Trials & Filings

  • Lilly Ceases Development of Alzheimer's Drug

    Eli Lilly and Co. will stop development of semagacestat, a gamma secretase inhibitor in Phase III development as a potential treatment for Alzheimer's disease.

  • Elan, Transition Therapeutics Advance Alzheimer’s Drug

    Elan Corp. and Transition Therapeutics, Inc reported results from a Phase II study of ELND005 (Scyllo-inositol) in patients with mild to moderate Alzheimer’s disease.

  • YM BioSciences JAK1/2 Inhibitor Gets Orphan Designation

    YM BioSciences’ highly selective JAK1/2 inhibitor, CYT387 has been granted Orphan Drug Designation.

  • EMD Serono’s Cladribine Tablets Get Priority Review

    EMD Serono’s NDA for Cladribine Tablets has accepted for filing as a therapy for relapsing forms of multiple sclerosis (MS).

  • Eisai, Pfizer Gain Approval for Higher-Dose Aricept

    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).

  • FDA Approves Daiichi’s Hypertension Combo Product

    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 Gets Positive Phase III Scenesse Results

    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.

  • Botox Gets UK Approval for Migraine

    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 Submits T-DM1 BLA

    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.

  • Capsules

    Teva Gains Approval for Effexor Generic

    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.

  • Pfizer Suspends Tanezumab Osteoarthritis Trials

    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.

  • FDA Approves Merck Asthma Drug Dulera

    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.

  • Pfizer To Pull Mylotarg From U.S. Market

    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).

  • Capsules

    Tasigna Approved for CML

    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 Resumes Stimuvax Program

    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.

  • Genzyme MS Drug Gets Fast Track

    MS Drug currently in two Phase III trials against Rebif

  • Nexavar Fails Phase III NSCLC Trial

    Bayer, Onyx drug shows no survival improvement in study

  • Human Genome Sciences, GSK Submit Benlysta BLA

    Human Genome Sciences, Inc. (HGS) has submitted a BLA to the FDA for approval to market Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE).

  • Afinitor Phase III Trial Meets Endpoint

    Novartis Pharmaceuticals Corp.’s Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint in patients with advanced pancreatic neuroendocrine tumors (NET).

  • Perrigo’s Miconazole Generic Gains FDA Approval

    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.