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Newly Approved OTC Eye Drop Could Boost Valeant Turnaround Outlook

 
• By Malcolm Spicer

Valeant's Bausch + Lomb subsidiary will have market exclusivity for Lumify, the first OTC brimonidine eye drop. It likely will provide a needed revenue boost as the parent firm navigates a turnaround after incurring more than $30bn debt during the turbulent period under previous management.

Bausch & Lomb Inc. plans in 2018 to launch the first US OTC ophthalmic solution containing brimonidine tartrate, emphasizing that it differs from the currently available nonprescription ingredient to relieve ocular redness by selectively constricting veins in the eye.

With market exclusivity for Lumify as the first OTC brimonidine eye drop, Bausch + Lomb likely will provide a significant revenue boost for parent firm Valeant Pharmaceuticals International Inc.,...

FDA's Dec. 22 approval letter to Bausch + Lomb notes Lumify was cleared as a 0.025% brimonidine tartrate solution for the relief of redness of the eye due...

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Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
• By David Ridley

HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

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People On The Move: Appointments At ANEPF, Inula, Opella

 
• By Tom Gallen

A round-up of the latest consumer health people moves: ANEFP elects president; Inula Group appoints CEO; Opella names ANZ head.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

Value Of Consumer Wearables Within The Clinic Currently Unknown, Says Cardiologist

 
• By Natasha Barrow

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”