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top stories
1. California to manufacture and produce its own insulin as Congress debates $35 monthly cap
2. Struggling biotech sells its API manufacturing arm to narrow its focus
3. Manufacturing roundup: FDA clears the way for more monkeypox vaccines to be released; Discovery Life Science nets acquisition
4. Texas biotech expands R&D and manufacturing capabilities following Catalent partnership
5. German chemicals company to expand its reach into mRNA ingredient production
6. Emergent nets another manufacturing deal, this time for Ridgeback's Ebola treatment
7. Amid global expansion, Samsung Biologics pledges emissions drops in new ESG report
8. Jubilant HollisterStier pumps $77M into Montreal facility to double its capacity
9. Another Indian drug manufacturer hit with a Form 483 over recent observations
10. FDA lifts hold on Greenwich LifeSciences as biotech will forge ahead with immunotherapy drug candidate
more stories
 
Tyler Patchen
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The Golden State’s gambit to bring insulin prices down will include a multi-million investment to manufacture the drug. The investment will be welcome news for both those seeking employment and those looking for better insulin prices. Stay tuned to the manufacturing report for updates on this story and others in the wider manufacturing world.

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Tyler Patchen
News Reporter, Endpoints News
@TPatchenendpts
California Governor Gavin Newsom (AP Photo/Rich Pedroncelli, File)
1
by Tyler Patchen

As the Sen­ate de­bates cap­ping out-of-pock­et in­sulin costs at $35 per month, Cal­i­for­nia is mov­ing for­ward with its plans to take mat­ters in­to its own hands.

Gov. Gavin New­som set aside $100 mil­lion in the state bud­get for the man­u­fac­ture of its in­sulin, with the hopes of mak­ing it more af­ford­able for res­i­dents of the state. Ac­cord­ing to the bud­get, the in­sulin that will even­tu­al­ly be de­vel­oped and man­u­fac­tured will be a low-cost biosim­i­lar in­sulin prod­uct.

New­som re­cent­ly high­light­ed that $50 mil­lion will go to­ward the de­vel­op­ment of low-cost in­sulin prod­ucts, with an ad­di­tion­al $50 mil­lion for a Cal­i­for­nia-based man­u­fac­tur­ing fa­cil­i­ty. The idea is to pro­vide both high-pay­ing jobs and a stronger sup­ply chain for the drug.

The ef­fort is part of New­som’s wider plan for the state to make more of its own pre­scrip­tion drugs.

“Noth­ing epit­o­mizes mar­ket fail­ures, more than the cost of in­sulin. Many Amer­i­cans ex­pe­ri­ence out-of-pock­et costs any­where from $300 to $500 per month for this life-sav­ing drug,” New­som said in a press con­fer­ence. “Cal­i­for­nia is now tak­ing mat­ters in­to our own hands the bud­get I just signed sets aside $100 mil­lion so we can con­tract to make our own in­sulin at a cheap­er price close to at cost and to make it avail­able to all.”

How­ev­er, the state has not pre­sent­ed any specifics on the man­u­fac­tur­ing lo­ca­tion or when work will start.

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Johnson Lau, Athenex CEO (AP Images)
2
by Tyler Patchen

Af­ter a stock plunge in 2021 fol­low­ing a key FDA re­jec­tion, can­cer biotech Athenex crashed in­to pen­ny stock ter­ri­to­ry this year and is now look­ing to sell a piece of it­self to make some cash.

The com­pa­ny has agreed to sell off all its eq­ui­ty in­ter­ests in its Chi­na sub­sidiaries, which are pri­mar­i­ly en­gaged in API man­u­fac­tur­ing, to Ti­He Cap­i­tal (Bei­jing).

The es­ti­mat­ed $19 mil­lion deal will see Athenex re­ceive at least 70% of the pro­ceeds at clos­ing, and the pro­ceeds will be used to pay down ex­ist­ing debt and for gen­er­al op­er­a­tions, the com­pa­ny said. How­ev­er, Athenex and Ti­He al­so plan to en­ter in­to a long-term sup­ply agree­ment for the man­u­fac­ture and sup­ply of cer­tain APIs but were mum on the de­tails.

The deal is sub­ject to cus­tom­ary clos­ing con­di­tions, in­clud­ing ob­tain­ing cer­tain reg­u­la­to­ry ap­provals in Chi­na.

“Fol­low­ing the sale of our Dunkirk fa­cil­i­ty, as well as the sale of our U.S. and Eu­ro­pean tir­ban­ibu­lin roy­al­ty and mile­stone in­ter­ests , the Athenex team con­tin­ues to ex­e­cute on our strat­e­gy to mon­e­tize our non-core as­sets, bol­ster our bal­ance sheet, ex­tend our cash run­way and fo­cus on our po­ten­tial best-in-class NKT cell ther­a­py pro­gram,” said Athenex CEO John­son Lau in a state­ment.

This sell-off comes as the Buf­fa­lo, NY-based biotech has been fac­ing sev­er­al is­sues over the past few years. In 2019, the fir­m's API fa­cil­i­ty in Chongqing, Chi­na had vol­un­tar­i­ly sus­pend­ed pro­duc­tion ac­tiv­i­ties, which had come amidst oth­er ac­ci­dents at chem­i­cal plants ear­li­er that year in cer­tain provinces of Chi­na that led to in­dus­try-wide plant in­spec­tions fo­cused on prod­uct safe­ty.

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3
by Tyler Patchen

While the mon­key­pox virus con­tin­ues to rage across the coun­try, more vac­cines are mak­ing their way to the US.

Ac­cord­ing to a re­port from the AP, thou­sands more dos­es of the mon­key­pox and small­pox vac­cine Jyn­neos, man­u­fac­tured by Bavar­i­an Nordic, are ex­pect­ed to soon be shipped to the US af­ter the FDA said they had com­plet­ed an in­spec­tion of a Den­mark-based man­u­fac­tur­ing plant.

More than 1.1 mil­lion dos­es of the vac­cine pur­chased by the US gov­ern­ment are cur­rent­ly sit­ting in Bavar­i­an Nordic’s fa­cil­i­ty. The com­pa­ny pre­vi­ous­ly said that it need­ed au­tho­riza­tion from an on-site FDA in­spec­tion be­fore it could be shipped state­side.

So far, Bavar­i­an Nordic has shipped 300,000 vac­cine dos­es that were made at a third-par­ty fa­cil­i­ty that had pre­vi­ous­ly been au­tho­rized by the FDA. The US reg­u­la­tor typ­i­cal­ly re­quires in­spec­tions of all vac­cine plants to en­sure there are no safe­ty or steril­i­ty is­sues, pri­or to a vac­cine to hit the mar­ket, al­though the Pfiz­er and Mod­er­na Covid-19 vac­cines were no­table ex­cep­tions as the agency con­duct­ed no new in­spec­tions pri­or to their au­tho­riza­tions.

Bavar­i­an Nordic’s Jyn­neos has been well tout­ed by sev­er­al gov­ern­ments since the mon­key­pox out­break and the com­pa­ny has se­cured sev­er­al con­tracts in­clud­ing a con­tract with Cana­da worth $56 mil­lion as well as with Ger­many and sev­er­al oth­er Eu­ro­pean na­tions.

Dis­cov­ery Life Sci­ence ac­quires cell provider

Al­aba­ma-based Dis­cov­ery Life Sci­ence has net­ted the ac­qui­si­tion of Cal­i­for­nia-based re­search cell provider All­Cells.

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Glenn Mattes, TFF Pharmaceuticals CEO
4
by Tyler Patchen

On­ly months af­ter Texas-based TFF Phar­ma­ceu­ti­cals net­ted a part­ner­ship with Catal­ent, the com­pa­ny is ex­pand­ing its R&D and man­u­fac­tur­ing op­er­a­tions in the cap­i­tal of the Lone Star State, through the lease of a new 3,500-square-foot fa­cil­i­ty.

The new space will be cen­tered on in­creas­ing TFF’s to­tal lab space. The ex­pan­sion adds a ded­i­cat­ed lab for the down­stream pro­cess­ing of prod­ucts cre­at­ed via its thin film freez­ing as the com­pa­ny is look­ing to in­crease its in-house re­search. The ad­di­tion­al lab space will al­low the com­pa­ny to house larg­er equip­ment to scale up its man­u­fac­tur­ing abil­i­ties and pro­duce sup­plies for pre­clin­i­cal stud­ies. TFF plans to take its new space on­line by Au­gust.

TFF al­so plans to ex­pand its prod­uct de­vel­op­ment team in Austin, which will be based at the new fa­cil­i­ty but did not dis­close the num­ber of hands it wants to bring on. The lease arrange­ment was al­so used to fi­nance the fa­cil­i­ty. TFF dis­closed in an email to End­points News that the ex­pan­sion was self-fund­ed, but no hard fig­ure was giv­en.

Ac­cord­ing to the com­pa­ny, the fa­cil­i­ty was pre­vi­ous­ly used as a health­care test­ing lab­o­ra­to­ry and the com­pa­ny has, over the past two to three months, made mod­i­fi­ca­tions to en­able prod­uct de­vel­op­ment and test­ing of their tech­nol­o­gy.

“The Austin fa­cil­i­ty will en­able us to in­crease test­ing ca­pac­i­ty so that we can run a larg­er num­ber of fea­si­bil­i­ty stud­ies, in­clud­ing a fo­cus on bi­o­log­ics where de­mand has con­tin­ued to grow. Ad­di­tion­al­ly, as many of our part­nered pro­grams move to clin­i­cal eval­u­a­tion, the abil­i­ty to scale-up man­u­fac­tur­ing in par­al­lel be­comes mis­sion crit­i­cal,” said John Koleng, TFF’s VP of prod­uct de­vel­op­ment and man­u­fac­tur­ing.

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Rendering of the mRNA competence center at the Wacker Biotech site in Halle (Credit: Wacker Chemie AG)
5
by Tyler Patchen

As the mR­NA field has be­come more pop­u­lar over the past sev­er­al years, thanks in large part to the de­vel­op­ment of cer­tain wild­ly pop­u­lar Covid-19 vac­cines, such as those from Mod­er­na and BioN­Tech, more com­pa­nies are look­ing to sink funds to ac­com­mo­date its pro­duc­tion.

Ger­man chem­i­cal com­pa­ny Wack­er Chemie AG, which has been around since 1914, has been a main­stay in the pro­duc­tion of sil­i­cone-based prod­ucts and oth­er med­i­c­i­nal chem­i­cals, but now its biotech di­vi­sion is look­ing to sink nine fig­ures in­to mR­NA pro­duc­tion.

On Tues­day, the com­pa­ny an­nounced it is in­vest­ing over €100 mil­lion, or over $101 mil­lion, in­to the de­vel­op­ment of the com­pa­ny’s biotech site in Halle, Ger­many in­to a new cen­ter to man­u­fac­ture mR­NA ac­tive in­gre­di­ents.

The pro­duc­tion ca­pac­i­ty at the site will more than triple as part of the ex­pan­sion. Ac­cord­ing to the de­sign firm Exyte, which is the de­sign­er and builder of the project, the site will add a to­tal of 7,400 square me­ters to the gross floor area and 1,600 square me­ters will serve as a clean room. Four new pro­duc­tion lines are to be built, with part of the space be­ing made avail­able to the Ger­man gov­ern­ment for a pro­gram to pre­pare for any fu­ture pan­demics.

“We are hap­py that our ex­per­tise in mak­ing mR­NA vac­cines will con­tribute to the fight against fu­ture pan­demics. The ex­pan­sion of our Halle site will cre­ate ca­pac­i­ty to pre­pare for pan­demics and be­yond,” said Wack­er CEO Chris­t­ian Har­tel.

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Bob Kramer, Emergent BioSolutions CEO
6
by Tyler Patchen

While Covid-19 and mon­key­pox cur­rent­ly dom­i­nate head­lines and so­cial health pri­or­i­ties, gov­ern­ment of­fi­cials aren’t for­get­ting about Ebo­la and its po­ten­tial for se­ri­ous out­breaks.

Emer­gent BioSo­lu­tion inked an agree­ment last week with Ridge­back Bio­ther­a­peu­tics in a col­lab­o­ra­tion to ex­pand the avail­abil­i­ty of Ebo­la treat­ment Eban­ga. Un­der the deal, Emer­gent will be re­spon­si­ble for the man­u­fac­tur­ing, sale and dis­tri­b­u­tion of Eban­ga in the US and Cana­da. Ridge­back Bio for its part will serve as the glob­al part­ner for the drug and en­sure it re­mains avail­able to pa­tients in en­dem­ic coun­tries free of charge through its com­pas­sion­ate use pro­gram.

Fi­nan­cial de­tails and time­line for the ini­tia­tive were not dis­closed.

“This re­la­tion­ship with Ridge­back Bio builds on our strate­gic fo­cus and deep ex­per­tise in de­vel­op­ing and sup­ply­ing med­ical coun­ter­mea­sures against se­ri­ous health threats. Eban­ga is cru­cial in the on­go­ing fight to con­tain Ebo­la and we are ex­cit­ed about the fu­ture of this col­lab­o­ra­tion to cre­ate a health­i­er, more se­cure world,” Emer­gent CEO Bob Kramer said in a press re­lease.

Eban­ga is a mon­o­clon­al an­ti­body sin­gle in­jec­tion de­vel­oped for the treat­ment of Ebo­la by Ridge­back un­der li­cense from the NI­AID. Ridge­back pro­vid­ed the fund­ing and op­er­a­tional sup­port for clin­i­cal test­ing, with ad­di­tion­al fund­ing un­der con­tracts with BAR­DA for late-stage man­u­fac­tur­ing and reg­u­la­to­ry ac­tiv­i­ties.

The drug was ap­proved by the FDA in 2020 and was the sec­ond Ebo­la treat­ment to gain US ap­proval. Re­gen­eron’s an­ti­body cock­tail was first, get­ting an FDA nod in Oc­to­ber 2020 and cho­sen by BAR­DA for the na­tion­al stock­pile in case of an out­break.

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John Rim, Samsung Biologics CEO
7
by Tyler Patchen

As the biotech man­u­fac­tur­ing arm of one of Ko­rea’s largest con­glom­er­ates is aim­ing to rapid­ly ex­pand its glob­al pres­ence af­ter a large in­vest­ment by its par­ent, Sam­sung Bi­o­log­ics is al­so keep­ing a close eye on en­vi­ron­men­tal, so­cial and gov­er­nance (ESG) goals.

Its sec­ond ESG re­port breaks down the com­pa­ny’s goals for re­new­able en­er­gy in fu­ture projects as well as a big­ger com­mit­ment to re­duce emis­sions.

The re­port lays out progress in re­duc­ing both di­rect and in­di­rect emis­sions and dou­bles down on its com­mit­ment to drop the to­tal by 54% by 2026 com­pared to 2021. That comes on top of a 32% re­duc­tion year over year. Sam­sung Bi­o­log­ics al­so said it would cut "oth­er" emis­sions such as in­di­rect green­house gas­es from trans­porta­tion and dis­tri­b­u­tion by about 26% by 2026.

The com­pa­ny is al­so ac­tive­ly work­ing with sup­pli­ers to tran­si­tion to net ze­ro emis­sions as well as in­vest in re­new­able en­er­gy.

CEO John Rim told End­points News in an email that along with the emis­sions drops, the big change since the last re­port is that the com­pa­ny is now par­tic­i­pat­ing in a se­ries of cli­mate change-re­lat­ed ini­tia­tives. That in­cludes the com­pa­ny's in­volve­ment in the Sus­tain­able Mar­kets Ini­tia­tive, which was launched by the roy­al fam­i­ly in the UK to re­duce emis­sions in the sup­ply chain. Sam­sung al­so plans to par­tic­i­pate in a cli­mate risk man­age­ment mod­el­ing project by Fi­nan­cial Su­per­vi­so­ry Ser­vice, called Fron­tier 1.5D, and the Car­bon Dis­clo­sure Pro­ject where it cur­rent­ly holds a B rat­ing.

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Pramod Yadav, Jubilant Pharma Limited CEO
8
by Tyler Patchen

Fresh off net­ting a con­tract from the US gov­ern­ment for its fa­cil­i­ty in Wash­ing­ton, CD­MO Ju­bi­lant Hol­lis­ter­Sti­er is look­ing north of the bor­der for its next move.

The com­pa­ny, a sub­sidiary of Sin­ga­pore-based Ju­bi­lant Phar­ma Lim­it­ed, has se­cured a deal with the Gov­ern­ment of Quebe to spend $77 mil­lion to ex­pand the ca­pac­i­ty at its fa­cil­i­ty in Mon­tre­al. In­vestisse­ment Que­bec grant­ed a $19.2 mil­lion loan to help with the ex­pan­sion ef­forts.

Ac­cord­ing to Ju­bi­lant, the in­vest­ment will seek to mod­ern­ize and more than dou­ble the site's drug pro­duc­tion ca­pac­i­ty but did not spec­i­fy by how much.

Ju­bi­lant will al­so look to ac­quire new equip­ment and out­fit the plant with a sin­gle-use ster­ile prepa­ra­tion room to max­i­mize its fill­ing process in the pro­duc­tion of liq­uid ster­ile prod­ucts. The fa­cil­i­ty al­so has an ar­ray of non-ster­ile man­u­fac­tur­ing ser­vices pro­duc­ing oint­ments, creams, gels and oth­er liq­uid prod­ucts.

CEO Pramod Ya­dav said in a state­ment, "Ju­bi­lant is ex­cit­ed to be cho­sen as a part of the eco-sys­tem be­ing de­vel­oped by Cana­da to make it self-de­pen­dent for its fu­ture needs of vac­cines and treat­ments in case of a pan­dem­ic. This fund­ing will en­able our con­tin­ued ef­fort to ex­pand our ca­pa­bil­i­ties in Cana­da and cre­ate more jobs."

In May, the com­pa­ny al­so en­tered in­to a co­op­er­a­tive agree­ment for $149.6 mil­lion with the Army Con­tract­ing Com­mand, to en­able Ju­bi­lant to dou­ble its in­jectable fill­ing pro­duc­tion ca­pac­i­ty at its Spokane, WA man­u­fac­tur­ing fa­cil­i­ty for a to­tal cost of $193 mil­lion. That project is slat­ed for com­ple­tion in 2025.

9
by Tyler Patchen

Sev­er­al In­di­an drug man­u­fac­tur­ers have been put un­der a mi­cro­scope by the FDA, as ma­jor gener­ics man­u­fac­tur­ers have been hit in re­cent months by Form 483s. And now Dr. Red­dy’s Lab­o­ra­to­ries is the lat­est to get the slap.

Ac­cord­ing to the In­di­an busi­ness news site Busi­ness Stan­dard, Dr. Red­dy’s Lab­o­ra­to­ries was served a Form 483. The form high­light­ed two ob­ser­va­tions af­ter in­spect­ing its man­u­fac­tur­ing fa­cil­i­ty lo­cat­ed at Srikaku­lam, In­dia, a city in the east.

The reg­u­la­to­ry fil­ing not­ed that the fa­cil­i­ty in ques­tion is Dr. Red­dy’s for­mu­la­tion fa­cil­i­ty dubbed FTO 11. How­ev­er, the specifics of what was ob­served have not been re­leased. The in­spec­tion it­self was con­duct­ed from June 30 to Ju­ly 7 of this year.

Dr. Red­dy’s Lab­o­ra­to­ries site in Srikaku­lam has not es­caped the gaze of the FDA in the past. The site was hit with 483’s in 2014 and 2017, with the com­pa­ny re­ceiv­ing 14 pri­or Form 483s since 2017.

The re­sult of the 483 is not great for the in­vest­ment line for Dr. Red­dy’s as they have seen their stock price drop 14% since Jan­u­ary.

How­ev­er, Dr. Red­dy’s is not the on­ly In­di­an com­pa­ny that is man­ag­ing to rack up a high num­ber of in­spec­tions and ob­ser­va­tions. Sun Phar­ma’s plant in Halol, In­dia re­ceived sev­er­al stark ob­ser­va­tions from the FDA in­clud­ing de­fi­cient pro­ce­dures to pre­vent mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion of drugs, as well as de­fi­cient asep­tic pro­cess­ing ar­eas for mon­i­tor­ing en­vi­ron­men­tal con­di­tions and equip­ment and uten­sils not be­ing cleaned or san­i­tized at ap­pro­pri­ate in­ter­vals, among oth­ers.

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10
by Tyler Patchen

While the bear mar­ket still has its hold over the biotech sec­tor, Green­wich Life­Sciences is wel­com­ing the lat­est news from the FDA.

The biotech an­nounced Tues­day that the FDA has re­moved the clin­i­cal hold on a Phase III tri­al for GLSI-100, an im­munother­a­py in HLA-A*02 pos­i­tive and HER2/neu pro­tein pos­i­tive sub­jects who are at el­e­vat­ed risk for breast can­cer re­cur­rence. With the hold lift­ed, reg­u­la­tors are al­low­ing the piv­otal tri­al, dubbed Flamin­go-01, to pro­ceed.

In­vestors jumped at the news, send­ing Green­wich shares GLSI up more than 50% in ear­ly Tues­day trad­ing.

The tri­al is for pa­tients who have com­plet­ed both neoad­ju­vant and post­op­er­a­tive ad­ju­vant stan­dard of care ther­a­py. Ac­cord­ing to clin­i­cal­tri­als.gov, 598 par­tic­i­pants have tak­en part in Green­wich’s tri­als.

The com­pa­ny said in a state­ment that the Phase III tri­al was placed on hold due to the man­u­fac­tur­ing and phar­ma­cy process, al­though no specifics were giv­en. As part of the tri­al's re­sump­tion, Green­wich will in­cor­po­rate ad­di­tion­al test­ing of GP2 in the phar­ma­cy process.

Ac­cord­ing to Green­wich's first quar­ter re­port to the SEC, the com­pa­ny had com­plet­ed the last steps of man­u­fac­tur­ing GP2 and re­leased three clin­i­cal lots of drug prod­uct be­lieved to have met all re­lease spec­i­fi­ca­tions. The biotech was await­ing FDA re­view of the man­u­fac­tur­ing da­ta.

How­ev­er, Green­wich said the FDA had pre­vi­ous­ly asked the com­pa­ny in­for­mal­ly to de­lay the Phase III tri­al un­til it had sub­mit­ted up­dat­ed man­u­fac­tur­ing in­for­ma­tion, as that da­ta pack­age was in­com­plete with some lots still be­ing test­ed for the first time. The FDA then im­posed the hold to halt the tri­al's launch un­til Green­wich pro­vid­ed such in­for­ma­tion.

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