FDA hands Bris­tol My­ers a land­mark ap­proval in ear­ly-stage lung can­cer af­ter just five days

On Feb. 28, the FDA ac­cept­ed Bris­tol My­ers Squibb’s ap­pli­ca­tion for ap­proval of a new use of block­buster check­point in­hibitor Op­di­vo and said it would make a de­ci­sion by Ju­ly 13.

That es­ti­mate turned out to be con­ser­v­a­tive, to say the least. On Fri­day, just five days af­ter ac­cept­ing the ap­pli­ca­tion, the FDA OK’d it, hand­ing the Big Phar­ma a land­mark ap­proval.

Op­di­vo can now be used to treat pa­tients with ear­ly-stage non-small cell lung can­cer pri­or to re­ceiv­ing surgery to re­move their tu­mor. Al­though Op­di­vo and oth­er PD-(L)1 in­hibitors have al­ready trans­formed treat­ment for more ad­vanced forms of the dis­ease, im­prov­ing sur­vival by re­plac­ing or sup­ple­ment­ing tox­ic chemother­a­py with more tol­er­a­ble and ef­fec­tive mol­e­cules that take the “brakes” off the im­mune sys­tem, the drugs have yet to reach many of the ear­li­est stage pa­tients.

Op­di­vo’s new ap­proval is part of a broad­er race by Big Phar­mas to move their PD-(L)1 drugs in­to ear­li­er lines of ther­a­py, a push that ex­perts say could con­tin­ue to re­make the stan­dard-of-care treat­ment (along with com­pa­nies’ pock­ets).

It’s al­so a key win for Bris­tol My­ers, the #2 play­er in the check­point world, in gain­ing a toe­hold on Mer­ck’s dom­i­nant po­si­tion on the mar­ket. Al­though Bris­tol put the first PD-(L)1 drug on the mar­ket, it lost its pre­ferred sta­tus among clin­i­cians af­ter fail­ures in ad­vanced non-small lung can­cer, where Mer­ck pro­duced prac­tice-chang­ing re­sults.

In the Phase III tri­al that led to ap­proval, 388 pa­tients with op­er­a­ble lung can­cer were ran­dom­ized to re­ceive chemother­a­py alone or chemother­a­py plus Op­di­vo pri­or to surgery. Pa­tients in the Op­di­vo arm went a me­di­an of 31.6 months with­out any type of re­cur­rence, com­pared to 20.8 months for pa­tients on chemo alone.

Mark Awad

Just un­der a quar­ter of pa­tients on Op­di­vo al­so saw patho­log­ic com­plete re­sponse — biop­sies with no signs of can­cer un­der close in­spec­tion — com­pared to 2.2% of pa­tients on chemo alone. Op­di­vo pa­tients al­so ap­peared to live longer, al­though that num­ber was not yet sta­tis­ti­cal­ly sig­nif­i­cant.

Mark Awad, clin­i­cal di­rec­tor of the Lowe Cen­ter for Tho­racic On­col­o­gy at the Dana-Far­ber Can­cer In­sti­tute and a study in­ves­ti­ga­tor, said in a state­ment that the ap­proval “marks a turn­ing point in how we treat re­sectable NSCLC.”

Mer­ck, of course, is now run­ning its own tri­als in the same set­ting, as are oth­er PD-(L)1 play­ers such as Roche. They are all al­so com­pet­ing to be first in ear­ly lines of ther­a­py for oth­er can­cers.

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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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.

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.

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.