The FDA has announced its 2018 Strategic Policy Roadmap, which highlights the agency’s policy priorities. Key items on the agency’s agenda are policies for: deterring opioid abuse, promoting generic and biosimilar competition, and advancing digital health technologies. Read More

Celgene has agreed to acquire Impact Biomedicines, a biopharmaceutical company developing drugs to treat myeloproliferative neoplasms, a type of blood cancer, in a deal worth up to $7 billion. Rea d More

Sanofi and Regeneron Pharmaceuticals, a biopharmaceutical company, have agreed to expand their investment for the clinical development of cemiplimab, a PD-1 antibody for oncology, and dupilumab, for treating Type II allergic diseases. Read More

Takeda has entered into an offer agreement with TiGenix, a company developing stem-cell therapies, for a potential voluntary public takeover bid of approximately EUR 520 million ($620 million). Read More

Shire plans to create two distinct business divisions within the company: a Rare Disease Division and a Neuroscience Division. This follows Shire’s August 2017 announcement that it was conducting a strategic review of its neuroscience business. Read More

The US Senate Committee on Finance held a hearing relating to confirming President Trump’s nominee for Secretary of the US Department of Health and Human Services (HHS), Alex Azar, a former executive at Eli Lilly and Company and former HHS Deputy Secretary and General Counsel. Read More

The FDA has denied separate citizen petitions from Novo Nordisk, Amneal Pharmaceuticals, and Allergan that asked the agency to refrain from approving any abbreviated new drug applications (ANDAs) referencing certain blockbuster drugs. Read More

Perrigo has appointed Uwe Röhrhoff as chief executive officer (CEO) and president, effective January 15, 2018, following the retirement of John T. Hendrickson, the company’s current CEO. Read More

AMRI, a contract research, development, and manufacturing organization, has appointed Michael Mulhern as chief executive officer (CEO), succeeding William S. Marth . Read More

The FDA approved 46 new molecular entities (NMEs) in 2017, more than double the number approved in 2016, and marking a 21-year high.   Read More