FDA

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

BARDA extends contract with Cytori for thermal burn treatment

Wednesday, August 20, 2014 01:29 PM

Cytori Therapeutics, a California-based developer of cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions, and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, have announced the execution of a contract option to fund the continued investigation and development of Cytori Cell Therapy for use in thermal burn injuries.

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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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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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Group of 19 institutional investors seeks support for biosimilars from top biopharma companies

Thursday, August 14, 2014 02:34 PM

Don’t bad mouth biosimilars—they are needed to help hold down skyrocketing drug costs.

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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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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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BioElectronics president outlines four-part growth strategy

Monday, August 4, 2014 02:09 PM

In a letter to shareholders, Andrew J. Whelan, president of BioElectronics, emphasized a four-part growth strategy initiated in the last year. 

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FDA approves Jardiance to treat type 2 diabetes

Friday, August 1, 2014 01:33 PM

The FDA has approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.

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Ebola outbreak highlights need to improve biosafety, infrastructure to handle future health emergencies

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Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

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Benefits outweigh the complexities, challenges of finding right vendors

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