DIA Biosimilars 2013

BARDA

GSK inks agreement with BARDA to supply anthrax treatment

Friday, September 20, 2013 11:32 AM

GlaxoSmithKline has signed a new four-year contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), for the provision of its inhalation anthrax treatment, raxibacumab. The U.S. government is purchasing the medicine as a counter measure against a potential bioterrorist attack.

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Cenduit: Now with Patient Reminders

HHS partners with GSK for new antibiotics

Wednesday, June 12, 2013 02:19 PM

GlaxoSmithKline and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), are collaborating to support the development of several antibiotics to fight antibiotic resistance and bioterrorism.

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CRF Health – eCOA Forum

Achaogen awarded $60M contract

Wednesday, June 12, 2013 02:16 PM

Achaogen, a biopharmaceutical company focused on discovering, developing and commercializing treatments for serious infections caused by multi-drug resistant gram-negative bacteria, has been awarded a $60 million contract option from the Biomedical Advanced Research and Development Authority (BARDA). The option supports the conduct of a global phase III study to evaluate the efficacy and safety of plazomicin in treating patients with gram-negative bacterial infections due to CRE.

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BARDA awards Cempra $58M contract to develop antibiotic for pediatric use

Wednesday, May 29, 2013 01:59 PM

BARDA (Biomedical Advanced Research and Development Authority) has awarded Cempra, a clinical-stage pharmaceutical company focused on differentiated antibiotics, with a five year contract valued up to $58 million for the development of solithromycin to treat infections in pediatric populations and for the treatment of infections by bioterror threat pathogens. 

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FDA grants Soligenix Fast Track for OrbeShield for gastrointestinal acute radiation syndrome

Thursday, January 31, 2013 02:00 PM

Soligenix, a development-stage biopharmaceutical company, announced today that its OrbeShield (oral beclomethasone 17, 21-dipropionate or oral BDP) development program for the treatment of gastrointestinal acute radiation syndrome (GI ARS) has received Fast Track designation from the FDA.

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Cellerant awarded $36.4M to develop CLT-008 for acute radiation syndrome

Thursday, September 6, 2012 07:48 AM

Cellerant Therapeutics, a biotech developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, has been awarded $36.4 million under an option exercised by the Biomedical Advanced Research and Development Authority (BARDA) in the office of the assistant secretary for preparedness and response of the Department of Health and Human Services, for the advanced development of CLT-008, a first-in-class, allogeneic, cell-based therapy for the treatment of acute radiation syndrome (ARS).

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Emergent BioSolutions secures funding from BARDA for anthrax vaccine

Monday, June 4, 2012 11:33 AM

Emergent BioSolutions of Rockville, Md., has reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to conduct a non-interference study to be used to support a post-exposure prophylaxis (PEP) indication for BioThrax, an adsorbed anthrax vaccine.

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Biota and Nabi merge to form Biota Pharmaceuticals

Monday, April 23, 2012 09:36 AM

Biota Holdings, an Australian anti-infective drug development company, and Nabi Biopharmaceuticals of Rockville, Md., have signed a Merger Implementation Agreement to form the combined company Biota Pharmaceuticals, to be headquartered in the U.S.

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AMRI and Biota strike development and manufacturing deal

Wednesday, April 18, 2012 09:44 AM

AMRI, a global contract research and manufacturing organization, was selected by Biota Holdings, an Australian anti-infective drug development company, to further develop and manufacture influenza antiviral CS8958 (laninamivir), a second-generation, long-acting neuraminidase inhibitor.

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Avaxia raises $2.2 million in Series A financing

Friday, November 11, 2011 10:44 AM

Avaxia Biologics, a privately-held biotech company, has completed its first close of $2.2 million of a Series A angel-led financing. Cherrystone Angels of Providence, Rhode Island led the round, with participation from Boston Harbor Angels and other undisclosed individuals. Mr. Robert Manning, the co-Chairman of Cherrystone Angels, will join the Avaxia board.

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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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The CenterWatch Monthly

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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