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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MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

Innovative MedTech Demands Specialist Clinical Trial Regulatory Affairs and Design

Tom Avery

Scientific and Medical Affairs Specialist, Medical Devices

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

August 13, 2022 06:00 AM EDT

Weekly

Historic drug pricing reforms pass; Pfizer acquires GBT; The long search for non-opioid pain drugs; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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August 12, 2022 09:19 AM EDT

R&D

Pharma

Gold for adults, silver for infants: Pfizer's Prevnar 2.0 headed to FDA months after Merck's green light

Kyle LaHucik

Associate Editor

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Experimental Drug Development Centre

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August 12, 2022 07:22 AM EDT

Pharma

Novartis reports two patient deaths after treatment with Zolgensma

Amber Tong

Senior Editor

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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August 12, 2022 12:47 PM EDTUpdated 02:10 PM

Pharma

FDA+

FDA approves second indication for AstraZeneca and Daiichi's Enhertu in less than a week

Aayushi Pratap

News Reporter

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Benjamin Oakes, Scribe Therapeutics CEO

August 12, 2022 07:46 AM EDTUpdated 01:01 PM

Cell/Gene Tx

CEO of Doudna spinout: Within five years, genome editors will have a 'really big impact' on patients' lives

Zachary Brennan

Senior Editor

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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Elcin Barker Ergun, Menarini Group CEO

August 11, 2022 09:32 AM EDTUpdated 01:57 PM

Pharma

FDA+

Amid Roche and Sanofi's oral SERD setbacks, Menarini gets speedy review at FDA

Kyle LaHucik

Associate Editor

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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Boston, MA, USA

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August 12, 2022 05:36 PM EDTUpdated 31 minutes ago

Law

House passes historic drug pricing reforms, lining up decades-in-the-making win for Biden and Democrats

Zachary Brennan

Senior Editor

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

August 12, 2022 02:02 PM EDTUpdated 03:16 PM

Pharma

Law

Senate Finance chair continues his investigation into pharma taxes with requests for Amgen

Zachary Brennan

Senior Editor

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.