Amgen attorneys win a megablockbuster patent case, dealing Novartis a severe setback on biosimilars play

August 10, 2019 08:50 PM EDTUpdated August 12, 05:06 AM

Amgen attorneys win a megablockbuster patent case, dealing Novartis a severe setback on biosimilars play

John Carroll

Editor & Founder

Don’t bet against Amgen attorneys.

That’s what Umer Raffat’s old mentor Mark Schoenbaum told the Evercore ISI analyst when he was prepping for a recent deep dive on Amgen’s Enbrel.

Like other classic remarks about Amgen’s litigious nature, it was dead on.

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March 1, 2021 05:22 PM ESTUpdated 18 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Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the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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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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Pascal Soriot, AstraZeneca CEO (AP Images)

March 1, 2021 06:29 AM ESTUpdated 06:41 AM

Pharma

Pascal Soriot cashes in AstraZeneca’s chips on Moderna for $1.2B cash injection

Amber Tong

Senior Editor

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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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.

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 07:03 AM ESTUpdated 09:33 AM

Publisher's note

Introducing EndpointsFDA+, 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.

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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