GSK’s ‘breakthrough’ BCMA cancer drug gets a priority review — and a big win for the oncology R&D team

Hal Barron and Emma Walmsley, GSK

January 21, 2020 09:21 AM EST

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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Healthcare Disparities and Sickle Cell Disease

Frank Lee

CEO of Forma Therapeutics

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

September 20, 2021 01:15 PM EDTUpdated 02:06 PM

Bioregnum

Exclusives: Eli Lilly out to crash the megablockbuster PD-(L)1 party with 'disruptive' pricing; reveals cancer biotech buyout

Paul Schloesser

Editorial Intern

John Carroll

Editor & Founder

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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September 21, 2021 03:29 PM EDTUpdated 2 hours ago

People

Bioregnum

So what happened with Novartis' gene therapy group? Here's your answer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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ENDPOINTS CAREERS

Senior Analyst, Oncology

Brass Tacks Health

Remote

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September 21, 2021 06:49 AM EDT

Editor's note

Who are the women supercharging biopharma R&D? Nominate them for this year's special report

Nicole DeFeudis

Editor

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

September 20, 2021 07:55 AM EDT

People

Fresh off FerGene's meltdown, David Meek takes over at Mirati with lead KRAS drug racing to an approval

Kyle Blankenship

Managing Editor

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

September 20, 2021 10:12 AM EDTUpdated 02:59 PM

R&D

In Focus

As Bayer, Novartis stack up their radiopharmaceutical data at #ESMO21, a key debate takes shape

Amber Tong

Senior Editor

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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September 20, 2021 07:30 AM EDT

R&D

Mirati triumphs again in KRAS-mutated lung cancer with a closely watched FDA filing now in the cards

Kyle Blankenship

Managing Editor

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

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Senior Scientific Research Analyst

American Association for Cancer Research

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September 21, 2021 08:16 AM EDTUpdated 10:27 AM

FDA+

When efficacy is borderline: FDA needs to get more consistent on close-call drug approvals, agency-funded research finds

Zachary Brennan

Senior Editor

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Ted White, Verrica CEO

September 21, 2021 07:10 AM EDT

R&D

Verrica hits another bump in the road with CMO related letter from FDA

Josh Sullivan

Associate Editor

The FDA has rejected Verrica’s new drug application for VP-102 again, with the company pinning the CRL on problems at a CMO that it was partnered with, the company announced Monday.

The FDA didn’t raise issues that directly relate to the manufacturing of VP-102, the company said, but raised “general quality issues” at the CMO’s facility. There were also no clinical concerns, it said, or need to collect more data.