Scoop: J&J confirms that the FDA put AML drug on complete hold

September 19, 2016 10:05 AM EDT

Scoop: J&J confirms that the FDA put AML drug on complete hold

John Carroll

Editor & Founder

J&J tells Endpoints News that a bispecific antibody it is partnered on with Genmab for acute myeloid leukemia has been put on clinical hold after patients in the trial suffered serious adverse events.

The drug, JNJ-63709178, targets both CD3 and CD123 and was in an early stage study when the hold was instituted, forcing investigators to suspend patient recruitment, according to the clinicaltrials.gov web site. The complete hold, which should stop dosing, followed.

A spokesperson for J&J confirmed the news, but declined to say just what adverse events were seen in the study.

“Janssen R&D temporarily suspended the study on Aug 8; the FDA put it on complete clinical hold effective Aug 16,” says the company spokesperson. “We’re working with the FDA now to address recommended changes to the study. At this point, we don’t have any additional details to share. We’re hoping to resume the study with appropriate guidance from the FDA.”

News of the clinical hold was first raised in a tweet from Evaluate Pharma’s Jacob Plieth.

Severe adverse event -> suspension of $JNJ $GEN CD123 bispecific JNJ-63709178. (H/t Nordea) $NVS $XNCR $MGNX $CLLS pic.twitter.com/4q2bTAhv2d

— Jacob Plieth (@JacobPlieth) September 19, 2016

AUTHOR

John Carroll

Editor & Founder

john@endpointsnews.com @JohnCendpts

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Biotech Halftime Report: After a bumpy year, is biotech ready to rebound?

Brian Abrahams

Co-Head of Biotechnology Research

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

October 21, 2021 11:09 AM EDT

FDA+

How to collect and submit RWD to win approval for a new drug indication: FDA spells it out in a long-awaited guidance

Zachary Brennan

Senior Editor

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

October 20, 2021 03:56 AM EDT

People

Renowned Dana-Farber scientist, mentor and biopharma advisor David Livingston has died

John Carroll

Editor & Founder

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

ENDPOINTS CAREERS

Venture Senior Analyst/Associate

Austin, TX, USA

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David Lockhart, ReCode Therapeutics CEO

October 21, 2021 08:13 AM EDTUpdated 10:51 AM

Financing

Cell/Gene Tx

Pfizer throws its weight behind LNP player eyeing mRNA treatments for CF, PCD

Amber Tong

Senior Editor

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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October 19, 2021 10:35 AM EDT

R&D

Novo CEO Lars Fruergaard Jørgensen on R&D risk, the deal strategy and targets for gender diversity

John Carroll

Editor & Founder

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

October 21, 2021 04:05 PM EDTUpdated 05:18 PM

People

Exclusive: Athira CEO Leen Kawas resigns after investigation finds she manipulated data

Jason Mast

Editor

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Pascal Soriot, AstraZeneca CEO (via Getty images)

October 20, 2021 10:24 AM EDTUpdated 02:12 PM

R&D

UPDATED: FDA slaps AstraZeneca's MCL-1 cancer drug with a hold after safety issue — 2 years after Amgen axed a troubled rival

John Carroll

Editor & Founder

There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

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Rubius Therapeutics

Cambridge, MA, USA

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October 20, 2021 07:26 AM EDTUpdated 07:38 AM

R&D

Discovery

Surgeons successfully attach pig kidney to a human for the first time, using tech from United's Revivicor

Max Gelman

Editor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

October 21, 2021 10:59 AM EDT

FDA+

Senators back FDA's plan to require mandatory prescriber education for opioids

Zachary Brennan

Senior Editor

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.