Sage, Biogen post new ph. 3 depression data

Today's Big News

Oct 17, 2022

Biogen's ALS ambitions on pause as FDA delays approval decision by 3 months

Gilead grabs MacroGenics’ blood-cancer focused bispecific in $1.76B license-option deal

Sage, Biogen post fresh phase 3 depression data as FDA filing nears completion

Things don’t look good for NGM’s Merck-partnered eye asset as phase 2 fail sends stock plummeting

After 2020 flop, Milestone's arrhythmia nasal spray hits in phase 3

Months after slimming its R&D focus, Orion realigns stars in top-down organizational restructure

Game, set, Matchpoint: Sanofi-backed biotech launches with $70M series A to ace covalent molecule wins

 

Featured

Biogen's ALS ambitions on pause as FDA delays approval decision by 3 months

The long and winding road Biogen’s tofersen has taken to FDA approval just got longer, with the agency delaying its decision on the amyotrophic lateral sclerosis drug until April.
 

Top Stories

Gilead grabs MacroGenics’ blood-cancer focused bispecific in $1.76B license-option deal

MacroGenics' decision to pivot its focus to its asset MGD024 appears to have paid off, with Gilead pledging up to $1.7 billion in biobucks for the phase 1 bispecific antibody.

Taking Bold, Growth-Focused Actions During a Time of Economic Volatility in the Biotech Market

Cullinan Oncology’s strategic approach to research and development, focusing on modality-agnostic target oncology, positions the company to thrive.

Revealing new insights from the Tumor Microenvironment with AI-powered digital pathology

TME research is recognized as one of the most promising areas in oncology drug development. AI-powered digital pathology reveals new insights previously hidden by laborious manual pathology methods.

Sage, Biogen post fresh phase 3 depression data as FDA filing nears completion

Sage Therapeutics and Biogen have shared a closer look at phase 3 data on zuranolone in postpartum depression, presenting secondary endpoint results from SKYLARK while racing to wrap up a filing for FDA approval.

Things don’t look good for NGM’s Merck-partnered eye asset as phase 2 fail sends stock plummeting

As NGM Biopharmaceuticals’ phase 2 trial misses the mark, dreams for its macular degeneration treatment may be disappearing from sight.

After 2020 flop, Milestone's arrhythmia nasal spray hits in phase 3

Milestone Pharmaceuticals’ rescue mission has delivered a pivotal primary endpoint hit. Thirty months after failing its first phase 3, the nasal spray treatment for abnormal heart rhythm has beaten placebo in a second study, putting Milestone on track to file for FDA approval around the middle of next year.

Months after slimming its R&D focus, Orion realigns stars in top-down organizational restructure

After a tough year marred by staff layoffs and discarded development programs, Orion Group will enter 2023 with a restructured business to reflect its amended priorities.

Game, set, Matchpoint: Sanofi-backed biotech launches with $70M series A to ace covalent molecule wins

Matchpoint Therapeutics is unveiling with $70 million in fresh series A funds backed in part by Sanofi's venture arm. The company hopes to build a foundation with covalent chemistry, prioritizing targets in immunology.

The top 10 vaccine companies worldwide

What a difference five years—and a global pandemic—can make in reshaping an industry. Our latest profile of the top vaccine players includes twice the number of companies as last time along with a handful of new names.

Moderna halts vaccine supply to COVAX in favor of new agreement for omicron-adjusted shots in 2023

Moderna and COVAX have canceled their existing COVID-19 vaccine supply agreement, replacing it with a deal for the company’s variant-busting shot. The new version of Moderna’s Spikevax jab will be supplied to COVAX in 2023 at the lowest figure in the company’s tiered pricing structure. The World Health Organization’s COVAX effort was established to provide low-income countries with vaccines at no or low cost.

As FDA rule takes effect, Lucid Hearing launches over-the-counter line of hearing aids

Monday marked the first day that some hearing aids may be sold over the counter, without requiring any prescriptions, hearing tests or fitting appointments, thanks to a recently finalized—and long-awaited—ruling from the FDA.
 
Fierce podcasts

Don't miss an episode

'The Top Line': The most productive pharmas, Biogen's shift in leadership

This week on "The Top Line," we talk about our latest analysis on the world’s most productive biopharmas. We also discuss Biogen's tumultuous year and who it is considering for a new CEO.
 

Resources

Whitepaper

EHR vs Registry Data for RWE – Heart Failure as a Case Study

Electronic health records (EHR) and patient registries are both important sources of real-world evidence – but which is right for your needs?
Research

Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

Learn more about adaptive ascending dose escalation designs and considerations for determining the optimal approach to meet your drug development objectives

eBook

The Essential Components of a Successful Remote Patient Monitoring Program

Looking to implement a remote patient monitoring (RPM) program at your organization? Download the eBook from Health Catalyst to learn the essential components of successful RPM programs.
eBook

How the Cloud Puts Precision Medicine Within Reach for Startups

In this free guide, explore how Cloud Computing is enabling emerging biopharma organizations to decrease time-to-discovery in pursuit of breakthrough treatment modalities.
eBook

Optimize the value and impact of your real-world data

With real-world data playing a significant role in health care decisions, life sciences leaders need to maximize their data investments. The best place to start is right here, with our e-book on the four steps to a more coordinated, connected real-world data strategy.
Whitepaper

Navigating the Data Deluge: Turning Data Into Insight Across the Health Care and Life Sciences Industries

Learn the benefits of unlocking data insights across the healthcare and life sciences ecosystem.

Whitepaper

A Guide to Pre-Validated Software-as-a-Service LIMS

SaaS LIMS from LabVantage Solutions Is Pre-Validated for Regulated Industries, Delivering Maximum Flexibility, Uptime, and Security.
Whitepaper

Cutting Through the Noise: Crossing the New Real World Data Landscape

Read about key factors and trends in RWE and how our data luminaries are the right partner to lead the way forward.
Whitepaper

Commercializing Gene Therapies, Part I - Introduction

This paper is the first in a 4-part series focused on developing commercial models for gene therapies
Video

Building a Broader Tissue Research Ecosystem

Learn how a centralized platform for pathology images, metadata, and analysis results can connect previously siloed research initiatives and advance our collective understanding of tissue.
Video

Improve Life Sciences Research with AI Workflow Automation

Can an optimized research process--including AI-powered workflow and process automation tools--help get breakthrough drugs to market faster?
Whitepaper

The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?
Research

Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.
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

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.

Webinar

The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.
Custom Resource Center

Scaling life sciences companies: Discover resources to support growth and innovation

Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals.

Whitepaper

Softgel Formulation Enables Oral Delivery of Testosterone

Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy.

Whitepaper

Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules

Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success.

Whitepaper

Plan for scalable process liquid and buffer preparation

Explore how Thermo Scientific’s Process Liquid Preparation Services can help you plan for scalable buffer preparation.

eBook

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Whitepaper

Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

Whitepaper

Intranasal Drug Product Development: Formulation to Manufacturing

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

 

Industry Events

Drug Development Boot Camp® 2022