Selected fourth quarter product approvals. (A) Algeta ASA (OSE:ALGETA) is being acquired by Bayer AG (Xetra:BAYN); (B) Gentium S.p.A. (NASDAQ:GENT) is being acquired by Jazz Pharmaceuticals plc (NASDAQ:JAZZ)



Actelion Ltd. (SIX:ATLN)

FDA approves Opsumit macitentan to treat pulmonary arterial hypertension (PAH). EC approves the product as a monotherapy or in combination with phosphodiesterase-5 (PDE5) inhibitors or prostacyclin to treat PAH in adults

Algeta ASA (OSE:ALGETA)/Bayer AG (Xetra:BAYN) (A)

EC approves Xofigo radium-223 dichloride to treat adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases

Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL)/BioSpecifics Technologies Corp. (NASDAQ:BSTC)

FDA approves Xiaflex collagenase clostridium to treat Peyronie's disease in adult men who have a plaque that can be felt and a curve in their penis greater than 30 degrees

Basilea Pharmaceutica AG (SIX:BSLN)

Ceftobiprole is approved under the EU's decentralized procedure to treat community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP), in adults

Bayer AG (Xetra:BAYN)

FDA approves Adempas riociguat to treat PAH and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgery in pulmonary hypertension patients

Bial-Portela & Ca. S.A./Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506)

FDA approves Aptiom eslicarbazepine (formerly Stedesa) as an add-on therapy to treat partial-onset seizures in adults with epilepsy


India approves Canmab, a biosimilar of Herceptin trastuzumab, to treat HER2-positive, metastatic breast cancer

Biogen Idec Inc. (NASDAQ:BIIB)/Genentech Inc./Roche (SIX:ROG; OTCQX:RHHBY)

FDA approves Gazyva obinutuzumab in combination with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL)

Bristol-Myers Squibb Co. (NYSE:BMY)

EC approves a label expansion for Yervoy ipilimumab to include treatment of previously untreated patients with unresectable or metastatic melanoma


FDA approves Varithena (formerly Varisolve) to treat varicose veins

Fresenius SE & Co. KGaA (Xetra:FRE; OTCQX:FSNUY)/Galenica Ltd. (SIX:GALN)

FDA approves Velphoro sucroferric oxyhydroxide to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis

Genentech Inc./ImmunoGen Inc. (NASDAQ:IMGN)/Roche (SIX:ROG; OTCQX:RHHBY)

EC approves Kadcyla ado-trastuzumab emtansine to treat HER2-positive, unresectable, locally advanced or metastatic breast cancer in patients who previously received Herceptin trastuzumab and/ortaxane

General Electric Co. (NYSE:GE)

FDA approves PET imaging agent Vizamyl [18F]-flutemetamol for use in estimating beta amyloid neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline

Gentium S.p.A. (NASDAQ:GENT)/Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) (B)

EC approves Defitelio defibrotide to treat severe hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation

Gilead Sciences Inc. (NASDAQ:GILD)

FDA approves Sovaldi sofosbuvir in combination with ribavirin to treat HCV genotypes 2 and 3 infection

Gilead Sciences Inc. (NASDAQ:GILD)/Japan Tobacco Inc. (Tokyo:2914)

EC approves Vitekta elvitegravir to treat HIV-1 infection in adults without known mutations associated with resistance to elvitegravir