GSK’s ‘breakthrough’ BCMA cancer drug gets a priority review — and a big win for the oncology R&D team
John Carroll
Editor & Founder
After largely whiffing the past 2 years on the pharma R&D front, GlaxoSmithKline research chief Hal Barron has seized boasting rights to a key win that puts them back in the cancer drug development game.
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5AM Ventures: Fueling the Next Generation of Innovators
Brian Abrahams
Managing Director and Co-Head of Biotechnology Equity Research
By RBC Capital Markets With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures
Key Points
Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.
What does $29B buy you in Big Pharma? In GlaxoSmithKline’s case, a whole lot of uncomfortable questions about the pipeline
John Carroll
Editor & Founder
Talk about your bad timing.
A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.
And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.
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Fast on GlaxoSmithKline's heels, Aurinia wins OK to steer a second lupus nephritis drug straight to the market
Amber Tong
Senior Editor
GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.
Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.
Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.
Eli Lilly's antibody cuts risk of Covid-19 by up to 80% among the most vulnerable — but will it have a place next to vaccines?
Amber Tong
Senior Editor
Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.
But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.
Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.
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Endpoints poll: Janet Woodcock takes the (interim) helm at the FDA. And a large majority of our readers want her to stay there
Amber Tong
Senior Editor
It’s official: Janet Woodcock is now the acting chief of the FDA.
And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.
To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.
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What’s next for Endpoints — and how to support our independent biopharma news mission
Arsalan Arif
Publisher & Founder
The firehose of biopharma news is gushing these days.
That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.
Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)
Yale cancer specialist Charlie Fuchs tapped as new global development chief for Roche/Genentech
John Carroll
Editor & Founder
Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.
I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.
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Can a new CRISPR technique unlock the secrets of how cancer spreads?
Jason Mast
Editor
Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.
The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.
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GlaxoSmithKline scraps a LAG3 study, marking another failure for the pipeline after a critical setback
John Carroll
Editor & Founder
Another gap has appeared in GlaxoSmithKline’s pipeline.
Friday morning the Australian biotech Immutep put out word that Hal Barron’s R&D group at GSK had decided to scrap a Phase II proof-of-concept study in ulcerative colitis for their anti-LAG3 therapy GSK2831781. According to the biotech, the program didn’t survive an interim review.
The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.
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