Tag Archives: Novartis

J.P. Morgan: Pharma's Agenda for 2014

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action. Company executives honed in on their chosen therapeutic areas and made the case for aggressive spending in R&D to bring the next generation […]
Posted in Biotech, Corporate Responsibility, Deals, Emerging Markets, Europe, Events, FDA, Gene therapy, Global, IP, leadership, Legal, Manufacturing, Market Access, Orphan Drugs, People, pricing, R&D, Regulatory, Safety, Sales, Strategy, Technology | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

Where's the Vaccine for Meningitis B?

The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in US to prevent this deadly disease, when such a therapy is approved in Europe and Australia. The current Princeton health danger prompted the Centers for Disease Control and Prevention (CDC) to request emergency import of […]
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Behind the China Bribery Scandals

The last few weeks have seen the media swamped with stories about the rampant bribery clawing the pharmaceutical industry in China. Big names were engulfed in the scandal, including GSK, AstraZeneca, Sanofi, Novartis, Eli Lilly, Novo Nordisk and UCB amongst others. Last month, four GSK executives were put under investigation for allegedly paying up to […]
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The List So Far: FDA Breakthrough Designations

With announcements pouring in since the beginning of this year, FDA’s fourth and newest expedited approval pathway for medicines has begun to bear fruit. Established in 2012 within the FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designations have so far totaled 25 as of the end of July. With a separate senior management team […]
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FDA Issues Warning Letter to Novartis's Austrian Plant

FDA has issued a Warning Letter to Novartis for cGMP violations at its manufacturing facility for finished pharmaceuticals in Unterach, Austria. The site became part of Sandoz and Novartis through the acquisition of EBEWE Pharma in 2009. The Warning Letter was issued based on an inspection of the facility from Oct. 15–23, 2012 at which […]
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