Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

FDA re­jects Gilead’s next big HIV drug over glass vial is­sues

Gilead on Tues­day re­ceived a re­jec­tion let­ter for its lat­est po­ten­tial first-in-class HIV drug, as the com­pa­ny said the FDA cit­ed Chem­istry Man­u­fac­tur­ing and Con­trols (CMC) is­sues re­lat­ing to the com­pat­i­bil­i­ty of lenaca­pavir with its pro­posed con­tain­er vial.

Reg­u­la­tors pre­vi­ous­ly slapped a clin­i­cal hold on 10 tri­als study­ing in­jectable ver­sions of the ex­per­i­men­tal HIV treat­ment, known as lenaca­pavir, due to con­cerns that vials made of borosil­i­cate glass could lead to the for­ma­tion of sub-vis­i­ble glass par­ti­cles in the so­lu­tion.

Mer­dad Parsey

“Gilead in­tends to pro­vide FDA with a com­pre­hen­sive plan and cor­re­spond­ing da­ta to use a dif­fer­ent vial type,” Gilead CMO Mer­dad Parsey said in a state­ment. “We look for­ward to dis­cussing this fur­ther with FDA over the com­ing months so that we can make this in­ves­ti­ga­tion­al new ther­a­py avail­able to peo­ple liv­ing with mul­tidrug-re­sis­tant HIV as soon as pos­si­ble.”

On the pos­i­tive side for Gilead, the FDA did not re­quest any new clin­i­cal tri­als in its CRL. An­a­lysts pre­vi­ous­ly es­ti­mat­ed that lenaca­pavir sales will reach al­most $900 mil­lion by 2026, ac­cord­ing to Eval­u­ate.

Gilead’s sub­mis­sion to the FDA was based on da­ta from a Phase II/III tri­al, which eval­u­at­ed the safe­ty and ef­fi­ca­cy of lenaca­pavir ad­min­is­tered sub­cu­ta­neous­ly every six months in com­bi­na­tion with an an­ti­retro­vi­ral back­ground reg­i­men in heav­i­ly treat­ment-ex­pe­ri­enced peo­ple with mul­ti-drug re­sis­tant HIV-1 in­fec­tion.

Af­ter a year’s worth of da­ta, Gilead said the find­ings demon­strat­ed that lenaca­pavir “achieved high rates of vi­ro­log­ic sup­pres­sion and clin­i­cal­ly mean­ing­ful in­creas­es in CD4 counts in peo­ple liv­ing with HIV whose virus was no longer ef­fec­tive­ly re­spond­ing to their cur­rent ther­a­py.” The most com­mon ad­verse events in the study were in­jec­tion site re­ac­tions (63%), nau­sea and di­ar­rhea (13% each), and Covid-19 (11%).

Gilead’s been work­ing on lenaca­pavir, an HIV-1 cap­sid in­hibitor, for both the treat­ment and pre­ven­tion of HIV-1 in­fec­tion. While most an­tivi­rals act on just one stage of vi­ral repli­ca­tion, the com­pa­ny says lenaca­pavir is de­signed to in­hib­it HIV-1 at mul­ti­ple stages of its life­cy­cle. If ap­proved, it would be the first HIV cap­sid in­hibitor on the mar­ket.

Back in March, the com­pa­ny al­so signed a co-de­vel­op­ment pact to study its next-gen HIV can­di­date in com­bi­na­tion with Mer­ck’s is­la­travir.

How­ev­er, Mer­ck slammed the brakes on its pro­gram in No­vem­ber af­ter in­ves­ti­ga­tors flagged a drop in im­mune cell counts that an ex­ter­nal com­mit­tee de­ter­mined was re­lat­ed to is­la­travir. The FDA placed an of­fi­cial clin­i­cal hold on the ex­per­i­men­tal treat­ment ear­li­er this month.

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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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.

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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.

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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.

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.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.