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Novartis’ valsartan woes escalated Thursday as Japan followed the U.S. in filing a legal complaint against the Swiss drugmaker over its marketing practices for the blood pressure drug. Read More
Teva Pharmaceuticals has chosen an agro-chemicals expert as its new CEO. Former Makhteshim Agan Industries (MAI) chief Erez Vigodman takes Teva’s helm Feb. 11, Teva said Thursday. Read More
The International Society of Pharmaceutical Engineering (ISPE) is recommending six quality metrics that the FDA should consider collecting from manufacturers as part of the agency’s new quality metrics program. Read More
Drugmakers should evaluate a product’s UV-visible absorption spectrum before starting clinical development, the ICH says in a new guideline that will standardize photosafety testing standards across the EU, Japan and U.S. Read More
The European Medicines Agency is encouraging drugmakers looking to apply novel drug development tools to seek the EMA’s blessing first and get qualification or prospective advice. Read More
Forest Laboratories is acquiring N.J.-based drugmaker Aptalis from global investment firm TPG in a deal worth $2.9 billion, the companies said Wednesday. Read More
Less than a month after AstraZeneca said it was buying out Bristol-Myers Squibb’s part of its diabetes pipeline partnership, the FDA Wednesday approved their type 2 diabetes drug Farxiga. Read More
The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More
FDA Commissioner Margaret Hamburg has named Howard Sklamberg as the agency’s new deputy commissioner of global regulatory operations and policy. Read More