De­spite a lack of for­mal ap­proval from the Eu­ro­pean Med­i­cines Agency, Mod­er­na is mov­ing to nail down pro­duc­tion ca­pac­i­ty for the dos­es of its mR­NA-based Covid-19 vac­cine that will be jabbed in­to arms out­side of the U.S.

Just be­fore the new year, Mod­er­na inked a deal with Re­ci­pharm, the Swedish CD­MO, for for­mu­lat­ing and fill-fin­ish work on an undis­closed por­tion of Mod­er­na’s vac­cine sup­ply out­side of the US at Re­ci­pharm’s drug prod­uct man­u­fac­tur­ing fa­cil­i­ty lo­cat­ed in France.

Fi­nan­cial terms of the Re­ci­pharm-Mod­er­na deal were not dis­closed. The deal, of course, is pend­ing of­fi­cial ap­proval for the vac­cine’s ad­min­is­tra­tion — a key point that re­mains up in the air.

Reuters re­port­ed Mon­day that the EMA hasn’t yet been able to reach a de­ci­sion on ap­prov­ing the vac­cine, de­spite the reg­u­la­to­ry agency’s hu­man med­i­cines com­mit­tee call­ing an un­sched­uled meet­ing two days ahead of a planned meet­ing on Wednes­day.

It was un­clear why the com­mit­tee didn’t reach a de­ci­sion, and while an ap­proval could still come Wednes­day, the process re­mains a bit murky.

“This is how it goes, of course we had hoped for more, but we knew it could be im­pos­si­ble to an­swer all ques­tions in de­tail in one meet­ing,” CBG chair­man Ton de Boer told Reuters. “I hope there will be a de­ci­sion on Wednes­day. But I don’t know.”

The EMA has set a Jan. 12 dead­line for whether to rec­om­mend Mod­er­na’s vac­cine for us­age. It rec­om­mend­ed the Pfiz­er-BioN­Tech vac­cine for us­age in treat­ing the res­pi­ra­to­ry virus on Dec. 21.

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.