Janet Woodcock, acting FDA commissioner (AP Images)

Eli Lil­ly’s Covid-19 drug bam­lanivimab is no longer dis­trib­uted in 3 states be­cause of a vari­ant, Wood­cock says

The US gov­ern­ment is no longer dis­trib­ut­ing Eli Lil­ly’s bam­lanivimab in­to Cal­i­for­nia, Ari­zona and Neva­da be­cause of the preva­lence of a vi­ral vari­ant that is not sus­cep­ti­ble to the mon­o­clon­al an­ti­body, FDA act­ing com­mis­sion­er Janet Wood­cock told physi­cians tak­ing part in a we­bi­nar with the Amer­i­can Med­ical As­so­ci­a­tion on Wednes­day.

Wood­cock did not elab­o­rate fur­ther on the vari­ant or the de­ci­sion to halt the dis­tri­b­u­tion, but over­all, the FDA re­mains unique­ly po­si­tioned to screen the mon­o­clon­als against the dif­fer­ent vari­ants, Wood­cock added, and that’s been pre­dic­tive of how and where the treat­ments will work.

A Lil­ly spokesper­son told End­points News in a state­ment: “We rec­og­nize the U.S. gov­ern­ment has made the de­ci­sion to no longer al­low di­rect or­der­ing of bam­lanivimab alone in Cal­i­for­nia, Ari­zona and Neva­da due to con­cerns about the preva­lence of the ‘Cal­i­for­nia’ vari­ant, with the spe­cif­ic L452R sub­sti­tu­tion found in B.1.429/B.1.427 lin­eages (a.k.a. 20C/CAL.20C). Im­por­tant­ly, pre­clin­i­cal da­ta from our labs demon­strate that the com­bi­na­tion of bam­lanivimab and ete­se­vimab main­tains its neu­tral­iz­ing ef­fect against this vari­ant, specif­i­cal­ly.”

Over­all, Wood­cock ac­knowl­edged that the ini­tial roll­out of the mon­o­clon­al an­ti­bod­ies “wasn’t the great­est” be­cause it was cen­tered on a dis­tri­b­u­tion mod­el for Gilead’s an­tivi­ral remde­sivir, and “hos­pi­tals were in no po­si­tion to give out mon­o­clon­als.”

“We’re get­ting there but it’s tak­en quite a long time,” Wood­cock said in ref­er­ence to the mon­o­clon­al an­ti­bod­ies in the US. “Mass vac­ci­na­tion is hard enough but mass in­fu­sion is a re­al chal­lenge for our health care sys­tem.”

John Far­ley, di­rec­tor of the FDA’s of­fice of in­fec­tious dis­eases, said that the FDA ex­pects to soon broad­en the de­f­i­n­i­tion of who falls in­to the “high risk” cat­e­go­ry that de­ter­mines who can re­ceive the mon­o­clon­al an­ti­bod­ies.

“We know from the field that we would ben­e­fit by broad­en­ing this a bit and we’re ex­pect­ing to do that soon,” he said.

He al­so said that the three au­tho­rized mon­o­clon­al an­ti­bod­ies re­main ac­tive against the vari­ant orig­i­nat­ing in the UK, but there are “oth­er, more wor­ri­some vari­ants” and physi­cians should ex­pect to soon see more in­for­ma­tion on those.

As far as the wider ther­a­peu­tic land­scape for Covid-19, Wood­cock again not­ed the fact that just 5% of clin­i­cal tri­als for Covid-19 treat­ments were ad­e­quate­ly pow­ered and ran­dom­ized to pro­vide ac­tion­able da­ta.

“Low ac­cru­al rates and in­ad­e­quate pow­er mean that safe­ty and ef­fi­ca­cy da­ta will be un­in­ter­pretable,” she said. She al­so crit­i­cized the slow roll­out of the NIH-run tri­als for Covid-19 ther­a­peu­tics.

Over­all, she ex­plained some of the ma­jor chal­lenges that she saw as head of ther­a­peu­tics at Op­er­a­tion Warp Speed, and mov­ing for­ward, she dis­cussed what a ro­bust ecosys­tem for clin­i­cal tri­als in the US would look like.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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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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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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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.

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.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Herriot Tabuteau, Axsome CEO (Owen Hoffmann/Patrick McMullan via Getty Images)

Ax­some's long de­layed de­pres­sion drug is back up for la­bel dis­cus­sions at the FDA, trig­ger­ing a big spike in the share price

Axsome’s on-and-off quest to obtain an FDA approval for their depression drug AXS-05 is back on again.

After the markets closed on Monday, the biotech issued a short, simple alert in an SEC filing saying the team had “received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.”

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.