Man­u­fac­tur­ing woes con­tin­ue for Au­robindo af­ter FDA's warn­ing let­ter

An ac­tive phar­ma­ceu­ti­cal in­gre­di­ent site in In­dia has been hand­ed a warn­ing let­ter from the FDA, fol­low­ing an Au­gust 2021 in­spec­tion.

Au­ro­Life Phar­ma’s Hy­der­abad site, which is part of the Au­robindo group of com­pa­nies, was hand­ed the let­ter in No­vem­ber. It’s the lat­est in a string of man­u­fac­tur­ing woes the com­pa­ny has bat­tled as of late.

Unit 1 of its Hy­der­abad site was in­spect­ed, and re­ceived an of­fi­cial ac­tion ini­ti­at­ed no­tice from the FDA. “The com­pa­ny be­lieves that this will not im­pact the ex­ist­ing busi­ness from this fa­cil­i­ty,” it said in a fil­ing.

Mean­while, in a No­vem­ber quar­ter­ly up­date, in­vestors asked for clar­i­fi­ca­tions on the warn­ing let­ter.

“Unit I got in­spect­ed and we have re­spond­ed with­in the stip­u­lat­ed time. We are await­ing fur­ther in­put from the reg­u­la­tor for an an­swer on Unit I,” man­ag­ing di­rec­tor N Govin­dara­jan said on the call. He has since stepped down from the role. “The Au­ro­Life in­spec­tion is on­go­ing. FDA in­spec­tion is on­go­ing.”

A heavy-hand­ed warn­ing let­ter in 2020 re­vealed the agency said that the com­pa­ny’s staff failed to in­ves­ti­gate un­ex­plained dis­crep­an­cies or fail­ures in API batch­es and left wa­ter leaks in pack­ing rooms at a New Jer­sey site as well.

Au­robindo al­so failed to iden­ti­fy im­pu­ri­ty re­sults from con­t­a­m­i­na­tion due to mor­tar, and lots of the API ex­ceed­ed spec­i­fi­ca­tion lim­its, yet were not quar­an­tined.

Au­ro­Life al­so failed to main­tain the build­ings used in the man­u­fac­tur­ing, pack­ing and hold­ing process. Four ex­am­ples of wa­ter leaks in an en­cap­su­la­tion room were found, and there were an­oth­er five in­stances in pack­ing rooms, some of them above pack­ag­ing lines. Am­bi­ent mois­ture runs the risk of ru­in­ing the pu­ri­ty of the APIs.

The FDA al­so said that Au­ro­Life failed to es­tab­lish and fol­low prop­er pro­ce­dures for the clean­ing and main­te­nance of equip­ment, and iden­ti­fy­ing the strength, qual­i­ty and pu­ri­ty of drug prod­ucts.

“You did not have da­ta to sup­port that your process was in a state of con­trol pri­or to re­leas­ing those batch­es,” the let­ter said. “Your eval­u­a­tion of the process change af­ter im­ple­men­ta­tion con­clud­ed that the new process re­sult­ed in a non-uni­form blend, your pre­vi­ous man­u­fac­tur­ing process was more con­sis­tent and ro­bust, and the re­main­ing batch­es should be held pend­ing fur­ther dis­cus­sion. Eight months af­ter this ini­tial eval­u­a­tion you made the de­ci­sion to re­vert to the old process. How­ev­er, your firm de­ter­mined that the quar­an­tined batch­es could be dis­trib­uted.”

Mean­while, the com­pa­ny was sued in the US in April 2020 as a part of a class-ac­tion suit, af­ter a Flori­da law firm said that it can­celed facts about a can­cer-caus­ing agent in met­formin. The in­dus­try has con­tin­ued to strug­gle with re­calls of met­formin, with Viona Phar­ma­ceu­ti­cals re­call­ing 33 lots af­ter find­ing traces of ND­MA ear­li­er in Jan­u­ary.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.