HHS post­pones re­view of over 95% of FDA’s reg­u­la­tions so crit­i­cal re­sources are not di­vert­ed from Covid-19

The De­part­ment of Health and Hu­man Ser­vices said late Thurs­day that it’s post­pon­ing a last-minute rule en­act­ed by for­mer Pres­i­dent Trump’s HHS that would’ve re­quired the FDA to re­view al­most every one of its reg­u­la­tions, which would’ve di­vert­ed nec­es­sary re­sources away from the agency’s on­go­ing work on the pan­dem­ic.

“Based on a count cit­ed in the SUN­SET fi­nal rule, un­der the time­line and de­f­i­n­i­tions pro­vid­ed in the fi­nal rule, over 7,000 sec­tions of the Code of Fed­er­al Reg­u­la­tions pro­mul­gat­ed by the Food and Drug Ad­min­is­tra­tion (FDA) are more than ten years old or would be­come more than ten years old dur­ing the first five years the rule would be in ef­fect, rep­re­sent­ing over 95 per­cent of its cur­rent reg­u­la­tions,” HHS said in an­nounc­ing the post­pone­ment.

HHS al­so said in its Fed­er­al Reg­is­ter no­tice that if the sun­set fi­nal rule be­came ef­fec­tive as sched­uled on March 22, then to avoid au­to­mat­ic ex­pi­ra­tion of these reg­u­la­tions, FDA and HHS “would need to im­me­di­ate­ly di­vert re­sources to­ward as­sess­ment and re­view dur­ing the on­go­ing COVID-19 pub­lic health emer­gency. In that event, FDA’s re­views of med­ical prod­uct ap­pli­ca­tions, ful­fill­ment of user fee com­mit­ments, and ac­tions to ad­dress ur­gent pub­lic health mat­ters such as on­go­ing COVID-19 pan­dem­ic re­lief ef­forts, out­breaks of food­borne ill­ness, in­spec­tions, re­calls, and oth­er pub­lic health pri­or­i­ties would be sig­nif­i­cant­ly im­pact­ed.

“This con­cen­tra­tion of re­sources in con­duct­ing reg­u­la­to­ry re­view pur­suant to the SUN­SET rule could pre­vent FDA from mod­ern­iz­ing its reg­u­la­to­ry over­sight more ef­fi­cient­ly and ad­dress­ing new reg­u­la­to­ry needs,” HHS added, not­ing that it’ll de­lay the ef­fec­tive date of the rule by a year.

The de­part­ment al­so said that it thinks a re­cent law­suit from the Cen­ter for Sci­ence in the Pub­lic In­ter­est and oth­er groups to over­turn the rule has some mer­its, and that this ex­ten­sion will al­low the suit to pro­ceed.

“Based on HHS’s ini­tial re­view of the Com­plaint, HHS be­lieves that the Court could find mer­it in some of Plain­tiffs’ claims,” HHS said. “Plain­tiffs’ al­le­ga­tions of harm are cred­i­ble; a post­pone­ment will per­mit HHS to re­view the SUN­SET fi­nal rule in light of the claims raised in the lit­i­ga­tion; and the bal­ance of eq­ui­ties and the pub­lic in­ter­est war­rant post­pone­ment of the ef­fec­tive date to pre­serve the sta­tus quo while the Court con­sid­ers the chal­lenge to the SUN­SET fi­nal rule.”

If the suit does not halt the rule, the Biden ad­min­is­tra­tion could just with­draw it, ex­perts pre­vi­ous­ly told End­points News, al­though HHS would still need to go through a no­tice-and-com­ment pro­ce­dure to do so.

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

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Robert Davis, Merck CEO

Mer­ck shares slide as re­sponse to its oral Covid an­tivi­ral plunges on lat­est up­date

After a second look, Merck says that its big breakthrough on the Covid front doesn’t look so good.

The pharma giant updated its data on its oral antiviral molnupiravir on Friday, and said that its drug reduced the rate of hospitalization and death by 30% — a sharp plunge from the 50% rate reported at the beginning of October during their interim readout.

And the news sparked a sharp retreat on Merck’s shares, which fell 4% ahead of the bell on Friday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.