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Teva Pharmaceuticals has been named in a patent infringement lawsuit as it attempts to develop a generic version of Belbuca, a long-acting opioid painkiller sponsored by BioDelivery Sciences International and Arius Two. Read More
Aspen Pharma and Deco Pharma, the company’s distributor, face disciplinary proceedings from Spain’s antitrust authority for allegedly limiting the distribution and hiking the prices of drugs. Read More
Former FDA deputy commissioner Scott Gottlieb emerged as the favorite to serve as the next leader of the FDA in a survey of 53 pharmaceutical companies. Read More
The EMA is clarifying agency expectations on the implementation of risk-based models and exposure limits to prevent cross-contamination during manufacturing in a Q&A guideline, telling manufacturers that all products should have health-based exposure limits (HBEL). Read More
Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. Read More
The FDA will no longer redact the CVs of its advisory committee members, in response to a Freedom of Information Act lawsuit filed by Public Citizen last year. Read More
The Office of Management and Budget on Friday clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over $100 million per year — and said the release of new guidance documents would be considered on a case-by-case basis. Read More