Pharmaceuticals, Biotechnology and Life Sciences
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.
Belupo, Croatia-based pharmaceutical company and a part of the Podravka Group has opened new factory worth €71 million.
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.
The Saudi Food and Drug Administration (SFDA) has approved Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinone) capsules in all strengths (2 mg, 5 mg, 10 mg and 20 mg) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
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.
Nicox, the international ophthalmic R&D company, appointed Lauren P. Silvernail to the its Board of Directors, for a period of four years.
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.
German drug company Stada Arzneimittel AG has not been approached by Advent International or Shanghai Pharmaceuticals Holding with a counter offer, two sources close to the matter told Reuters on Monday.
The United States District Court for the District of New Jersey upheld the validity of Horizon Pharma’s patent covering Pennsaid (diclofenac sodium topical solution) 2% w/w, which Actavis Laboratories UT, Inc.(Actavis) has admitted that its proposed generic diclofenac sodium topical solution product would infringe.
Mereo BioPharma Group, a clinical stage, biopharmaceutical company focused on rare and specialty diseases, has completed patient enrolment in the AETHER, multi-centre, double-blind, placebo-controlled Phase 2 dose-ranging study of acumapimod (BCT-197), for the treatment of patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD).