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Certara promotes Amin Rostami to senior vice president of R&D, chief scientific officer

Thursday, February 5, 2015 01:41 PM

Certara, a global biosimulation technology-enabled drug development and drug safety consulting company, has promoted Amin Rostami, Pharm.D., Ph.D., to senior vice president of R&D and chief scientific officer at Certara. Professor Rostami previously was co-founder and vice president of R&D for Certara’s Simcyp Business Unit.

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Vyvanse is FDA-approved for moderate to severe binge eating disorder

Thursday, February 5, 2015 01:29 PM

The FDA has approved Shire’s Vyvanse (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week. Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions.

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Cord Blood Registry forms scientific and medical advisory board

Thursday, February 5, 2015 01:17 PM

Cord Blood Registry (CBR) has announced the establishment of a scientific and medical advisory board (SMAB). Composed of internationally renowned stem cell experts, the SMAB will provide input and guidance to help advance CBR's mission to expand the scope of newborn stem cell therapies that may be available to patients and their families. The founding members of the SMAB are Dr. Charles Cox, Dr. Mahendra Rao, Dr. Leslie Silberstein and Dr. Alan Trounson. Rao will be the inaugural chairman of the SMAB, and he also will be acting as CBR's chief clinical and regulatory advisor.

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Ebola vaccine trial opens in Liberia

Thursday, February 5, 2015 01:09 PM

A large clinical trial to assess the safety and efficacy of two experimental vaccines to prevent Ebola virus infection now is open to volunteers in Liberia. The trial is being led by a recently formed Liberia-U.S. clinical research partnership and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The Partnership for Research on Ebola Vaccines in Liberia or PREVAIL, a phase II/III study, is designed to enroll approximately 27,000 healthy men and women aged 18 years and older.

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Lycera names Paul Sekhri president and CEO

Thursday, February 5, 2015 12:58 PM

Lycera, a biopharmaceutical company developing breakthrough medicines to treat cancer and autoimmune disease, has named Paul Sekhri president, CEO and a member of the board of directors, effective immediately. Sekhri brings more than 25 years of operational experience in the life sciences industry, including business development and strategy, general management, drug development, and commercial strategy.  He succeeds Kathleen M. Metters, Ph.D., who currently serves as senior advisor to the company.

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NIHR, Janssen partner on rheumatoid arthritis biological treatments

Thursday, February 5, 2015 12:50 PM

A new clinical research study has been launched that will explore why the current gold standard biological treatment for people with rheumatoid arthritis does not work in around a third of patients. The National Institute for Health Research (NIHR) study in partnership with Janssen will investigate key mechanisms associated with a lack of response to this treatment and its findings should open new routes for developing therapies for these patients.

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Neomed creates a new Biologics and Vaccine Center of Excellence

Thursday, February 5, 2015 12:15 PM

Neomed has launched the Biologics and Vaccine Center of Excellence in Laval under a proposed partnership with GlaxoSmithKline (GSK). This Center will be unique in Canada and GSK has committed $47 million towards its establishment. Neomed is a nonprofit that fosters the development of promising therapeutic approaches emerging from academia and biotechnology companies and is jointly funded by the pharmaceutical industry, the Ministère de l'Économie, de l'Innovation et des Exportations du Québec and the Networks of Centers of Excellence (NCE) of Canada.

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Lubrizol, Cleveland Clinic ink collaboration to advance medical innovation

Thursday, February 5, 2015 12:12 PM

Lubrizol and Cleveland Clinic announce that as part of a new joint collaboration, Lubrizol LifeSciences and Cleveland Clinic Innovations are aiming to identify—and ultimately speed the development of—new, groundbreaking products for the medical device and pharmaceutical industries.

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The Medicines Company acquires Annovation Biopharma

Thursday, February 5, 2015 12:08 PM

The Medicines Company has completed its acquisition of all of the outstanding equity of Annovation Biopharma, a company focused on creating more effective, safer therapies for anesthesia and critical care. Based on technology licensed from Massachusetts General Hospital, Annovation is developing ABP-700, a novel intravenous anesthetic which in phase I clinical studies has demonstrated potent and rapidly reversible anesthetic effects.

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Pfizer to acquire Hospira for $17 billion

Thursday, February 5, 2015 12:06 PM

Pfizer has agreed to acquire Hospira, a provider of injectable drugs and infusion technologies and a global provider in biosimilars headquartered in Lake Forest, Ill., for $90 a share in cash, for a total enterprise value of approximately $17 billion.

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CenterWatch Drugs in Clinical Trials

February 23

Venture capital investors funding novel drug R&D three times more than companies repurposing, improving existing drugs

In appreciation: Karen Woodin will be remembered for her teaching, writing and lasting friendships

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Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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