FDA re­leas­es flur­ry of new, re­vised drug-spe­cif­ic guid­ance doc­u­ments

In an ef­fort to pro­vide sup­port for ab­bre­vi­at­ed new drug ap­pli­ca­tions, the FDA on Thurs­day is­sued a flur­ry of prod­uct-spe­cif­ic rec­om­men­da­tions, pro­vid­ing guid­ance for com­pa­nies look­ing to de­vel­op gener­ic ver­sions of a num­ber of pop­u­lar med­i­cines, in­clud­ing My­lan’s EpiPen (ep­i­neph­rine) al­ter­na­tive Adrenaclick, No­var­tis’ can­cer treat­ment Afin­i­tor (everolimus) and As­traZeneca’s can­cer treat­ment Lyn­parza (ola­parib).

In to­tal, new guid­ance was pub­lished for 32 drugs. On top of these new drafts, FDA re­leased 19 re­vised guid­ance doc­u­ments, in­clud­ing one for com­pa­nies look­ing to de­vel­op gener­ics of Eli Lil­ly’s erec­tile dys­func­tion drug Cialis, and oth­er glau­co­ma treat­ments and an­tibi­otics.

In ad­di­tion, FDA on Thurs­day re­leased Fed­er­al Reg­is­ter no­tices and draft guid­ance doc­u­ments on two oth­er prod­ucts that are unique.

In its prod­uct-spe­cif­ic guid­ance for tiotropi­um bro­mide in­hala­tion pow­der, the agency notes it ini­tial­ly ap­proved Boehringer In­gel­heim’s new drug ap­pli­ca­tion for the prod­uct, known as the Spiri­va Hand­i­haler, in 2004, though in 2012 Boehringer sub­mit­ted a cit­i­zen pe­ti­tion re­quest­ing that FDA adopt and ap­ply cer­tain re­quire­ments for gener­ic ver­sions of the bron­chodila­tor.

But FDA said Thurs­day that it will con­sid­er any com­ments on the draft guid­ance be­fore re­spond­ing to Boehringer’s cit­i­zen pe­ti­tion.

Sim­i­lar­ly, FDA in 2009 ap­proved Glax­o­SmithK­line’s treat­ments known as Serevent Diskus, Flovent HFA and Flovent Diskus 100, and the com­pa­ny sub­mit­ted a cit­i­zen pe­ti­tion re­quest­ing that FDA with­hold ap­proval of any AN­DA or 505(b)(2) ap­pli­ca­tion for gener­ic oral in­hala­tion prod­ucts con­tain­ing sal­me­terol xi­nafoate and/or flu­ti­ca­s­one pro­pi­onate un­less cer­tain con­di­tions were sat­is­fied, in­clud­ing some re­lat­ed to demon­strat­ing bioe­quiv­a­lence.

FDA again said it will con­sid­er any com­ments on the new draft guid­ance doc­u­ments be­fore re­spond­ing to GSK’s cit­i­zen pe­ti­tion.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

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.

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.

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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.”

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

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.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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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.

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