May 19, 2017
FDA expands Kalydeco indication for cystic fibrosis
The U.S. Food and Drug Administration (FDA) expanded the approved indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for the treatment of cystic fibrosis (CF).
Pharmaceuticals, Biotechnology and Life Sciences
Category: North America
May 18, 2017
FDA OK’s Vertex’s cystic fibrosis drug
U.S. Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
May 17, 2017
Hikma launches Ethacrynic Acid Tablets in the US market
Hikma Pharmaceuticals’s US subsidiary West-Ward Pharmaceuticals has launched Ethacrynic Acid Tablets USP in 25mg strength, the generic equivalent to Edecrin (ethacrynic acid) for the treatment of edema when an agent with greater diuretic potential than those commonly employed is required.
May 17, 2017
Bayer wins FDA’s Priority Review for its follicular lymphoma drug
The U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for Bayer’s copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies.
May 16, 2017
New York county sues Purdue, J&J over opioid marketing
A county in New York state has sued Purdue Pharma LP, Johnson & Johnson <JNJ.N> and other drugmakers, accusing them of engaging in fraudulent marketing that played down the risks of prescription opioid painkillers, leading to a drug epidemic.
May 10, 2017
Lilly welcomes new member of executive committee
Leigh Ann Pusey will join Eli Lilly as senior vice president of corporate affairs and communications, effective June 12, 2017. She will be a member of Lilly’s executive committee reporting directly to president and chief executive officer, David A. Ricks.
May 9, 2017
J&J discloses U.S. probe related to arthritis drug
Healthcare conglomerate Johnson & Johnson <JNJ.N> said on Monday the U.S. Justice Department has opened an investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that bought two of its drugs.
May 9, 2017
Portola Pharmaceuticals reports loss of $41.7M
Portola Pharmaceuticals has reported financial results for the quarter ended March 31, 2017.
May 8, 2017
MT Pharma America accepts ALS challenge – wins FDA approval
Its have been three years since Ice bucket challenge went viral promoting awareness of amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease and encourage donations to research.
May 5, 2017
Tetraphase Pharmaceutical reports $29.5M for Q1 2017
Tetraphase Pharmaceutical has reported a net loss of $29.5 million for the first quarter of 2017 which is decrease compared to a net loss of $16.7 million for the same period in 2016.