lagged be­hind in its vac­ci­na­tion roll­out. Kaza­khstan al­ready has pro­duced the two-jab Sput­nik V, and re­ceived im­ports of the vac­cine from Rus­sia.

Sci­en­tists in Rus­sia re­port­ed 92% ef­fi­ca­cy in a Phase III tri­al of Sput­nik V, a num­ber that’s sur­passed ade­n­ovirus-based vac­cines, though ev­i­dence was scarce. Sput­nik V has been ap­proved by 70 coun­tries, in­clud­ing Hun­gary, Slo­va­kia and Syr­ia.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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House pass­es two bills on con­tin­u­ous man­u­fac­tur­ing, stock­pil­ing ahead of fu­ture pan­demics

The House of Representatives this week passed two bills to strengthen America’s national stockpile of medical supplies and to allow the FDA to designate colleges and universities as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.

The stockpile bill, known as HR 3635, passed by a vote of 397-22. Introduced by Rep. Elissa Slotkin (D-MI) and 15 other cosponsors, the bill would improve America’s ability to respond to future pandemics, as well as handle the ongoing Covid-19 pandemic too.

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