The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Piramal Enterprises Limited (PEL) reports that its Good Laboratory Practices (GLP) Department at Research & Development (R&D) facility in Goregaon, Mumbai has received the GLP Compliance Certification from the National Good Laboratory...
Novartis reports that FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approval for RLX030 (serelaxin) for the treatment of acute heart failure (AHF). RLX030 is under review to improve the symptoms of AHF...
Roche reports that the European Commission (EC) has approved a new subcutaneous (SC) formulation of MabThera (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. Following the approval of Herceptin...
Baxter International Inc. has announced plans to create two separate, independent global healthcare companies:one focused on developing and marketing biopharmaceuticals and the other on medical products. "Baxter has an established history...
GlaxoSmithKline (GSK) is alerting consumers that some bottles of its alli® over-the-counter weight loss medication have been tampered with. The company reports that it has started an investigation and is working with FDA. These tampered...
GlaxoSmithKline (GSK) has been granted marketing authorization by the European Commission for its once-weekly diabetes treatment, Eperzan® (albiglutide). Eperzan is indicated for the treatment of Type 2 diabetes mellitus in adults, to...
AstraZeneca today announced it has completed the purchase of Sumitomo Chemical's remaining shares in AstraZeneca K.K., the company's Japanese subsidiary. The purchase was valued at approximately JPY10 billion ($102 million) and gives...
NanoBio Corporation has formed a licensing agreement with a subsidiary of Merck & Co., Inc., known for the use of its nanoemulsion (NE) adjuvant technology. Under the agreement, Merck receives exclusive rights to NanoBio's NE adjuvant for...
AmerisourceBergen Corporation has agreed to acquire a minority stake in Profarma Distribuidora de Produtos Farmacêuticos S.A. (Profarma), a pharmaceutical wholesaler in Brazil. In addition, AmerisourceBergen and Profarma will establish a joint...
Sun Pharmaceutical Industries Ltd. reported on March 13, 2014, that FDA had issued an import alert for its cephalosporin facility located at Karkhadi, Gujarat in India. This import alert was issued by FDA as a follow-up to the last...
Otsuka Pharmaceutical Co., Ltd. (Otsuka) has received regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD) through the approval of Samsca® (tolvaptan) in Japan in 7.5-mg and 15-mg tablet...
AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved FORXIGA® (dapagliflozin in 5 and 10 mg tablets), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, as an once-daily oral treatment for Type 2...
FDA has approved Celgene Corporation's OTEZLA® (apremilast) an oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic...
Novozymes Biopharma, part of Novozymes A/S, has formed a collaboration with Janssen Research & Development, LLC (Janssen). The agreement will enable Janssen to evaluate Novozymes Biopharma's engineered albumin-based VELTIS...
Novartis has announced the launch of the Lucentis® (ranibizumab) prefilled syringe (PFS) in Germany, with other markets to follow throughout 2014. The Lucentis PFS, which received European approval in October 2013, is a new way of administering...
