Poll: Should Joshua Sharfstein or Janet Woodcock lead the FDA from here?

Janet Woodcock and Joshua Sharfstein (AP, Images)

January 19, 2021 09:38 AM EST

Poll: Should Joshua Sharfstein or Janet Woodcock lead the FDA from here?

John Carroll

Editor & Founder

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Woodcock knows where all the bodies are buried, and did most of the digging herself. Sharfstein is an experienced player who has been an outspoken advocate for greater integrity at the FDA after a period when President Trump routinely bullied his FDA chief, Stephen Hahn.

So who would you pick, and why?

Please be sure to name your pick in the response and then explain. Here’s the link.

AUTHOR

John Carroll

Editor & Founder

john@endpointsnews.com @JohnCendpts

John Carroll on LinkedIn

March 6, 2021 07:36 AM EST

Weekly

The top 100 biopharma VCs, Bob Bradway places $2B bet in cancer, gene editing pioneer's new big idea, and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

March 4, 2021 08:51 AM ESTUpdated March 6, 12:47 PM

Deals

UPDATED: Amgen snaps up cancer drug player Five Prime, adding PhIII-ready FGFR2b drug in $2B M&A play

John Carroll

Editor & Founder

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

March 4, 2021 06:57 AM ESTUpdated March 5, 12:48 AM

Discovery

In Focus

David Liu has a new big idea: proteome editing. It could one day shred tau, RAS and some of the worst disease-causing proteins

Jason Mast

Editor

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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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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March 3, 2021 10:23 AM ESTUpdated March 5, 12:57 PM

Regulatory

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 slapdown, 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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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

March 5, 2021 03:12 PM ESTUpdated 03:36 PM

Deals

Jazz CEO Bruce Cozadd campaigned for 6 months to buy GW Pharma. A 90% premium sealed the deal — along with $17.6M in ‘retention’ incentives

John Carroll

Editor & Founder

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

March 5, 2021 10:03 AM ESTUpdated 12:58 PM

Financing

UPDATED: Not 3 weeks after taking Humacyte public, Rajiv Shukla launches another blank check company

Max Gelman

Associate Editor

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Paul Hudson, Getty Images

March 5, 2021 09:14 AM ESTUpdated 01:33 PM

People

How does Paul Hudson's $13.5M comp package stack up against other CEOs? He's in the 'first quartile'

Nicole DeFeudis

Associate Editor

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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CMO Levi Garraway (Genentech)

March 5, 2021 06:48 AM EST

Pharma

Regulatory

Focusing on the bright side, FDA OKs Roche's Actemra for rare lung disease despite PhIII flop

Amber Tong

Senior Editor

Actemra’s failure to hit the primary endpoint in a Phase III study didn’t stop the FDA from granting Roche priority review. And it’s certainly not standing in the way of a sixth approval for Roche’s IL-6 drug.

Regulators have cleared Actemra, or tocilizumab, for systemic sclerosis-associated interstitial lung disease in adult patients. Roche’s big Genentech subsidiary notes that it is the first biologic approved for this rare disease.