Market Access

Analyzing An EU Medtech Regulation Crisis In The Making

EU medical device consultant Trevor Lewis takes note of the recent, if belated, progress towards the building of the post-MDR playing field for medical device companies in Europe, but calls political decision-makers and economic operators to account: getting it right is nothing short of a matter of life and death, he tells In Vivo.

How To Decarbonize Pharma R&D

As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.

IV-MarketAccess (Premium-1): Stimulant Medications Don’t Cause Psychosis, New Study Finds

 
• By 

Instead, the new study found children with more severe attention and hyperactivity issues or other mental health conditions such as anxiety were more likely to be medicated for ADHD.

[Test]With 75 Pipeline Candidates, TIL Therapies Gain Momentum in Solid Tumor Space

 
• By 

Tumor infiltrating lymphocyte therapies show promise for solid tumors, with a first FDA approval, but face manufacturing and access challenges as development continues.


In Search Of Rare Disease Treatments, Nonprofits Can Lead the Charge

 
• By 

Nonprofits are finding new ways to address market gaps and develop treatments for rare diseases with little commercial attraction.

Nancy Tests SPARC-1034

 
• By 

I am testing to see if the extra space above QF and KT boxes, and related articles have been removed.

Arrowhead Moving Into Commercial Territory

 
• By 

Christopher Anzalone is spearheading Arrowhead Pharmaceuticals' transformation from a development-focused to a commercial-stage biotech. The CEO touts an “almost plug and play” platform, a derisked development strategy and a busy pipeline with vast potential.

Slow Progress: A Decade Of Cell Therapy In Japan

 
• By 

After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.


Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.

Why EU App Makers May Need A Notified Body More Often Than They Realized

 

Any apps, or indeed any software, which assist communication in the medical field need to be carefully evaluated against a tricky-to-comprehend rule in the EU’s Medical Device Regulation.

Mpox: WHO Steps Up Calls For Urgent Prevention And Vaccination Efforts

 
• By 

National authorities urged to address knowledge gaps and generate evidence about the dynamics of mpox transmission.

Freely Available Microbiome Data ‘Atlas’ Could Provide Industry Boost

 

King’s College London has released a freely available ‘Human Gut Microbiome Atlas’ to help researchers better understand how microorganisms in the gut impact disease.


Schumacher Looks To Steer Tubulis To The Top Of The ADC Tree

 
• By 

It has been quite a year for German biotech Tubulis, and CEO Dominik Schumacher tells In Vivo that the group has the potential to be “a really meaningful, sizable leader” in the antibody-drug conjugate space.

H2 Investment Life Sciences Uptick Anticipated But Markets Remain Enduringly Cautious

 
• By 

Taylor Wessing investment partners share their thoughts about market trends, the surge in AI interest and the new UK government’s approach to the life sciences agenda.

Medtechs Worry That Europe’s Biggest Killer Could Escape Their Grasp

 
• By 

The European Alliance for Cardiovascular Health is three years old in September. Its remit to improve patient health has attracted strong support from stakeholders, but more investment and attention are required to ensure its momentum towards implementation is not lost. Experts at MedTech Forum 2024 explained what is at stake.

Tackling The Challenge Of Malaria Clinical Trials In Africa

 
• By 

Novartis leads the fight against malaria, pioneering innovative studies in sub-Saharan Africa to combat parasite resistance to current antimalarials.


After Humira Biosimilars, Will It Be Groundhog Day For Stelara?

 
• By 

With ustekinumab biosimilars set to launch in Europe imminently and in the US early next year, the off-patent industry may be wondering whether it will be in for a rerun of its experiences with competition on Humira – or whether the landscape has changed sufficiently to allow for different pricing and uptake trends.

After Humira Biosimilars, Will It Be Groundhog Day For Stelara?

 
• By 

With ustekinumab biosimilars set to launch in Europe imminently and in the US early next year, the off-patent industry may be wondering whether it will be in for a rerun of its experiences with competition on Humira – or whether the landscape has changed sufficiently to allow for different pricing and uptake trends. 

Podcast: Navigating Challenges – The Changing Role Of Big Pharma

 

Stefan Woxström, senior vice president of AstraZeneca, Europe and Canada, discusses the growing challenges in the industry and addresses the role big pharma must adopt in resolving them.

Why US Payers Aren’t Reimbursing Obesity Meds

 
• By 

Payers are restricting access to obesity drugs due to huge patient numbers and a wave of innovation in other areas