J&J beats No­var­tis' block­buster ri­val in a head-to-head show­down over the pso­ri­a­sis mar­ket

Score a round in the bat­tle of the pso­ri­a­sis block­busters for J&J.

The phar­ma gi­ant her­ald­ed a win for their head-to-head study of Trem­fya (guselkum­ab) against No­var­tis’ dom­i­nant ri­val Cosen­tyx. Re­searchers said that 84.5% of the pso­ri­a­sis pa­tients tak­ing their IL-23 drug hit a PASI90 score at 48 weeks, com­pared to 70% for the IL-17 drug Cosen­tyx.

That bodes well for on­go­ing late-stage stud­ies of their drug in pso­ri­at­ic arthri­tis and Crohn’s dis­ease.

Lead study in­ves­ti­ga­tor Richard Lan­g­ley, though, al­so added that the da­ta “con­firm a slight­ly more rapid on­set of re­sponse with Cosen­tyx,” while tout­ing their win for longterm dura­bil­i­ty. 

The pic­ture on key sec­on­daries was more mixed, with J&J’s drug edg­ing out the No­var­tis ri­val on PASI75 at 12 and 48 weeks, which was not sta­tis­ti­cal­ly sig­nif­i­cant.

Cosen­tyx has been the drug to beat ever since No­var­tis wran­gled its first land­mark ap­proval for the drug. And it’s es­sen­tial for the phar­ma gi­ant, earn­ing $750 mil­lion in Q3, up 37%.

No­var­tis quick­ly rushed to the de­fens­es of its top new drug, set­ting up a call with re­porters cov­er­ing the field. 

“The im­por­tant thing is to put it in con­text,” com­ment­ed Er­ic Hugh­es, glob­al de­vel­op­ment unit head for the Im­munol­o­gy, He­pa­tol­ogy and Der­ma­tol­ogy unit. No­var­tis has da­ta from more than 100 stud­ies, cov­er­ing scalp, hands, joints and much more, he adds. That da­ta should safe­guard the fran­chise, ac­cord­ing to No­var­tis, but don’t look for any­one at J&J to agree with that.

The show­down be­tween these two ther­a­pies, though, is far from over. No­var­tis has its own Phase III tri­al in the works, in­tent on pro­tect­ing a ma­jor new fran­chise.

Mean­while, Gilead and Gala­pa­gos have been tout­ing their come-from-be­hind progress with fil­go­tinib. The crowd­ed au­toim­mune field al­so in­cludes Eli Lil­ly’s Taltz, Siliq from the biotech for­mer­ly known as Valeant and Dupix­ent from Sanofi and Re­gen­eron.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.

Laurie Glimcher and Ansbert Gadicke (Justin Knight, Dana-Farber Cancer Institute)

Ty­ing ba­sic sci­ence to spin­outs, Dana-Far­ber de­buts sis­ter funds to­tal­ing $126M with MPM Cap­i­tal

As one of the most prestigious cancer institutes in the US, Dana-Farber has enjoyed considerable support for its entrepreneurial pursuits, spinning out about 30 companies in the past 12 years.

“Now where we’ve always struggled — where every cancer center struggled — is support of basic science,” Barrett Rollins, chief scientific officer emeritus, told Endpoints News.

And then two of its trustees had an idea. What if they tied philanthropy to investment in Dana-Farber startups, requiring a donation to basic science as a condition for accessing its brightest biotech venture ideas?