Rin­voq nabs new ap­proval in sec­ond-line UC; Sen­so­ri­on says its failed drug now works in sub­set analy­sis

Ab­b­Vie’s Rin­voq racked up an­oth­er ap­proval late Wednes­day af­ter­noon.

The drug is now OK’d in adults with mod­er­ate­ly to se­vere­ly ac­tive ul­cer­a­tive col­i­tis who have had an in­ad­e­quate re­sponse or in­tol­er­ance to one or more TNF block­ers, Ab­b­Vie said in a press re­lease. It’s the first ap­proval for the drug in gas­troen­terol­o­gy, the com­pa­ny added, with da­ta stem­ming from three Phase III stud­ies.

“There re­mains an un­met need for pa­tients with mod­er­ate­ly to se­vere­ly ac­tive UC, who suf­fer from de­bil­i­tat­ing symp­toms that are of­ten un­pre­dictable and bur­den­some,” said Thomas Hud­son, Ab­b­Vie CSO. “With the ap­proval of Rin­voq as a new treat­ment op­tion, Ab­b­Vie con­tin­ues our lead­er­ship in ad­vanc­ing re­search that can help im­pact the lives of peo­ple liv­ing with ul­cer­a­tive col­i­tis.”

Wednes­day’s ap­proval comes a few months af­ter the agency slapped a new warn­ing on the drug af­ter Pfiz­er’s Xel­janz saw in­creased side ef­fects, rel­e­gat­ing the drug to sec­ond-line use in rheuma­toid arthri­tis. The warn­ing came amid the back­drop of a larg­er safe­ty saga play­ing out for the en­tire JAK class of drugs. — Max Gel­man

Sen­so­ri­on claims vic­to­ry on ex­plorato­ry end­points af­ter PhII fail­ure

French biotech Sen­so­ri­on got ham­mered back in Jan­u­ary af­ter its on­ly clin­i­cal stage drug failed to meet the pri­ma­ry end­point in a Phase II study — los­ing 40% of its share val­ue af­ter the news was an­nounced about its lead drug SENS-401, a treat­ment of sud­den sen­sorineur­al hear­ing loss (SSNHL).

To­day, the biotech says it has some more da­ta. And this time, it says that they found some sta­tis­ti­cal­ly sig­nif­i­cant treat­ment ef­fects in spe­cif­ic pop­u­la­tions af­ter they re­viewed ex­plorato­ry end­points. Those in­clude pa­tients suf­fer­ing from pro­found hear­ing loss treat­ed with cor­ti­cos­teroids see­ing an im­prove­ment of 19-26 dB from base­line com­pared to place­bo.

Ex­plorato­ry end­points, how­ev­er, are gen­er­al­ly con­sid­ered far less con­clu­sive than end­points that were set ahead of time, and are gen­er­al­ly used on­ly to de­sign fu­ture tri­als, rather than to of­fer de­fin­i­tive an­swers on ef­fi­ca­cy.

In­vestors re­spond­ed fa­vor­ably to the new de­vel­op­ment, ini­tial­ly sky­rock­et­ing the stock up over 43% be­fore sta­bi­liz­ing at around a 20% in­crease.

The drug is still in play in a col­lab­o­ra­tion on hear­ing preser­va­tion fol­low­ing cochlear im­plants. Sen­so­ri­on and part­ner Cochlear Lim­it­ed are mov­ing for­ward with a tri­al and have sub­mit­ted tri­al de­sign plans to reg­u­la­tors in Aus­tralia and France. — Paul Schloess­er

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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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.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

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(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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