Sanofi’s oncology R&D group marks a pair of setbacks on isatuximab/Libtayo combo as cancer studies fizzle out

October 31, 2019 08:30 AM EDTUpdated October 31, 11:17 PM

Sanofi's oncology R&D group marks a pair of setbacks on isatuximab/Libtayo combo as cancer studies fizzle out

John Carroll

Editor & Founder

Sanofi’s cancer R&D group has suffered a setback with the failure of a pair of clinical trials matching their CD38 contender isatuximab with Regeneron’s PD-1 checkpoint Libtayo (cemiplimab) for non-small cell lung as well as prostate cancers.

All we know from the pharma giant is contained in a brief mention of the burial in their Q3 report out Thursday, noting that the combination studies were iced after investigators found that they had fizzled on the efficacy side. Safety was not an issue.

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March 1, 2021 05:22 PM ESTUpdated March 2, 06:22 AM

Pharma

Regulatory

UPDATED: Merck pulls Keytruda in SCLC after accelerated nod. Is the FDA getting tough on drugmakers that don't hit their marks?

Kyle Blankenship

Managing Editor

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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March 3, 2021 08:33 AM EST

Deals

The 2021 top 100 biopharma investors: As the pandemic hit and IPOs boomed, VCs swung into action like never before

John Carroll

Editor & Founder

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Hal Barron, Endpoints UKBIO19

March 3, 2021 10:48 AM EST

R&D

Coronavirus

GSK, Vir's hopes for a Covid-19 antibody fall flat in NIH 'master protocol' with no benefit in hospitalized patients

Kyle Blankenship

Managing Editor

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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March 3, 2021 10:23 AM EST

R&D

As BrainStorm continues to tout ‘clear signal’ on ALS drug, the FDA offers a rare public slapdown on the data

John Carroll

Editor & Founder

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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March 3, 2021 08:10 AM ESTUpdated 09:15 AM

R&D

Eli Lilly claims success in a new JAK indication: hair loss

Jason Mast

Editor

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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March 2, 2021 07:03 AM ESTUpdated 3 hours ago

Publisher's note

Introducing Endpoints FDA+, our new premium weekly regulatory news report led by Zachary Brennan

Arsalan Arif

Publisher & Founder

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

March 3, 2021 07:21 AM ESTUpdated 08:12 AM

Deals

Thank you, next: Takeda hands Ovid $196M cash to rein back in Phase III-ready seizure drug, reviving battered stock

Amber Tong

Senior Editor

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Michael Shpigelmacher

March 3, 2021 03:00 AM ESTUpdated 11:42 AM

R&D

Khosla joins bet on unconventional startup looking to send drug delivering robots into the brain

Jason Mast

Editor

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepreneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film “Fantastic Voyage,” the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his and his co-founders’ own accounts, along with some seed cash from friends and family.

Antoine Papiernik, Sofinnova managing director (Business Wire)

March 3, 2021 10:52 AM EST

Financing

Sofinnova Partners stays focused on late-stage deals with a new, $540M crossover fund

John Carroll

Editor & Founder

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.