FDA restarts do­mes­tic drug man­u­fac­tur­ing in­spec­tions

Af­ter a pause of 41 days, the FDA restart­ed its do­mes­tic phar­ma-re­lat­ed sur­veil­lance in­spec­tions on Mon­day.

That de­ci­sion to restart, which came as a re­sult of the steep de­cline in Covid-19 cas­es across the coun­try, fol­lowed the agency’s pre­vi­ous de­ci­sion to pause these do­mes­tic in­spec­tions in De­cem­ber.

“In ad­di­tion to the re­sump­tion of plan­ning and con­duct­ing do­mes­tic sur­veil­lance in­spec­tions on Feb. 7, the FDA con­tin­ues to con­duct both for­eign and do­mes­tic mis­sion-crit­i­cal in­spec­tions, as well as pro­vide ef­fec­tive over­sight of foods, drugs, med­ical prod­ucts and to­bac­co lever­ag­ing a va­ri­ety of tools, in­clud­ing re­mote as­sess­ments. The agency al­so con­tin­ues to pro­ceed with pre­vi­ous­ly planned for­eign sur­veil­lance in­spec­tions that have re­ceived coun­try clear­ance and are with­in the Cen­ter for Dis­ease Con­trol and Pre­ven­tion’s Lev­el 1 or Lev­el 2 COVID-19 trav­el rec­om­men­da­tion,” FDA said Fri­day.

The in­spec­tions have been stop­ping and start­ing since the pan­dem­ic be­gan.

More re­cent­ly, at the start of Jan­u­ary, the FDA an­nounced that it paused in­spec­tions not con­sid­ered mis­sion-crit­i­cal for “at least two weeks” to en­sure the safe­ty of FDA em­ploy­ees. Some­what nor­mal in­spec­tions had on­ly just re­sumed in Ju­ly.

The paus­es have had a sig­nif­i­cant im­pact on the bio­phar­ma in­dus­try. A No­vem­ber 2021 re­port not­ed that 52 new drug ap­pli­ca­tions were de­layed, in part due to the back­log of in­spec­tions.

Plan­ning for ad­di­tion­al for­eign sur­veil­lance in­spec­tions is on­go­ing, FDA said, not­ing an “an­tic­i­pat­ed goal of con­duct­ing for­eign pri­or­i­tized in­spec­tions start­ing in April.”

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:

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

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.

Bob Nelsen (Lyell)

UP­DAT­ED: 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 an interview with Endpoints News, ARCH managing director and co-founder Bob Nelsen brushed off concerns about the broader market troubles, saying the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels won’t impact ARCH’s mindset too much because it typically focuses on company formation.

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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.

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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?”

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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.

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.