Novartis jumps into Covid-19 vaccine hunt, as Big Pharma and big biotech commit to billions of doses

May 28, 2020 10:25 AM EDT

Novartis jumps into Covid-19 vaccine hunt, as Big Pharma and big biotech commit to billions of doses

Jason Mast

Editor

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by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

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.

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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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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March 2, 2021 09:20 AM ESTUpdated 09:42 AM

Deals

AbbVie tees up a biotech buyout after sizing up their Parkinson's drug spun out of Kevan Shokat's lab

John Carroll

Editor & Founder

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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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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March 2, 2021 07:24 AM EST

Regulatory

FibroGen shares skid lower as a surprise adcomm raises risks on roxa OK

Amber Tong

Senior Editor

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

March 2, 2021 07:08 AM ESTUpdated 09:03 AM

Coronavirus

Covid-19 roundup: AstraZeneca ships first COVAX doses as Canada recommends against 65+ use; Inovio, still stuck in PhIII, to respond to FDA in May

Max Gelman

Associate Editor

AstraZeneca’s Covid-19 vaccine has had a bumpy ride, but the prominent drugmaker is ready to start supplying their shots to COVAX.

The first doses of the AstraZeneca/Oxford vaccine were shipped to Ghana and Cote D’Ivoire, AstraZeneca announced Tuesday, with more set to begin arriving this week in the Philippines, Indonesia, Fiji, Mongolia and Moldova. For many of these countries, these doses represent their first Covid-10 vaccines, AstraZeneca said.