Tag Archives: Novartis

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 […]
Posted in Europe, FDA, Global, Market Access, R&D, Safety, Strategy | Also tagged , , , , , | Leave a comment

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 […]
Posted in Emerging Markets, Global, Guest Blog | Also tagged , , , , , , , , | Leave a comment

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 […]
Posted in Europe, FDA, Global, Guest Blog, Manufacturing, Regulatory | Also tagged , , , | Leave a comment

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
  • Categories

  • Meta