Vertex's CRISPR tech nabs EMA nod

Today's Big News

Jan 25, 2023

Matt Gline wants you to stop thinking of Roivant as a discard company. In 2023, he'll prove it


Bristol Myers CMO still skeptical about cancer vaccines as BioNTech, Moderna march ahead with I-O partners


EMA validates Vertex's CRISPR application, clearing barrier on road to landmark approval


Cidara wins ‘difficult’ AdComm vote, securing near-unanimous support despite antifungal data doubts


Inhibikase, FDA find common ground to lift hold on Parkinson's drug


Creating a new dimension: Biotech VC merging tech and life sciences unveils with $350M


KSQ scores 'double-digit million' payment from Japan's Ono for preclinical cancer programs

 

Featured

Matt Gline wants you to stop thinking of Roivant as a discard company. In 2023, he'll prove it

Entering his third year on the job, Roivant CEO Matt Gline is pushing back against the company's reputation as a discard company fishing for projects to rebuild.
 

Top Stories

Bristol Myers CMO still skeptical about cancer vaccines as BioNTech, Moderna march ahead with I-O partners

Moderna and BioNTech recently reported positive early clinical data for their mRNA cancer vaccine in partnership with PD-1/L1 inhibitors. But as over a decade of research has failed to transpire into approved therapies, several biopharma executives remain on the fence about the future of these vaccines future, while others believe the field is getting closer to finding its sweet spot.

EMA validates Vertex's CRISPR application, clearing barrier on road to landmark approval

Vertex and CRISPR Therapeutics have taken a small step toward a landmark approval, securing European Medicines Agency (EMA) validation of the approval application for their CRISPR-Cas9 candidate.

Enhancing Clinical Trials with More Diverse Recruitment

We initiate a discussion focused on the relation of clinical trials and the need for geographical inclusion versus societal exclusivity. With some trial sites including only 20% of the disease population in the United States, innovation is needed.

Cidara wins ‘difficult’ AdComm vote, securing near-unanimous support despite antifungal data doubts

Cidara Therapeutics has overcome the uncertainties raised by the FDA’s advisory committee to receive near-unanimous backing for its antifungal drug, boosting the prospects of the therapy winning approval in March.

Inhibikase, FDA find common ground to lift hold on Parkinson's drug

After a brief 2.5-month hold, Inhibikase Therapeutics’ Parkinson’s disease therapy is heading back to the clinic.

Creating a new dimension: Biotech VC merging tech and life sciences unveils with $350M

Dimension debuted dramatically today as the first sector specialist firm taking aim at the intersection of tech and the life sciences. With an oversubscribed fund of $350 million in hand, the VC touts the lofty goal of bridging the gap between the present and the future.  

KSQ scores 'double-digit million' payment from Japan's Ono for preclinical cancer programs

Two years after signing a collab with Takeda, KSQ Therapeutics has garnered interest from another Japanese pharma. This time it’s Ono Pharmaceutical, which is handing over a “double-digit million” upfront payment for a number of preclinical oncology programs.

As Scangos bids adieu, Vir taps Bayer dealmaker De Backer as its next CEO

On April 3, George Scangos, Ph.D., who’s been chief executive officer at Vir since the start of 2017, will hand over the reins to Marianne De Backer, Ph.D. De Backer comes over from Bayer, where she currently heads up pharmaceutical strategy, business development and licensing.

Tidepool lands long-awaited FDA nod for app connecting CGMs, insulin pumps for automated diabetes management

More than two years after submitting it for FDA review, Tidepool has scored the agency’s clearance for a smartphone app that allows people with Type 1 diabetes to build their own closed-loop “artificial pancreas” system.

COVID-19 caused surge in heart disease deaths in first year of pandemic: report

Deaths from cardiovascular disease climbed to their highest levels ever in 2020, according to the American Heart Association, reflecting the indirect and direct effects of COVID-19.

UPDATED: Horizon CEO Walbert in line for major payday after Amgen sale

Horizon Therapeutics CEO Tim Walbert has made routine appearances in rankings of the biopharma industry's best-paid executives, and he's set to collect once again with his company's sale to Amgen.

'Podnosis': Fierce's JPM Week panel about big retailers reshaping primary care and Ramita Tandon on Walgreens' drug research plans

In this week's episode of "Podnosis," we take you inside Fierce's JPM Week event. Listen in on snippets from a panel on what big retailers have to gain by moving into healthcare. And hear from Ramita Tandon about Walgreens' strategy around drug development.
 
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'The Top Line': Highlights from Fierce's JPM Week

This week on "The Top Line," we take you inside Fierce's JPM Week event. Listen in on snippets from a lively panel discussion on how companies will navigate the drug pricing policies the Biden administration rolled out just last year. And hear from Christine Roth, head of Bayer's oncology strategic business unit, about the company's plans to become a strong competitor in cancer.

 

Resources

Reduce control arm sizes by up to 35% for Alzheimer's disease

RCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease.

Quality attributes that are important for GMP-grade NTPs

What makes nucleotides suitable for current good manufacturing practices?

Medical Affairs Metamorphosis V: The (R)evolution in Medical Communications

This paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series).

Writing the Future of Antibody Discovery Solutions

See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

Scale-Up Strategies for Late-Stage Cell Therapies

Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more.

Linear Compression vs. Parallel Processing: Speeding Biologics Through Development and Into Clinical Trials

Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more.

Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?

Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.

Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

 

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