Daiichi Sankyo received FDA approval of Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one combination drug taken once-daily for the treatment of hypertension in patients who are not adequately controlled with other anti
Clinuvel Pharmaceuticals achieved positive results from a Phase III trial of Scenesse in patients with erythropoietic protoporphyria (EPP), showing that the drug has the ability to reduce and prevent painful phototoxic reactions.
Allergan’s Botox has been licensed by the MHRA in the UK for the prevention of headaches in adults who have chronic migraine (headaches on at least 15 days per month of which at least eight days are with migraine).
Genentech has submitted a BLA to the FDA for trastuzumab-DM1 (T-DM1) to treat advanced HER2-positive breast cancer in patients that previously received multiple HER2-targeted medicines and chemotherapies.
Pfizer, Inc. has suspended the osteoarthritis clinical program for its investigational drug tanezumab following a request by the FDA based a several reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement.
Merck received approval from the FDA for Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combo asthma treatment for patients 12 years of age and older.
Following a priority review, Novartis received FDA approval for Tasigna 150 mg capsules for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML).
EMD Serono, Inc., an affiliate of Merck KGaA, is resuming its Stimuvax (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC), which includes a pair of Phase III studies.
Perrigo Co. has received approval from the FDA for its aNDA for OTC Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat -1 Combination Pack, for the treatment of vaginal yeast infections.