FDA com­mis­sion­er Scott Got­tlieb sets some goals: Find ways to low­er drug prices, use new tech to speed de­vel­op­ment

Scott Got­tlieb start­ed his first full week as FDA com­mis­sion­er by lay­ing out some goals and guide­lines for the agency now un­der his di­rec­tion, hop­ing to al­le­vi­ate some con­cerns he’s been hear­ing about the fu­ture. In an all-hands speech to staff on Mon­day, Got­tlieb re­it­er­at­ed some now fa­mil­iar themes on what he hopes to ac­com­plish, and how every­one at the FDA is now ex­pect­ed to lend a hand.

Aside from some health ini­tia­tives on smok­ing and com­bat­ing the opi­oid ad­dic­tion cri­sis in the coun­try, Got­tlieb pledged to find new ways to low­er drug prices, push­ing through com­plex gener­ics and biosim­i­lars while lay­ing the ground­work to pre­vent any more sweet­heart deals to de­lay the ar­rival of low-cost knock­offs, im­ply­ing that he’s prepar­ing to take ac­tion on that front.

He not­ed:

We al­so need to take steps to make sure the gener­ic drug process isn’t be­ing in­ap­pro­pri­ate­ly gamed to de­lay com­pe­ti­tion and dis­ad­van­tage con­sumers. I hope to have much more to say on this top­ic in the com­ing weeks.

In the area of new drug de­vel­op­ment:

Con­gress gave us a clear man­date to be for­ward-lean­ing when it comes to how we’ll eval­u­ate safe­ty and ef­fi­ca­cy in view of emerg­ing sci­en­tif­ic in­sight and bet­ter an­a­lyt­i­cal tools. Im­ple­ment­ing the 21st Cen­tu­ry Cures Act is a key pri­or­i­ty. We need to make sure we’re tak­ing steps to fos­ter in­no­va­tion and reg­u­lat­ing ar­eas of promis­ing new tech­nol­o­gy in ways that don’t raise the cost of de­vel­op­ment or re­duce in­no­va­tion….

We need to be pa­tient-cen­tric and sci­ence-based in every­thing we do. And, we must make sure that in all our ef­forts, we main­tain the gold stan­dard for reg­u­la­to­ry sci­ence and in­de­pen­dent, sci­ence-led de­ci­sion-mak­ing, all led by a strong ca­reer work­force.

Got­tlieb al­so high­light­ed a change­up in the Of­fice of Reg­u­la­to­ry Af­fairs. As Bloomberg re­port­ed ear­li­er Mon­day, Got­tlieb is fo­cus­ing work­ers on spe­cif­ic ar­eas like drugs and de­vices in or­der to achieve greater ex­per­tise as they in­spect fa­cil­i­ties and probe con­sumer com­plaints, aban­don­ing the old re­gion­al fo­cus with shared re­spon­si­bil­i­ties.

“As ORA’s man­date be­comes more com­plex and more glob­al, we look for­ward to achiev­ing op­er­a­tional ef­fi­cien­cies that can im­prove our abil­i­ty to ful­fill our pub­lic health mis­sion and pro­tect con­sumers,” not­ed Got­tlieb.

None of this is a dra­mat­ic de­par­ture for the FDA. But Got­tlieb is al­so send­ing the mes­sage that busi­ness as usu­al won’t be the theme for his tenure as head of the FDA. His im­me­di­ate pre­de­ces­sor, Robert Califf, of­fered a quick thumbs up for get­ting start­ed ear­ly with a re­or­ga­ni­za­tion.

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.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better,

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

As­traZeneca, Mer­ck push block­buster fran­chise to an­oth­er key FDA ap­proval, rel­e­gat­ing a ri­val to sec­ond-fid­dle sta­tus

Prostate cancer patients have another PARP inhibitor option in a matter of days.

Clovis’ Rubraca won its prostate cancer approval on Friday, but data from AstraZeneca and Merck rival Lynparza put a damper on commercial expectations. Now, the FDA has approved Lynparza in the prostate cancer setting, months ahead of its expected decision date.

Lynparza has been approved for patients with metastatic castration-resistant prostate cancer (mCRPC), who carry BRCA or ATM mutations, which account for roughly 20-30% of patients with mCRPC. The approval was based on the late-stage PROfound trial, which found the drug eclipsed the impact of the androgen therapies at reducing the risk of disease progression or death by a sharp 66%.

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An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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Ger­man Mer­ck bests US Mer­ck in UK copy­right tus­sle of Mer­ck v. Mer­ck

Before Merck and Merck, there was only Merck.

A single company was founded as a drugmaker in the pre-Bismarckian days of an industrializing Germany that, in 1891, decided to launch an outpost in New York. It was a successful idea, launching a smallpox vaccine just 7 years later, until World War I, when the US government seized the US branch under the Trading with the Enemy Act, splitting the global corporation in two and setting off a century of intercontinental brand confusion.