Moderna’s Stéphane Bancel plans to double down on vaccine production, new variants as mRNA rules in pandemic fight

February 24, 2021 04:14 PM ESTUpdated March 1, 12:31 AM

Moderna's Stéphane Bancel plans to double down on vaccine production, new variants as mRNA rules in pandemic fight

Jason Mast

Editor

Stéphane Bancel thought he’d be sleeping more by now.

The 48-year-old Moderna CEO figured that by 2021 he’d have his vaccine through the clinic, authorized, and in mass production — that the hard part would be over. Instead, he’s still working Saturdays and Sundays, talking with his lab and manufacturing teams and fielding calls with two to three world leaders a day to answer their concerns about supply and emerging new variants.

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Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

August 18, 2022 10:00 AM EDT

R&D

In Focus

Those big billion-dollar PhIII studies? Martin Landray says they can be done for a tiny fraction of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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IDC: Life Sciences Firms Must Embrace Digital Transformation Now

James Allgood

Sr Product Marketing Manager, Life Sciences, Egnyte

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

James Dentzer, Curis CEO

August 18, 2022 10:35 AM EDT

R&D

FDA+

FDA lifts partial hold on Curis' lymphoma study — shares spike

Paul Schloesser

Associate Editor

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

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Head of Site Finance mRNA - Cell & Gene

Lonza

Geleen, Netherland

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August 17, 2022 01:45 PM EDTUpdated 4 hours ago

Cell/Gene Tx

FDA approves one of the priciest new treatments of all time — bluebird's gene therapy for beta thalassemia

Zachary Brennan

Senior Editor

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

August 18, 2022 09:10 AM EDT

People

Longtime analyst Geoffrey Porges departs SVB to lead finances at a drug discovery shop

Kyle LaHucik

Associate Editor

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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August 18, 2022 10:30 AM EDT

News Briefing

Astellas' hot flashes drug will get speedy review at FDA; US opts out of Valneva vaccine

Kyle LaHucik

Associate Editor

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

Kate Haviland, Blueprint Medicines CEO

August 17, 2022 11:10 AM EDT

R&D

Blueprint met all its endpoints in bid for expanded Ayvakit label — but stock trends lower anyway

Lei Lei Wu

News Reporter

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

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Head of Quality Systems

Lonza

Lexington, MA, USA

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

August 17, 2022 06:21 AM EDTUpdated 10:49 AM

R&D

Updated: Hit by another PhIII flop, Sanofi culls breast cancer drug — sounding alarm for the class

Amber Tong

Senior Editor

John Carroll

Editor & Founder

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

August 17, 2022 02:17 PM EDT

Pharma

Marketing

Bayer aims to simplify the complexities of CKD with an ABC-themed ad campaign

Beth Snyder Bulik

Senior Editor

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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