Sanofi sends Revolution's lead asset to the docks

Today's Big News

Dec 8, 2022

Novartis takes another swipe at AstraZeneca's rare disease gems Soliris and Ultomiris


Vertex pays Entrada $224M for preclinical rare disease drug, opening new front in assault on dystrophy


Sanofi sets Revolution back, sending $550M SHP2 inhibitor deal to the docks


Relmada rails against depression data both 'implausible' and 'unplausible' in latest phase 3 flunk


Instil Bio takes the ax to its lead asset, cutting 60% of its staff in the process


Califf wants more diversity in clinical trials. We just have to overcome the health care system itself


Life sciences M&A values halve, volumes plunge. Will we ever see deals pick up again?


Following Biden's cancer pledge, European orgs launch a moonshot of their own focused on rare diseases

 

Featured

Novartis takes another swipe at AstraZeneca's rare disease gems Soliris and Ultomiris

Novartis is hoping to be appointed leader in a rare blood disease, and the latest data that iptacopan increases hemoglobin levels in patients with a disease called paroxysmal nocturnal hemoglobinuria should help.
 

Top Stories

Vertex pays Entrada $224M for preclinical rare disease drug, opening new front in assault on dystrophy

Vertex has opened another front in its attempt to treat a rare cause of muscle weakness, paying Entrada Therapeutics $224 million upfront for the preclinical prospect ENTR-701.

Sanofi sets Revolution back, sending $550M SHP2 inhibitor deal to the docks

Back in 2018, Revolution Medicines launched its SHP2 inhibitor with a splash thanks to a $550 million licensing deal with Sanofi. But, after four years, Sanofi is docking the deal.

Relmada rails against depression data both 'implausible' and 'unplausible' in latest phase 3 flunk

In a statement that calls the results “implausible” four times, and “unplausible” once, Relmada made the case that its RELIANCE I study was undone by data from two high-enrolling sites.

Instil Bio takes the ax to its lead asset, cutting 60% of its staff in the process

Instil Bio is looking to install a new path forward, culling its lead asset and laying off 60% of its staff. But dosing remains paused in the phase 1 trial of the company's now-sole clinical-stage med.

Califf wants more diversity in clinical trials. We just have to overcome the health care system itself

As the FDA prepares updated guidance on ways to boost clinical diversity for research trials, the agency’s head is urging administrators to prioritize the issue.

Life sciences M&A values halve, volumes plunge. Will we ever see deals pick up again?

PwC is out today with its annual rundown of deals to date and what’s to come in the year ahead, finding that life sciences M&A volume was down by 48% this year while valuations plunged 28%.

Following Biden's cancer pledge, European orgs launch a moonshot of their own focused on rare diseases

Following President Joe Biden's cancer initiative, European organizations are launching a moonshot of their own aimed at rare diseases. A coalition of seven European organizations hopes to accelerate the development of new therapies and improve clinical trials.

Sitero, CRIO partner to streamline clinical trial data for sites and sponsors

Florida-based CRO Sitero is partnering with healthcare technology firm CRIO to help streamline clinical trial data that can bog down sites and sponsors.

Theranos' Sunny Balwani lands 13-year fraud sentence after ex-partner Elizabeth Holmes gets 11 years

Ramesh “Sunny” Balwani was sentenced to nearly 13 years in prison for the part he played in defrauding investors and patients while helping lead blood testing startup Theranos, a federal judge ruled Wednesday.

FDA looks to pull approval for Oncopeptides' troubled multiple myeloma drug Pepaxto

The odd saga of Oncopeptides' multiple myeloma drug—thriving in Europe while sidelined in the U.S.—continued Wednesday with the FDA requesting a withdrawal of the U.S. marketing authorization for Pepaxto.

Amazon shuts down support for Alexa HIPAA-compliant programs for hospitals, payers

Amazon will no longer support HIPAA compliance on its Alexa devices after launching a program three years ago for some hospitals and payers.

Merck escapes nearly 1,200 Zostavax shingles vaccine lawsuits as plaintiffs' testimony falls short

Plaintiffs in the now-dismissed clutch of cases argued Merck's vaccine Zostavax caused their shingles. But the medical expert attempting to back up that claim failed to consider whether plaintiffs’ disease occurred naturally because they’d had chickenpox as kids, according to court filings published this week.

Apple wins battle in patent war with AliveCor over portable ECG tech

More than a year into its patent dispute with Apple over the heart-monitoring technology embedded in the tech giant’s eponymous smartwatch, AliveCor has been dealt a serious blow.
 
Fierce podcasts

Don't miss an episode

'The Top Line': Biogen's new CEO, plus this week's headlines

This week on “The Top Line,” we discuss the current state of Biogen and recent investor reactions to the new hire. Plus we cover the week's news including: What Albert Bourla said that has him in hot water, a $3.5 million drug, and we tease a possible major acquisition. 

 

Resources

Video

Discover the future of mAb manufacturing

Revolutionize your monoclonal antibody (mAb) manufacturing with expert insights.
Whitepaper

Enhance the cost-effectiveness of your chemical supply chain

Learn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific.
Whitepaper

Plan for scalable process liquid and buffer preparation

Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.
Webinar

Webinar: Writing the Future of Antibody Discovery Solutions

Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

Executive Summary

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.

Whitepaper

Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?
Whitepaper

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.

Whitepaper

Intranasal Drug Product Development: Formulation to Manufacturing

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

Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.
Whitepaper

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.
Whitepaper

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.
Research

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.

 

Industry Events

 

Upcoming Fierce Events

10
Jan
San Francisco, CA
17-19
Jan
Virtual Event
27-28
Feb
Arlington, VA
14-15
Mar
San Francisco, CA
20-22
Mar
West Palm Beach, FL

View all events