Erez Israeli, Dr. Reddy’s Laboratories CEO

An­oth­er In­di­an drug man­u­fac­tur­er hit with a Form 483 over re­cent ob­ser­va­tions

Sev­er­al In­di­an drug man­u­fac­tur­ers have been put un­der a mi­cro­scope by the FDA, as ma­jor gener­ics man­u­fac­tur­ers have been hit in re­cent months by Form 483s. And now Dr. Red­dy’s Lab­o­ra­to­ries is the lat­est to get the slap.

Ac­cord­ing to the In­di­an busi­ness news site Busi­ness Stan­dard, Dr. Red­dy’s Lab­o­ra­to­ries was served a Form 483. The form high­light­ed two ob­ser­va­tions af­ter in­spect­ing its man­u­fac­tur­ing fa­cil­i­ty lo­cat­ed at Srikaku­lam, In­dia, a city in the east.

The reg­u­la­to­ry fil­ing not­ed that the fa­cil­i­ty in ques­tion is Dr. Red­dy’s for­mu­la­tion fa­cil­i­ty dubbed FTO 11. How­ev­er, the specifics of what was ob­served have not been re­leased. The in­spec­tion it­self was con­duct­ed from June 30 to Ju­ly 7 of this year.

Dr. Red­dy’s Lab­o­ra­to­ries site in Srikaku­lam has not es­caped the gaze of the FDA in the past. The site was hit with 483’s in 2014 and 2017, with the com­pa­ny re­ceiv­ing 14 pri­or Form 483s since 2017.

The re­sult of the 483 is not great for the in­vest­ment line for Dr. Red­dy’s as they have seen their stock price drop 14% since Jan­u­ary.

How­ev­er, Dr. Red­dy’s is not the on­ly In­di­an com­pa­ny that is man­ag­ing to rack up a high num­ber of in­spec­tions and ob­ser­va­tions. Sun Phar­ma’s plant in Halol, In­dia re­ceived sev­er­al stark ob­ser­va­tions from the FDA in­clud­ing de­fi­cient pro­ce­dures to pre­vent mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion of drugs, as well as de­fi­cient asep­tic pro­cess­ing ar­eas for mon­i­tor­ing en­vi­ron­men­tal con­di­tions and equip­ment and uten­sils not be­ing cleaned or san­i­tized at ap­pro­pri­ate in­ter­vals, among oth­ers.

Au­robindo Phar­ma, which has stacked up 15 483’s since 2016, was re­cent­ly sent a warn­ing let­ter from the Se­cu­ri­ties Ex­change Board of In­dia, SE­BI, over dis­clo­sures made by the com­pa­ny on an on­go­ing FDA au­dit of the com­pa­ny’s Unit-1 API fa­cil­i­ty in Hy­der­abad, In­dia as well as ob­ser­va­tions made by the FDA be­tween 2019 and 2022.

Au­robindo al­so had to close its site in New Jer­sey in March.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

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.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.