Insight Pharma

Dear Reader:

This month’s edition of Pharma Intelligence’s newsletter, developed in alliance with the IPA, packs in interviews with leaders from industry and regulatory agencies, providing important insights on a range of topics.

The US FDA’s first permanent chief information officer, Vid Desai, in an exclusive interview, outlines how the agency’s modernization initiatives could improve inspections and drug reviews, while Moshe Shoham, an authority in medical robotics, talks about futuristic scenarios in brain surgery and other fascinating developments in the field.

There’s also a piece on technological advances that could become mainstream in the not-too-distant future - genomic medicine could be gearing for prime time.

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
Vid Desai On How US FDA’s Modernization Will Improve Inspections And Drug Reviews Oral Humira Biosimilar Could Be A Game-Changer, Says Rani CEO

FDA’s chief information officer talks to the Pink Sheet about why the agency relied on COVID data from foreign countries, and describes pilot projects to target inspections and manage warehouse data.
 

Oral delivery of biosimilars could bring significant benefits for patients as well as offering a key differentiating factor for competing developers, especially in the US adalimumab arena, Rani Therapeutics CEO Talat Imran tells Generics Bulletin.
 

alt_text LICENSING & COLLABORATION AGREEMENTS
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Repare Gets Cash And Validation In DNA Damage Repair Alliance With Roche Asia Deal Watch: Astellas, GO Team Up On Targeted Cancer Therapy

Roche is paying $125m upfront to in-license potential blockbuster lead candidate camonsertib from Repare, which calls it a best-in-class ATR inhibitor and has the chance to opt back in on US commercialization.
 

Astellas subsidiary Xyphos will partner with GO to discover novel antibodies against two glycoprotein targets. SciNeuro picks up abandoned GSK programs in cardiovascular medicine for potential use in the neurodegeneration space.
 

alt_text NEXT GEN: R&D
alt_text Kabi Brings In Reddy’s Rituximab As Biosimilar Breakeven Date Retreats
Advanced Antibodies Will Revolutionize The Future Of IO Exec Chat: Israel’s Authority On Medical Robotics Lifts Curtain Behind Technion’s Success Stories

Immuno-oncology is a key area for biological drug development and activity has exploded over the past decade. Today, IO therapies represent a third of the biologics pipeline, and antibody development remains the focus.
 

Medtech Insight talked with Moshe Shoham about the innovative technologies behind surgical robotics companies Microbot Medical, XACT Robotics, Tamar Robotics and ForSight Robotics, which were all spun out of his laboratory in Israel.
 

alt_text DIGITAL INNOVATION
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Q&A: Meet DHCOE Acting Chief Brendan O’Leary, FDA’s New Digital Health Guru Seven Trending Technologies On The Cusp Of Mainstream Uptake

In this revealing interview, the new acting director of the US FDA’s Digital Health Center of Excellence talks about his new role at the DHCOE, the big shoes he’ll have to fill now that former center head Bakul Patel is gone.
 

At HIMSS22, NEO.Life’s Jane Metcalfe identified seven trending technologies that are set to move from the fringes of medicine to the center of attention.
 

Informa Pharma Intelligence 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

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