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The CenterWatch Monthly, September 2014

Tuesday, September 2, 2014 07:00 AM
Today’s fastest, most economical sponsors

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Scientists looking across human, fly and worm genomes find shared biology

Thursday, August 28, 2014 02:47 PM

Researchers analyzing human, fly, and worm genomes have found that these species have a number of key genomic processes in common, reflecting their shared ancestry.  The findings, appearing in the journal Nature, offer insights into embryonic development, gene regulation and other biological processes vital to understanding human biology and disease. 

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Amgen submits BLA for evolocumab to the FDA

Thursday, August 28, 2014 02:14 PM

Amgen has submitted a Biologics License Application (BLA) to the FDA for evolocumab seeking approval for the treatment of high cholesterol. Evolocumab is an investigational, fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.

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Pfizer, Merck to collaborate on anti-cancer combination regimen

Wednesday, August 27, 2014 10:01 AM

Pfizer and Merck have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (XALKORI) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a phase Ib clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC).  The financial terms of the agreement have not been disclosed. 

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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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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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September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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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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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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