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.

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

All­Cells, a provider of clin­i­cal-grade and ROU pri­ma­ry cell prod­ucts, has more than 30 years of col­lec­tive cell and gene ther­a­py ex­pe­ri­ence, All­Cells and Dis­cov­ery will fo­cus on pro­vid­ing prod­ucts and ser­vices for cus­tomers in the cell and gene ther­a­py space in­clud­ing ba­sic dis­cov­ery and com­mer­cial­iza­tion.

“We are very ex­cit­ed to wel­come the All­Cells team to the Dis­cov­ery fam­i­ly. Bring­ing these two great com­pa­nies to­geth­er cre­ates a scal­able, end-to-end so­lu­tion that gives our clients un­prece­dent­ed ac­cess to re­li­able hu­man cel­lu­lar start­ing ma­te­ri­als with in­te­grat­ed mul­ti-om­ic an­a­lyt­ic ser­vices to sup­port cell and gene ther­a­pies,” said Dis­cov­ery CEO Glenn Bi­lawsky in a state­ment.

Ac­cord­ing to Dis­cov­ery, they will com­bine its ex­ist­ing CGT prod­ucts and ser­vices with All­Cells to cre­ate a new busi­ness unit dubbed All­Cells, a Dis­cov­ery Life Sci­ences Com­pa­ny. All­Cells CEO and pres­i­dent Dan­ny Zheng will lead the com­bined en­ti­ty.

In an email to End­points News, Dis­cov­ery said the next step for the new en­ti­ty is “busi­ness as usu­al”.

“The dif­fer­ence now is the avail­abil­i­ty of the com­bi­na­tion of Dis­cov­ery and All­Cells’ uni­fied of­fer­ings un­der a sin­gle brand; cre­at­ing a unique ven­dor ca­pa­ble of speed, scale, and flex­i­bil­i­ty that was pre­vi­ous­ly un­avail­able to ac­cel­er­ate cell and gene ther­a­py pro­grams,” the state­ment said.

This marks an­oth­er ac­qui­si­tion for Dis­cov­ery as, in 2021, ac­quired Al­bert Li’s project. Li, who found­ed the he­pa­to­cyte in­ven­to­ry com­pa­ny IVAL in 2004, joined the Dis­cov­ery lead­er­ship team as the CSO of phar­ma­col­o­gy and tox­i­col­o­gy.

Span­ish life sci­ence play­er Agarose Bead Tech­nolo­gies (ABT) is plan­ning a ma­jor ex­pan­sion of its man­u­fac­tur­ing ca­pa­bil­i­ties.

Ac­cord­ing to a re­port from Man­u­fac­tur­ing Chemist, the com­pa­ny is tripling its pro­duc­tion ca­pac­i­ty to meet the de­mand for agarose resins and plans to in­crease its space by 1000 square me­ters.

The com­pa­ny is aim­ing to man­u­fac­ture and de­liv­er a con­tin­u­ous sup­ply of agarose resins to even­tu­al­ly sup­port nov­el ther­a­pies world­wide in­clud­ing the mR­NA-based COVID-19 vac­cines. How­ev­er, the cost and ex­act size were not dis­closed.

ABT will al­so seek to ex­pand its three in­de­pen­dent ware­hous­es lo­cat­ed in the Unit­ed States and Spain as well. The project is set to come on­line in 2023.

W.R. Grace & Co., a spe­cial­ty sil­i­ca and chem­i­cals pro­duc­er, to­day an­nounced it is pro­ceed­ing with an ex­pan­sion of its con­tract de­vel­op­ment and man­u­fac­tur­ing (CD­MO) fa­cil­i­ty in South Haven, MI.

The ex­pan­sion will bring a new 4,000-gal­lon mul­ti-use re­ac­tor train and a new cen­trifuge to fa­cil­i­tate prod­uct iso­la­tion, which aims to en­hance its com­mer­cial ca­pa­bil­i­ties.

The project will bring their South Haven fa­cil­i­ty up to three re­ac­tor trains en­abling its man­u­fac­tur­ing ser­vices busi­ness to sup­port the con­tin­ued growth of small mol­e­cule drug pro­duc­tion in­clud­ing cus­tom APIs, cGMP in­ter­me­di­ates, and gener­ic APIs. The ex­pan­sion is es­ti­mat­ed to be com­plet­ed in Jan­u­ary 2024. The cost and size of the ex­pan­sion were not dis­closed.

The fa­cil­i­ty was ac­quired by Grace in June last year by Albe­mar­le to ex­pand its phar­ma­ceu­ti­cal port­fo­lio.

“Our South Haven ex­pan­sion demon­strates this com­mit­ment and ad­dress­es the in­creased mar­ket de­mand in small mol­e­cule drug sub­stance man­u­fac­tur­ing that has tak­en place year over year in the past decade. An­tic­i­pat­ing the needs of the mar­ket, cou­pled with our ex­per­tise, are key Grace ca­pa­bil­i­ties that work to­geth­er to en­able cus­tomer suc­cess,” said Grace CEO Bob Pa­tel in a state­ment.

Gran­ite Bio, biotech built through Ver­sant Ven­ture’s dis­cov­ery en­gine Ridge­line Dis­cov­ery, and Pro­Bio­Gen have closed on an agree­ment to sup­port the de­vel­op­ment of Gran­ite Bio’s mAb pipeline.

The Swiss biotech’s lead can­di­date is a nov­el mon­o­clon­al an­ti­body for the treat­ment of au­toim­mune and cer­tain can­cer in­di­ca­tions. The deal will see Pro­Bio­Gen start cell line de­vel­op­ment with mul­ti­ple can­di­dates, from which one se­lect­ed can­di­date will fi­nal­ly be fur­ther man­u­fac­tured.

“In ad­di­tion to Pro­Bio­Gen’s proven ex­per­tise in cell line and CMC de­vel­op­ment, it was their pro­pri­etary tech­nolo­gies and flex­i­bil­i­ty that en­abled a tai­lored start of the project and con­vinced us to se­lect Pro­Bio­Gen as a part­ner for our lead can­di­date,” said Alexan­der May­weg, chair­man of the board of Gran­ite Bio in a state­ment.

A not-so-funny thing happened to Novartis’ high-profile bid to take a PD-1 checkpoint out of China and get it approved in the US this year.

After paying BeiGene $650 million for US-plus ex-China commercialization rights for the drug — the latest in a long string of contenders to follow Keytruda and Opdivo — the FDA is deferring action on their application.

And there’s no new timeline on when the agency will make a decision.

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Hello. Good morning. I’m Zachary Brennan, senior editor at Endpoints News. And thank you for joining us virtually at BIO for our panel on decentralized trials. Joining me today, we have Ronan Brown, Senior Vice President of IQVIA, Craig Lipset, founder of Clinical Innovation Partners, and Bari Kowal, senior vice president of Regeneron. I’m excited for today’s discussion and I’m sure you are too, but before we get into it, we have a brief word from Vice President Matt Blume with today’s sponsor, Catalent.

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Hello, and welcome to today’s Fireside Chat. I’m Zachary Brennan, senior editor at Endpoints News and with me today is Ian Thompson, senior vice president of Amgen.

Today we’ll be discussing the evolution of the US biosimilar space, which has seen not only a slow start when we compare to our European counterparts, but also long delays between when certain biosimilars win approval and when they actually launch in the US market. So, first off I wanted to start by welcoming Ian and I also wanted to hear his take on how he’s seen the momentum building around the biosimilar industry in recent years, and maybe why he thinks that is the case that has been building more in recent years.

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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.

The life science industry is no doubt still growing in the US, but research talent is getting more and more difficult to come by, according to the latest report from CBRE on 2021.

The report, titled “Life Science’s Research Talent 2022” noted that the life sciences sector has grown by 79% between 2001-2021, compared with 8% growth for all other occupations in the US.

Graduates in biological and biomedical sciences have totaled more than 163,000 in 2020, double the number just 15 years ago.

The new Ken Burns PBS documentary “Hiding in Plain Sight” was delayed by the Covid pandemic, but the documentary about young people and mental health sponsored by Otsuka and debuting now is more relevant than ever.

Anecdotal and statistical evidence point to a rising mental health crisis among many demographic groups, and particularly among teens and young adults.

HHS and the US Surgeon General issued a rare public health advisory on the worsening mental health of young people late last year. They pointed to national studies showing “alarming increases” in mental health issues even before the pandemic, and exacerbated by pandemic effects on school, social, healthcare and financial issues.

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When Marinus Pharmaceuticals completed its turnaround and finally pushed its sole drug across the FDA finish line, the company noted it would sell the priority review voucher it received for its efforts. On Thursday, Marinus revealed the buyer — and it’s a big name.

Danish pharma Novo Nordisk bought the voucher for $110 million, Marinus said in an SEC filing early Thursday, giving one of its programs a free pass to an accelerated review process. It’s the third voucher Novo has bought since 2014, according to the Endpoints News tally, tied for fourth-most among biopharma companies in that span.

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Hi, good afternoon and welcome to our DIA 2022 panel on FDA Over the Next Five Years. Today, we are joined by Holly Fernandez Lynch from the University of Pennsylvania, Mariana Socal from Johns Hopkins University and Kurt Karst, Director at Hyman, Phelps & McNamara, who also publishes the FDA Law Blog. So thank you all for joining us. As an introduction, I just wanted to mention that every five years, the FDA industry and various stakeholder groups come together and negotiate their user fee deals, which typically means that the FDA has to hit certain review milestones in exchange for more money from industry. And Congress has until the end of September to reauthorize this package of legislation, and if Congress doesn’t meet that deadline, then thousands of medical product reviewers that the FDA would likely be laid off. This year’s deal also includes some new reforms around the accelerated approval pathway and some other interesting details around diversity in clinical trials and other provisions that the Senate and the House have both yet to fully agree on but we will talk about some of those differences right now.

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Hi, good afternoon. Welcome to endpoints DIA 2020. We are joined at this afternoon’s fireside chat with a special guest, Harvard Professor of Medicine, Aaron Kesselheim. If you follow the FDA closely, you’ve probably come across Aaron’s research frequently, but I wanted to begin today’s discussion because I think a lot of the reason we’re talking about accelerated approval reforms and FDA reforms over the next five years are linked to a recently approved drug that has been very controversial, known as Biogen’s Aduhelm, which is a treatment for Alzheimer’s disease.

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

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