Pfizer’s celebrated Covid-19 vaccine freezes many people out — but a rival mRNA team says they thawed out a solution

Franz-Werner Haas, CureVac CEO

November 12, 2020 09:52 AM ESTUpdated 10:14 AM

Pfizer’s celebrated Covid-19 vaccine freezes many people out — but a rival mRNA team says they thawed out a solution

John Carroll

Editor & Founder

Once the euphoria began to wane a bit following Pfizer’s dramatic unveiling of a 90%-plus effectiveness rate from its pivotal Covid-19 vaccine study earlier this week, less affluent countries and regions around the world began to wonder if they would ever be able to get in line for it.

The vaccine has to be shipped in -70 degrees celsius temps and then used within 5 days of being thawed. For distributors in China, that means building a unique distribution system to deliver the first dose and then a booster. And there are plenty of countries that say they can’t afford to go that route — adding a big obstacle in front of a huge logistical challenge.

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July 27, 2021 07:03 AM EDT

R&D

In Focus

How one startup foretold the neuroscience renaissance after '50 years of shitshow'

Max Gelman

Editor

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

July 26, 2021 07:36 AM EDTUpdated 08:11 AM

R&D

Denali slips as a snapshot of early data raises some troubling questions on its pioneering blood-brain barrier neuro work

Max Gelman

Editor

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is Oncology Drug Development Research Late to the Digital Biomarkers Game?

Tyler Guthrie

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

ENDPOINTS CAREERS

Director-Regulatory

Icosavax, Inc.

Seattle, WA, USA

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Art Levinson (Calico)

July 27, 2021 10:58 AM EDTUpdated 11:14 AM

Deals

R&D

Google-backed Calico doubles down on anti-aging R&D pact with AbbVie as partners ante up $1B, start to detail drug targets

John Carroll

Editor & Founder

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

July 27, 2021 07:07 AM EDT

R&D

Manufacturing

BioNTech is spearheading an mRNA vaccine development program for malaria, with a tech transfer planned for Africa

John Carroll

Editor & Founder

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

July 27, 2021 04:47 PM EDTUpdated 05:04 PM

Deals

Amgen bellies back up to the M&A table for another biotech buyout, this time with a $2.5B deal for an antibody player focused on PSMA

John Carroll

Editor & Founder

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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July 26, 2021 10:08 AM EDT

R&D

Eyeing quick approval, AbbVie offers a close-up on their presbyopia drug data

John Carroll

Editor & Founder

AbbVie picked up some bonus points earlier this year as one of its pipeline adds from the $63 billion Allergan buyout hit its top-line marks. And now the researchers have produced the detailed data on the case they are making with regulators, with an eye on a major new market and a hoped-for approval before New Year’s.

AGN-190584 is aiming to be the first easy-on eyedrop for presbyopia, a common ailment for large numbers of people who find it harder and harder to read things like a watch or cell phone close up. Anyone who’s held a book out at arm’s length in order to read it will be very familiar with the condition, if not the exact diagnosis.

ENDPOINTS CAREERS

Director, High-Throughput Screening (HTS) Drug Discovery Group

Pliant Therapeutics

South San Francisco, CA, USA

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July 27, 2021 10:08 AM EDTUpdated 01:20 PM

R&D

Pharma

FDA+

UPDATED: Panel of neuroscience experts lays out the complications with using Biogen's new Alzheimer's drug

Zachary Brennan

Senior Editor

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Christophe Weber, Takeda CEO (Kyodo via AP Images)

July 27, 2021 09:22 AM EDTUpdated 10:42 AM

Deals

R&D

Takeda fleshes out CNS pact with peptide drugmaker, setting aside $3.5B in future milestones

Kyle Blankenship

Managing Editor

One of a suite of drugmakers looking to reinvest in the neuroscience space, Takeda has been aggressive in signing on new partners to help build up its pipeline in that space. But sometimes the best partner is the one you already have.

Takeda will set aside $3.5 billion in future milestones and an undisclosed upfront payment to build out its drug discovery deal with Japanese peptide conjugate maker PeptiDream, adding neurodegeneration to the partnership’s list of CNS targets, the companies said Tuesday.

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