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Fuad El-Hibri (via East West Protection)

Fol­low­ing a tu­mul­tuous year, Emer­gen­t's founder will re­tire in April

After what was almost certainly the most turbulent year in his company’s history, Fuad El-Hibri, the founder and original CEO of Emergent BioSolutions, will retire in April.

The move comes 24 years after Emergent was founded as BioPort with just one product, its anthrax vaccine BioThrax. El-Hibri was the CEO for 14 years and took the company public in 2006. After he stepped down as the CEO, he remained on board as chairman for the next 10 years.

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FDA con­cerns at con­trac­tor Catal­ent site spurred on short­ages of No­vo Nordisk's semaglu­tide — re­port

Just before the start of the new year, Novo Nordisk revealed its supply of obesity med Wegovy was low and that it would not be able to meet demand in the US until the second half of 2022.

Thanks to a Form 483 from the FDA, we now know that issues at Catalent’s flagship syringe filling site in Brussels, Belgium, was the reason for the delay, BioProcess International reported.

The site is 265,000 square feet and has been handed 12 483s in nine FDA visits, a source told BioProcess, though it is believed that this is the first that has halted production.

Largest Catal­ent site will ex­pand cold chain of­fer­ings; First phase com­plet­ed for Avid's CA up­grade 

A Philadelphia Catalent site will get an increase in cold-chain packaging capabilities to gear up for any future increases in gene and cell therapies.

The site will be expanded by 20,000 square feet and add an additional seven temperature-controlled processing suites. Those suites can either be in refrigerated or frozen conditions to match the needs of the drugs handled. There will also be more storage space, and the suites are designed for small-scale batches of commercial products.

Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Pfiz­er says it's ready to ramp up Paxlovid pro­duc­tion. Ex­perts say it's not that easy

Upon the FDA’s authorization of the first at-home Covid-19 pill to keep people out of the hospital, Pfizer CEO Albert Bourla announced his company has confidence it can make 120 million treatments in 2022, good for 3.6 billion tablets.

The drug has people excited: Paxlovid was found to reduce the risk of hospitalization by 89% in trial with the same safety profile as placebo, Pfizer reported. Not a single person dosed with the oral antiviral in the trial died of Covid-19, while 10 patients who received the placebo did.

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Jenn Azar, NECI CEO

Q&A: NECI's newest CEO talks pas­sion, dis­rup­tion and not fear­ing change

Engineer. Massachusetts bar-style pizza devotee. CEO.

That last one is the latest title for Jenn Azar, who was named the successor to Tom Ramundo as the CEO at Mansfield, MA-based manufacturing service provider NECI at the start of the year.

NECI works with companies across a range of industries in the northeast to improve their industrial automation and digital transformation. Most famously, the company worked with Moderna to establish digital tools that helped accelerate the authorization of its Covid-19 vaccine, which has gone into the arms of millions of people around the globe.

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#JPM22: Catal­ent CEO John Chimin­s­ki with John Car­roll — Our pre­dic­tions for the bio­phar­ma in­dus­try in 2022

During our JPM22 week of events, I had a chance to sit down with Catalent CEO John Chiminski for our annual forecast for the year ahead. It’s always a lot of fun, and Chiminski had a chance to talk about the big transition ahead for his company, CDMOs, and what looks like a very eventful 12 months for biopharma. — John Carroll

John Carroll:

Okay! Well. Hey, everybody. This is John Carroll, I’m the editor of Endpoints News. And I am very happy to introduce John Chiminski back again, CEO of Catalent. And John is joining me once again to be talking about what’s going on next year, what’s happening. We’ve done this before. Generally, it’s always good to have you be here, John. But one thing that we can say that’s absolutely certain that’s going to happen in 2022 is there’s going to be a transition at Catalent. And I wanted to talk a little bit about that.

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Keith Kleeman, Optimvia CEO

In pur­suit of bet­ter he­parin man­u­fac­tur­ing process, Gink­go teams up with an Ohio-based biotech

The manufacturing process to make biosynthetic heparin, a drug used for preventing blood clots, is not a particularly clean one.

In a slaughterhouse, someone must remove the intestine casings from a pig. The mucosal linings are then scraped. The steps to get heparin are enormous, and the process is complicated.

“It’s not like you kill a pig and you have heparin,” Ohio-based Optimvia CEO Keith Kleeman told Endpoints News in an interview. “It’s a filthy, disgusting place for a medication to start. I can’t think of a more disgusting place for an important medicine to start.”

Center for Breakthrough Medicines‘ headquarters at the Discovery Labs, King of Prussia, Pennsylvania

Ko­re­an con­glom­er­ate SK takes out stake in cell and gene ther­a­py CD­MO with plans for a ma­jor hir­ing spree out­side Philly

A Pennsylvania CDMO specializing in cell and gene therapy manufacturing is receiving a big influx of cash from a South Korean drugmaker — and it has plans for a major hiring spree.

SK, the holding company of SK bioscience, will invest $350 million of equity financing into the Center for Breakthrough Medicines, with plans to add an additional 2,000 employees as part of a redux at the CDMO’s King of Prussia, PA facility.

Jianxin Chen, ZhenGe Biotech chairman and CEO

Low-pro­file Shang­hai-based CD­MO se­cures high pro­file in­vestors for 9-dig­it Se­ries C

In a bid to expand R&D and manufacturing capabilities, Shanghai-based ZhenGe Biotech netted a $100 million Series C Tuesday.

With offices in Shanghai and the US, the transpacific CDMO garnered the support of Goldman Sachs Asset Management, who co-led the financing round with Sofina. Other investors joined in the round, including Novo Holdings, Qiming Venture Capital, and several other firms.

The series brings the company up to $225 million raised since it was founded in 2017. As part of the raise, ZhenGe named Kevin Xu, a managing director at Goldman Sachs Asset Management, to its board.

Re­call re­port: An­oth­er month, an­oth­er is­sue with ND­MA

It’s been six months since the last incident, but 2021 ended with the tally resetting back to “zero days.”

Viona Pharmaceuticals is recalling 33 lots of metformin hydrochloride after finding traces of NDMA, a known probable human carcinogen with cancer-causing potential. It’s a much larger recall than the two lots of 750 mg extended-release tablets it recalled in June.

Metformin is used to help improve glucose control in adults with type 2 diabetes, and is packaged in bottles of 100 tablets. The drug can be identified by its capsule-shaped, uncoated off-white color tablets that feature a “Z” and a “C” on one side and “20” on the other.