FDA says vol­ume man­u­fac­tur­ing dead­line is not a re­quire­ment af­ter drug­mak­ers lash out

Back in Oc­to­ber, the FDA re­leased a con­tro­ver­sial draft guid­ance ex­plain­ing to drug man­u­fac­tur­ers how, be­gin­ning on Feb. 15, 2022, the FDA would start col­lect­ing an­nu­al man­u­fac­tur­ing re­ports.

It would start with 2020 man­u­fac­tur­ing da­ta, in­clud­ing the vol­ume or amount of each drug, and the same for ac­tive phar­ma­ceu­ti­cal in­gre­di­ents.

The re­ports were cre­at­ed as part of the CARES Act, en­act­ed in May 2020, which aid­ed the Covid-19 re­sponse fund­ing and added new pro­vi­sions, like this one, meant to ad­dress pan­dem­ic-ex­ac­er­bat­ed drug short­ages, by im­prov­ing FDA’s vis­i­bil­i­ty in­to drug/API sup­ply chains.

Drug­mak­ers al­most uni­form­ly called for a de­lay in the time­lines of these vol­ume re­ports, not­ing they would need more time to set up sys­tems to track this re­quest­ed in­fo and not­ing that ear­li­er years’ da­ta might mis­lead­ing­ly sug­gest short­ages that no longer ex­ist.

In­dus­try group BIO in­quired in­to how the FDA might use this new da­ta, and how it will en­force the re­port­ing re­quire­ment, and which penal­ties, if any, would be im­posed on es­tab­lish­ments that do not re­port on the quan­ti­ty of a drug in­tend­ed for com­mer­cial dis­tri­b­u­tion.

“With over 275,000 fin­ished and un­fin­ished drug pack­age ND­Cs, ac­cord­ing to FDA’s NDC di­rec­to­ry, the Agency is ask­ing in­dus­try to com­pile, for­mat, and sub­mit over 3.3 mil­lion da­ta points to the Agency in less than four months af­ter is­suance of the draft guid­ance,” gener­ic drug­mak­er Vi­a­tris said in its com­ment.

Pfiz­er al­so raised con­cerns with FDA that the guid­ance is­sued may cre­ate prob­lems for com­pa­nies that have con­fi­den­tial­i­ty agree­ments with their con­tract man­u­fac­tur­ers.

“Pro­vid­ing re­ports as re­quired un­der sec­tion 510(j)(3) could be con­sid­ered a breach of these agree­ments and may be im­pact­ful to the CMO busi­ness,” Pfiz­er wrote.

While the draft guid­ance said that re­ports for 2020 should be sub­mit­ted by this past Tues­day, and that re­ports for 2021 should be sub­mit­ted by mid-May, the agency now says those aren’t hard dead­lines.

In a rare note, re­leased the day be­fore the first dead­line, the FDA sig­naled that it heard in­dus­try’s ques­tions loud and clear, and that this first Feb. 15 dead­line is not ac­tu­al­ly a re­quire­ment. FDA ex­plains:

FDA is con­sid­er­ing com­ments to our draft guid­ance on Re­port­ing Amount of List­ed Drugs and Bi­o­log­i­cal Prod­ucts Un­der Sec­tion 510(j)(3) of the Fed­er­al Food, Drug, and Cos­met­ic Act, in­clud­ing com­ments about the rec­om­mend­ed time­lines for sub­mit­ting the re­quired re­ports. The draft guid­ance doc­u­ment is not a bind­ing doc­u­ment, and the rec­om­mend­ed Feb­ru­ary 15, 2022 re­port­ing date for 2020 da­ta is not a re­quire­ment. We are care­ful­ly re­view­ing all is­sues raised by stake­hold­er com­ments to the dock­et, in­clud­ing re­gard­ing the rec­om­mend­ed re­port­ing time­frames. We will con­sid­er up­dat­ing the draft guid­ance’s rec­om­mend­ed time­frames for re­port­ing, as ap­pro­pri­ate, along with oth­er is­sues raised by such stake­hold­er feed­back.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to 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 US regulator between 2019 and 2022.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

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

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.