The Sen­ate fum­bles its first stab at phar­ma prof­i­teer­ing, keep­ing the is­sue front and cen­ter in 2017

End­points News as­sess­es the big bio­phar­ma R&D sto­ry this week in a spe­cial year-end send­off. Chances are, this is al­so what we’ll be talk­ing about in 2017. And it will cer­tain­ly be front and cen­ter at the up­com­ing J.P. Mor­gan Health­care Con­fer­ence.

The Sen­ate of­fers a weak re­sponse to price goug­ing

The Sen­ate this week high­light­ed just how lit­tle the bio­phar­ma in­dus­try needs to fear from law­mak­ers when it comes to con­trol­ling drug prices right now. In­ves­ti­gat­ing four clear cas­es of price goug­ing on old prod­ucts, two or­ches­trat­ed by Mar­tin Shkre­li, the Sen­ate pol­ished off a mix of dusty reg­u­la­to­ry in­cen­tives as their sug­ges­tion for rein­ing in prof­i­teer­ing: “spe­cial” pri­or­i­ty re­views when need­ed, vouch­ers to help re­ward a fast re­sponse, maybe a spe­cial reim­por­ta­tion pass to pro­vide cheap com­pe­ti­tion, a man­date to move gener­ics through the FDA faster. None of it would ac­tu­al­ly nip the whole thing in the bud. “It is pos­si­ble that the busi­ness mod­el pur­sued by the Valeants and Tur­ings of the world was at­trac­tive in part be­cause it was le­gal,” the re­port states, in a mas­sive un­der­state­ment. (Ya think?) Noth­ing the sen­a­tors sug­gest­ed would ac­tu­al­ly pre­vent the next Shkre­li from do­ing ex­act­ly the same thing. If law­mak­ers are un­will­ing to tack­le ob­vi­ous price goug­ing, then what are the chances they can ever come to grips with the much big­ger is­sue of sys­temic rip-offs, the an­nu­al price spikes that have kept Big Phar­ma look­ing healthy as their R&D ef­forts con­tin­ue to un­der­per­form?

It’s time to get re­al

Drug pric­ing as a po­tent po­lit­i­cal is­sue, though, isn’t go­ing any­where. As Shkre­li told mein a Twit­ter ex­change on Thurs­day, the two deals he en­gi­neered for Tur­ing and Retrophin are still mak­ing plen­ty of “guap” as law­mak­ers fud­dle about. Don­ald Trump has made his own broad, un­de­fined pledge to con­trol pric­ing. And elect­ed of­fi­cials have to be acute­ly aware that the pub­lic’s anger will on­ly grow. One of the most com­pelling in­dus­try re­spons­es has been Al­ler­gan CEO Brent Saun­ders’ pledge to hold an­nu­al price in­creas­es to sin­gle dig­its.

Fair pric­ing prac­tices on old­er drugs will be es­sen­tial to main­tain­ing greater con­trol over the price of new drugs. It’s im­por­tant to re­mem­ber that pub­lic anger is not fixed on the price of im­por­tant new drugs that make a dif­fer­ence in peo­ple’s lives. It’s the old­er drugs, where the price goes up when the fran­chise should be fad­ing in val­ue, that rile the peo­ple and of­fend their sense of fair­ness. No one likes be­ing ripped off. And with­out ag­gres­sive pric­ing on many, though not nec­es­sar­i­ly all, new drugs, R&D will be­come un­sus­tain­able.

If this is­sue has your at­ten­tion, I’d en­cour­age you to come to End­points News’ first live event dur­ing the J.P. Mor­gan Health­care Con­fer­ence in San Fran­cis­co, where we’ll be joined by Saun­ders and a great pan­el dis­cussing the sin­gle most press­ing is­sue of the year.

Your tick­et rev­enue will be used to help grow the pub­li­ca­tion in 2017. So you can view this as a way to par­tic­i­pate in a great dis­cus­sion, a net­work­ing event you won’t want to miss, and a sign of your sup­port for what we’re do­ing here.

John Car­roll, Ed­i­tor

Hap­py hol­i­days, and I hope to see you in San Fran­cis­co Jan­u­ary 10.— John Car­roll

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?