In a first, FDA warns a researcher for failing to submit data 3 years after trial completion

Andrey Petrikovets

September 10, 2021 09:51 AM EDTUpdated 10:27 AM

In a first, FDA warns a researcher for failing to submit data 3 years after trial completion

Josh Sullivan

Associate Editor

For the first time ever, the FDA has threatened an individual clinical trial investigator with a fine after he failed to publish trial data on a government database. The warning is part of a wider attempt to hold researchers and companies accountable for submitting trial results after trials finish.

Andrey Petrikovets, a surgeon from Los Angeles, ran a study on pain drug regimens following vaginal pelvic floor reconstructive surgery, but failed to publish results on time, the FDA said in a warning letter posted this week.

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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 16, 2021 06:00 AM EDT

Weekly

Covid-19 vaccine boosters earn big thumbs up, but Moderna draws ire over world supply; What's next for Merck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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October 15, 2021 10:21 AM EDTUpdated 11:05 AM

R&D

Novartis development chief John Tsai: 'We go deep in the new platforms'

John Carroll

Editor & Founder

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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October 15, 2021 04:03 PM EDT

Pharma

FDA+

Roche's Tecentriq crosses the finish line first in adjuvant lung cancer, potentially kicking off gold rush

Kyle Blankenship

Managing Editor

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

October 14, 2021 11:07 AM EDTUpdated 11:32 AM

Startups

A star Stanford professor leaves his lab for a startup out to remake psychiatry

Jason Mast

Editor

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

October 14, 2021 10:55 AM EDTUpdated October 15, 03:10 PM

R&D

AstraZeneca oncology R&D chief Susan Galbraith: 'You're going to need orthogonal combinations'

John Carroll

Editor & Founder

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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October 15, 2021 03:20 PM EDTUpdated 04:52 PM

FDA+

FDA adcomm votes unanimously in support of a J&J Covid-19 booster two months after one-dose shot

Nicole DeFeudis

Editor

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

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October 15, 2021 10:22 AM EDT

FDA+

Incyte yanks EU application for PD-1 drug, citing inability to answer regulators' 'major concerns'

Kyle Blankenship

Managing Editor

Hoping to wedge its way into a crowded PD-(L)1 field, Incyte faced a huge setback when the FDA sent back its application for an initial indication earlier this year. Now, the drugmaker is giving up hope in Europe as well.

Incyte has withdrawn its EU application for PD-1 drug Zynyz, or retifanlimab, after saying it couldn’t adequately address the CHMP’s questions over survival data underpinning its market hopes in squamous cell carcinoma of the anal cavity, the EMA revealed.

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October 14, 2021 03:37 PM EDT

FDA+

Coronavirus

FDA's vaccine adcomm unanimously supports Moderna's booster in same populations as Pfizer's booster

Zachary Brennan

Senior Editor

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.