FDA

NIH releases new priority list of drugs it wants tested in children

Thursday, August 28, 2014 01:09 PM

The NIH has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on.

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WIRB Copernicus Group

Roche to acquire InterMune for $8.3 billion

Monday, August 25, 2014 02:02 PM

Roche and InterMune have entered into a definitive merger agreement under which Roche will fully acquire InterMune for $74 per share in cash, for a total transaction value of $8.3 billion on a fully diluted basis.

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ViaCyte, Janssen R&D ink agreement

Friday, August 22, 2014 11:54 AM

ViaCyte, a San Diego-based, privately held regenerative medicine company, has entered into a $20 million rights agreement with Janssen R&D, a unit of Johnson & Johnson. The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01 combination product that ViaCyte is developing for type 1 diabetes. This right will continue through the initial evaluation of clinical efficacy of VC-01. 

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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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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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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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The CenterWatch Monthly

August

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

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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