Clinical Intelligence

FDA advisory committee recommends approval of Tiotropium Respimat COPD

Thursday, August 21, 2014 10:31 AM

The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted (10 yes, three no) t/news-online/company/Boehringer+Ingelheimhat existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.

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WIRB Copernicus Group

Positive results released for Amgen’s phase III study of AMG 416

Thursday, August 21, 2014 10:24 AM

Amgen has announced that a second placebo-controlled, phase III study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints.

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FDA approves Biogen Idec’s Plegridy for multiple sclerosis

Monday, August 18, 2014 09:13 AM

The FDA has approved Biogen Idec’s Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.

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FDA approves Avastin to treat aggressive and late-stage cervical cancer

Friday, August 15, 2014 12:43 PM

The FDA has approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

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Juventas Therapeutics completes enrollment of phase I/II RETRO-HF trial

Friday, August 15, 2014 12:41 PM

Juventas Therapeutics, a private, clinical-stage company developing a drug-based approach to regenerative medicine, has successfully completed the phase I arm of the RETRO-HF clinical trial, and fully enrolled the phase II arm that is evaluating the safety and preliminary clinical efficacy for retrograde infusion of JVS-100 in patients with heart failure.

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FDA approves new sleep drug Belsomra

Friday, August 15, 2014 09:17 AM

The FDA has approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

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FDA approves Orbactiv to treat skin infections

Friday, August 8, 2014 12:44 PM

The FDA has approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.

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BioSpecifics Technologies initiates phase II study of CCH for Lipoma

Friday, August 8, 2014 12:33 PM

BioSpecifics Technologies, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX in the E.U., has injected the first patient in its placebo-controlled phase II clinical trial of CCH for the treatment of lipoma. The company expects to complete patient enrollment in this trial during the first quarter of 2015.

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FDA expands approval of Lumizyme to treat Pompe disease

Monday, August 4, 2014 03:27 PM

The FDA has approved Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than eight years of age. In addition, the risk evaluation and mitigation strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.

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The CenterWatch Monthly, August 2014

Friday, August 1, 2014 01:46 PM

Reality of costs and impact rain on Sunshine Act

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