‘You have to get up on the podium’: Incoming BIO chair Paul Hastings on diversity, drug pricing and working with the FDA

Paul Hastings (Nkarta)

June 14, 2021 11:16 AM EDT

‘You have to get up on the podium’: Incoming BIO chair Paul Hastings on diversity, drug pricing and working with the FDA

Amber Tong

Senior Editor

Paul Hastings’ day job as CEO of Nkarta has him talking about natural killer cells and their potential applications in cancer. But throughout the pandemic you’ll likely remember him in his other role: As vice chair of BIO, the biotech trade group, he would often sign his name right under chairman (and Ovid CEO) Jeremy Levin, calling for FDA independence, standing up for the right to vote, and encouraging others to speak out.

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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.

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 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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Carl June (Brian Ach/Getty Images for TIME 100 Health Summit)

October 20, 2021 07:53 AM EDT

People

Cell/Gene Tx

Carl June lends 'wings' to Chinese CAR-T startup led by former postdoc, pursuing off-the-shelf approach with CRISPR flavor

Amber Tong

Senior Editor

Carl June still has plenty of energy to bring forth new iterations of CAR-T technology — wherever they’re coming from.

Adding another role to his already lengthy list of titles, June is joining the scientific advisory board at Nanjing Bioheng Biotech, where he will serve as chairman.

The appointment, if slightly out of the ordinary, is both a testament to the fruitfulness of June’s lab at the University of Pennsylvania and China’s increasing appeal to biotech entrepreneurs educated overseas.

October 20, 2021 07:37 AM EDTUpdated 08:25 AM

Coronavirus

Manufacturing

Manufacturing woes for Novavax’s Covid jab badly disrupt plans for rollout to the poor — report

Josh Sullivan

Associate Editor

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

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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October 20, 2021 07:12 AM EDTUpdated 09:01 AM

Pharma

Breaking: Biogen sells just $300K worth of Aduhelm in Q3, as questions on long term viability remain

Zachary Brennan

Senior Editor

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more coverage, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. Biogen said on its earnings call that about 120 sites so far have infused at least one patient with Aduhelm, which is priced at $56,000 annually. Morgan Stanley previously predicted about 14,000 patients will access Aduhelm by the end of 2022.

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Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

October 20, 2021 06:32 AM EDT

Coronavirus

Gates Foundation pledges $120M to ramp up generic supply of Merck's Covid-19 pill while activists blast Pfizer's disproportionate power

Amber Tong

Senior Editor

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

October 19, 2021 07:14 AM EDTUpdated 11:16 AM

FDA+

With hundreds of millions spent on failed accelerated approvals, researchers call for faster FDA withdrawals

Zachary Brennan

Senior Editor

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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