Biogen, Sage tout latest depression data

Today's Big News

Oct 17, 2022

Special Report: The top 10 vaccine companies worldwide 

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

Post Dobbs fallout tracker—HHS investigating Walgreens, CVS over reports of withheld prescriptions

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

FDA staffers pull no punches on Makena as Covis' preterm birth drug faces expert panel reckoning 

GE Healthcare debuts redesigned, all-digital PET/CT scanner platform

 

Featured

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.
 

Top Stories

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.

Post Dobbs fallout tracker—HHS investigating Walgreens, CVS over reports of withheld prescriptions

Follow along with the latest news and insights from the Fierce Healthcare team on the fallout from the Supreme Court's Dobbs decision.

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.

FDA staffers pull no punches on Makena as Covis' preterm birth drug faces expert panel reckoning

When a long-awaited FDA hearing over Covis Pharma’s recurrent preterm birth drug Makena kicked off Monday, the agency paraded out a half dozen of its experts to convince the panel it should recommend withdrawal of the medicine.

GE Healthcare debuts redesigned, all-digital PET/CT scanner platform

The company said it hopes its "future-ready" Omni Legend system will set the stage for the imaging modality for next 10 to 20 years.

SPAC is EBAC: Swiss biotech with ocular pipeline takes blank-check route

As SPAC deals in biotech make a slow comeback, another merger has been penned, this time between Swiss biotech Oculis and European Biotech Acquisition Corp.

Walgreens targeting tech acquisition as it looks to scale healthcare business unit

Retail drugstore giant Walgreens is bullish on scaling up its primary, post-acute and home care businesses as part of its long-term strategy to become a consumer-centric healthcare company. On the heels of a recent buying spree, the company may be eyeing a health technology acquisition as its next strategic play.

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.

Johnson & Johnson sells baby powder plant it never opened to Hetero

In 2014, when Johnson & Johnson broke ground on an ambitious manufacturing facility in India and announced its plan to employ 1,500, local dignitaries hailed the initiative and its promise to bring major development to a rural area near Hyderabad. Eight years later, the company has sold the site without ever conducting operations there.

Amid travel nursing rate spikes, a 'record-breaking' number of PE investments deserves scrutiny: report

Last year saw 27 private equity deals in the medical staffing space, representing 21.1% of the sector's total deal volume, according to data cited in a new report from nonprofit Private Equity Stakeholder Project.

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.

Eyenuk hits bull’s-eye with $26M for diabetic retinopathy screening AI

All eyes are on Eyenuk, now that the Los Angeles-based startup has more than doubled its lifetime fundraising haul and set its sights on bringing AI-powered diagnostic tools to even more diseases and conditions.
 
Fierce podcasts

Don't miss an episode

'The Top Line': The most productive pharmas, Biogen's 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?
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

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

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

Commercializing Gene Therapies, Part I - Introduction

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

The Hands-Free, Low-Volume, Microfluidic Elisa Alternative

Advanced research requires advanced tools. The next-generation ELISA takes a fraction of the time to run eight analytes simultaneously while saving your sample volume.

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?
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.
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

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