Biden's chief science officer for Covid-19 steps down amid dearth of ... - Endpoints News

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David Kessler, outgoing CSO for the Biden administration

January 17, 2023 12:37 PM EST

Zachary Brennan

Senior Editor

David Kessler, the Biden administration’s main subject serviceman for Covid-19, volition measurement down this week amid question marks astir what the adjacent iteration of the Covid vaccine (from booster to price) volition look similar moving forward, and soon aft the admin’s different long-time main aesculapian advisor, Tony Fauci, stepped down.

Buttressed by his FDA commissioner acquisition from 1990-1997, Kessler stood atop the reincarnated mentation of Operation Warp Speed, helping to bring the bivalent booster to millions, arsenic good arsenic millions of caller doses of oral antivirals.

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Stéphane Bancel, Moderna CEO (Joel Saget/AFP via Getty Images)

January 17, 2023 04:05 PM ESTUpdated 05:41 PM

John Carroll

Editor & Founder

There’s a ft contention processing for the pb of a multibillion-dollar vaccine market. And erstwhile again, Moderna $MRNA promises to beryllium close successful the heavy of things arsenic immoderate of the biggest blockbuster players successful biopharma hustle toward the decorativeness line.

After the marketplace closed connected Tuesday, the large biotech, which has been successful the vanguard of the mRNA gyration connected Covid vaccines, enactment retired connection that it had aced its pivotal proceedings for a caller RSV vaccine dubbed mRNA-1345 among older radical supra the property of 60. Moderna CEO Stéphane Bancel headlined the quality with a intelligibly statistically important effect offering 83.7% efficacy successful preventing little respiratory tract illness among radical with 2 oregon much symptoms of disease.

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January 17, 2023 02:34 PM EST

Zachary Brennan

Senior Editor

Although sponsors of crab drugs person historically gone aft the maximum tolerated dose (MTD), peculiarly with chemotherapy, the FDA released caller draught guidance contiguous explaining however that accepted paradigm needs to beryllium tweaked with much targeted crab drugs.

The reforms are indispensable arsenic the FDA notes that this existent paradigm tin effect successful a recommended dosage that is poorly tolerated, adversely impacts prime of life, and whitethorn wounded a patient’s quality to stay connected a drug.

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January 16, 2023 08:59 AM EST

Welcome backmost to Endpoints Weekly, your reappraisal of the week’s apical biopharma headlines. Want this successful your inbox each Saturday morning? Current Endpoints readers can sojourn their scholar profile to adhd Endpoints Weekly. New to Endpoints? Sign up here.

Hello — we cognize it’s not Saturday but Monday, but since Endpoints News is taking a interruption for MLK Day, we thought we’d alteration up the clip this week. Whether you’re recovering from the JP Morgan league similar maine oregon watched from afar, this variation of the Endpoints Weekly has got you covered connected everything you request to cognize from past week. I was thrilled to conscionable immoderate of you successful San Francisco and learned truthful overmuch from conversations, ceremonial oregon informal. It’s been much than 3 years since I’ve stepped ft successful the US (or near Asia!), truthful the travel was other special.

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A kid plays Akili's FDA-approved EndeavorRx video crippled to dainty ADHD.

January 17, 2023 04:11 PM EST

Akili Interactive is axing astir a 3rd of its workforce, the institution revealed past week, portion reorganizing the pipeline astir its FDA-cleared video crippled for attraction shortage hyper enactment upset (ADHD).

CEO Eddie Martucci said successful an internal connection to employees connected Jan. 12 that Akili’s enforcement squad has travel to the “necessary but hard decision” to accidental goodbye to 46 staffers. Those affected person been notified, and each layoffs volition instrumentality spot by the extremity of the quarter, according to an SEC filing.

January 14, 2023 01:06 PM EST

Drew Armstrong

Executive Editor

The FDA and the CDC are investigating a “preliminary signal” of whether determination mightiness beryllium an accrued hazard of changeable for radical who got Pfizer and BioNTech’s updated Covid-19 vaccine booster.

In a statement posted connected the CDC’s website, the bureau said its monitoring strategy for vaccine broadside effects had been triggered to look for a imaginable contented with the shots successful radical ages 65 and older.

Illustration: Assistant Editor Kathy Wong for Endpoints News

January 17, 2023 12:37 PM EST

Beth Snyder Bulik

Senior Editor

Science was the sanction of the crippled successful pharma drugs past twelvemonth — literally. FDA-approved cause names successful 2022 leaned heavy connected subject associations, according to experts. While that’s not unusual, successful a twelvemonth of less approvals than immoderate successful the past six years, the wide naming conventions much often recalled acquainted strategy than breakout surprise.

Why? One of the starring reasons is that it’s conscionable harder to travel up with unique, attribute-related names. In part, that’s due to the fact that they’ve already been trademarked and are off-market, portion the FDA is much discerning astir the overt usage of merchandise attributes oregon imaginable benefits successful marque names.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP Images)

January 17, 2023 11:27 AM ESTUpdated 12:46 PM

Pfizer is doubling down connected its efforts to code wellness inequities, shifting its afloat portfolio to a not-for-profit exemplary successful 45 lower-income countries.

The determination builds connected Pfizer’s “An Accord for a Healthier World” inaugural launched backmost successful May to summation entree to the pharma giant’s drugs and vaccines. While the archetypal pledge lone included 23 patented products disposable successful the US and EU, the latest committedness covers each on- and off-patent brands, bringing the full offering to astir 500 products.

Chris Viehbacher, Biogen CEO (Scott Eells/Bloomberg via Getty Images)

January 17, 2023 11:24 AM ESTUpdated 12:00 PM

Biogen has been connected a roller coaster implicit the past mates of years. It survived the arguable support and disastrous rollout of its archetypal Alzheimer’s cause Aduhelm aft information connected its 2nd cause showed promise. And it got accelerated support earlier this period for that drug, to beryllium marketed arsenic Leqembi.

New CEO Chris Viehbacher is spearheading a caller strategy, hoping to crook Leqembi into a afloat support aboriginal this twelvemonth and march Biogen connected the comeback path. But manufacture analysts person their ain ideas astir what to expect pursuing the yearly JP Morgan Healthcare Conference.

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January 17, 2023 11:24 AM EST

Beth Snyder Bulik

Senior Editor

As Eli Lilly readies for the FDA reappraisal of Alzheimer’s illness campaigner donanemab adjacent month, it’s rolling retired an unbranded, 15-second TV commercialized astir “memory and reasoning issues.” The abbreviated advertisement features a pistillate voiceover asking herself questions including “Did I get eggs?” and “Where are my keys?” Another voiceover chimes successful with: “Memory and reasoning issues support piling up? It whitethorn beryllium much than conscionable mean aging.”

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