Trials & Filings
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August 10, 2010
YM BioSciences’ highly selective JAK1/2 inhibitor, CYT387 has been granted Orphan Drug Designation.
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July 28, 2010
EMD Serono’s NDA for Cladribine Tablets has accepted for filing as a therapy for relapsing forms of multiple sclerosis (MS).
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July 26, 2010
Eisai and Pfizer received approval from the FDA for a new once-daily, higher-dose Aricept (donepezil HCl) 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease (AD).
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July 26, 2010
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
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July 13, 2010
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.
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July 9, 2010
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).
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July 7, 2010
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.
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June 29, 2010
Teva Pharmaceutical Industries, Ltd. received approval from the FDA for Venlafaxine HCl ER Capsules, the company’s generic version of Wyeth’s antidepressant Effexor XR.
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June 24, 2010
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.
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June 24, 2010
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.
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June 22, 2010
Following discussions with the FDA, Pfizer will discontinue commercial availability of Mylotarg (gemtuzumab ozogamicin for Injection) for the treatment of relapsed acute myeloid leukemia (AML).
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June 18, 2010
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).
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June 17, 2010
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.
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June 15, 2010
MS Drug currently in two Phase III trials against Rebif
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June 14, 2010
Bayer, Onyx drug shows no survival improvement in study
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91 - 105 of 604 results
