| 09.29.22 | Biohaven's post-Nurtec ambitions face fresh roadblock; Aligos hits back at Janssen 'theft' allegations

Laden...

2 jaren geleden

Html
Tekst

Driving Oncology Product Development and Finding the Fast Track in Early-Phase Programs

Innovative biotech and specialty pharma companies face many challenges when planning and executing early-phase oncology trials. Download our white paper to learn key factors sponsors must consider during planning and execution. Premier Research. Built for Biotech℠

Today's Big News

Sep 29, 2022

Biohaven's Nurtec-less pipeline takes another gut punch, fails ALS trial

Aligos demands jury trial to settle Janssen theft allegations, files fraud counterclaims

Troubled CytoDyn ditches COVID-19 indication, enters tricky NASH landscape with new leader at helm

Novo enters NLRP3 arena, paying Ventus $70M for NASH hopeful

Galecto links blood cancer prospect to reduced fibrosis in early data drop

Good Idera: Pharma buys rare-disease-focused Aceragen in all-stock deal to keep money flowing

With cash dwindling, Axcella shares look at blinded NASH data

Download eCOA Implementation Best Practices

Regulators, payers and providers advocate for the patient’s perspective in clinical trial data. Build your patient-centric eCOA strategy and avoid missteps. Download 8 key recommendations from our eCOA experts.

Featured

Biohaven's Nurtec-less pipeline takes another gut punch, fails ALS trial

By Max Bayer

Biohaven failed its second clinical trial since the company sold off its migraine franchise to Pfizer back in May. The company's ALS treatment verdiperstat didn't improve symptoms over placebo.

Aligos demands jury trial to settle Janssen theft allegations, files fraud counterclaims

By Gabrielle Masson

Aligos Therapeutics has responded to Janssen Biopharma’s lawsuit that alleges theft, throwing back their own claims of unfair competition and promissory fraud, as well as demanding a jury trial to settle the matter.

Enhancing Patient Engagement with THREAD’s eCOA Solution

Agilex Biolabs expands GLP Toxicology capacity with the commissioning of its new purpose designed testing facility

Troubled CytoDyn ditches COVID-19 indication, enters tricky NASH landscape with new leader at helm

By Gabrielle Masson

Like many biotechs amid the prolonged bear market, CytoDyn is axing some of its lead programs and trimming down its pipeline. The company's job may be harder than most, however, as it faces an ongoing clinical hold and has decided to focus its efforts on the tricky indication of nonalcoholic steatohepatitis (NASH).

Novo enters NLRP3 arena, paying Ventus $70M for NASH hopeful

By James Waldron

Novo Nordisk is the latest Big Pharma to get in on the NLRP3 action, paying $70 million upfront for the exclusive license for Ventus Therapeutics’ VENT-01 program in peripherally restricted NLRP3 inhibitors targeting nonalcoholic steatohepatitis, chronic kidney disease and other cardiometabolic conditions.

Galecto links blood cancer prospect to reduced fibrosis in early data drop

By Nick Paul Taylor

Galecto has linked its myelofibrosis candidate GB2064 to reduced collagen fibrosis in a small clinical trial, offering early validation of the ability of the LOXL2 inhibitor to act on a variable that affects outcomes.

Good Idera: Pharma buys rare-disease-focused Aceragen in all-stock deal to keep money flowing

By James Waldron

With cash expected to run out within a year, Idera Pharmaceuticals was on the lookout for a fresh strategy. And it seems to have found one in the acquisition of Aceragen and the biotech’s pipeline of late-stage rare disease therapies.

With cash dwindling, Axcella shares look at blinded NASH data

By Nick Paul Taylor

Axcella Therapeutics has presented a glimpse at data from its ongoing, blinded phase 2b nonalcoholic steatohepatitis (NASH) trial, linking the high dose of its orally active mixture of amino acids to improved liver stiffness at week 24.

Editor’s Corner: Eisai and Biogen need to meet CMS halfway after lecanemab's Alzheimer's clinical trial win

By Angus Liu

An FDA approval now looks all but certain for Eisai and Biogen's lecanemab. But before lecanemab can clear the name of the amyloid beta theory after the fallout from Biogen's Aduhelm launch and before the drug can realize its megablockbuster sales potential down the road, there’s one major hurdle to cross—reimbursement.

End of the EUA Era: FDA begins to wind down emergency authorizations for COVID-19 tests

By Conor Hale

After more than 430 emergency green lights for COVID-19 tests since the start of the pandemic, the FDA is beginning to wind down its expedited review programs for coronavirus diagnostics, instead urging developers to follow its traditional regulatory paths to market.

FDA blasts Chinese drug ingredients outfit for subpar impurity testing and poor equipment hygiene

By Fraiser Kansteiner

The FDA has scolded a Chinese drugmaker in the wake of an inspection in the spring. In its warning letter, the regulator laid out a laundry list of complaints tied to lapses in Zhejiang Tianyu Pharmaceutica's API production.

Nonprofit hospitals expanded charity care policies after COVID. But some changes raise red flags, study finds

By Dave Muoio

Three in 10 hospitals adopted "distinctly" more generous charity care policies while about 8% became more restrictive from 2019 to 2021, researchers found. Still, vague language among many policies as well as merger and acquisition trends raised concerns.

Fierce podcasts

Don't miss an episode

'The Top Line': How some Big Pharmas are bolstering their environmental sustainability efforts, the most expensive drug and more

This week on "The Top Line," we'll discuss how two Big Pharma companies, GSK and Takeda, made moves this week to bolster their environmental sustainability efforts. We'll discuss their strategies and what we can expect for the future.

'Podnosis': Broadening artificial intelligence's scope in healthcare, how payers can invest in social needs


A message from Fierce Pharma

Resources

eBook

Make the most out of hybrid conferences

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

Sponsored by: Ferma.AI, a Product of ZoomRx

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

Optimize Digital Engagement Across the Patient Journey

Improve patient engagement, adherence, and outcomes

Achieving faster formulation for First In Human supplies

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

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.

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?

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?

Sponsored by: Catalent

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.

Sponsored by: Catalent

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?

Sponsored by: Catalent

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.

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.

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

Sponsored by: ReachBio | The Cell Biology Experts™

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.

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.

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

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.

Sponsored by: Catalent

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.

Sponsored by: Catalent

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).

Sponsored by: Blue Matter, strategic consultants in the life sciences

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.

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

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

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Sponsored by: Catalent

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?

Sponsored by: Catalent

Whitepaper

Intranasal Drug Product Development: Formulation to Manufacturing

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

Sponsored by: Catalent

Multimedia

Lead the way to the next breakthrough

ZS helps life sciences companies shape the future of medicine by turning healthcare data into transformative insights. Discover the power of R&D innovation