UP­DAT­ED: 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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new details of what needs fixing, Lupin disclosed last week that the FDA recently sent a warning letter to its Tarapur, India-based site.

After an inspection from March 22 to April 4, Lupin disclosed in an April stock filing that it received a Form 483 with four observations, but it didn’t offer any details on the observations.

Similar to comments made in April, the company said last week it does not believe the FDA slap will disrupt its drug supplies or the existing revenues from operations of this facility.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.