Con­sor­tium of 5 drug reg­u­la­tors plot path to in­crease har­mo­niza­tion through 2024

A group of drug reg­u­la­tors from Aus­tralia, Cana­da, Sin­ga­pore, Switzer­land and the UK on Tues­day un­veiled their strate­gic plans for the next three years, lay­ing out how they’ll work to­geth­er on re­view­ing new drugs to re­duce du­pli­ca­tion across bor­ders.

While un­der­stand­ing that the bio­phar­ma in­dus­try is tru­ly glob­al, the group, known col­lec­tive­ly as the Ac­cess Con­sor­tium, seeks to bet­ter align their re­spec­tive reg­u­la­to­ry and pol­i­cy ap­proach­es for phar­ma­ceu­ti­cals, with an aim to fa­cil­i­tate faster ac­cess to high qual­i­ty, safe and ef­fec­tive health prod­ucts.

Through 2024 the con­sor­tium will seek to in­crease the num­ber and va­ri­ety of new drug ap­pli­ca­tions that the reg­u­la­tors col­lec­tive­ly as­sess, in ad­di­tion to cap­tur­ing lessons learned from the pan­dem­ic to im­prove their work-shar­ing process­es.

In ad­di­tion, the reg­u­la­tors will al­so ex­plore col­lab­o­ra­tions with na­tion­al health tech­nol­o­gy as­sess­ment or­ga­ni­za­tions, which can in­form re­im­burse­ment de­ci­sions.

The con­sor­tium al­so said, ac­cord­ing to its new strate­gic plan, that it’s con­sid­er­ing col­lab­o­ra­tive work on clin­i­cal tri­al de­signs and pro­vid­ing spon­sors with mu­tu­al av­enues for ad­vice.

The group said it will gauge its suc­cess based on in­creas­es in prod­ucts made avail­able, re­duced ef­fort and du­pli­ca­tion for in­dus­try and reg­u­la­tors, in­creased col­lab­o­ra­tion on man­u­fac­tur­ing and clin­i­cal in­spec­tions, and by de­creas­ing the av­er­age time to mar­ket for prod­ucts as­sessed un­der the group.

The orig­i­nal con­sor­tium formed in 2007 with all of the reg­u­la­tors ex­cept for the UK’s MHRA, which joined last Oc­to­ber.

MHRA is al­so now part of an­oth­er over­lap­ping group of reg­u­la­tors in­clud­ing the US FDA, Brazil’s AN­VISA, the Eu­ro­pean Med­i­cines Agency, Japan’s Phar­ma­ceu­ti­cals and Med­ical De­vices Agency, and all of the mem­bers of the Ac­cess Con­sor­tium. The reg­u­la­tors work to­geth­er on con­cur­rent sub­mis­sions and re­views of can­cer drugs as part of what’s known as Pro­ject Or­bis.

In April 2020, Seagen’s tu­ca­tinib in com­bi­na­tion with trastuzum­ab and capecitabine was the first new mol­e­c­u­lar en­ti­ty ap­proved un­der the FDA-led group of reg­u­la­tors.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Alarmed by side ef­fect, FDA slaps clin­i­cal hold on Sarep­ta's next-gen Duchenne drug

Sarepta Therapeutics’ next-gen Duchenne muscular dystrophy drug has been hit with a clinical hold after investigators flagged a serious case of low magnesium levels in one patient’s blood.

Screening and dosing will be halted in what is known as Part B of the Phase II MOMENTUM study, which has enrolled about half of the planned patients. Sarepta said it will be submitting information on all cases of the condition, known as hypomagnesemia, per the FDA’s request and proposing some changes to the risk mitigation and safety monitoring plan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Although it’s exceedingly rare for the FDA to rescind a breakthrough designation once it’s granted, there has been a recent uptick — as in 2020 and 2021 combined, the agency rescinded 17 BTDs, compared to just 18 rescinded from 2015 to 2019 combined.

Protagonist Therapeutics saw this reality up close and personal in April after a clinical hold lifted on its experimental blood cancer drug, as the company revealed that the FDA sought to revoke the BTD. The decision, Protagonist says, stems from “observed malignancies” related to the hold, initially imposed in September 2021.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.