Crossject Reports Positive Results From Bioequivalence Study With Needle Free ZENEO Methrotrexate

The needle-free injection with ZENEO® Methrotrexate produces similar blood levels to the current injectable formulation Study data an important milestone in the development of CROSSJECT’s portfolio of ZENEO® needle-free products November 24, 2014 CROSSJECT, the creator of ZENEO®, a needle free injection system, announces the similarity between the ZENEO® Methotrexate needle-free injection system and the current injectable formulation. ZENEO® Methotrexate …

U.S. FDA Grants Fast Track Designation to Novavax’ RSV F-Protein Nanoparticle Vaccine for Protection of Infants Via Maternal Immunization

November 20, 2014 Novavax, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax’ RSV F-Protein nanoparticle vaccine candidate (RSV F vaccine) for protection of infants via maternal immunization. “The FDA’s granting of Fast Track designation …

FDA Approves Use of Menactra® Vaccine for Booster Immunization Against Potentially Deadly Disease

Approval aligns with Centers for Disease Control and Prevention’s recommendations for meningococcal vaccination September 11, 2014 Sanofi Pasteur, the vaccines division of Sanofi , announced today that the U.S. Food and Drug Administration (FDA) approved use of Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] for booster vaccination against meningococcal disease in persons 15 years …

Studies have shown that two, instead of three doses, of the HPV vaccine may be enough to prevent the virus

The HPV Cancer Vaccine: Two Doses May Be Enough

Studies have shown that two, instead of three doses, of the HPV vaccine may be enough to prevent the virus On Monday the 25th of August, the 29th International Papillomavirus Conference came to a close in Seattle, USA. Amongst the most hotly debated topics at the conference was lowering the number of doses of the vaccine to boost adherence rates. …

The future of vaccine administration my change forever with Pharmajet's needle-free injector

FDA Approves AFLURIA Flu Vaccine To Be Administered With Pharmajet’s Needle-Free Injector

The future of vaccine administration my change forever with Pharmajet’s needle-free injector The FDA has approved the first needle-free drug system for the delivery of bioCSL’s influenza vaccine AFLURIA. Now, doctors and other health care workers can chose whether they want to administer the influenza vaccine via a needle or through PharmaJet’s needle-free system. Ron Lowy, the CEO of PharmaJet, …

Batu Biologics Achieves Goal in Successful Crowdfunding Campaign

Biotech Startup Aims for FDA Approval for Novel Anti-Angiogenic Cancer Vaccine August 18th, 2014 Using a fundraising approach seldom seen in the life sciences sector, Batu Biologics, an immunotherapy company working to develop the first anti-angiogenic cancer vaccine, has successfully raised $100,000 through the Indiegogo crowdfunding platform. Batu Biologics launched the crowdfunding campaign in June 2014 to fund the completion …

BioTime Receives FDA Premarket Notification Clearance for Premvia™ 510(k)

August 12th, 2014 -BioTime, Inc. (NYSE MKT: BTX) today announced that it has received notice from the FDA’s Center for Devices and Radiologic Health that Premvia™ has been cleared for marketing as a Class II medical device. Premvia™ is the first FDA-cleared member of BioTime’sHyStem® family of hydrogels, which are designed to mimic the natural structures of the human body’s extracellular matrix. According to …

On Wednesday, Pharmaceutical Giant Pfizer Agreed to Buy Baxter International's Vaccines Unit Worth $635 Million

Pfizer Announces FDA Acceptance Of And Priority Review Designation For Biologics License Application For Investigational Meningococcal B Vaccine

August 14, 2014 Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the …