As the mR­NA push con­tin­ues, Sam­sung will ex­pand its drug sub­stance man­u­fac­tur­ing at South Ko­re­an hub

As the de­mand for mR­NA ca­pac­i­ty grows, Sam­sung Bi­o­log­ics has an­nounced the ad­di­tion of drug sub­stance pro­duc­tion ca­pa­bil­i­ty to its fa­cil­i­ties by the first half of 2022, in an ef­fort to en­sure end-to-end mR­NA vac­cine man­u­fac­tur­ing at an ex­ist­ing South Ko­rea plant.

The move is part of the com­pa­ny’s longterm strat­e­gy as it’s been ex­pand­ing its port­fo­lio and ca­pac­i­ty to meet the rapid­ly ris­ing mar­ket de­mand be­yond its cur­rent busi­ness fo­cused on mon­o­clon­al an­ti­bod­ies. This move will com­ple­ment the con­struc­tion of its fourth — and largest — man­u­fac­tur­ing site in In­cheon, South Ko­rea.

“mR­NA has been the tech­nol­o­gy of choice for many COVID-19 vac­cines due to its char­ac­ter­is­tics of safe­ty and fast scal­a­bil­i­ty in man­u­fac­tur­ing,” the com­pa­ny said in a re­lease.

Last week, Sam­sung and Mod­er­na an­nounced that the South Ko­re­an CD­MO’s pro­duc­tion line in In­cheon will sup­port 100s of mil­lions of dos­es, good for dis­tri­b­u­tion at the start of Q3. Mod­er­na an­nounced last Fri­day that its vac­cine was ap­proved by the Japan­ese and South Ko­re­an gov­ern­ments. Dis­tri­b­u­tion will hap­pen in Japan im­me­di­ate­ly, with the help of Take­da, as a part of a three-way agree­ment.

Since the emer­gence of Pfiz­er and Mod­er­na’s Covid-19 vac­cines, there has been in­creased at­ten­tion on mR­NA vac­cines. Both com­pa­nies have pledged up to 3 bil­lion dos­es of the vac­cine a year, which has put a spot­light on con­tract work.

The In­cheon plant will hold a to­tal of 620,000 liters of cell cul­ture ca­pac­i­ty and pro­vide end-to-end, fill-fin­ish ser­vices for clients, the com­pa­ny said.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

Ugur Sahin, AP Images

Covid-19 man­u­fac­tur­ing roundup: BioN­Tech an­nounces plans to pro­duce mR­NA vac­cines in Africa; As­traZeneca de­liv­er­ies from Thai­land de­layed

BioNTech, Pfizer’s partner on its Covid-19 vaccine, will look to establish mRNA vaccine production facilities in Africa, the Financial Times reported Wednesday.

The move is a part of a larger push to tackle diseases beyond Covid-19, and as the EU looks to up its manufacturing capacity on the continent. Right now, Africa imports over 99% of the vaccines it uses, the FT reports. The plan was outlined in a call between CEO Ugur Sahin and European Commission President Ursula von der Leyen before the G7 summit.

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.