FDA com­mis­sion­er Scott Got­tlieb sets some goals: Find ways to low­er drug prices, use new tech to speed de­vel­op­ment

Scott Got­tlieb start­ed his first full week as FDA com­mis­sion­er by lay­ing out some goals and guide­lines for the agency now un­der his di­rec­tion, hop­ing to al­le­vi­ate some con­cerns he’s been hear­ing about the fu­ture. In an all-hands speech to staff on Mon­day, Got­tlieb re­it­er­at­ed some now fa­mil­iar themes on what he hopes to ac­com­plish, and how every­one at the FDA is now ex­pect­ed to lend a hand.

Aside from some health ini­tia­tives on smok­ing and com­bat­ing the opi­oid ad­dic­tion cri­sis in the coun­try, Got­tlieb pledged to find new ways to low­er drug prices, push­ing through com­plex gener­ics and biosim­i­lars while lay­ing the ground­work to pre­vent any more sweet­heart deals to de­lay the ar­rival of low-cost knock­offs, im­ply­ing that he’s prepar­ing to take ac­tion on that front.

He not­ed:

We al­so need to take steps to make sure the gener­ic drug process isn’t be­ing in­ap­pro­pri­ate­ly gamed to de­lay com­pe­ti­tion and dis­ad­van­tage con­sumers. I hope to have much more to say on this top­ic in the com­ing weeks.

In the area of new drug de­vel­op­ment:

Con­gress gave us a clear man­date to be for­ward-lean­ing when it comes to how we’ll eval­u­ate safe­ty and ef­fi­ca­cy in view of emerg­ing sci­en­tif­ic in­sight and bet­ter an­a­lyt­i­cal tools. Im­ple­ment­ing the 21st Cen­tu­ry Cures Act is a key pri­or­i­ty. We need to make sure we’re tak­ing steps to fos­ter in­no­va­tion and reg­u­lat­ing ar­eas of promis­ing new tech­nol­o­gy in ways that don’t raise the cost of de­vel­op­ment or re­duce in­no­va­tion….

We need to be pa­tient-cen­tric and sci­ence-based in every­thing we do. And, we must make sure that in all our ef­forts, we main­tain the gold stan­dard for reg­u­la­to­ry sci­ence and in­de­pen­dent, sci­ence-led de­ci­sion-mak­ing, all led by a strong ca­reer work­force.

Got­tlieb al­so high­light­ed a change­up in the Of­fice of Reg­u­la­to­ry Af­fairs. As Bloomberg re­port­ed ear­li­er Mon­day, Got­tlieb is fo­cus­ing work­ers on spe­cif­ic ar­eas like drugs and de­vices in or­der to achieve greater ex­per­tise as they in­spect fa­cil­i­ties and probe con­sumer com­plaints, aban­don­ing the old re­gion­al fo­cus with shared re­spon­si­bil­i­ties.

“As ORA’s man­date be­comes more com­plex and more glob­al, we look for­ward to achiev­ing op­er­a­tional ef­fi­cien­cies that can im­prove our abil­i­ty to ful­fill our pub­lic health mis­sion and pro­tect con­sumers,” not­ed Got­tlieb.

None of this is a dra­mat­ic de­par­ture for the FDA. But Got­tlieb is al­so send­ing the mes­sage that busi­ness as usu­al won’t be the theme for his tenure as head of the FDA. His im­me­di­ate pre­de­ces­sor, Robert Califf, of­fered a quick thumbs up for get­ting start­ed ear­ly with a re­or­ga­ni­za­tion.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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