Tag Archives: Novartis

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 […]
Posted in Biotech, FDA, Orphan Drugs, Regulatory | Also tagged , , , , , , , , , , , | Leave a comment

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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Does India's Glivec Decision Make April Fools of Us All?

By Helen Disney, Pugatch Consilium. On April 1, India’s Supreme Court denied an appeal challenging the rejection of a patent for Novartis’s cancer drug, Glivec. The drug is a life-saving medicine for certain forms of cancer, patented in nearly 40 other countries — including many which are not noted for the strength of their intellectual […]
Posted in Global, Guest Blog, IP, Legal, Op-Ed | Also tagged , , | 2 Comments

The Patent Black Label: Six Side-Effects of India's Novartis Glivec Ruling

Monday’s decision by India’s Supreme Court to deny a patent for the top-selling oncologic drug Glivec took nearly a decade of litigation to resolve – but the implications in and beyond India are both immediate and lasting.  Here’s a list of six that Pharm Exec thinks are most important:
Posted in Emerging Markets, Global, IP, Legal, Manufacturing, Market Access, pricing, Strategy | Also tagged , , , , , , , | 6 Comments

European Commission Investigates J&J, Novartis

By Stephanie Sutton. The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.
Posted in Europe, Global, Guest Blog, Regulatory | Also tagged , , | Leave a comment
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