The generics firm essentially paid the brand to keep its product off the market, FTC alleges in case about Opana ER litigation. Endo considered bringing back its original formulation of oxymorphone but instead reached agreement with Impax to share profits of its generic, antitrust suit claims.

GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.

Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.

Revised draft guidance about scientific information on unapproved uses (SIUU) of medical products is “impermissibly paternalistic and overly restrictive of scientific speech,” MIWG says.

Lilly representative suggests having more informal communication with FDA and consistent feedback across divisions. The firm had a positive experience participating in CID pilot with master protocol for chronic pain therapies.

Company sought court order to vacate agency’s approval of the fibrinogen products of three blood centers, saying they were wrongly exempt from clinical trials required for Octapharma’s Fibryga.