Analysts are quick to pan Eli Lilly’s puzzling first cut of positive clinical data for its Covid-19 antibody

Dan Skovronsky, Eli Lilly CSO

September 16, 2020 07:16 AM EDTUpdated September 17, 12:03 AM

Analysts are quick to pan Eli Lilly's puzzling first cut of positive clinical data for its Covid-19 antibody

John Carroll

Editor & Founder

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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March 1, 2021 05:22 PM ESTUpdated 21 hours ago

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Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the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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Michael Shpigelmacher

March 3, 2021 03:00 AM ESTUpdated 03:20 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 entrepeneur 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 own account, along with some seed cash from friends and family.

March 2, 2021 09:45 AM EST

Coronavirus

Manufacturing

After bailing on Covid-19 vaccines, Merck will team up with J&J to produce its shot as part of unusual Big Pharma pact

Kyle Blankenship

Managing Editor

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Paul Sekhri

March 2, 2021 08:00 AM ESTUpdated 09:10 AM

Financing

R&D

The next big biotech superstar? Paul Sekhri has some thoughts on that

Jason Mast

Editor

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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February 27, 2021 06:30 PM ESTUpdated February 28, 06:52 PM

Regulatory

Coronavirus

UPDATED: Feds clear the road for J&J to start delivering millions of doses of their Covid-19 vaccine — but frets linger about runner-up status

John Carroll

Editor & Founder

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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Amit Munshi, Arena

March 2, 2021 05:44 PM EST

R&D

One of Arena's top drugs flops in a PhIIb study for IBS pain. But researchers tease out a possible path forward as CEO explores 'strategic options'

John Carroll

Editor & Founder

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

March 2, 2021 05:17 PM ESTUpdated 05:34 PM

Manufacturing

With stars aligned and cash in reserve, Bob Nelsen's Resilience plans a makeover at 2 new facility additions to its drug manufacturing upstart

John Carroll

Editor & Founder

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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CEO Marco Taglietti (Scynexis)

March 2, 2021 10:48 AM EST

R&D

'Never been more urgent:' Scynexis looks to tackle superbug crisis with late-stage readout for antifungal hopeful

Nicole DeFeudis

Associate Editor

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

March 2, 2021 10:32 AM EST

R&D

A spotlight schizophrenia drug in Neurocrine's $2B Takeda deal flunks its first major test. But it's not giving up yet

Amber Tong

Senior Editor

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).