Illustration: Assistant Editor Kathy Wong for Endpoints News
February 7, 2023 12:30 PM ESTUpdated 12:53 PM
Pharma
Marketing

Chat­G­PT and gen­er­a­tive AI land in phar­ma mar­ket­ing with sense of awe — and plen­ty of cau­tion

Beth Snyder Bulik

Senior Editor

A professionally dressed woman stands in front of an office background and introduces herself to talk about the use of artificial intelligence in pharma marketing.

Except she’s not a real person. “She” is an AI-generated avatar in a video created in less than a minute using the generative AI application Synthesia along with a typed script from a real person — in this case, a healthcare agency executive showing an example of how a generative AI avatar can work.

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SPONSORED
March 20, 2023 06:00 AM EDT

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

Sean Dodge

Healthcare Technology Analyst, RBC Capital Markets

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

March 25, 2023 06:00 AM EDT
Weekly

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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March 24, 2023 10:37 AM EDT
R&D

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

Zachary Brennan

Senior Editor

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

March 24, 2023 11:40 AM EDTUpdated 05:37 PM
R&D
Pharma

Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Kyle LaHucik

Associate Editor

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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March 22, 2023 06:09 PM EDT
Pharma
FDA+

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

Max Gelman

Senior Editor

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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March 24, 2023 02:40 PM EDTUpdated March 24, 08:22 PM
R&D
Pharma

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Katherine Lewin

News Reporter

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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March 24, 2023 03:19 PM EDTUpdated March 24, 08:35 PM
Pharma
Marketing

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

Beth Snyder Bulik

Senior Editor

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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The Melon family, as seen in Concussion Awareness Now's latest campaign
March 24, 2023 02:17 PM EDT
Pharma
Marketing

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Nicole DeFeudis

Editor

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.

Clay Siegall, Morphimmune CEO
March 23, 2023 07:07 AM EDTUpdated March 24, 02:24 AM
People

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Amber Tong

Senior Editor

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Chat­G­PT and gen­er­a­tive AI land in phar­ma mar­ket­ing with sense of awe — and plen­ty of cau­tion

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech