Emer­gent nets it­self more trou­ble as it re­ceives a warn­ing let­ter from the FDA

Emer­gent BioSo­lu­tions is fac­ing a fresh set of man­u­fac­tur­ing trou­bles as the FDA is­sued a warn­ing to the com­pa­ny re­gard­ing its Bal­ti­more site.

Emer­gent re­vealed in an SEC fil­ing on Fri­day that the US reg­u­la­tor is­sued a warn­ing let­ter on Aug. 10, flag­ging two ar­eas of con­cern at the com­pa­ny’s Cam­den man­u­fac­tur­ing fa­cil­i­ty in Bal­ti­more.

The FDA let­ter point­ed to de­fi­cien­cies in the Emer­gent plant’s sys­tems for clean­ing and main­te­nance of equip­ment to pre­vent con­t­a­m­i­na­tion of drug prod­ucts, specif­i­cal­ly re­lat­ed to par­tic­u­lates from the met­al trays. It al­so not­ed de­fi­cien­cies in process­es and prac­tices sur­round­ing asep­tic pro­cess­ing.

The warn­ing let­ter from the FDA said that most of the tray units at the fa­cil­i­ty have suf­fered ap­par­ent dam­age and were al­so in­ad­e­quate for use in ster­ile drug pro­duc­tion. Emer­gent al­so lacked any specifics re­gard­ing its doc­u­ment ac­tiv­i­ties for the in­spec­tion, iden­ti­fi­ca­tion, seg­re­ga­tion, eval­u­a­tion, re­pair or re­tire­ment of de­fec­tive tray units.

While Emer­gent stat­ed to the FDA that it im­prove­ments to the pro­gram mon­i­tor­ing asep­tic pro­cess­ing per­son­nel be­hav­ior and class­room train­ing on asep­tic be­hav­iors the US reg­u­la­tor found that that re­sponse was not ad­e­quate.

The FDA rec­om­mend­ed to Emer­gent that it should re­view and as­sess its qual­i­ty man­age­ment sys­tem and en­gage a con­sul­tant to go over the com­pa­ny’s CGMP op­er­a­tions. In the SEC fil­ing, Emer­gent said it re­tained a third par­ty to con­duct an ad­di­tion­al re­view of the fa­cil­i­ty and to pro­vide over­sight of on­go­ing process­es at the Cam­den site.

“Bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing is com­plex, and the stakes are high. That is why we have made sig­nif­i­cant in­vest­ments to up­grade our phys­i­cal ca­pa­bil­i­ties and are fo­cused on strength­en­ing our cul­ture of qual­i­ty and com­pli­ance. This is a process that doesn’t hap­pen overnight, but one to which we are com­mit­ted,” ac­cord­ing to a state­ment from Emer­gent.

Emer­gent did not re­spond to any fur­ther in­quiries from End­points News.

How­ev­er, this is not the first time the Mary­land-based man­u­fac­tur­er has crossed paths with the FDA. In April 2021, Emer­gent had to shut down pro­duc­tion at its Bayview fa­cil­i­ty and quar­an­tine any ex­ist­ing ma­te­ri­als in the wake of a John­son & John­son vac­cine man­u­fac­tur­ing fi­as­co. At the time, FDA in­ves­ti­ga­tors found the com­pa­ny’s qual­i­ty unit failed to en­sure ba­sic func­tions of its op­er­a­tions, in­clud­ing elec­tron­ic da­ta that were ma­nip­u­lat­ed and delet­ed, and qual­i­ty unit pro­ce­dures that had not been put in­to writ­ing, among an ar­ray of oth­er is­sues.

And it’s not the on­ly prob­lem that Emer­gent is deal­ing with. Last month, Emer­gent claimed that J&J that it will have to pay some­where in the range of $125 mil­lion to $420 mil­lion if J&J ter­mi­nates its Covid man­u­fac­tur­ing con­tract as the Big Phar­ma winds down its Covid-19 vac­cine op­er­a­tions be­fore ful­fill­ing the min­i­mum re­quire­ments in its con­tract with Emer­gent.

Ad­di­tion­al Emer­gent man­u­fac­tur­ing is­sues around the J&J vac­cine al­so are be­ing re­vealed in new con­gres­sion­al com­mit­tee find­ings re­leased last Thurs­day. It showed that 135 mil­lion more coro­n­avirus vac­cine dos­es man­u­fac­tured at Emer­gent’s Bal­ti­more-based fa­cil­i­ty for J&J were des­ig­nat­ed for de­struc­tion due to qual­i­ty de­fi­cien­cies. That brings the to­tal num­ber of dos­es wast­ed to north of 525 mil­lion.

Emer­gent has 15 days from Aug. 10 to re­spond to the FDA and they are en­cour­aged to cor­rect any vi­o­la­tions prompt­ly. Fail­ure to ad­dress the mat­ter may re­sult in reg­u­la­to­ry or le­gal ac­tion or the with­hold­ing of ex­port cer­tifi­cates, among oth­er ac­tions.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,600+ biopharma pros reading Endpoints daily — and it's free.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,600+ biopharma pros reading Endpoints daily — and it's free.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,600+ biopharma pros reading Endpoints daily — and it's free.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.