Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden wants a re­view of the API sup­ply chain. Will that par­lay in­to an ef­fort to 'on­shore' drug man­u­fac­tur­ing?

When for­mer Pres­i­dent Don­ald J. Trump was vot­ed out of of­fice Nov. 2, his gung-ho ef­fort to “on­shore” drug man­u­fac­tur­ing was left most­ly up in the air. Joe Biden has been most­ly mum on whether he would con­tin­ue that ef­fort, but a new ex­ec­u­tive or­der could pro­vide a clue — at least in a few months.

In an or­der signed Wednes­day, Biden de­mand­ed a 100-day gov­ern­men­tal re­view of key sup­ply chains, in­clud­ing for ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) used in Amer­i­can drugs.

Biden’s ef­fort doesn’t amount to full-scale ef­fort launched un­der the Trump ad­min­is­tra­tion to in­fuse bil­lions in­to Amer­i­can-made drug man­u­fac­tur­ers, but a key note in the pres­i­dent’s pre­pared fact sheet could in­di­cate his goal. In that doc­u­ment, his team high­light­ed that 70% of US API pro­duc­ers had moved off­shore in re­cent decades — po­ten­tial­ly threat­en­ing the sup­ply of a sta­ble sup­ply chain dur­ing fu­ture pan­demics.

Since his in­au­gu­ra­tion, it’s been un­clear whether Biden would adopt the ex­plic­it na­tivist tone of Trump’s “Buy Amer­i­ca” ini­tia­tive, which cul­mi­nat­ed in an Au­gust ex­ec­u­tive or­der aim­ing to dri­ve new in­vest­ment in on­shore drug pro­duc­tion.

That game plan some­times led to a few ques­tion­able in­vest­ments, most no­tably a $765 mil­lion loan through the ad­min­is­tra­tion’s de­vel­op­ment fi­nance arm to cam­era mak­er Ko­dak. Af­ter the loan was an­nounced, ac­cu­sa­tions of in­sid­er trad­ing and an SEC in­ves­ti­ga­tion even­tu­al­ly sent that ini­tia­tive in­to a tail­spin in Au­gust.

Mean­while, the gov­ern­ment made a more di­rect in­vest­ment in the up­start Phlow Cor­po­ra­tion in May, a pre­vi­ous­ly un­known com­pa­ny that was tapped to part­ner with gener­ics mak­er Civi­ca Rx, among oth­ers, to build a Vir­ginia plant for crit­i­cal hos­pi­tal drugs. In Jan­u­ary, Civi­ca an­nounced it would dole out $124.5 mil­lion to build its first in-house man­u­fac­tur­ing op­er­a­tion in Pe­ters­burg, Vir­ginia — close to Phlow and the oth­er part­ners in the gov­ern­ment con­tract, Med­i­cines for All In­sti­tute and AM­PAC Fine Chem­i­cals.

Out­side the gov­ern­ment’s purview, oth­er big-name play­ers have stepped up in re­cent months to put their own big down pay­ments on Amer­i­can-made drugs.

In Jan­u­ary, bil­lion­aire in­vestor Mark Cuban put his name to a new com­pa­ny dubbed Mark Cuban Cost Plus Drugs, a gener­ics start­up us­ing flat-rate mar­gins at whole­sale to dri­ve down the cost of ex­pen­sive gener­ics. The goal is even­tu­al­ly to launch more than 100 drugs on­to the mar­ket by the end of this year, but the firm will start with an­tipar­a­sitic al­ben­da­zole, which it says it will of­fer at an av­er­age price per tablet of $20 com­pared with the cur­rent av­er­age of $225 MSRP. For in­sured pa­tients, that price could go “as low as a dol­lar,” the com­pa­ny said on its web­site.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Governor John Carney, Lieutenant Governor Bethany Hall-Long, Mayor Kenneth Branner, Jr., Delaware Prosperity Partnership President Kurt Foreman, WuXi AppTec Chairman and CEO Ge Li, WuXi AppTec Co-CEO and WuXi STA CEO Minzhang Chen, and others celebrate the groundbreaking for the WuXi STA Middletown campus.

WuXi breaks ground on Delaware fa­cil­i­ty, boost­ing its US pres­ence

While Middletown, Delaware’s main claim to fame was the site location for the film the Dead Poets Society, the city will soon play host to a massive manufacturing outfit.

WuXi AppTec’s contract research and manufacturing subsidiary WuXi STA, has broken ground on a 190-acre manufacturing campus in Middletown.

According to the company, this site will be WuXi’s second facility in the US, and it will create around 500 full-time jobs by 2026, but there are plans to kick off operations in 2025.

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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