Regulatory
Drug-Diagnostic Development Stymied by Payer Concerns
One reason for slow drug-diagnostic co-development is uncertainty about the FDA regulatory process for bringing such combination products to market. Different rules and procedures govern drugs and medical devices, and limited FDA authority over laboratory-developed tests further muddies the picture, writes Jill Wechsler ...Read more
Regulatory
FDA, Sponsors Seek Study Endpoints Earlier in Development
The challenge for industry is to identify clinically relevant endpoints early enough to ensure that clinical trials produce data that will support commercialization. Sponsors are adopting an “endpoint mode” to R&D that entails deciding which endpoints are clinically relevant and meaningful even before launching Phase 2 trials
...Read more
Drug Delivery
Allergy Shots in a Pill?
Showing up for a shot at the doctor’s office isn’t fun or convenient, especially when it’s 50 appointments over several years. ALK Pharma CEO Jens Bager hopes to bring two new orally-formulated allergy immunotherapy products to market in time for this spring’s sneezes and watery eyes, allowing many patients to skip the needle entirely, writes Ben Comer ...Read more
Europe
Italian Ruling on Roche and Novartis Resonates Across Europe
Roche and Novartis have been fined in Italy on pricing conspiracy charges, fueling a wider debate across Europe about expenditure, efficiency and off-label prescribing. Reflector reports ...Read more
Event
Digital Summit Preview: Improving Brand Engagement
The upcoming digital marketing forum, iPharma2014 (May 8–9, New York City) will bring together more than 40 of the top minds to share fresh insights and innovative approaches in brand engagement and patient/physician interaction and relationship management ...Read more
Leadership
Pharm Exec’s Emerging Pharma Leaders 2014 — Nominate Now
It's time for you to tell us who you think should receive Pharm Exec's 2014 Emerging Pharma Leadership Award. Read more for details of how to nominate a colleague — or yourself. ...Read more |
