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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Michel Vounatsos, Biogen CEO (via YouTube)

August 7, 2020 07:47 AM EDTUpdated 10:38 AM

R&D

UPDATED: Biogen scores a priority review for its Alzheimer's drug aducanumab, moving one giant leap forward in its controversial quest

John Carroll

Editor & Founder

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

August 6, 2020 08:42 AM EDTUpdated 02:14 PM

Deals

Biogen hands Denali $1B-plus in cash, $1B-plus in milestones to partner on late-stage Parkinson’s drug

John Carroll

Editor & Founder

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Moncef Slaoui, Getty Images

August 7, 2020 12:54 PM EDT

R&D

Coronavirus

When will it end? Big Pharma's top vaccine expert at OWS offers a speedy timeline for a Covid-19 vaccine — either before or right after the election

John Carroll

Editor & Founder

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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August 7, 2020 10:28 AM EDT

R&D

Perceptive fields SPAC #3 as another group of biotechs scoops up $364M in latest Nasdaq romp

Nicole DeFeudis

Associate Editor

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

August 7, 2020 07:04 AM EDTUpdated 10:55 AM

Coronavirus

Covid-19 roundup: Gates Foundation pours $150M into India’s Serum Institute; Pfizer teams with Gilead on remdesivir

Max Gelman

Associate Editor

Jason Mast

Associate Editor

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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August 7, 2020 06:55 AM EDT

R&D

In surprising setback, combo of Roche’s Tecentriq and chemo fails to help patients with triple-negative breast cancer

Jason Mast

Associate Editor

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

August 6, 2020 07:01 AM EDTUpdated 10:32 AM

R&D

Roche-backed Dicerna pushes into the pack racing toward the blockbuster hep B goal line, armed with PhI data

John Carroll

Editor & Founder

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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ENDPOINTS CAREERS

Director of Clinical Operations

Recursion Pharmaceuticals

Salt Lake City, UT

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August 5, 2020 03:11 PM EDT

R&D

Lundbeck sounds taps on another CNS drug, retreating from a mine field still occupied by a Merck team

John Carroll

Editor & Founder

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

August 3, 2020 01:40 PM EDTUpdated August 4, 03:38 AM

R&D

Coronavirus

When will it end? Goldman economist gives late-stage vaccines a good shot at targeting 'large shares' of the US by mid-2021 — but the downside is daunting

John Carroll

Editor & Founder

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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