FDA sends warn­ing let­ter to My­lan over 'i­nad­e­quate' man­u­fac­tur­ing process­es at In­dia plant

My­lan has once again run afoul of the FDA over its lack of up­keep at man­u­fac­tur­ing plants.

For the sec­ond time in the last 12 months, the agency has sent a warn­ing let­ter to the gener­ic drug­mak­er call­ing out its fail­ure to main­tain in­dus­try-stan­dard clean­ing pro­ce­dures that pre­vent con­t­a­m­i­na­tion. In the let­ter, sent on Aug. 20 and pub­lished Tues­day, reg­u­la­tors al­so al­lege My­lan $MYL did not test in­com­ing API for im­pu­ri­ties, have mech­a­nisms in place to de­tect such im­pu­ri­ties from en­ter­ing prod­ucts, or keep clean­ing records for bulk stor­age tanks.

The FDA’s con­cerns arose dur­ing an in­spec­tion at a plant in In­dia last Feb­ru­ary.

“These re­peat­ed fail­ures at mul­ti­ple sites man­u­fac­tur­ing API demon­strate that your com­pa­ny’s over­sight and con­trol over the man­u­fac­ture of drugs is in­ad­e­quate,” wrote Fran­cis God­win, the di­rec­tor of the FDA’s Of­fice of Man­u­fac­tur­ing Qual­i­ty and Of­fice of Com­pli­ance at the Cen­ter for Drug Eval­u­a­tion and Re­search.

God­win al­so told My­lan, “You should im­me­di­ate­ly and com­pre­hen­sive­ly as­sess your com­pa­ny’s glob­al man­u­fac­tur­ing op­er­a­tions to en­sure that sys­tems and process­es, and ul­ti­mate­ly, the prod­ucts man­u­fac­tured, con­form to FDA re­quire­ments at all your sites.”

In­vestors re­act­ed some­what poor­ly to the news, send­ing My­lan shares down about 5% in Tues­day trad­ing. The stock showed a slight re­bound ear­ly Wednes­day, hov­er­ing around a 1.5% in­crease.

My­lan re­spond­ed with a state­ment say­ing that it does not fore­see any in­ter­rup­tions to oc­cur re­gard­ing man­u­fac­tur­ing or dis­tri­b­u­tion, as there are no “sig­nif­i­cant” launch­es com­ing out of the plant through the end of the year. “No sig­nif­i­cant com­mer­cial im­pact is ex­pect­ed,” My­lan said, and not­ed that af­ter a pre­vi­ous warn­ing let­ter sent in No­vem­ber 2019, the com­pa­ny “put ad­di­tion­al con­trols, cor­rec­tive ac­tions and im­prove­ments in place.”

“Im­por­tant­ly, ex­ten­sive test­ing of APIs man­u­fac­tured and dis­trib­uted by the site was per­formed for the pres­ence of ni­trosamine im­pu­ri­ties and no ev­i­dence of cross con­t­a­m­i­na­tion was iden­ti­fied,” the state­ment went on.

That No­vem­ber let­ter ul­ti­mate­ly prompt­ed the Feb­ru­ary in­spec­tions af­ter the FDA found “poor con­trol” of sol­vents at a sep­a­rate man­u­fac­tur­ing plant in In­dia. God­win wrote at the time that sim­i­lar sub­stan­dard clean­ing prac­tices and im­pu­ri­ty test­ing al­leged­ly took place.

The warn­ing let­ter puts a dent in a large­ly suc­cess­ful last few months for My­lan, which in late Ju­ly earned a win in the courts as an in­junc­tion block­ing its Tec­fidera gener­ic was lift­ed. Though the com­pa­ny would still be fil­ing for an ap­proval at-risk, giv­en that Tec­fidera mak­er Bio­gen is ap­peal­ing, My­lan has asked the FDA to move up its PDU­FA date from No­vem­ber.

Tec­fidera racked up $4.4 bil­lion in 2019 sales for Bio­gen, and if even some of that pie heads My­lan’s way, it could see a sig­nif­i­cant wind­fall.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

Endpoints Premium

Premium subscription required

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

CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Nadim Ahmed (Bristol Myers Squibb)

Bris­tol My­er­s' top hema­tol­ogy ex­ec is on his way out — right on the heels of a $6B CVR im­plo­sion

Fourteen days after the $6.3 billion CVR tied to the approval of liso-cel went up in smoke, one of the top execs in charge of the work at Bristol Myers Squibb is preparing to step out of his job.

Mizuho analyst Salim Syed, who’s been following every twist and turn in the CVR saga, told investors on Thursday morning that Nadim Ahmed is on his way out. Syed’s note:

Recall, Ahmed is EVP and President of Hematology at BMY (i.e. JCAR017 and bb2121 are both hematological drugs). He’s still listed on the BMY management page. This is true — he’s still technically there. However, I have confirmed w/ BMY that his last day is tomorrow, Friday 1/15. To my best knowledge, Ahmed does not have another job lined up post his departure tomorrow.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Am­gen tops cost watch­dog's price gougers list based on 'un­sup­port­ed' in­creas­es for En­brel with­out mean­ing­ful da­ta

In a top 10 ranking of the most egregious price gougers from 2019, Amgen’s Enbrel topped US cost watchdog ICER’s naughty list with “unsupported” markups that added as much as $403 million to the nation’s drug spend during that time.

Price increases for some of pharma’s most popular drugs have long been a focus of consumer ire, but the industry has argued those increases are routine and meant to cover the cost of R&D innovation. Without meaningful guidance at the state or federal level, ICER looked to connect how much a drug had progressed in the clinic compared with its increase in both wholesale and net price in 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis gets break­through des­ig­na­tion for Xo­lair suc­ces­sor, set­ting up spot­light for PhI­II read­out lat­er this year

With its Roche-partnered Xolair no longer under patent protection, Novartis and CEO Vas Narasimhan are looking for the next drug up to step into the sales void. Now, Narasimhan’s targeted successor is getting some love from the FDA, and it could spell a filing down the road.

The FDA granted breakthrough therapy designation to the company’s ligelizumab compound for the treatment of chronic spontaneous urticaria in patients who respond poorly to antihistamines, Novartis said Thursday.

Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.