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.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

Bull­ish biotech mar­ket pro­pels Pli­ant to $144M IPO — as No­var­tis pro­vides a $10M boost

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.