Pramod Yadav, Jubilant Pharma Limited CEO

Ju­bi­lant Hol­lis­ter­Sti­er nets US gov­ern­ment con­tract to in­crease ac­tiv­i­ty at its grow­ing fa­cil­i­ty

A phar­ma­ceu­ti­cal con­tract man­u­fac­tur­er that has been grow­ing its pres­ence in the US has se­cured it­self a siz­able con­tract from the US gov­ern­ment.

Ju­bi­lant Hol­lis­ter­Sti­er, a sub­sidiary of Sin­ga­pore-based Ju­bi­lant Phar­ma Lim­it­ed, has en­tered in­to a co­op­er­a­tive agree­ment for $149.6 mil­lion with the Army Con­tract­ing Com­mand. The deal is al­so in co­or­di­na­tion with the Joint Pro­gram Ex­ec­u­tive Of­fice for Chem­i­cal, Bi­o­log­i­cal, Ra­di­o­log­i­cal and Nu­clear De­fense (JPEO-CBRND) on be­half of BAR­DA.

The ef­fort, which was fund­ed un­der the Amer­i­can Res­cue Plan, will en­able Ju­bi­lant Hol­lis­ter­Sti­er to dou­ble its in­jectable fill­ing pro­duc­tion ca­pac­i­ty at its Spokane, WA man­u­fac­tur­ing fa­cil­i­ty for a to­tal cost of $193 mil­lion. The project is slat­ed for com­ple­tion in 2025, ac­cord­ing to the com­pa­ny.

The com­pa­ny has a his­to­ry of sup­port­ing both HHS and the DOD with biode­fense and med­ical coun­ter­mea­sure pro­grams, in­clud­ing pro­duc­tion for na­tion­al pre­pared­ness ef­forts.

“Ju­bi­lant Hol­lis­ter­Sti­er LLC is com­mit­ted to mak­ing the US phar­ma­ceu­ti­cal sup­ply chain more re­silient with do­mes­tic man­u­fac­tur­ing fa­cil­i­ties and less re­liant on for­eign sup­pli­ers,” Ju­bi­lant Phar­ma CEO Pramod Ya­dav said in a state­ment.

In 2021, Ju­bi­lant sought to ex­pand its ster­ile in­jectable man­u­fac­tur­ing ca­pac­i­ty at its Spokane site to keep up with the de­mand sur­round­ing the Covid-19 vac­cine push. The ini­tial $92 mil­lion in­vest­ment is planned to in­crease man­u­fac­tur­ing ca­pac­i­ty by 50% with the in­clu­sion of 2,300-square-foot lyophiliz­ers and 50,000 square feet of build­ing space. The up­grades will al­low for 400 vials a minute to be filled.

Ear­li­er last year, the com­pa­ny al­so struck a deal with Eli Lil­ly for the man­u­fac­tur­ing of bam­lanivimab at the Spokane plant. How­ev­er, bam­lanivimab’s emer­gency use au­tho­riza­tion was re­voked by the FDA for the treat­ment of Covid-19.

In 2021, the com­pa­ny an­nounced that it had signed on with No­vavax to pro­vide fill-fin­ish ser­vices to its vac­cine can­di­date as well.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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