Canada hands Sanofi, Regeneron their first OK for sarilumab; Rigel raises $40 million

February 1, 2017 09:53 AM EST

Canada hands Sanofi, Regeneron their first OK for sarilumab; Rigel raises $40 million

Shehla Shakoor

Managing Director

Mark W. Schwartz

• The FDA stiff-armed Sanofi and Regeneron’s rheumatoid arthritis drug sarilumab, but Canadian officials were happy to give the drug its first regulatory green light. The FDA’s CRL was pointed to some manufacturing problems at Sanofi, which it’s been working to overcome. But most analysts expect a near-term US approval.

• Cerulean $CERU went 0 for 2 in Phase II last year, forcing a restructuring that eliminated half of its jobs. Now the company — which had $38 million in cash at the end of September — is following up with a look at its strategic alternatives.

• South San Francisco-based Rigel Pharmaceuticals has rounded up $40 million from a follow-on offering.

• Under investigation for its marketing practices, the biotech microcap Galena Biopharma $GALE has booted CEO Mark Schwartz.

AUTHOR

Shehla Shakoor

Managing Director

shehla@endpointsnews.com @ShehlaShakoor

Shehla Shakoor on LinkedIn

Biotech investors and CEOs see two paths to growth, but are they equally viable?

Noël Brown

Head of US Biotechnology Investment Banking, RBC Capital Markets

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

October 4, 2022 12:55 PM EDT

Pharma

Marketing

MarketingRx roundup: Novartis recruits NFL coach for Leqvio campaign; Pfizer promotes ‘Science’ merch on social media

Beth Snyder Bulik

Senior Editor

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

October 4, 2022 12:55 PM EDT

Pharma

Marketing

Q&A: Novo Nordisk digital innovation chief Amy West discusses pharma pain points and a healthcare 'easy button’

Beth Snyder Bulik

Senior Editor

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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ENDPOINTS CAREERS

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

October 4, 2022 06:00 AM EDTUpdated 11:21 AM

People

Pharma

In Focus

Father starts lab after intellectual property issues stymie rare disease drug development

Jared Whitlock

Features Editor

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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October 4, 2022 11:11 AM EDT

R&D

News Briefing

Astellas, Pantherna add organ to mRNA tie-up; Rocket launches sale of six figures worth of stock

Lei Lei Wu

News Reporter

Tyler Patchen

News Reporter

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Benjamine Liu, TrialSpark CEO

October 4, 2022 11:04 AM EDT

Deals

Pharma

Paul Hudson and TrialSpark's mutual desire to speed up development converges in three-year, six-drug goal

Kyle LaHucik

Associate Editor

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

October 3, 2022 07:31 AM EDTUpdated 02:42 PM

Deals

Updated: AstraZeneca nabs a small rare disease gene therapy player for 667% premium

Max Gelman

Senior Editor

Kyle LaHucik

Associate Editor

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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ENDPOINTS CAREERS

Head of Quality Systems

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Dave Marek, Myovant CEO

October 3, 2022 07:27 AM EDT

Deals

R&D

Myovant board balks as majority owner Sumitomo swoops in with a $2.5B deal to buy them out

John Carroll

Editor & Founder

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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October 4, 2022 10:00 AM EDTUpdated 11:14 AM

Manufacturing

Takeda to pull key hypoparathyroidism drug from the market entirely by end of 2024 after years of manufacturing woes

Zachary Brennan

Senior Editor

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.