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The head of the World Health Organization is speaking out against the Trans Pacific Partnership, contending that the 12-country deal could cause drug prices to spike. Read More
Two senators are pressing the Department of Health and Human Services to authorize prescription drug importation to combat price manipulation. Read More
To spur greater mutual inspection reliance between the FDA and EU, the agency and Congress are working to grant the EMA access to unredacted inspection reports. Read More
Pfizer and Allergan announced Nov. 23 that they have struck an agreement on their rumored merger, joining forces in a massive $160 billion deal that would create the world’s largest drugmaker and combine brand names such as Botox, Lipitor and Viagra. Read More
The board of directors of Brazil’s Anvisa has suspended the deadline for companies to submit data for a new drug tracking system and is repealing the system’s implementing legislation. Read More
A ruling by the Court of Justice of the European Union has clarified when drug patents expire, in a decision that could prove lucrative for drugmakers even though it adds only a few days of patent protection. Read More
Some of the world’s poorest nations have been granted an extended exemption from enforcing pharmaceutical patent protections by a World Trade Organization body overseeing intellectual property rights. Read More
To beef up scrutiny of drugs, India’s health ministry has proposed a roughly U.S. $277 million plan to overhaul the Central Drugs Standard Control Organization — by strengthening the inspections framework, establishing new national testing laboratories and firming up databases of products and clinical trials. Read More
The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says. Read More
The U.S. Food and Drug Administration issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More