The U.S. FDA issued a Complete Response Letter to Netherlands-based Pharming Group for the company’s supplemental Biologics License Application for Ruconest.
The U.S. FDA approved a first-of-its-kind drug from Shire Plc to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling.
Shire plc announced the U.S. Food and Drug Administration accepted the Biologics License Application and granted priority review for lanadelumab (SHP643).
KalVista Pharmaceuticals Inc. inked a collaboration deal with Merck & Co. for potential therapeutic treatments for diabetic macular edema.
London-listed drugmaker Shire successfully tested a new medicine that prevents attacks in patients with hereditary angioedema (HAE).
FDA granted orphan-drug exclusivity for Haegarda for the prevention of hereditary angioedema attacks.
Investors are cooling off on Biocryst Pharmaceuticals despite the company’s strong interim reports for its Phase II hereditary angioedema (HAE) treatment. After rising about 45 percent in premarket trading, shares of Biocryst were down more than 14 percent.
Shire’s 2015 bet on Dyax and its experimental drug to treat the rare illness, hereditary angioedema (HAE), is paying off. The company revealed stellar Phase III data for lanadelumab that could transform the way HAE patients are treated.
The European Commission approved a label extension for three new indications for Shire’s Cinryze, broadening its use to children with hereditary angioedema.
Dublin-based Shire (SHPG) announced today that it will acquire Burlington, Mass.-based Dyax Corporation (DYAX) for about $5.9 billion. Shire will pay $37.30 per Dyax share in cash, totaling around $5.9 billion. In addition, if Dyax’s pipeline product, DX-2930 for the treatment of HAE, a rare, debilitating genetic inflammatory condition, is approved, Dyax shareholders will receive […]