Re­pub­li­can lead­ers of the House Com­mit­tee on En­er­gy & Com­merce sent a five-page let­ter yes­ter­day an­nounc­ing an in­ves­ti­ga­tion in­to the on­go­ing drug short­ages that have ran­kled the US dur­ing the pan­dem­ic and the FDA's re­sponse to it.

The let­ter, signed by Chair Cathy Mc­Mor­ris Rodgers (R-WA), ex­plains how short­ages have be­come more com­mon over the past decade, while point­ing to a re­port from the Na­tion­al Acad­e­mies of Sci­ence, En­gi­neer­ing and Med­i­cine find­ing that drug short­ages have been "on the rise" over the past sev­er­al decades and are last­ing longer, with new drug short­ages in the US see­ing a 30% in­crease from 2021 to 2022.

How­ev­er, the com­mit­tee’s let­ter writes that it is “not clear” that the FDA is us­ing some of its ex­ist­ing au­thor­i­ties to mit­i­gate the short­ages.

The let­ter points to the CARES Act pro­vi­sion that re­quired man­u­fac­tur­ers to re­port the vol­ume of each drug pro­duced, pre­pared or processed for dis­tri­b­u­tion on an an­nu­al ba­sis and where ac­tive in­gre­di­ents and fin­ished dos­es were made -- help­ing to pin­point where the vast ma­jor­i­ty of the drugs are made.

“It is not clear to this Com­mit­tee what the FDA has done with the new da­ta. To date, the FDA has not pub­licly re­leased any sum­ma­ry of these re­ports in an ag­gre­gat­ed way that may in­form pol­i­cy mak­ers and pro­vide the da­ta Con­gress and oth­ers need as we ex­am­ine ways to make sure the sup­ply chain for drugs Amer­i­cans need is se­cure,” the let­ter says.

The US phar­ma gi­ant Eli Lil­ly will be in­creas­ing its fi­nan­cial com­mit­ment to a man­u­fac­tur­ing site in Ire­land.

Ac­cord­ing to a re­lease from Ire­land’s In­dus­tri­al De­vel­op­ment Agency (IDA) on Mon­day, Lil­ly will be in­vest­ing an­oth­er $500 mil­lion in its man­u­fac­tur­ing fa­cil­i­ty in Lim­er­ick, Ire­land — bring­ing the to­tal in­vest­ment in­to the fa­cil­i­ty to ap­prox­i­mate­ly $1 bil­lion.

In Jan­u­ary of last year, Lil­ly an­nounced it was plac­ing a $446 mil­lion in­vest­ment in­to the site to ex­pand ac­tive phar­ma­ceu­ti­cal in­gre­di­ent and mon­o­clon­al an­ti­body pro­duc­tion.

The IDA wrote that con­struc­tion on the 500,000-square-foot fa­cil­i­ty is cur­rent­ly un­der­way and will cre­ate over 300 jobs in the sci­ence, en­gi­neer­ing and op­er­a­tions fields. How­ev­er, no oth­er in­for­ma­tion was im­me­di­ate­ly avail­able on the ex­pan­sion of the in­vest­ment.

End­points News reached out to Lil­ly and IDA Ire­land, but did not get a re­sponse by press time.

Lil­ly has had a pres­ence on the Emer­ald Isle since 1978, and cur­rent­ly has over 2,700 em­ploy­ees in Coun­ty Cork where it main­tains a man­u­fac­tur­ing fa­cil­i­ty — as well as an­oth­er fa­cil­i­ty in the city of Lit­tle Is­land.

"The news demon­strates their com­mit­ment to Ire­land and high­lights the wealth of tal­ent we have to of­fer. The com­pa­ny pro­duces key health­care prod­ucts which are aid­ing in the fight against a va­ri­ety of the world’s most se­ri­ous ill­ness­es," said Si­mon Coveney, Ire­land's min­is­ter for En­ter­prise, Trade and Em­ploy­ment, in the re­lease.

That is not the on­ly ma­jor in­vest­ment that Lil­ly is mak­ing in its man­u­fac­tur­ing ca­pa­bil­i­ties. Last year, Lil­ly an­nounced a $2.1 bil­lion in­vest­ment in­to two man­u­fac­tur­ing sites close to home in Lebanon, IN. These new fa­cil­i­ties will pro­duce APIs and ge­net­ic med­i­cines. Lil­ly al­so an­nounced a $450 mil­lion in­vest­ment in­to its fa­cil­i­ty in North Car­oli­na in Jan­u­ary of this year.

The mR­NA play­er Mod­er­na is fur­ther ce­ment­ing its pres­ence on the African con­ti­nent.

Mod­er­na an­nounced on Thurs­day that it has fi­nal­ized an agree­ment with Kenya’s gov­ern­ment to part­ner up and bring an mR­NA man­u­fac­tur­ing fa­cil­i­ty to the east African na­tion. The new fa­cil­i­ty aims to man­u­fac­ture up to 500 mil­lion dos­es of vac­cines an­nu­al­ly. Mod­er­na al­so said the new fa­cil­i­ty will have the abil­i­ty to spike its pro­duc­tion ca­pa­bil­i­ties to re­spond to pub­lic health emer­gen­cies on the con­ti­nent or glob­al­ly.

Ac­cord­ing to a Mod­er­na spokesper­son, it ze­roed in on Kenya for the new fa­cil­i­ty due to the coun­try hav­ing a “dy­nam­ic econ­o­my” and be­ing a grow­ing busi­ness and trans­porta­tion hub. Mod­er­na al­so an­nounced that it will op­er­ate in the coun­try un­der Spe­cial Eco­nom­ic Zone sta­tus.

How­ev­er, no fur­ther de­tails on the lo­ca­tion of the fa­cil­i­ty, the job num­bers or the time­line for con­struc­tion were giv­en by Mod­er­na.

“Our goal is to build an im­por­tant, long-term pres­ence in the coun­try,” the spokesper­son said to End­points News in an email.

When the mem­o­ran­dum of un­der­stand­ing was signed last year, Mod­er­na stat­ed it would in­vest $500 mil­lion in­to the new site.

"The fi­nal­iza­tion of our agree­ment with the Gov­ern­ment of the Re­pub­lic of Kenya is a key pil­lar of our glob­al pub­lic health strat­e­gy, where we hope to bring mR­NA in­no­va­tion to the peo­ple of Africa in ar­eas of high un­met need, such as acute res­pi­ra­to­ry in­fec­tions, as well as per­sis­tent in­fec­tious dis­eases like HIV and out­break threats such as Zi­ka and Ebo­la," Mod­er­na CEO Stéphane Ban­cel said in a state­ment.

Last year, South African-based vac­cine man­u­fac­tur­er As­pen Phar­ma­care was fac­ing re­ports that it had not re­ceived a sin­gle or­der for its man­u­fac­tured Covid-19 shots and that man­u­fac­tur­ing lines were sit­ting idle. But now the vac­cine pro­duc­er is look­ing to turn things around.

As­pen’s dis­clo­sure of its fi­nan­cial re­sults in March un­veiled that man­u­fac­tur­ing rev­enue had de­creased by 12% to R 603 mil­lion ($33.8 mil­lion), which Lor­raine Hill, As­pen Group’s COO, said is at­trib­ut­able to low­er Covid vac­cine sales.

How­ev­er, things were not all neg­a­tive as As­pen said it was in ne­go­ti­a­tions with cus­tomers seek­ing to "se­cure a por­tion of As­pen's ster­ile man­u­fac­tur­ing ca­pa­bil­i­ties."

As­pen CEO Steven Saad said in a re­lease:

As­pen had ini­tial­ly in­vest­ed in three ster­ile man­u­fac­tur­ing lines at its pro­duc­tion site in Gqe­ber­ha, South Africa, and had plans to in­vest in two more pro­duc­tion lines. The in­ten­tion was to tran­si­tion the man­u­fac­tur­ing of its own anes­thet­ic prod­ucts from third-par­ty pro­duc­ers to en­hance the sup­ply, Hill told End­points News in an email.

“The COVID pan­dem­ic, how­ev­er, fast-tracked our plans to man­u­fac­ture vac­cines as we piv­ot­ed and re-pri­or­i­tized in-hous­ing our anes­thet­ic prod­ucts to man­u­fac­ture the COVID vac­cine,” Hill said.

Ther­mo Fish­er Sci­en­tif­ic is putting down more roots in the Bay Area.

The man­u­fac­tur­er opened the doors to a new cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty next to the Uni­ver­si­ty of Cal­i­for­nia-San Fran­cis­co Med­ical Cen­ter’s Mis­sion Bay cam­pus and on the uni­ver­si­ty's cam­pus.

UCSF and Ther­mo Fish­er have had a part­ner­ship since 2021, with the new site fo­cus­ing on man­u­fac­tur­ing cell ther­a­peu­tics for cer­tain can­cers, in­clud­ing glioblas­toma and mul­ti­ple myelo­ma. The new site plans to use Ther­mo Fish­er’s ex­per­tise in man­u­fac­tur­ing ser­vices to help UCSF ac­cel­er­ate the de­vel­op­ment of cell ther­a­pies and even­tu­al­ly get them in­to the clin­ic, said Dan Her­ring, the gen­er­al man­ag­er of cell ther­a­py ser­vices at Ther­mo Fish­er, in an in­ter­view with End­points News.

“CAR-T cell ther­a­pies are mov­ing ear­li­er and ear­li­er. They're late-stage right now, but we want to be part of the team that is dri­ving them to be more pro­lif­ic at the ear­li­er treat­ment op­tions,” Her­ring said.

The fa­cil­i­ty is 44,000 square feet and con­tains six man­u­fac­tur­ing suites which are now up and run­ning. Her­ring said the build­ing is a for­mer plumb­ing parts ware­house and man­u­fac­tur­ing build­ing that UCSF ac­quired. It was con­vert­ed to a cell ther­a­py man­u­fac­tur­ing site by Ther­mo Fish­er.

There's al­so room to build six more suites, Her­ring said, adding that the site can make au­tol­o­gous and al­lo­gene­ic cell ther­a­pies and will have an­a­lyt­i­cal de­vel­op­ment as well as the stan­dard man­u­fac­tur­ing process­es and the abil­i­ty for tech trans­fers. He did not con­firm head­count or cost of the fa­cil­i­ty to End­points.

Catal­ent will be man­u­fac­tur­ing a low-cost ver­sion of the opi­oid over­dose treat­ment nalox­one as part of a con­tract with Harm Re­duc­tion Ther­a­peu­tics.

Catal­ent plans to man­u­fac­ture the treat­ment at its fa­cil­i­ty in Mor­risville, NC. No fi­nan­cial de­tails on the deal were dis­closed.

Harm Re­duc­tion was grant­ed pri­or­i­ty re­view sta­tus for the NDA on its spray last year. The com­pa­ny has been work­ing on a nalox­one prod­uct since 2017. It is an­tic­i­pat­ing ap­proval in Ju­ly of this year and a US launch in ear­ly 2024.

“This agree­ment marks a ma­jor mile­stone for Harm Re­duc­tion Ther­a­peu­tics and is al­so a sig­nif­i­cant step for­ward in tack­ling a ma­jor pub­lic health is­sue in this coun­try,” said Car­la Vo­zone, VP of in­hala­tion strat­e­gy at Catal­ent, in a re­lease.

CSL is open­ing a new 140,000-square-foot R&D cen­ter in Waltham, MA.

The new site will in­clude 54,000 square feet of lab space and will serve as the hub for CSL’s cur­rent and fu­ture vac­cine de­sign.

CSL al­ready has sev­er­al lo­ca­tions across the US as well as Aus­tralia, Ger­many, the Nether­lands and Switzer­land.

An In­di­an-based man­u­fac­tur­er of cough syrup, Mar­i­on Biotech which had al­leged­ly led to deaths in Uzbek­istan, had its li­cense re­voked by the lo­cal gov­ern­ment.

Ac­cord­ing to a re­port from the BBC, au­thor­i­ties in the In­di­an state of Ut­tar Pradesh can­celed the li­cense of Mar­i­on Biotech, stop­ping it from fur­ther man­u­fac­tur­ing ac­tiv­i­ties.

Liv­er­pool may be known for rock and roll and pre­mier league foot­ball, but the Chi­na-based con­tract man­u­fac­tur­er Phar­maron is look­ing to make it a big­ger hub for cell and gene ther­a­py man­u­fac­tur­ing.

As part of Phar­maron’s fur­ther com­mit­ment to Mersey­side coun­ty, it plans to build an 8,000-square-me­ter fa­cil­i­ty, or around 86,000 square feet, which in­cludes a boost to the man­u­fac­tur­ing ca­pac­i­ty of 3,500 square me­ters, or 37,600 square feet. The price tag for the ex­pan­sion will be £151 mil­lion ($186 mil­lion), with Phar­maron re­ceiv­ing a grant from the UK Gov­ern­ment’s Life Sci­ences In­no­va­tion Man­u­fac­tur­ing Fund (LSIMF).

The ma­jor­i­ty of the fund­ing comes from Phar­maron, but a "sig­nif­i­cant pro­por­tion" is from the UK gov­ern­ment via the grant, said Derek El­li­son, VP of bi­o­log­ics ser­vices, Eu­rope at Phar­maron, in an email to End­points News. Con­struc­tion start­ed in Jan­u­ary of this year and is slat­ed to be com­plet­ed some­time in 2024.

The project will boost the process and de­vel­op­ment ca­pac­i­ty in Liv­er­pool “4-fold,” El­li­son said. The fa­cil­i­ty cur­rent­ly man­u­fac­tures plas­mid DNA and vi­ral vec­tors for vac­cines as well as cell and gene ther­a­pies. The ex­pan­sion, ac­cord­ing to El­li­son, will al­low 12 prod­ucts to be de­vel­oped at the same time. The site cur­rent­ly has 185 em­ploy­ees, and 174 more jobs are ex­pect­ed to be cre­at­ed on the back of the ex­pan­sion.

Phar­maron pur­chased the Liv­er­pool site from Ab­b­Vie in 2021 for around $118 mil­lion. The site has been in op­er­a­tion since 2007 and was ini­tial­ly op­er­at­ed by Al­ler­gan be­fore the merg­er be­tween it and Ab­b­Vie.

The gov­ern­ment of the Unit­ed King­dom is giv­ing out grants to sev­er­al man­u­fac­tur­ers that have a pres­ence in Eng­land, Wales and North­ern Ire­land.

The gov­ern­ment an­nounced that four com­pa­nies, in­clud­ing Ipsen, con­tract man­u­fac­tur­er Phar­maron, DNA man­u­fac­tur­er Touch­light and di­ag­nos­tic test pro­duc­er Ran­dox, will re­ceive a to­tal of £277 mil­lion ($341.1 mil­lion). Ac­cord­ing to a re­lease from the UK gov­ern­ment, this rep­re­sents the first por­tion of grants from the Life Sci­ences In­no­v­a­tive Man­u­fac­tur­ing Fund.

The UK gov­ern­ment has put £17 mil­lion ($20.9 mil­lion) in­to the fund, with the oth­er £260 mil­lion ($320 mil­lion) com­ing from pri­vate in­vest­ment. The idea is to back com­pa­nies that are in­vest­ing in man­u­fac­tur­ing projects in the UK that can help grow the econ­o­my.

“This is an im­por­tant step to­wards strength­en­ing the UK’s long-term man­u­fac­tur­ing ca­pa­bil­i­ty while sup­port­ing the de­vel­op­ment of in­no­v­a­tive tech­nolo­gies and ground break­ing med­i­cines,” Min­is­ter of State for Health Will Quince said in a re­lease.

For the phys­i­cal de­ploy­ment of the funds, Ipsen will have £75 mil­lion ($99.2 mil­lion) to­tal to ex­pand its ca­pa­bil­i­ties at its man­u­fac­tur­ing site in Wrex­ham, Wales and to cre­ate around 39 new jobs. The phar­ma re­ceived £2.7 mil­lion ($3.3 mil­lion) from the gov­ern­ment fund while it will cov­er the rest.    Ipsen's fa­cil­i­ty in Wrex­ham con­ducts R&D and man­u­fac­tur­ing for med­i­cines for neu­ro­log­i­cal con­di­tions. The funds specif­i­cal­ly will be used for a new fa­cil­i­ty, said Guy Oliv­er, gen­er­al man­ag­er for Ipsen UK and Ire­land, in an email to End­points News.

Oliv­er added the in­vest­ment in Wrex­ham has been made de­spite an “in­creas­ing­ly chal­leng­ing en­vi­ron­ment” that the UK mar­ket is hav­ing in the phar­ma in­dus­try:

A hand­ful of CD­MOs have made changes at the top over the past few weeks, in­clud­ing Genezen and Cu­ria.

That al­so in­cludes Aus­tralian CD­MO BioCi­na, which an­nounced last week that Mark Wom­ack would be tak­ing the helm. Wom­ack pre­vi­ous­ly served as chief busi­ness of­fi­cer at AGC Bi­o­log­ics, CEO of In­di­an man­u­fac­tur­er Stelis Bio­phar­ma and most re­cent­ly, CEO at CD­MO KBI Bio­phar­ma and Se­lex­is SA.

BioCi­na com­plet­ed the takeover of a Pfiz­er man­u­fac­tur­ing fa­cil­i­ty in Ade­laide in 2021 and is now prep­ping for wider growth. End­points News sat down with Wom­ack to dis­cuss his new role, plans for the fu­ture, and how to com­pete in the wider CD­MO mar­ket. This in­ter­view has been edit­ed for brevi­ty and clar­i­ty.

End­points: What made you want to take the CEO role at BioCi­na?

Wom­ack: The most sat­is­fy­ing thing in my ca­reer to­day was be­ing able to help build out AGC Bi­o­log­ics from what be­gan as CMC Bi­o­log­ics. And then ul­ti­mate­ly, three CD­MOs we com­bined to cre­ate AGC Bi­o­log­ics and then make that a ma­jor glob­al play­er in the in­dus­try... To take the scale of what CMC was at one point and then ul­ti­mate­ly build out to AGC Bi­o­log­ics, which again in­clud­ed a cou­ple of oth­er small CM­DOs and then re­al­ly build some­thing great on the glob­al stage of the in­dus­try was ex­hil­a­rat­ing and was in­cred­i­bly sat­is­fy­ing. And that's the op­por­tu­ni­ty here, and to do it even bet­ter from every­thing learned.

Or­der­ing and procur­ing sup­plies and ma­te­ri­als for re­searchers and pro­duc­ers in the life sci­ences in­dus­try is an im­por­tant step, but it can be a com­plex process to nav­i­gate. It can be filled with in­ef­fi­cien­cy, but one start­up is look­ing to im­prove the process.

Lab­vi­va, a Mass­a­chu­setts-based start­up, is a dig­i­tal mar­ket­place that aims to pro­vide a user-friend­ly plat­form for or­ga­ni­za­tions in the life sci­ences field. The site com­bines AI with pro­cure­ment sys­tems such as SAP Ari­ba and Mi­crosoft Dy­nam­ics 365 to al­low buy­ers, main­ly large re­search or­ga­ni­za­tions or in­sti­tu­tions, to con­nect with ma­jor sup­pli­ers such as Ther­mo Fish­er Sci­en­tif­ic or Sar­to­rius. The Se­ries A an­nounced Mon­day is worth $20 mil­lion.

The site aims to en­sure cus­tomers are not at the mer­cy of one sup­pli­er and can see of­fers from mul­ti­ple sup­pli­ers, Lab­vi­va CEO and co-founder Sia­mak Ba­har­loo said in an in­ter­view with End­points News.

Lab­vi­va start­ed with Ba­har­loo and his co­founder Nicholas Ri­oux in 2017 over a few beers and the de­sire to dis­rupt the pro­cure­ment in­dus­try.

"We thought that we could bring a lot more ef­fi­cien­cy in­to that process, lever­ag­ing tech­nol­o­gy, but al­so re­al­ly have a plat­form that al­lows those large buy­ers to be able to bet­ter man­age their pur­chas­ing and pro­cure­ment," Ba­har­loo said.

Ba­har­loo said the $20 mil­lion in­vest­ment will go to­ward adding ad­di­tion­al func­tions to the plat­form and scal­ing up the com­pa­ny in the US and Eu­rope. Lab­vi­va cur­rent­ly has 40 em­ploy­ees but will ex­pand to 70 by the end of the year.

Bio­phar­ma man­u­fac­tur­er Re­silience has net­ted a ma­jor in­vest­ment from the US De­part­ment of De­fense.

Re­silience inked a fi­nanc­ing agree­ment for a $410 mil­lion long-term loan from the DOD, work­ing with the US In­ter­na­tion­al De­vel­op­ment Fi­nance Cor­po­ra­tion. The loan will be used to bol­ster Re­silience's do­mes­tic bio­man­u­fac­tur­ing ca­pac­i­ty and ca­pa­bil­i­ties for sev­er­al prod­ucts, ac­cord­ing to a press re­lease. This in­cludes bi­o­log­ics such as an­ti­bod­ies, pro­teins, vac­cines and mR­NA prod­ucts.

In ad­di­tion to boost­ing the US sup­ply chain for vac­cines and med­i­cines, the cash in­fu­sion will al­so help Re­silience se­cure enough man­u­fac­tur­ing room in case of a fu­ture pan­dem­ic. The fi­nanc­ing was se­cured through the De­fense Pro­duc­tion Act Loan Pro­gram, af­ter Re­silience en­tered dis­cus­sions with the US gov­ern­ment in late 2020 and re­ceived a com­mit­ment let­ter in March 2022, said Re­silience CEO Rahul Singhvi in an email to End­points News.

The loan is “long-term," Singhvi said, adding that the low in­ter­est rate will help strength­en Re­silience’s fi­nan­cial out­look.

The fund­ing is meant to go be­yond any one dis­ease and boost "ca­pa­bil­i­ties for bi­o­log­ics, vac­cines, and nu­cle­ic acids – ther­a­peu­tic modal­i­ties and med­ical coun­ter­mea­sures which have the po­ten­tial to sup­port a broad range of dis­ease in­di­ca­tions," he said.

With the fund­ing in­flux, Re­silience says it will be able to man­u­fac­ture around a bil­lion dos­es of vac­cines with­in its net­work.

The last ma­jor in­vest­ment Re­silience re­ceived came last year when it roped in a $625 mil­lion Se­ries D which put its to­tal pri­vate eq­ui­ty fund­ing north of $2 bil­lion since 2020.

Brii Bio­sciences said it will stop man­u­fac­tur­ing its Covid-19 an­ti­body com­bi­na­tion, sold in Chi­na, and is work­ing to with­draw its emer­gency use au­tho­riza­tion re­quest in the US, which it start­ed in Oc­to­ber 2021.

The Bei­jing and North Car­oli­na biotech com­mer­cial­ly launched the treat­ment in Chi­na last Ju­ly but is now ax­ing the work and re­vert­ing re­sources to oth­er “high-pri­or­i­ty pro­grams,” per a Fri­day up­date. The fo­cus now is name­ly he­pati­tis B vi­ral in­fec­tion, post­par­tum de­pres­sion and ma­jor de­pres­sive dis­or­ders.

“Con­stant­ly evolv­ing” Covid-19 up­dates, as well as the May ex­pi­ra­tion of the US’ pub­lic health emer­gency, are spelling an end to Brii’s pan­dem­ic pro­gram. The biotech al­so cit­ed “pro­tract­ed reg­u­la­to­ry in­spec­tions” of its con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion sites as rea­son­ing for flash­ing the red light.

With that, Brii is al­so work­ing to with­draw its bi­o­log­ics li­cense ap­pli­ca­tion with Chi­na’s med­ical prod­ucts reg­u­la­tor in the third quar­ter. The drug­mak­er said it has sold “sub­stan­tial­ly all avail­able prod­ucts of the amubarvimab/rom­lu­se­vimab com­bi­na­tion,” since launch­ing it com­mer­cial­ly last sum­mer. Pri­or to that com­mer­cial roll­out in 358 hos­pi­tals, Brii had do­nat­ed about 3,000 dos­es for emer­gency use at 22 hos­pi­tals in Chi­na.

Rev­enue for the prod­uct was about 51.6 mil­lion RMB, or $7.5 mil­lion, Brii said, not­ing it does not ex­pect sig­nif­i­cant rev­enue from the pro­gram go­ing for­ward.

Chi­na ap­proved the mon­o­clon­al an­ti­body, pre­vi­ous­ly known as BRII-196/BRII-198, in De­cem­ber 2021. Ear­li­er that year, Brii’s cock­tail did not work in hos­pi­tal­ized pa­tients and was pulled from an NIH-spon­sored tri­al, which al­so in­clud­ed flops for Eli Lil­ly and a GSK/Vir duo.

The dis­cov­ery arm of the health­care in­vest­ment play­er Deer­field Man­age­ment Com­pa­ny is get­ting a ma­jor fi­nan­cial boost.

Deer­field Dis­cov­ery and De­vel­op­ment will re­ceive $25 mil­lion, over five years, from the state of New York and Em­pire State De­vel­op­ment, a state or­ga­ni­za­tion that of­fers grants, loans and oth­er as­sis­tance to com­pa­nies. An­oth­er $25 mil­lion will come from Deer­field Man­age­ment.

The funds will go to­ward the build­out of a 6,000-square-foot lab space at Cure, a health­care cam­pus found­ed by Deer­field at 345 Park Ave. South in New York City. The mon­ey will al­so be used for pur­chas­ing equip­ment and soft­ware, op­er­at­ing costs and oth­er items.

Deer­field Dis­cov­ery and De­vel­op­ment be­gan talks with the state in April 2020 to try to find a more “eco­nom­i­cal­ly fea­si­ble” way to do pre­clin­i­cal re­search in New York, CEO Michael Fo­ley said in an email to End­points News.

The lab it­self, dubbed the Lab of the Fu­ture, is a col­lab­o­ra­tive ef­fort be­tween Deer­field and oth­er par­ties. Fo­ley said that dur­ing the pi­lot phase, Deer­field Dis­cov­ery plans to work on new and ex­ist­ing re­search ini­tia­tives with its aca­d­e­m­ic re­search part­ners, along with res­i­dents at Cure and oth­er Deer­field part­ners. Cer­tain parts of the lab are ex­pect­ed to come on­line in 2024, with the ex­pec­ta­tion for it to be ful­ly op­er­a­tional in 2025.

Fo­ley said that af­ter those five years, Deer­field Dis­cov­ery and De­vel­op­ment will es­tab­lish an “in­de­pen­dent com­mer­cial en­ti­ty” based on the lab’s tech­nol­o­gy and drug dis­cov­ery ap­proach and will make the tech wide­ly avail­able to oth­er biotechs. At that stage, Fo­ley added that more cap­i­tal would be need­ed to stand that com­pa­ny up.

The FDA to­day ap­proved Emer­gent BioSo­lu­tions’ Nar­can brand nalox­one nasal spray for over-the-counter sales. The nod was ex­pect­ed and comes on the heels of a unan­i­mous 19-0 ad­vi­so­ry com­mit­tee vote in fa­vor of ap­proval last month.

The move to OTC means the opi­oid over­dose re­ver­sal agent will now be avail­able on gro­cery, con­ve­nience and gas sta­tions shelves, as well as po­ten­tial­ly for pur­chase on­line.

Nar­can should ar­rive on shelves by late sum­mer, tak­ing in­to ac­count man­u­fac­tur­ing ad­just­ments such as new non-pre­scrip­tion pack­ag­ing and la­bel­ing and sup­ply chain changes, Emer­gent said. In the mean­time, Nar­can will con­tin­ue to be dis­pensed by phar­ma­cists in every state with­out a pre­scrip­tion to any cus­tomer who re­quests it.

While Emer­gent called the OTC ap­proval an “his­toric mile­stone” in fight­ing the opi­oid epi­dem­ic, one per­son dies every eight min­utes in the US from an opi­oid over­dose.

FDA Com­mis­sion­er Robert Califf echoed the sig­nif­i­cance of the OTC ap­proval to help re­duce opi­oid over­dose deaths in a press re­lease, and re­gard­ing cost and ac­cess, added: “We en­cour­age the man­u­fac­tur­er to make ac­ces­si­bil­i­ty to the prod­uct a pri­or­i­ty by mak­ing it avail­able as soon as pos­si­ble and at an af­ford­able price.”

A com­pa­ny spokesper­son said it is not re­veal­ing pric­ing yet and some ex­perts are con­cerned it like­ly will not be cheap­er than what peo­ple with in­sur­ance al­ready pay.