Plus the top stories of the week

This Week

Sep 29, 2023

FDA's no-holds barred objection to BrainStorm's NurOwn on display days before advisory panel rejects the ALS cell therapy


As RSV vaccine showdown looms, Pfizer's Abrysvo wins CDC blessing for maternal protection


AstraZeneca, Daiichi hit first goal in pivotal breast cancer ADC trial, teeing up filings to challenge Gilead


Seagen and Astellas' Padcev, in Keytruda combo, delivers 'practice-changing' bladder cancer win


Rockley Photonics plows ahead in developing noninvasive glucose sensor


J&J, IBM face class-action lawsuit over patient data breach

 

Featured

FDA's no-holds barred objection to BrainStorm's NurOwn on display days before advisory meeting

“Scientifically incomplete.” “Grossly deficient.” “Lacking scientific rigor.” These are just a few of the ways the FDA has described BrainStorm Cell Therapeutics’ application for the amyotrophic lateral sclerosis treatment NurOwn—a therapy that has already been rejected twice and is now getting its day before an agency advisory committee meeting after being filed over protest.
 

Top Stories

BrainStorm's ALS cell therapy resoundingly rejected by FDA advisers

FDA advisers voted down BrainStorm's cell therapy for ALS, saying that there was not enough evidence to demonstrate the treatment's potential efficacy. The committee also raised issues with the lack of data on the company's manufacturing and delivery process.

As RSV vaccine showdown looms, Pfizer's Abrysvo wins CDC blessing for maternal protection

While GSK’s Arexvy was first out the gate in this summer’s respiratory syncytial virus (RSV) vaccine race, Pfizer has kept the pressure up with its rival shot Abrysvo. Now, as the RSV season creeps up, Pfizer’s vaccine has received a formal endorsement from the CDC to be used during pregnancy to protect infants.

AstraZeneca, Daiichi hit first goal in pivotal breast cancer ADC trial, teeing up filings to challenge Gilead

AstraZeneca and Daiichi Sankyo are coming for Gilead Sciences' breast cancer business. The partners plan to file for approval of datopotamab deruxtecan (Dato-DXd) after linking their antibody-drug conjugate to improved outcomes, although the immature overall survival data leave a key question unanswered.

Seagen and Astellas' Padcev, in Keytruda combo, delivers 'practice-changing' bladder cancer win

In a critical win, the Padcev-Keyturda combo significantly reduced the risk of death in first-line bladder cancer patients who are eligible for platinum-based chemotherapy at an interim analysis of the closely watched EV-302 trial.

Rockley Photonics plows ahead in developing noninvasive glucose sensor

Hot on the heels of study data showing that its cuffless blood pressure monitor is well on its way to reaching desired accuracy levels, Rockley Photonics is boasting similar progress in the development of another of its biosensor technologies—this one to monitor blood sugar levels for people with diabetes.

J&J, IBM face class-action lawsuit over patient data breach

As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach.

AbbVie axes Caribou CAR-T deal, continuing cascade of punted cancer pacts

AbbVie has decided it can do without Caribou Biosciences. The Big Pharma is terminating its off-the-shelf CAR-T pact with Caribou, depriving the biotech of the chance to pocket up to $350 million in milestones per program.

NFL star Travis Kelce teams up with Pfizer to run a new educational COVID vaccine campaign

Kansas City Chiefs tight end Travis Kelce has recently been the subject of rumors regarding his romantic involvement with singer Taylor Swift, but there is no doubt when it comes to his new pharmaceutical partnership.

Hydrogel formulation of HIV drug extends treatment longevity to 6 weeks in mice

Researchers have developed a new injectable hydrogel that maintains plasma concentrations of a common HIV drug, lamivudine—also known as 3TC—for six weeks in mice. Eventually, the scientists hope to add other HIV drugs given alongside 3TC to the same hydrogel, so they can all be administered at once. 

Glenmark solves its 'decade-long' debt problem with $681M sale of API unit to Nirma

By divesting 75% of its API business, Glenmark has finally resolved its debt problem, described by an Indian news outlet as a “decade-long troubled affair.”
 
Fierce podcasts

Don’t miss an episode

'Podnosis': Breaking down barriers to cancer screenings

In this week's episode of "Podnosis," Heather Landi from Fierce Healthcare engages in a conversation with Othman Laraki, co-founder and CEO of Color Health. They delve into strategies for boosting screenings and explore the partnership between Color Health and the American Cancer Society, aimed at making convenient cancer screenings more accessible.
 

Resources

eBook

Improving yield and reproducibility with advanced sample prep

Learn how to get better results from suboptimal biospecimens for NGS and protein analysis.
Whitepaper

Real-world data: The new growth guide for biotech and pharma in 2023

As the field of real-world data and evidence is constantly evolving, it can be hard to keep-up with best practices. Do you know the definitive characteristics of a high-quality dataset? What questions to ask if you decide to outsource your research to consultants? Here’s everything you need to know in one, must-have guide.

Whitepaper

Achieving Excellence in Tender and Deal Management

Read this paper to learn how pharmaceutical and medical device manufacturers can improve their tender and deal management, as well as how to choose a global management platform and the best practices for implementing it.
eBook

An Introduction to Organ-on-a-Chip Technology

Emulate in vivo biology with next-generation in vitro technology.
Whitepaper

Five strategies for enlivening the legacy biopharma campus

Discover five creative and innovative ways to reimagine your legacy biopharma campus and unlock value.

Whitepaper

Five ways to get the most from your lab and manufacturing facilities

Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives.

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The UX of Rx: Helping Consumers Overcome Adherence Barriers

Learn how pharma marketers and other players in the industry can ease the way for consumers, ultimately improving health outcomes and boosting adherence in five simple steps.
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Unlock potential in buffer preparation

Learn how outsourcing the buffer preparation can reallocate resources to support core activities of your bioprocess production.
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What Are the Benefits of Generative AI for Pharma?

From trial site feasibility and patient populations to data analysis, generative AI has the potential to revolutionize drug discovery and clinical trial recruitment at both the therapeutic area and indication level.
Whitepaper

Discovering High-Affinity, Functional Anti-GLP-1R Antibodies

Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties.
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Closing the Knowledge Gap for Cancer Patients: 3 Ways to Boost Condition, Treatment and Support Awareness

Learn how to close the knowledge gap for cancer patients by increasing awareness of important aspects of their condition, treatment options and support resources.
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Transitioning from using RUO to cGMP chemicals for clinical trials

By 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially.
Whitepaper

Biotech in the UK: Mapping the Runway to Success

15 biotech executives from the Cambridge area discuss the current biotech landscape, as well as challenges, opportunities, and best practices for emerging biotech companies seeking success in the UK and beyond.
 

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