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Two congressmen introduced right-to-try legislation in the House this week, which could find broad support from Congress and the White House. Read More
More than 160 biotech executives, investors and researchers have signed on to a letter opposing President Trump’s executive order restricting immigration from seven Middle Eastern and African countries. Read More
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