FDA requires Regeneron, Lilly to monitor variants as a condition of mAb EUAs
Zachary Brennan
Senior Editor
As part of an effort to shore up public confidence in the FDA’s emergency use authorization processes, the agency on Monday released additional scientific review documents on Eli Lilly’s and Regeneron’s monoclonal antibodies, which were authorized to treat mild to moderate Covid-19.
The newly released letters of authorization, which were updated in late February, show that the agency is increasingly concerned about the ability for certain variants, like B.1.351, the variant first identified in South Africa, to evade the antibody treatments.
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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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October 11, 2021 06:00 AM EDT
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.
Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton
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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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.
Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)
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.
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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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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Bristol Myers pledges to sell its Acceleron shares as activist investors circle Merck's $11.5B buyout — report
Amber Tong
Senior Editor
Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.
The pharma giant is planning to tender its Acceleron shares, Bloombergreported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.
To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.
Booster bonanza: FDA endorses 'mix-and-match' scheme, and Moderna and J&J too
Zachary Brennan
Senior Editor
The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.
On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.
