Insight Pharma Newsletter

Dear Reader :

New Year greetings from Citeline and the IPA and here’s to wishing all members a happy and prosperous 2023!

In this edition of the newsletter, we spotlight distinct strategies including how Rocket Pharma deftly avoided the “land grab” for the biggest targets in genetic disease and is now on course to file its pipeline candidates. Another piece deep dives into Sun Pharma’s acquisition of biotech firm Concert as it bolsters its global derma franchise with a potential best-in-class late-stage asset for alopecia areata.

We also bring you key takeaways from the Food and Drug Law Institute’s recent Enforcement, Litigation and Compliance Conference – combating clinical trial fraud and data integrity will remain an area for continued scrutiny and enforcement.

Anju Ghangurde - Executive Editor (Asia Pacific), Scrip/Pink Sheet
Dr. Shridhar Narayanan - Senior Technical Advisor - Innovation, IPA

Perspective from Industry Leaders


Accord Unveils New Ventures After A Year Of Change	Regulatory Reform Could Elevate Value-Added Medicines To Their ‘Rightful Place’, Says Narayan
A year after taking up the lead for Accord in the EMENA region, Paul Tredwell talks to Generics Bulletin in detail about the changes that he has already overseen in the role	Medicines for Europe is calling on the EU to recognize value-added medicines as its own separate group in its pharmaceutical legislation.

LICENSING & COLLABORATION AGREEMENTS


Amgen And Synaffix Alliance Could Be Biggest Preclinical ADC Licensing Deal Yet	Sun Pharma Will Take Concert’s Alopecia Drug The Rest Of The Way
Mersana signs its third ADC partnership with big pharmas for the year with Merck agreement.	Coming up after Lilly’s Olumiant and Pfizer’s ritlecitinib in alopecia areata, deuterated ruxolitinib is said to offer a differentiated profile including patient-reported outcomes data.

NEXT GEN: R&D


Sidestepping Gene Therapy ‘Land Grab’ Mistakes, Rocket Is Set For First Filings In 2023	CDI Market Snapshot: Microbiome Therapies Begin Descent On Landscape
While other gene therapy companies faced major clinical and financing problems in 2022, Rocket Pharma sidestepped some of these pitfalls and is gearing up for two US filings this year...	The recent US approval of Ferring’s microbiome-targeting Rebyota is set to change the treatment landscape for recurrent

CLINICAL TRIALS


Data Integrity Fallout: Sponsors Risk Reputational Damage, Negative Impacts On Other Research	Clinical Trial Diversity Action Plans Required Under US Funding Bill
US is going after fraudulent clinical trial conduct, and sponsors may be faced with determining the breadth of such fraud...	Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity...

Citeline Contact

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

Direct: +91 11143155159
Mobile: +91 9945273146
Email: poornachandra.tejasvi@informa.com

Client Services: clientservices@pharmaintel.informa.com

IPA Contact

Direct: +91 022 2610 9281
Email: info@ipa-india.org