Citeline Pharma Insights – September 2022

Welcome to the monthly Citeline Pharma Insights newsletter

Each month we bring you complimentary access to the latest news and insight coverage on the current trends impacting the pharma, generics and biosimilars, medtech, and consumer healthcare industries.

This coverage is brought to you by our global team of expert journalists and analysts with access to key industry decision makers and proprietary data to provide the strategic implications of worldwide clinical, regulatory, and commercial developments, and what they mean to your business.

Content Summary

Pharma Regulation and Policy Pharma Commercial News Generics and Biosimilars Strategic Analysis for Leaders Consumer Healthcare

Pharma Regulation and Policy

EU To Kick Off ‘Joint Action’ On Tackling Drug Shortages

By Ian Schofield

@ScripIanS
ian.schofield@informa.com

The joint action on ensuring security of medicines supply will be supported by the EU regulators’ shortages task force, which is to track efforts to coordinate member state activities on the supply and availability of medicines.

Requiring FDA Guidances Does Not Always Advance The Science, Gene Therapy Director Says

By Derrick Gingery

@dgingery
derrick.gingery@informa.com

OTAT Director Wilson Bryan says important cell and gene therapy guidances came from clear community needs, not user fee program requirements.

Indegene CTO On Pharma And Blockchain’s Promise Of Better Accountability, Trust

By Anju Ghangurde

@ScripAnjuG
anju.ghangurde@informa.com

Indegene’s chief technology officer, Tarun Mathur, talks to Scrip about blockchain’s potential in a number of areas across pharma’s operations including the clinical supply chain and trials as well as its role in enabling improved trust in the healthcare data ecosystem.

Merck KGaA Overcomes Ukraine Disruption To Keep MS Frontrunner On Track

By Andrew McConaghie

@awmcconaghie
andrew.mcconaghie@informa.com

The German group is optimistic evobrutinib can be a blockbuster in multiple sclerosis and has adapted its pivotal trial to cope with disruption caused by the war in Ukraine.

End Of Schultz Era Looms For Teva

By David Wallace

@Genericbulletin
david.wallace@informa.com

Teva is expecting to have a new CEO by the end of next year, after current leader Kåre Schultz indicated that he was unlikely to renew his contract. The president and chief executive has overseen an eventful and transformative period for the Israeli firm.

Sandoz Weighs In On US Adderall Shortages Amid Supply Disruption

By Dean Rudge

dean.rudge@informa.com

A spike in demand for Adderall and its generic versions has left patients scrambling to have their prescriptions filled, making headline news in the US. Leading generics manufacturer Sandoz told Generics Bulletin its current experience amid the supply squeeze.

Early Days For The Metaverse In The Life Sciences, But Experimentation Is Happening

By David Wild

@davidwild77
david.wild@Informa.com

Hype around the metaverse has made it a sexy topic, but a recent Accenture report grounds the concept in a sober, yet still exciting, reality. The consulting firm looked at how the metaverse is being applied in the life sciences sector and concluded that while it is early days and the concept remains nebulous, executives would be remiss if they ignored the growing possibilities the metaverse has to offer.

Re-Thinking Rare Disease

By Melanie Senior

@RealEndptsMel
melanieannsenior@gmail.com

Germany is drastically squeezing orphan drug pricing while new US laws protect rare diseases drugs from price negotiations. These contrasting moves fuel the longstanding debate over whether orphans still deserve special incentives.

Women in Germany, Italy And Spain Support OTC Access To Oral Contraceptive

By Tom Gallen

tom.gallen@informa.com

A study backed by HRA Pharma found that 65% of women in Italy, 55% in Spain and 49% in Germany feel positive about accessing a progestin-only oral contraceptive pill without a prescription. HRA told HBW Insight that the research "confirms it is now time for better access to more effective contraception:"

Collagen In Court: L’Oreal Fails To Dismiss Suit Over ‘Collagen Moisture Filler’ Claims

By Ryan Nelson

ryan.nelson@informa.com

How do reasonable consumers interpret the role of collagen in L’Oreal facial skin-care products in the context of labeled benefit claims? The question is central to class action litigation being waged in New York’s Southern District.

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