FDA opi­oid ad­comm chair blasts agency for 'will­ful blind­ness that bor­ders on the crim­i­nal'

In scathing re­marks di­rect­ed at the FDA’s han­dling of opi­oid ap­provals, the head of the agency’s ad­vi­so­ry pan­el has lam­bast­ed its “cozy, cozy re­la­tion­ships” with the phar­ma­ceu­ti­cal in­dus­try and called for a halt in con­sid­er­ing any new opi­oids for ap­proval.

Rae­ford Brown

Rae­ford Brown, chair of the FDA’s anes­thet­ic and anal­gesic drug prod­ucts ad­vi­so­ry com­mit­tee, did not pull any punch­es in his in­ter­view with the Guardian:

I think that the FDA has learned noth­ing. The modus operan­di of the agency is that they talk a good game and then noth­ing hap­pens. Work­ing di­rect­ly with the agency for the last five years, as I sit and lis­ten to them in meet­ings, all I can think about is the clock tick­ing and how many peo­ple are dy­ing every mo­ment that they’re not do­ing any­thing. The lack of in­sight that con­tin­ues to be ex­hib­it­ed by the agency is in many ways a will­ful blind­ness that bor­ders on the crim­i­nal.

The FDA’s ten­den­cy to put the in­ter­est of drug­mak­ers ahead of pub­lic health was most re­cent­ly man­i­fest­ed in the con­tro­ver­sial ap­proval of Acel­Rx’s Dsu­via, ac­cord­ing to Brown, an anes­the­si­ol­o­gist, who called it a “ter­ri­ble drug.”

Dsu­via was ap­proved fol­low­ing a 10-3 vote by the pan­el of out­side ex­perts in fa­vor of a green light, one year af­ter it was first re­ject­ed by the FDA. Brown was ab­sent from the ad­vi­so­ry pan­el meet­ing as he was away at a pro­fes­sion­al con­fer­ence.

“There’s no ques­tion in my mind right that they did that on pur­pose,” he told the Guardian. “The FDA has a lack of trans­paren­cy. They use the ad­vi­so­ry com­mit­tees as cov­er.”

The OK drew flak de­spite the lop­sided pan­el re­view vote as crit­ics pounced on the in­tro­duc­tion of an­oth­er pow­er­ful pain med that could be ripe for abuse. In a state­ment, FDA chief Scott Got­tlieb coun­tered his crit­ics by not­ing the need for a non-IV opi­oid as well as the de­fense de­part­ment’s de­mand for a ther­a­py that would be ben­e­fi­cial on the bat­tle­field.

That did lit­tle to con­vince Brown, who ac­cused FDA of­fi­cials of be­ing out of touch with the con­se­quences of the opi­oid epi­dem­ic, which has claimed hun­dreds of thou­sands of lives the in the US and con­tin­ues to be re­spon­si­ble for about 130 deaths every day.

“Noth­ing is fun­da­men­tal­ly be­ing done to ef­fect change in the reg­u­la­tion of opi­oids,” he said. “If the FDA con­tin­ues to en­cour­age the phar­ma­ceu­ti­cal in­dus­try to turn out opi­oid af­ter opi­oid af­ter opi­oid, and the reg­u­la­tion of those opi­oids is no bet­ter than it was in 1995, then we’ll be clean­ing this up for a long time.”

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.