Dear Reader:

We are entering the festive last quarter of 2022 and Pharma Intelligence and the IPA wishes all members a sparkling and prosperous Diwali!

This edition of the newsletter features a crop of stories on hot topics. There’s a piece on biosimilar interchangeabilty and the need to clarify semantics around that designation in the US, while we also encapsulate investor advice for cell and gene therapy developers from fundraising and platform development to manufacturing.

We’ve also spotlighted certain niche partnering efforts as French firm Allecra scouts for a US commercialization ally for its complicated urinary tract infection asset.

Anju Ghangurde - Executive Editor (Asia Pacific), Scrip/Pink Sheet
Archana Jatkar - Associate Secretary General, IPA

alt_text Perspective from Industry Leaders
Vid Desai On How US FDA’s Modernization Will Improve Inspections And Drug Review alt_text
Cutting Through The Confusion On US Biosimilar Interchangeability EU Regulators Clarify Rules On Nasal Spray Claims Ahead Of Cold & Flu Season

In the first part of an exclusive two-part interview, Samsung Bioepis’ development division leader Kyung-Ah Kim and Biogen’s global head of biosimilars Ian Henshaw discuss how the firms are aiming to capitalize...
 

The EU's medical device regulators have joined forces to remind consumer health firms of the rules which must be followed when marketing a nasal spray offering protection from viruses, such as influenza and SARS-CoV-2. 

alt_text LICENSING & COLLABORATION AGREEMENTS
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Amgen Played Waiting Game Before Agreeing $3.7bn ChemoCentryx Deal Allecra Seeks US Partnership For Urinary Tract Asset As Regulatory Filings Approach

Amgen’s latest deal shows the biotech major’s need to replenish its portfolios and also the cool heads required when negotiations get heated.

The French firm is searching for a US partner with strong foundations in the hospital sector after securing EU and China deals for its complicated...

alt_text NEXT GEN: R&D
alt_text Kabi Brings In Reddy’s Rituximab As Biosimilar Breakeven Date Retreats
A Promising Future For Oncolytic Viruses As Cancer Immunotherapies European Investor Sentiment Rebounds On Cell And Gene Therapy

The development of oncolytic virus therapy has gained momentum over the past decade, due to its relatively safe mode of action and potential to enhance existing treatment options.
 

Investors at the Advanced Therapies Europe conference in London struck a bullish note on the state of the market and offered up advice for cell and gene developers from fundraising...
 

alt_text CLINICAL TRIALS
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Decentralized Clinical Trials: EU To Demystify Differences Between Member States Under Pressure: Are Enhanced Global Efforts Enough For Trial Transparency?

A compilation of the differences and similarities in regulatory requirements for decentralized trials across the EU member states could help sponsors better understand the nuances per country.
 

Increasing scrutiny is being placed on trial sponsors and regulators to improve trial data reporting. Researchers complain that, without access to specific data, results cannot be easily duplicated, which inhibits greater...
 

Informa Pharma Intelligence Contact

Poornachandra Tejasvi .K, Senior Director - Emerging Markets, India

Direct: +91 11143155159
Mobile: +91 9945273146

Email: poornachandra.tejasvi@informa.com
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Email: info@ipa-india.org

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