As mR­NA tech has been made more pop­u­lar by the Covid-19 pan­dem­ic, in­vestor cash is mak­ing its way to man­u­fac­tur­ers and re­searchers.

In their lat­est move, Irish biotech Nor­max Bio­med has net­ted a €300 Mil­lion, or $305 mil­lion, in­vest­ment from pri­vate firm GEM Glob­al Yield.

The deal will see GEM pro­vide Nor­max with a share sub­scrip­tion fa­cil­i­ty of up to €50 Mil­lion for a 36-month term fol­low­ing the pub­lic list­ing of the Nor­max com­mon stock.

Nor­max will con­trol the tim­ing and max­i­mum amount of each draw­down un­der the fa­cil­i­ty and has no min­i­mum sub­scrip­tion oblig­a­tion. Nor­max is plan­ning to list it­self on ei­ther the  SIX Swiss Ex­change, SIX Dig­i­tal Ex­change (SDX), or the Lon­don Stock Ex­change as well.

Ac­cord­ing to Nor­max CEO Pe­ter Jensen, af­ter the cap­i­tal com­mit­ment, the com­pa­ny plans to al­so in­crease re­search and de­vel­op­ment of mR­NA vac­cines for Covid-19, TB, HIV and Malar­ia and de­ploy mod­u­lar mR­NA Vac­cine Fac­to­ries, in up 100 lo­ca­tions.

“In the event of an­oth­er pub­lic health emer­gency, we are al­so com­mit­ted to de­liv­er­ing fu­ture mR­NA vac­cines in 100 days, to help en­sure that Covid-19 is the last pan­dem­ic we will all suf­fer through. Dead­ly dis­eases wait for no man and no mar­ket,” Jensen said in a state­ment.

He al­so said that de­spite mar­ket con­di­tions not be­ing ide­al, Nor­max will go to mar­ket in 2022.

“Our Nor­max core busi­ness of mR­NA vac­cine R&D and man­u­fac­tur­ing can de­liv­er sus­tain­able re­turns on fun­da­men­tal health­care needs that bi­o­log­i­cal­ly will last for­ev­er. Pathogens are in­evitable, but dis­eases are not,” he said.

Ac­cord­ing to the com­pa­ny, it us­es mod­u­lar man­u­fac­tur­ing sites that can al­low the con­struc­tion of an mR­NA vac­cine fac­to­ry and the pro­duc­tion of mR­NA vac­cines wher­ev­er need­ed.

While Cy­ti­va has been plac­ing in­vest­ments in­ter­na­tion­al­ly, its lat­est move takes them to the wolver­ine state.

Ac­cord­ing to the com­pa­ny, it is in­vest­ing in more resins man­u­fac­tur­ing op­er­a­tions out­side of Swe­den for the first time in its his­to­ry.

The com­pa­ny has ac­quired a fa­cil­i­ty in Muskegon, Michi­gan. The new resins man­u­fac­tur­ing site is part of Cy­ti­va and Pall Cor­po­ra­tion’s $1.5 bil­lion ca­pac­i­ty ex­pan­sion in­vest­ment.

Cy­ti­va plans to trans­form the site in­to a 168,000-square-foot bio­man­u­fac­tur­ing cen­ter con­sist­ing of mul­ti­ple build­ings. Cy­ti­va is now ex­pand­ing be­yond Swe­den to man­u­fac­ture these resins. Resins are crit­i­cal in pu­ri­fy­ing and an­a­lyz­ing bio­mol­e­cules so phar­ma­ceu­ti­cal and life sci­ences com­pa­nies can make med­i­cines. The fa­cil­i­ty will al­so bring in an es­ti­mat­ed 200 em­ploy­ees when com­plet­ed, but the fi­nan­cial de­tails of the project were not dis­closed.

“When you’re look­ing to help pro­vide glob­al biotech­nol­o­gy so­lu­tions to the world, it re­quires you to be nim­ble and flex­i­ble. By in­vest­ing in Muskegon, Michi­gan, we will be clos­er to our North Amer­i­can cus­tomers, who are de­vel­op­ing ad­vanced bio­ther­a­peu­tics,” said Cy­ti­va CEO Em­manuel Lign­er in a state­ment.

The site re­ceived ben­e­fits from the Michi­gan Eco­nom­ic De­vel­op­ment Cor­po­ra­tion (MEDC) and the Michi­gan Strate­gic Fund (MSF). The site al­so has a co-op­er­a­tive agree­ment fund­ed through BAR­DA and has con­tract­ing sup­port from the DoD.

Con­struc­tion is planned to start at some point in Q3 2022, with man­u­fac­tur­ing ex­pect­ed to be­gin in 2026.

Chi­nese biotech Tri­astek and Eli Lil­ly have inked a deal to lever­age Tri­astek’s 3D print­ing tech­nol­o­gy to en­able tar­get­ed and pro­grammed re­lease of drugs in spe­cif­ic re­gions of the GI tract.

Ac­cord­ing to Tri­astek, the agree­ment will fo­cus on the re­lease of drugs in the in­tes­tine. Tri­astek will fo­cus on con­duct­ing an in-depth study of ex­cip­i­ent prop­er­ties and process pa­ra­me­ters to main­tain drug sta­bil­i­ty through­out the 3D print­ing man­u­fac­tur­ing process. The oth­er part of the deal will see Tri­astek iden­ti­fy­ing a dosage de­sign that will per­mit the pro­grammed re­lease of drugs in spe­cif­ic parts of the in­tes­tine, to im­prove the bioavail­abil­i­ty of oral­ly ad­min­is­tered drugs.

Tri­astek’s tech­nol­o­gy has ap­pli­ca­tions in both sol­id dosage form de­vel­op­ment and man­u­fac­tur­ing.

Lil­ly did not com­ment on the deal to End­points News.

“We en­vi­sion that the MED tech­nol­o­gy of Tri­astek can be used to solve the chal­lenges in for­mu­la­tions lead­ing to the de­vel­op­ment of clin­i­cal­ly valu­able prod­ucts for our glob­al part­ners,” said Tri­astek CEO Sen­ping Cheng.

WuXi AppTec and its sub­sidiary WuXi STA are stay­ing busy this week.

On Wednes­day, the par­ent com­pa­ny an­nounced a plan to build a new R&D and man­u­fac­tur­ing site in Sin­ga­pore.

The com­pa­ny in­tends to in­vest up to $1.43 bil­lion to con­struct and get the site ful­ly op­er­a­tional. The in­vest­ment is ex­pect­ed to be made in stages over the next 10 years, de­pend­ing on the com­pa­ny’s busi­ness needs.

The new site will be de­signed to ex­pand the com­pa­ny’s man­u­fac­tur­ing ca­pac­i­ty and en­hance its ca­pa­bil­i­ties but no there de­tails have been dis­closed.

“This in­vest­ment will fur­ther en­hance our ca­pac­i­ty and ca­pa­bil­i­ties so we can bet­ter sup­port our col­lab­o­ra­tive part­ners glob­al­ly and re­al­ize our shared vi­sion that every drug can be made, and every dis­ease can be treat­ed,” said WuXi CEO Ge Li in a state­ment.

Once com­plet­ed, the Sin­ga­pore site will al­so serve a role in its glob­al net­work across Asia, Eu­rope, and North Amer­i­ca.

Mary­land-based biotech De­ka Bio­sciences has bro­ken ground on a 14,000-square-foot head­quar­ters to hold its man­u­fac­tur­ing, R&D and process de­vel­op­ment ca­pa­bil­i­ties.

The new build­ing will be in the Wash­ing­ton, DC sub­urb of Ger­man­town, MD. The com­pa­ny is ex­pect­ing to move in around the first quar­ter of next year.

The site will fur­ther de­vel­op its nov­el cy­tokine ther­a­pies.

“Our new fa­cil­i­ty will pro­vide us with es­sen­tial space to ex­pand our re­search, de­vel­op­ment and man­u­fac­tur­ing ef­forts, al­low­ing us to con­tin­ue to suc­cess­ful­ly de­vel­op our Di­akine ther­a­pies, us­ing sin­gle-use tech­nol­o­gy to scale both quick­ly and eco­nom­i­cal­ly,” said De­ka CEO John Mumm, in a state­ment.

Ac­cord­ing to the com­pa­ny, this is al­so the first fa­cil­i­ty to house a dual-tar­get­ed cy­tokine de­vel­op­ment lab in the Wash­ing­ton DC area.

When gene editing exploded onto the scene over three decades ago, it brought previously inconceivable disease treatment and potentially curative therapies into view. Today, gene editing remains one of the most gripping topics in biopharma — and a recent wave of partnerships may move the industry even closer to broad, curative treatment for genetic disease.

Discoveries across the natural environment deriving in vivo and ex vivo biotechnologies have ushered a floodgate of development possibilities. With giants like Bayer, Moderna, Vertex and others signaling that gene editing will be a key driver of their future pipelines, how will the industry leverage this new frontier of genomic technology?

While biosimilars are seeing greater recognition from the federal government, most notably HHS’ Office of the Inspector General highlighting their cost-saving abilities, the inspection of manufacturing sites producing them is still lagging.

Juliana Reed, the executive director for the Biosimilars Forum, told Endpoints News in an interview that 90% of inspections at manufacturing sites for drugs and generics have continued apace, but for biosimilars, the rate has dropped to 67% as these inspections are a lower priority.

The room was packed and electric. That’s how it felt hosting an event in person for Endpoints News readers last month in San Diego.

It exceeded all our expectations, which wasn’t a given, with the pandemic changing the nature of live events. We hadn’t done one in over two years. And Endpoints grew a lot during that time. We quickly built a serious virtual events platform and developed big audiences around those online channels. But there’s nothing quite like being with your colleagues at a live event. Endpoints has a tradition of convening our audience of biopharma pros in major hubs worldwide since our start in 2016. And we’re thrilled to jump right back in.

Amid predictions of HIV advances unraveling during Covid, Gilead Sciences is doubling down on prevention, treatment options and on-the-ground community efforts, even as it awaits an FDA decision on its long-acting candidate.

At the AIDS 2022 conference beginning next week, Gilead will present new data and studies on HIV treatment Biktarvy and its long-acting PrEP and HIV candidate lenacapavir, but will also host a panel laying out the details — and importance — of community collaborations.

Roche CEO Severin Schwan will be moving to the board chairman role in a few months, making room for Thomas Schinecker — the current chief of the diagnostics division — to take the helm of the Swiss pharma conglomerate.

The changeover will take place at the company’s annual general meeting in March as Christoph Franz, chairman since 2014, decided not to seek re-election to the board.

The shuffle at the top comes as Roche has steadily beefed up its early-stage pipeline while vigilantly guarding its position as one of the top drugmakers around the world. By Evaluate’s estimate, it is set to rank second on the list of largest pharmas by 2028, falling just a tad behind AbbVie.

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Spanish heparin and API manufacturer Bioiberica is still not in the clear as far as the FDA is concerned, with a new warning letter related to contamination concerns.

The US regulator initially issued a Form 483 to the Spanish drugmaker’s manufacturing plant in Palafolls, north of Barcelona.

In an FDA inspection between Jan. 31 and Feb. 4 this year, the regulator found several major issues related to cleaning and contamination and a lack of control procedures among other observations. The agency has now issued a warning letter concerning significant deviations in cGMP for active APIs at the facility.

It’s been just over a month since Pfizer announced it was pumping $120 million into its Michigan facility to boost Paxlovid production, and now the Big Pharma is making another major investment in vaccine manufacturing, this time in its facility outside New York City.

According to a report from Bloomberg, Pfizer is looking to sink $470 million into expanding its vaccine research facilities at its location in Pearl River, NY, just 25 miles north of New York City. Pfizer will construct a new building as well as renovate existing facilities on the campus. The total expansion will be 260,000 square feet with an additional 55,000 square feet of lab space. The company is aiming for construction in the first quarter of 2026, the report said.

Scientists have long poked at tumor collagen. In some cases, collagen helped keep a tumor at bay. In others, it protected a tumor from T cells. One 2013 paper even described collagen as a “double-edged sword” when it came to cancer.

In a study published in Cancer Cell today, Raghu Kalluri of the University of Texas MD Anderson Cancer Center and colleagues illustrate how pancreatic cancer cells make their own unique type of collagen — one that not only protects them from the immune system, but also changes the very microbiome of the tumor itself. By drugging this unique cancer collagen, scientists hope to improve the effectiveness of cancer therapies such as checkpoint inhibitors, which is especially important for pancreatic cancers, where checkpoint inhibitors have had middling results.

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Mark Pruzanski spent more than 18 years growing Intercept from a startup to a commercial player looking for a landmark approval treating NASH. But 19 months after he stepped aside from his wounded biotech — after a CRL crushed its initial game plan for NASH — the longtime vet is getting up off the biotech board bench and getting back in the game, once again quarterbacking a startup that has some very familiar grand ambitions.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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