FDA+ roundup: FDA chief scientist departs to be deputy surgeon general; New transparency on oncology accelerated approvals

Denise Hinton, FDA

November 3, 2021 12:32 PM EDTUpdated 12:47 PM

FDA+ roundup: FDA chief scientist departs to be deputy surgeon general; New transparency on oncology accelerated approvals

Zachary Brennan

Senior Editor

Another senior leader at the FDA has moved on, and this time it’s FDA’s chief scientist Denise Hinton, a nearly 20-year agency veteran who has now moved over to serve as deputy surgeon general.

Rear Admiral Hinton, who first joined FDA in 2002, served as FDA’s chief scientist from July 2017 through October, and previously served as deputy director of the FDA’s Office of Medical Policy in the Center for Drug Evaluation and Research, where she concurrently served as Acting OMP Director from 2014 to 2016.

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Alexander Lefterov/Endpoints News

January 25, 2022 07:10 AM ESTUpdated 01:20 PM

R&D

In Focus

A new cancer immunotherapy brings cautious hope for a field long awaiting the next big breakthrough

Jason Mast

Editor

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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January 26, 2022 06:26 AM EST

FDA+

Days after Gilead yanks PI3K drug, Incyte withdraws NDA for its own PI3K — saying confirmatory trials would take too long

Amber Tong

Senior Editor

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

January 25, 2022 08:57 PM ESTUpdated 05:37 AM

R&D

FDA+

In a setback, FDA orders Gilead to hit the brakes on their late-stage, $5B cancer play

John Carroll

Editor & Founder

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Associate Director, Program Management - Cell & Gene Therapy Manufacturing

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Portsmouth, NH, USA

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Dominic Borie, Kyverna Therapeutics CEO

January 26, 2022 06:27 AM EST

Financing

Cell/Gene Tx

Well-connected, Gilead-backed biotech gets another stack of cash to pursue CAR-Ts for autoimmune disease

Josh Sullivan

Associate Editor

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Graphic: Alexander Lefterov for Endpoints News

January 25, 2022 01:19 PM ESTUpdated 2 hours ago

In Focus

Marketing

Small biotechs with big drug ambitions threaten to upend the traditional drug launch playbook

Amber Tong

Senior Editor

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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January 25, 2022 12:49 PM EST

Pharma

Marketing

MarketingRx roundup: Pfizer debuts Prevnar 20 TV ads; Lilly gets first FDA 2022 promo slap down letter

Beth Snyder Bulik

Senior Editor

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

January 24, 2022 07:19 AM ESTUpdated 08:15 AM

R&D

FDA bats back Merck’s ‘pipeline in a product,’ demands more efficacy data

John Carroll

Editor & Founder

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Director, Business Development, Cell & Gene Therapies

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

January 24, 2022 06:54 AM ESTUpdated 11:11 AM

R&D

UPDATED: Pfizer fields a CRL for a $295M rare disease play, giving rival a big head start

John Carroll

Editor & Founder

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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January 25, 2022 09:30 AM ESTUpdated 04:11 PM

FDA+

UPDATED: FDA slams Eli Lilly's 'misleading' Instagram ad for its type 2 diabetes injection

Zachary Brennan

Senior Editor

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.