Alnylam, Regeneron hit gas on NASH

Today's Big News

Sep 15, 2022
 

In the wake of the Inflation Reduction Act, newer and smaller biotechs may find it increasingly difficult to succeed on their own, Amgen CEO Robert Bradway told Bloomberg.  

Industry experts predict as CVS, Walgreens and Amazon invest in home health and primary care, there will be major disruptions for more traditional providers, such as hospitals.

After generating early evidence of efficacy, Alnylam and Regeneron have outlined plans to kick off a phase 2 trial of their RNAi candidate in the tricky NASH indication. - Gabrielle Masson

 

Featured

 

Amgen CEO Robert Bradway warns Biden's Inflation Reduction Act could blunt future biotech success stories

In an era of abundant pharma buyouts, small and midsized biotechs may find it increasingly difficult to go their own way, Amgen’s CEO Robert Bradway figures. And new drug cost legislation in the U.S. certainly won’t help, the helmsman added.
 
 
 
 

Top Stories

 

Healthcare plays by CVS, Walgreens and Amazon will drive more partnerships, tech investment, experts say

CVS, Walgreens and Amazon are ramping up their focus on in-home medical services and primary care and it will cause major disruptions for more traditional brick-and-mortar providers, industry experts say.
 
 
 

Alnylam, Regeneron hit go on phase 2 trial of genetic NASH therapy after generating signs of efficacy

Alnylam and Regeneron have hit the gas on their RNAi nonalcoholic steatohepatitis program, outlining plans to kick off a phase 2 clinical trial of the drug candidate after generating early evidence of efficacy.
 
 
 

Smith+Nephew’s absorbable rotator cuff implant sees 86% fewer new tears in 1 year

The postage stamp-sized Regeneten implant is designed to trigger the tissue’s healing response and be fully absorbed by the body in about six months.
 
 
 

Bristol Myers' Opdivo win tees up showdown with Keytruda in earlier-stage melanoma

On the heels of Merck & Co. rival Keytruda’s green light as an adjuvant treatment for earlier-stage melanoma, Bristol Myers Squibb’s Opdivo has ginned up data suggesting it won’t be locked in advanced disease for long.
 
 
 

Extended ACA subsidies will help hospitals weather a looming recession, HCA Healthcare CFO says

Many consumers who fall on hard times will be able to maintain their coverage in the marketplace, a luxury the industry hadn't seen in prior recessions, HCA Healthcare's Bill Rutherford said Tuesday during Morgan Stanley’s 20th Annual Global Healthcare Conference.
 
 
 

Are biotech SPACs back? Cancer-focused Apollomics next to take blank-check route

Are we witnessing the return of SPACs? It's worth considering as Apollomics merges with Maxpro Capital Acquisition Corp.—the second such transaction in recent weeks.
 
 
 

Mallinckrodt scores long-awaited FDA nod to treat life-threatening liver condition

After lots of trial and error, the FDA has finally signed off on Mallinckrodt's Terlivaz as the first approved treatment for hepatorenal syndrome (HRS) with rapid reduction in kidney function. The condition affects between 30,000 and 40,000 annually in the U.S.
 
 
 

NYU puts forward cancer test to help predict the success and toxicity of checkpoint inhibitor immunotherapies

Researchers at NYU have developed a single test they say can help determine which patients may see their cancer return after treatment with immunotherapies, as well as who may be at risk for severe side effects.
 
 
 

Here's how much Blue Cross NC's value-based care program saved last year

Blue Cross and Blue Shield of North Carolina touted major savings thanks to improved outcomes racked up by providers and the insurer through its Blue Premier program that relies heavily on value-based healthcare.
 
 
 

With Nasdaq delisting threat, IMV drops 3rd of staff in refocus on lead oncology asset

It’s been a turbulent first year for IMV’s CEO Andrew Hall. In July, the company was threatened with Nasdaq delisting. Now, IMV has initiated a significant strategic reorganization that will allow the biotech to focus on its lead, oncology asset at the expense of a third of his workforce.
 
 
 

FDA write-up reveals production flaws behind Alvotech's recent Humira biosim slapdown

In a write-up of Alvotehc's Reykjavik, Iceland, manufacturing facility, the FDA laid out 13 observations, including chidings related to procedural controls, management of manufacturing deviations, the presence of bacteria and mold, plus more.
 
 
 

Pfizer gears up to submit meningococcal shot for approval this year after phase 3 success

New phase 3 data of Pfizer's pentavalent meningococcal vaccine has the big pharma gearing up to go to regulators before the end of the year. The company found its new shot held up against alternatives, including GSK's offering.
 
 
 
 
Fierce podcasts

Don't miss an episode

 

'Podnosis': Gun violence's toll on hospitals and how investors are approaching the current market

This week on "Podnosis," we talk about how the emotional toll from gun violence impacts care in hospitals. We also chat about how investors are approaching the current market.
 
 

Resources

 
eBook

Make the most out of hybrid conferences

Improve your congress competitive intelligence and cut down costs by 50%

 
 
 
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.

 
 
 
eBook

Optimize Digital Engagement Across the Patient Journey

Improve patient engagement, adherence, and outcomes
 
 
 
Whitepaper

Achieving faster formulation for First In Human supplies

Supporting your product development programme through experience, expertise, and efficiency.

 
 
 
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.
 
 
 
Whitepaper

An Assay Platform to Evaluate Cytokine Release & T Cell Activation

How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation

 
 
 
Whitepaper

Expanding Healthcare Services with Digital Agreement Technology

Read our whitepaper and dive into the way healthcare providers can digitally transform day-to-day work by streamlining costs and increasing agility by removing manual paper burdens.

 
 
 
Research

Revealing better ways to do business with agile analytics

Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members

 
 
 
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.

 
 
 
Executive Summary

Leading lab instruments provider saves $2M a year

How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers

 
 
 
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

Medical Affairs Metamorphosis, Part III: How Medical Affairs is Becoming a Key Hub for Evidence Generation

This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series).

 
 
 
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.

 
 
 
Research

Reduce control arm sizes by up to 22% for HD & ALS RCTs

TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases.

 
 
 
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