Pharma News

The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.

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) 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...

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...