FDA requires Regeneron, Lilly to monitor variants as a condition of mAb EUAs

March 16, 2021 08:47 AM EDTUpdated March 19, 11:53 AM

FDA requires Regeneron, Lilly to monitor variants as a condition of mAb EUAs

Zachary Brennan

Senior Editor

As part of an effort to shore up public confidence in the FDA’s emergency use authorization processes, the agency on Monday released additional scientific review documents on Eli Lilly’s and Regeneron’s monoclonal antibodies, which were authorized to treat mild to moderate Covid-19.

The newly released letters of authorization, which were updated in late February, show that the agency is increasingly concerned about the ability for certain variants, like B.1.351, the variant first identified in South Africa, to evade the antibody treatments.

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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.

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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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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ENDPOINTS CAREERS

Senior Quality Assurance Compliance Specialist

Lonza

Houston, TX, USA

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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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Vlad Coric, Biohaven CEO

October 4, 2022 03:06 PM EDTUpdated 03:37 PM

Pharma

Vlad Coric charts course for new Biohaven with neuroscience push and Big Pharma vets on board

Nicole DeFeudis

Editor

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

October 4, 2022 02:54 PM EDT

Pharma

Marketing

AstraZeneca debuts annoying purple ‘Phil’ creatures, personified asthma eosinophils ‘behaving badly’

Beth Snyder Bulik

Senior Editor

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

October 3, 2022 02:38 PM EDT

Pharma

FDA+

Big Pharma heavyweights seek tweaks to FDA's clinical outcome assessment guidance

Zachary Brennan

Senior Editor

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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ENDPOINTS CAREERS

Head of Quality Systems

Lonza

Lexington, MA, USA

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Robert Califf, FDA commissioner (via AP Images)

October 4, 2022 01:12 PM EDT

FDA+

User fees in action: FDA unveils new shortened supplement review, rare disease pilots

Zachary Brennan

Senior Editor

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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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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