North America – Page 104 – pharmaceutical daily

May 23, 2017 Off

Novo Nordisk submits application in the US for label addition for its diabetes drug

Novo Nordisk has submitted a supplemental application to the US Food and Drug Administration (FDA) for including data in the label for Tresiba (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.

May 19, 2017 Off

FDA expands Kalydeco indication for cystic fibrosis

By Dino Mustafić

The U.S. Food and Drug Administration (FDA) expanded the approved indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for the treatment of cystic fibrosis (CF).

May 18, 2017 Off

FDA OK’s Vertex’s cystic fibrosis drug

By Dino Mustafić

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 Off

Hikma launches Ethacrynic Acid Tablets in the US market

By Dino Mustafić

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 Off

Bayer wins FDA’s Priority Review for its follicular lymphoma drug

By Dino Mustafić

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 Off

New York county sues Purdue, J&J over opioid marketing

By Dino Mustafić

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 Off

Lilly welcomes new member of executive committee

By Dino Mustafić

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 Off

J&J discloses U.S. probe related to arthritis drug

By Dino Mustafić

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 Off

Portola Pharmaceuticals reports loss of $41.7M

By Dino Mustafić

Portola Pharmaceuticals has reported financial results for the quarter ended March 31, 2017.

May 8, 2017 Off

MT Pharma America accepts ALS challenge – wins FDA approval

By Dino Mustafić

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.