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FDA and EMA Publish Assessment of QbD for Marketing Applications

August 20, 2013

Agencies collaborate to ensure consistent product quality.

FDA Reviews Outdated Guidance Documents

August 14, 2013

CDER withdraws some outdated guidance documents and makes plans to finalize others.

Onyx Rejects Amgen’s Unsolicited Acquisition Bid

July 2, 2013

The Onyx board of directors rejects $120-per-share proposal as significantly undervaluing the company.

Report from Brazil

July 1, 2013

Brazil offers opportunities and challenges for global pharmaceutical companies.

Johnson & Johnson Opens Partnering Office in London

June 28, 2013

The move is part of a strategy to cultivate innovation in key regions.

Report from Taiwan

June 1, 2013

The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.

Johnson & Johnson's Pharma Sector Poised for Growth, 10 New Product Filings Expected by 2017

May 28, 2013

Johnson & Johnson anticipates submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017; the announcement was made at a recent meeting with industry analysts. Upcoming new products include simeprevir for hepatitis C (already filed in Japan, Europe and the US); ibrutinib and daratumumab for haematologic malignancies; sirukumab and guselkumab for diseases of the immune system such as rheumatoid arthritis and psoriasis; and vaccines for influenza, rabies and polio.

US Government Signs Deal with GSK to Develop Antibiotics

May 23, 2013

Partnership will support development of drugs to fight antibiotic resistance and bioterrorism.

USP Offers Herbal Medicines Compendium

May 20, 2013

The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products.

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