FDA re­jects Tesaro’s IV ver­sion of ro­lap­i­tant, cit­ing man­u­fac­tur­ing is­sues

Mary Lynne Hed­ley, Tesaro Pres­i­dent & COO

Tesaro’s plans for build­ing up sales of Varu­bi — or ro­lap­i­tant — through a new in­tra­venous for­mu­la­tion of the drug will have to wait. The FDA shot down the biotech’s mar­ket­ing ap­pli­ca­tion, which the biotech says is sole­ly dur­ing to some out­stand­ing man­u­fac­tur­ing is­sues.

The pill ver­sion of the drug — used to treat chemo in­duced nau­sea and vom­it­ing — was OK’d back in 2015, trig­ger­ing a block­buster pro­jec­tion from the com­pa­ny. An­a­lysts, though, have been less than im­pressed with the roll­out, with Leerink pulling back its fore­cast on sales.

Reg­u­la­tors did not ques­tion the safe­ty and ef­fi­ca­cy of the IV ver­sion, Tesaro re­port­ed, but did have is­sues with the biotech’s switch of man­u­fac­tur­ers. Af­ter iden­ti­fy­ing “po­ten­tial de­fi­cien­cies” at the first man­u­fac­tur­er, de­vel­op­ers pro­vid­ed reg­u­la­tors with in vit­ro ev­i­dence of com­pa­ra­bil­i­ty in terms of the drug be­ing man­u­fac­tured.

The FDA is look­ing for ad­di­tion­al in­for­ma­tion and Tesaro says it plans to pro­vide it as ex­pe­di­tious­ly as pos­si­ble.

Tesaro’s shares were down about 3% in pre-mar­ket trad­ing on Thurs­day.

This is the lat­est in a long string of CRLs prompt­ed by man­u­fac­tur­ing is­sues over the past year, as the FDA plays hard­ball on pro­duc­tion qual­i­ty with com­pa­nies big and small.

While Tesaro won’t be helped by the de­lay, the big fo­cus at the com­pa­ny re­mains ni­ra­parib, a PARP in­hibitor that gained pri­or­i­ty re­view sta­tus at the FDA just ahead of Christ­mas.

Tesaro pres­i­dent and COO Mary Lynne Hed­ley said:

Tesaro is com­mit­ted to bring­ing this new in­tra­venous for­mu­la­tion of ro­lap­i­tant to physi­cians and pa­tients to en­able ad­di­tion­al flex­i­bil­i­ty and choice of antiemet­ic reg­i­mens, and we plan to ad­dress FDA’s ques­tions ex­pe­di­tious­ly and com­plete this ap­pli­ca­tion, which we ex­pect to en­able ap­proval in the first half of 2017.

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?