FDA commissioner Stephen Hahn (AP Images)

Stephen Hahn con­firmed as new FDA chief

The Sen­ate has vot­ed 72-18 to con­firm Stephen Hahn as the na­tion’s 24th com­mis­sion­er of food and drugs, ush­er­ing in a long­time re­searcher and med­ical ex­ec­u­tive that faced lit­tle back­lash in the con­fir­ma­tion process but was wide­ly seen as a sec­ondary choice for those around the agency.

Four ex-FDA chiefs and dozens of high-pro­file groups had pub­licly en­dorsed for the job act­ing com­mis­sion­er Ned Sharp­less, who served from Scott Got­tlieb’s sur­prise de­par­ture through No­vem­ber 1, when Pres­i­dent Don­ald Trump of­fi­cial­ly nom­i­nat­ed Hahn. Got­tlieb al­so gave his sup­port to Sharp­less on Twit­ter.

Brett Giroir has act­ed as com­mis­sion­er since Sharp­less’s de­par­ture.

The MD An­der­son ex­ec, though, large­ly sailed through his con­fir­ma­tion hear­ings last month. Con­tin­u­al­ly ex­tolling the virtues of sci­ence, da­ta and trans­paren­cy, Hahn evad­ed firm an­swers on ques­tions about drug pric­ing, opi­oids and e-cig­a­rettes that have be­come is­sues of na­tion­al de­bate.

“I’m very much in fa­vor of trans­paren­cy,” he said in re­sponse to a ques­tion from Re­pub­li­can Sen­a­tor Su­san Collins on Ab­b­Vie’s con­tro­ver­sial strat­e­gy to keep its Hu­mi­ra patents through 2023.

The vague stance – not un­com­mon for any con­fir­ma­tion hear­ing – fell well short of cost­ing him the job but was a fac­tor in how some sen­a­tors vot­ed. De­mo­c­ra­t­ic Sen­a­tor Mag­gie Has­san cit­ed non-com­mit­tal an­swers Hahn gave on e-cig­a­rettes and the agency’s his­to­ry with opi­oids in her “no” vote.

“The Food and Drug Ad­min­is­tra­tion has an es­sen­tial mis­sion to pro­tect the health and safe­ty of all Amer­i­cans – and its lead­ers must make de­ci­sions based on sci­ence, not po­lit­i­cal in­flu­ence,” Has­san said in a state­ment.

Many groups long close with the agency, in­clud­ing the Amer­i­can As­so­ci­a­tion for Can­cer Re­search, sup­port­ed Hahn once he was nom­i­nat­ed and pub­licly wel­comed the con­fir­ma­tion.

“The AACR is look­ing for­ward to work­ing close­ly with him and his ex­tra­or­di­nary team at the FDA to help fa­cil­i­tate and ex­pe­dite the de­vel­op­ment and ap­proval of safe and ef­fec­tive treat­ments for can­cer pa­tients,” they said in a state­ment.

Hahn comes with ex­pe­ri­ence in on­col­o­gy’s most cut­ting edge ther­a­pies, but he’s found him­self in con­tro­ver­sy be­fore, most re­cent­ly when Chi­nese re­searchers were dis­missed from MD An­der­son, rais­ing ques­tions about racial pro­fil­ing.

He steps in­to an FDA that faces its own bevy of ques­tions, in­clud­ing as to whether the agency’s push to get drugs to pa­tients as fast as pos­si­ble has gone too far.

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.

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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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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.

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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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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.