Citeline

Dear Reader :

This month’s newsletter, co-developed by the IPA and Citeline, spotlights important developments in the biosimilars space and also what US FDA Commissioner Robert Califf’s top priorities are in 2024.

We tell you about the EMA’s concept paper on re-evaluating the need for comparative efficacy studies to support biosimilar applications and the FDA chief’s views on combating medical misinformation.

There’s also a piece on biopharma’s collective crystal ball in the funding, M&A and partnering arena.

Anju Ghangurde - Executive Editor (Asia Pacific), Scrip/Pink Sheet
Dr. Shridhar Narayanan - Senior Technical Advisor - Innovation, IPA
IPA-Newsletter
Perspective From Industry Leaders
Senate CEO Hearing On Drug Prices Could (Almost) Have Taken Place Five Years Ago Califf’s Top Priorities For New Year: Misinformation And Evidence Generation
Senate CEO Hearing On Drug Prices Could (Almost) Have Taken Place Five Years Ago Califf’s Top Priorities For New Year: Misinformation And Evidence Generation

Discussion around the landmark developments in pricing reform established by the Inflation...

FDA Commissioner is ‘pretty excited’ about obtaining high quality evidence in the postmarket space...

Licensing & Collaboration Agreements
Novartis Makes An Ideal Match For MorphoSys Scrip Asks...What Does 2024 Hold For Biopharma? Part 2: The Funding Environment, M&A And Partnering
Novartis Makes An Ideal Match For MorphoSys Scrip Asks...What Does 2024 Hold For Biopharma? Part 2: The Funding Environment, M&A And Partnering

The Swiss major looks to have bagged a bargain in buying MorphoSys and its potential game-changer ...

Biotech entrepreneurs tend to be an optimistic group, and there were many pockets of hope for 2024...

Next Gen R&D
CGT Landscape: Recent Approvals, Deals And 2024 Catalysts Sangamo Shoots Up As Regulatory Path Clears For Fabry Gene Therapy
CGT Landscape: Recent Approvals, Deals And 2024 Catalysts Sangamo Shoots Up As Regulatory Path Clears For Fabry Gene Therapy

The last quarter of 2023 was an exciting one for the cell and gene therapy sector – with the first-ever approval...

The US group has had a tough year but the signs look more promising for isaralgagene civaparvovec as the FDA...

Clinical Trials
EMA Mulls Dropping Comparative Efficacy Trials For Biosimilars US FDA’s Pazdur Wants Clinicians To Help Set Oncology Research Agenda
EMA Mulls Dropping Comparative Efficacy Trials For Biosimilars US FDA’s Pazdur Wants Clinicians To Help Set Oncology Research Agenda

In a move that could hold major promise for the biosimilars industry, the European Medicines Agency....

Oncology Center of Excellence director said clinical trial participation may increase if the research questions...

Citeline Contact

Poornachandra Tejasvi .K,
Senior Director - Emerging Markets, India
Mobile: +91 9945273146
Email: poornachandra.tejasvi@citeline.com
Client Services: clientservices@citeline.com

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IPA Contact

Name: Hari Pranav K
Email: haripranav.k@ipa-india.org