The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in…
The European Medicines Agency published a new draft guideline on developing medicines and vaccines against respiratory syncytial virus infections, including monoclonal antibodies and direct-acting antivirals. Source: Drug Industry Daily
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement.…
The FDA is looking for creative approaches to the opioid crisis, including new requirements for product packaging, as ways to reduce overall exposure to the painkillers. Source: Drug Industry Daily
Kymera Therapeutics launched with a $30M Series A financing which was lead by Atlas Venture. Source: BioSpace
As part of consolidation program, Shire is looking to sell a manufacturing facility in Milford, MA that it gained through its 2015 acquisition of Baxalta. Source: BioSpace
Want to work for a company having a growth spurt? Source: BioSpace
Insys continues to receive an optics beating in the wake of the charges against company founder John Kapoor and multiple executives surrounding illegal sales practices of its cancer pain drug.…
On multiple occasions, President Donald Trump has aimed his ire at pharma companies. Source: BioSpace
Fosun Pharma said it would buy Tridem Pharma S.A.S. for $73M, in a move to expand its market share in Europe and Africa. Source: BioSpace