Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Green­Light li­cens­es mR­NA shin­gles vac­cine to Serum In­sti­tute fol­low­ing a $10M in­vest­ment

Green­Light Bio­sciences has come a long way from try­ing to shake up the pes­ti­cides mar­ket.

The Med­ford, MA biotech signed a deal Mon­day with the Serum In­sti­tute of In­dia to de­sign three mR­NA prod­ucts, in­clud­ing a shin­gles vac­cine, for de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion in a num­ber of mar­kets around the world.

Green­Light will re­tain the rights to North Amer­i­ca, Eu­rope, Aus­tralia, New Zealand, Chi­na, Japan and South Ko­rea, while SII will get a tech trans­fer to work in Africa, Latin Amer­i­ca, the Mid­dle East and much of Asia. The deal pig­gy­backs off of a $10 mil­lion in­vest­ment made by Serum Life Sci­ences in No­vem­ber 2021.

Green­Light will re­ceive up­front pay­ments and is el­i­gi­ble for ex­clu­siv­i­ty, de­vel­op­ment mile­stones, and man­u­fac­tur­ing tech­nol­o­gy trans­fer pay­ments. Mean­while, SII will pay for the de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion for each emerg­ing mar­ket, as Green­Light will re­tain a per­cent­age of those prof­its.

“Green­Light’s ap­proach res­onates with our mis­sion to make health­care eq­ui­table for all,” SII CEO Adar Poon­awal­la said in a state­ment. “Mes­sen­ger RNA tech­nol­o­gy will play a key role in re­duc­ing the bur­den of hu­man suf­fer­ing caused by vac­cine-pre­ventable dis­eases across LMICs.”

There is an op­tion to ex­pand the li­cense to two ad­di­tion­al vac­cines or ther­a­pies to be named lat­er, Green­Light said in a re­lease, and the shin­gles vac­cine man­u­fac­tur­ing process will be trans­ferred to the SII fa­cil­i­ty in Pune, In­dia.

The com­pa­ny was found­ed in 2008 to use its mR­NA tech­nol­o­gy most­ly on agri­cul­ture, in­clud­ing hon­ey­bees and crops. Since an Au­gust re­verse-merg­er, the com­pa­ny has been work­ing on a vac­cine for sea­son­al flu and a treat­ment for sick­le cell dis­ease.

It al­so land­ed a $1.5 bil­lion val­u­a­tion, and has pro­posed build­ing sev­en new mR­NA man­u­fac­tur­ing fa­cil­i­ties to bring glob­al ca­pa­bil­i­ties up to snuff. Green­Light’s plat­form com­bines two mR­NA ap­proach­es — one that in­volves fer­men­ta­tion-based process­es and an­oth­er uti­lized by high-pro­file com­pa­nies like Mod­er­na and BioN­Tech in­volv­ing tran­scrip­tion, and that helps pro­duce prod­ucts at a high­er scale in a more af­ford­able man­ner.

In De­cem­ber, Green­Light inked a deal with Sam­sung Bi­o­log­ics to man­u­fac­ture its mR­NA Covid-19 vac­cine com­mer­cial­ly. Right around that same time, SII an­nounced that it would waive its pro­tec­tion from le­gal li­a­bil­i­ties for any As­traZeneca-Ox­ford dos­es it pro­vid­ed to CO­V­AX, in an ef­fort to pro­vide mil­lions of mi­grants with ac­cess to the Covid-19 jab.

Many man­u­fac­tur­ers re­quire pro­tec­tion from any side ef­fects. That is not able to be guar­an­teed if there is no gov­ern­ment, as in a sit­u­a­tion with a non­prof­it al­liance such as Gavi. Asy­lum seek­ers, refugees, de­tainees, and peo­ple who are state­less are all el­i­gi­ble.

SII was found­ed in 1966 with the goal of mak­ing life­sav­ing drugs across the world, and ben­e­fit­ing glob­al health as well.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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