DIA Biosimilars 2013

United States

Soligenix receives IND clearance from FDA for SGX942 in oral mucositis

Wednesday, March 27, 2013 08:59 AM

The FDA cleared the Soligenix’s Investigational New Drug (IND) application for SGX942 for the treatment of oral mucositis resulting from radiation and/or chemotherapy treatment in head and neck cancer patients.

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Cenduit: Now with Patient Reminders

PRACS Institute closes; Chapter 7 imminent

Friday, March 22, 2013 01:23 PM

By Suz Redfearn
At 4:30 p.m. central time on Wednesday, March 20, the approximately 480 employees at PRACS Institute’s Fargo, N.D., facility—one of the largest phase I units in the world with 544 beds—were told via conference call that PRACS was shutting its doors, effective immediately.

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CRF Health – eCOA Forum

bluebird bio collaborates with Celgene to advance gene therapy in oncology

Friday, March 22, 2013 10:23 AM

bluebird bio, a Cambridge-Mass.-based privately-held biotechnology company focused on gene therapy, has formed a broad, global strategic collaboration with Celgene, a Summit, N.J.-based integrated global biopharmaceutical company focused on cancer and inflammatory diseases, to discover, develop and commercialize novel disease-altering gene therapies in oncology.

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Affymax cuts 75% of employees in midst of ongoing product investigation

Tuesday, March 19, 2013 03:34 PM

Palo Alto, Calif.-based Affymax will reduce its workforce as part of a plan to focus the company's resources on the ongoing investigation of reported hypersensitivity reactions in patients receiving Omontys injection following the nationwide voluntary recall of the product from the market. Approximately 230 employees (or 75%) will be cut, including its commercial and medical affairs field organizations and other officers and employees.

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New Alzheimer’s Association report reveals one in three seniors dies with dementia

Tuesday, March 19, 2013 03:32 PM

According to the Alzheimer's Association’s just released 2013 Alzheimer's Disease Facts and Figures report, one in three U.S. seniors dies with Alzheimer’s or another dementia.

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Avitide secures Series A financing for novel affinity purification tech

Monday, March 18, 2013 11:17 AM

Avitide, a biotech company dedicated to the discovery and development of custom affinity purification solutions, announced the closing of their Series A financing. The Avitide technology is designed to discover and develop affinity purification products that will improve the fundamental timeframes and economics of commercial bioprocessing.

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New Jersey to hire displaced pharmaceutical workers

Wednesday, March 13, 2013 02:08 PM

New Jersey has announced a financial hiring incentive to employers through the state Department of Labor and Workforce Development (LWD) if they hire and train former pharmaceutical industry employees. Employers willing to hire displaced pharmaceutical workers may reduce the cost to train new employees under this new on-the-job training program, which will reimburse each employer up to between 50% and 90% of a new hire’s salary for up to six months and a maximum of $14,000

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FDA grants Fast Track to Chimerix’s CMX001 for cytomegalovirus infection

Wednesday, March 13, 2013 12:06 PM

The FDA has granted Fast Track designation for CMX001 for the prevention of cytomegalovirus (CMV) infection, according to Chimerix, the drug’s developer. CMX001 is the company's broad spectrum, oral nucleotide analog lipid-conjugate that blocks replication of double-stranded DNA (dsDNA) viruses.

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Mayo, Sanford-Burnham extend collaborative agreement

Wednesday, March 13, 2013 10:10 AM

Sanford-Burnham Medical Research Institute and the Mayo Clinic signed a new collaborative agreement to build a pipeline of therapeutic drugs aimed at a variety of diseases with serious unmet medical needs.

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Report: Biologics research promises to bolster future of medicine

Monday, March 11, 2013 02:01 PM

America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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