Alexander Lefterov/Endpoints News

Mi­cro-in­flu­encers with a ma­jor plat­form: Are they the next big thing in phar­ma mar­ket­ing?

Dami­an Wash­ing­ton didn’t want to be “the MS guy.”

He was a life­long per­former — he booked his first com­mer­cial at 15 pro­mot­ing Cap­tain Crunch ce­re­al — and a fun­ny guy with a YouTube chan­nel full of clever videos. The on­ly prob­lem? He wasn’t get­ting a lot of views.

Un­til one day in May 2017. That’s when he filmed his ex­pe­ri­ence at an in­fu­sion cen­ter get­ting Genen­tech’s then-new mul­ti­ple scle­ro­sis treat­ment Ocre­vus. Sud­den­ly, the self-pro­claimed nerd with a de­gree from Mid­dle­bury Col­lege was get­ting hits.

To­day he’s what mar­ket­ing teams and tech-savvy teens call an in­flu­encer — the se­mi-fa­mous rulers of so­cial me­dia who are slow­ly re­plac­ing celebri­ties in phar­ma dig­i­tal ad cam­paigns.

Thou­sands of users watched Wash­ing­ton’s first in­fu­sion video, which wasn’t spon­sored. In the in­tro, he talks about his ex­pe­ri­ences tak­ing Co­pax­one and Rebif. The for­mer didn’t give him the de­sired ef­fect and the lat­ter came with side ef­fects that he de­scribed as a hang­over-like feel­ing mi­nus the night of drink­ing.

Dami­an Wash­ing­ton

“We kind of want to nip this dis­ease pro­gres­sion in the bud,” he says in the video, ex­plain­ing why he switched to Ocre­vus. Then he brings a cam­era to West Hills Hos­pi­tal & Med­ical Cen­ter in Los An­ge­les where he ex­plains each step of the in­fu­sion process as it’s hap­pen­ing, live while get­ting his IV drip.

“Done deal-y, for re­al­ly,” he says at the end. “First in­jec­tion, so far so good, quick and pain­less … Thanks Ocre­vus.”

Com­ments flood­ed in from oth­er MS pa­tients. To his sur­prise, Wash­ing­ton had in­ad­ver­tent­ly cre­at­ed a com­mu­ni­ty fo­rum for pa­tients who were ea­ger to share their own sto­ries.

“Great video! I’m mov­ing from Tysabri to Ocre­vus right now. It was good to see the process,” one com­menter post­ed.

“90 sec­onds got you a new sub­scriber bro. Great video, look­ing for­ward to check­ing out your oth­ers. I have to stop Tysabri and am con­sid­er­ing Ocre­vus,” an­oth­er said.

Af­ter that, Wash­ing­ton start­ed crank­ing out MS videos. The view­ers want­ed more — and so did Ocre­vus’ mak­er Genen­tech. Af­ter see­ing his videos, the phar­ma com­pa­ny be­gan sign­ing him on for pro­mo­tion­al work. Not all of his videos are spon­sored — and he’s nev­er di­rect­ly pro­mot­ed a drug for a phar­ma com­pa­ny — but his most re­cent gig was per­form­ing a rap rais­ing aware­ness for MS at the com­pa­ny’s #MSVis­i­bil­i­ty Vir­tu­al Con­cert em­ceed by Broad­way per­former David Os­mond.

“The aim is to shift the al­go­rithm on YouTube in my fa­vor as far as rel­e­vant con­tent and in­for­ma­tion for peo­ple with mul­ti­ple scle­ro­sis,” Wash­ing­ton said, adding that it’s al­so “an­oth­er way to put my­self in front of peo­ple and to be the an­swer to ques­tions that peo­ple have.”

In the di­rect-to-con­sumer space, this type of mar­ket­ing — al­go­rithm-dri­ven so­cial me­dia mar­ket­ing — is mov­ing to eclipse TV ad­ver­tis­ing by phar­ma mar­keters in terms of reach, Kathryn Aikin, se­nior so­cial sci­ence an­a­lyst and re­search team lead in the FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion, said at a re­cent Duke Uni­ver­si­ty event. On TV, phar­ma ads fea­ture fa­mil­iar faces like Queen Lat­i­fah, Ser­e­na Williams and An­nie Mur­phy, but many in­flu­encers on so­cial me­dia are just reg­u­lar peo­ple — with a lot of fol­low­ers.

Across the board, in­flu­encer mar­ket­ing was worth around $9.7 bil­lion in 2020, ac­cord­ing to In­flu­encer Mar­ket­ing Hub, which es­ti­mat­ed the mar­ket would grow to $13.8 bil­lion in 2021. At the same time, over­all dig­i­tal ad spend in the phar­ma space sky­rock­et­ed 242% year over year from Jan­u­ary to Feb­ru­ary in 2020 and 2021, Me­di­aRadar re­port­ed.

Health Union, which ac­quired WEGO Health in June, pairs phar­ma com­pa­nies with pa­tient in­flu­encers as one of its ser­vices. It al­so owns 38 — and count­ing — on­line health com­mu­ni­ties, such as mul­ti­plescle­ro­sis.net. While Wash­ing­ton is now proud to be “the MS guy,” Health Union has a com­bined net­work of more than 100,000 in­flu­encers in vir­tu­al­ly every con­di­tion.

Ear­ly fig­ures sug­gest the strat­e­gy is work­ing: In one case study, an In­sta­gram cam­paign by Health Union for a “niche on­col­o­gy brand” fea­tur­ing pa­tient and care­giv­er in­flu­encers saw 114% high­er traf­fic rates com­pared to the brand’s bench­marks on oth­er dig­i­tal me­dia.

As phar­ma ad­ver­tis­ing shifts to so­cial chan­nels like In­sta­gram and Tik­Tok, a num­ber of ques­tions arise: Who are in­flu­encers, who’s reg­u­lat­ing this kind of mar­ket­ing, and will it stick — or is it just an­oth­er fad?

For some, the word “in­flu­encer” con­jures im­ages of stilet­toed Kar­dashi­ans hawk­ing the lat­est fads — and that wouldn’t be com­plete­ly off-base. The Cana­di­an biotech Duch­es­nay did, af­ter all, re­ceive an FDA warn­ing let­ter back in 2015 af­ter Kim Kar­dashi­an en­dorsed its morn­ing sick­ness pill Di­clegis on In­sta­gram with­out de­tail­ing the drug’s risks. The re­al­i­ty TV star ul­ti­mate­ly is­sued an­oth­er post with the hash­tag #Cor­rec­tiveAd, in which she out­lined the risks.

And her sis­ter Khloe Kar­dashi­an is cur­rent­ly one of the celebri­ty mi­graine suf­fer­ers fronting Bio­haven’s Nurtec ODT dig­i­tal-first ad­ver­tis­ing cam­paign.

But to Jack Bar­rette, for­mer CEO of WEGO Health and cur­rent chief in­no­va­tion of­fi­cer of Health Union, the de­f­i­n­i­tion of an in­flu­encer in the phar­ma space is much dif­fer­ent.

“An in­flu­encer is, es­pe­cial­ly in the area of se­ri­ous ill­ness and chron­ic ill­ness as we de­fine it at Health Union, some­one who has a fol­low­ing of oth­er folks that they con­verse with and bring to­geth­er and pro­vide ad­vice to,” he said.

Jack Bar­rette (Cred­it: Chris­tine Hochkep­pel, Salty Broad Stu­dios)

When he co-found­ed WEGO more than 14 years ago, Bar­rette would have called them “health ac­tivists” or “pa­tient lead­ers.” If he had to guess, the name “in­flu­encer” be­gan to stick rough­ly three to five years ago when it be­came clear that so­cial me­dia com­mu­ni­ties were form­ing around these pa­tients.

Why would a com­pa­ny choose to work with reg­u­lar peo­ple when they could be work­ing with celebri­ties like Kar­dashi­an? In the age of so­cial me­dia, it’s all about es­tab­lish­ing a re­la­tion­ship, Bar­rette said. It may seem in­tu­itive, but some­one with 1,000 ded­i­cat­ed fol­low­ers has a more per­son­al con­nec­tion with con­sumers than some­one with hun­dreds of thou­sands. The small­er au­di­ence in­flu­encers of­ten per­son­al­ly re­spond to com­ments and an­swer ques­tions. The bonus for phar­ma com­pa­nies is out­reach to a much more tar­get­ed au­di­ence.

“What phar­ma­ceu­ti­cal com­pa­nies re­al­ly gain is a chance to be a part of that so­cial health con­ver­sa­tion, where peo­ple are ac­tu­al­ly know­ing each oth­er and pro­vid­ing in­for­ma­tion, in a trust­ed and au­then­tic way,” he said.

Then there are the in­flu­encers who lean more on the side of celebri­ty. Take Derek Thel­er, for in­stance, a hand­some TV sit­com sup­port­ing ac­tor who mar­kets for Dex­com’s glu­cose mon­i­tor­ing sys­tem on In­sta­gram. A re­cent im­age he post­ed wear­ing Dex­com’s sys­tem on his tor­so — tagged “paid part­ner­ship with Dex­com” — as he stands by a wa­ter­fall got more than 6,000 likes. The com­ments were flood­ed with fire and heart-eye emo­jis, along with some feed­back from pa­tients.

“It’s so strange see­ing the Dex­com on an adult’s body! My son is 6 years old and it takes up much more re­al es­tate! (Less than when he was 2, though). All the best, thanks for be­ing a pos­i­tive T1 am­bas­sador for peo­ple like my boy to look up to,” one com­menter wrote.

One of the rea­sons Dex­com’s cam­paign has been so suc­cess­ful, ac­cord­ing to Hyosun Kim, an as­sis­tant pro­fes­sor of com­mu­ni­ca­tion at In­di­ana State Uni­ver­si­ty, is that it brings in a lot of user-gen­er­at­ed con­tent.

Hyosun Kim

“A lot of peo­ple … post­ed on their so­cial me­dia, ‘I [am] a Type 1 di­a­betes pa­tient and I used Dex­com and it’s a mag­i­cal game-chang­er,’ or some­thing like that,” and that can be re­al­ly mean­ing­ful to fel­low pa­tients, she said. 

Bar­rette sees Health Union as a sort of li­ai­son be­tween phar­ma com­pa­nies and pa­tient in­flu­encers, al­though it’s not al­ways about sell­ing a drug. A lot of the work Health Union does is un­brand­ed, mean­ing the in­flu­encers are hired by a phar­ma com­pa­ny to do ed­u­ca­tion­al work or raise aware­ness for a dis­ease, with­out men­tion­ing any prod­uct names.

The end re­sult is some­thing like an ad, yet doesn’t look or sound like one.

“If you’re just scrolling on your phone, and you see a guy be­ing like, ‘Look, if you got MS man, lis­ten: Let me tell you about this oth­er thing, right here,’ that is a bit more en­gag­ing, and speaks more to the view­er,” Wash­ing­ton said.

What could go wrong? It de­pends on who you ask. While Kim sees the ben­e­fits of this type of mar­ket­ing, she’s al­so been close­ly study­ing the FDA’s con­cerns, and has picked up on a few key themes.

Be­ing from South Ko­rea, Kim had nev­er seen phar­ma­ceu­ti­cal ads un­til she came to the US for grad­u­ate school work and was shocked by a Vi­a­gra com­mer­cial on TV. She end­ed up writ­ing a pa­per on pre­scrip­tion drug ad­ver­tis­ing for her me­dia law class, and since then, she’s been on a mis­sion to learn every­thing she can. Re­cent­ly, she spoke at the vir­tu­al Duke Uni­ver­si­ty event along with Aikin that was called, “In­form­ing and Re­fin­ing the Pre­scrip­tion Drug Pro­mo­tion Re­search Agen­da.”

For the most part, Kim likes the idea of di­rect-to-con­sumer ad­ver­tis­ing. It puts some of the pow­er in­to pa­tients’ hands and al­lows them to have bet­ter dis­cus­sions with their doc­tors. But look­ing at warn­ing let­ters sent by the FDA, she iden­ti­fied three of the agency’s main con­cerns with so­cial me­dia ad­ver­tis­ing: the use of first-per­son nar­ra­tives, the pro­mo­tion of non-ap­proved drugs or prod­ucts, and mis­lead­ing ad tech­niques such as hav­ing to hov­er over a post to see the risks.

“Mar­keters are fas­ci­nat­ed by in­flu­encer mar­ket­ing be­cause these in­flu­encers are re­lat­able, touch­able, ap­proach­able, kind of, you know, per­son­al­i­ties,” Kim said. “Peo­ple see them as some­one like me, like fel­low con­sumers or fel­low pa­tients.”

But in re­al­i­ty, in­flu­encers work­ing with phar­ma­ceu­ti­cal com­pa­nies are not to­tal­ly like you — be­cause they have an in­cen­tive to post. Some crit­ics ar­gue in­flu­encers are sell­ing not on­ly prod­ucts, but a cer­tain lifestyle. Thel­er has di­a­betes, but with his Dex­com sys­tem, he al­so swims with his dog and pad­dle­boards in Se­quoia Na­tion­al Park, one In­sta­gram post sug­gests.

“[Con­sumers] are more like­ly to de­vel­op a strong re­la­tion­ship with this per­son,” Kim said. “And then they see this ad as less pro­mo­tion­al and more like in­for­ma­tion,” she said, adding that while that can be good news for the mar­keters, it may be con­cern­ing for view­ers.

One caveat to con­sid­er, of course, is that pa­tients can­not ac­cess pre­scrip­tion drugs with­out con­sult­ing with a physi­cian.

“It is a to­tal­ly dif­fer­ent ball­game,” Wash­ing­ton said. For one, he was tak­ing Ocre­vus be­fore Genen­tech be­gan spon­sor­ing him. And when he’s do­ing a video, he’ll of­ten make a dis­claimer sim­i­lar to: “This is not med­ical ad­vice. Speak to your doc­tor,” he said.

Still, crit­ics have poked holes in this type of mar­ket­ing ap­proach. For ex­am­ple, how do you know if an in­flu­encer has tak­en the drug they’re pro­mot­ing? Or if and how they’re be­ing paid?

The Fed­er­al Trade Com­mis­sion can rep­ri­mand and fine in­flu­encers who are pro­mot­ing with­out dis­clos­ing the fact that they’re be­ing paid for the con­tent. The reg­u­la­to­ry agency re­quires in­flu­encers to dis­close any “ma­te­r­i­al con­nec­tions” they have with a brand they are en­dors­ing.

In Oc­to­ber, the FTC an­nounced it sent out penal­ty no­tices to more than 700 com­pa­nies putting them on no­tice that they could face civ­il fines up to $43,792 per vi­o­la­tion for im­prop­er en­dorse­ments. Among the com­pa­nies on the list were more than a dozen phar­ma com­pa­nies in­clud­ing Ab­b­Vie, Bay­er, Bris­tol My­ers Squibb, Eli Lil­ly, Mer­ck, Pfiz­er and Take­da.

Still, the rules and reg­u­la­tions can get am­bigu­ous when a pa­tient is rais­ing aware­ness about a con­di­tion, rather than pro­mot­ing a drug.

While Bar­rette said there’s “room for in­ter­pre­ta­tion,” Health Union al­ways dis­clos­es spon­sor­ships. Wash­ing­ton has nev­er di­rect­ly pro­mot­ed a drug for a phar­ma­ceu­ti­cal com­pa­ny, but when com­pa­nies hire him to make videos rais­ing aware­ness for MS, they’ll have him ver­bal­ly dis­close if a video is spon­sored or in­clude it in the cap­tion. Back in 2020, the FDA pro­posed a study with sev­er­al types of en­dorsers (in­clud­ing in­flu­encers) to find out whether dis­clos­ing pay­ment sta­tus would af­fect pa­tient re­ac­tions.

As for dis­clos­ing whether an in­flu­encer has ac­tu­al­ly tak­en the drug they’re spon­sor­ing, Bar­rette isn’t aware of any spe­cif­ic FDA re­quire­ment to do so.

How­ev­er, Health Union and WEGO have tak­en what he calls a “proac­tive stance,” and in al­most all cas­es the pro­mo­tion­al con­tent will ref­er­ence the in­flu­encer’s per­son­al con­nec­tion with the drug. For ex­am­ple, an in­flu­encer may say, “While I have not tak­en this med­ica­tion my­self, many in my pa­tient com­mu­ni­ty are dis­cussing it.”

Is this the dawn of a new era in phar­ma mar­ket­ing? Bar­rette said the so­cial health move­ment, as he calls it, is ex­plod­ing. The pan­dem­ic has en­cour­aged peo­ple to con­nect in “a very re­al and ther­a­peu­tic way” through dig­i­tal means, and there’s no turn­ing back. In ad­di­tion, phar­ma dig­i­tal and so­cial spend­ing has on­ly con­tin­ued to grow over the last cou­ple years.

“This idea that dig­i­tal on­line con­nec­tions are valu­able — maybe it’s not in re­al life, but they have tremen­dous ben­e­fit to folks with es­pe­cial­ly chron­ic dis­ease and se­ri­ous ill­ness to be­come health­i­er be­cause they par­tic­i­pat­ed in the so­cial health move­ment,” Bar­rette said. “So I see a con­tin­u­ing growth … I think we saved five or 10 years in adop­tion of so­cial health be­cause of the pan­dem­ic.”

And the feed­back, so far, has been pos­i­tive. Health Union grew the num­ber of phar­ma com­pa­nies it worked with by about 30% from 2020 to 2021, ac­cord­ing to Bar­rette.

When Wash­ing­ton was di­ag­nosed with MS about five years ago, the dig­i­tal com­mu­ni­ty wasn’t as es­tab­lished. He turned to blogs like Ardra Shep­hard’s Trip­ping on Air. But it wasn’t the same as pick­ing up a smart­phone and watch­ing a full trip to an in­fu­sion cen­ter.

“I would say that it’s nev­er a good time to get MS. How­ev­er, this is a fab­u­lous time to get MS,” he said. “Me be­ing able to talk to some­one in Lon­don about their dis­ease, their con­di­tion, my ups and my downs and their ups and their downs …  it’s re­al­ly, re­al­ly re­mark­able what we have go­ing now.”

For Wash­ing­ton, it’s not about mar­ket­ing trends or even the spon­sor­ship pay­ments. When asked to pre­dict what’s next in so­cial me­dia, he said he’s just go­ing to keep do­ing what he’s do­ing.

He said, “I make videos every week so that peo­ple with mul­ti­ple scle­ro­sis feel less alone. Pe­ri­od.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.