|Two leading drug firms join forces for next-generation malaria vaccine|
|By Staff and Wire Reports|
|Monday, 06 June 2011 19:36|
GlaxoSmithKline (NYSE:GSK) and Johnson & Johnson (NYSE:JNJ), through its newly acquired Dutch unit Crucell, plan to start a clinical trial using the so-called "prime-boost" vaccine within the next couple of months.
GSK's first-generation vaccine, known as RTS,S or Mosquirix, is in late-stage development and could reach the market in 2015. It is only around 50 percent effective and the hope is the next one will take things to a new level.
The new vaccine is an amended version of the current GSK shot that adds an engineered common cold virus developed by Crucell to "prime" the immune system to get a stronger response.
Patients will get a single dose of Crucell's weakened virus vaccine, followed by two doses of Mosquirix.
In preclinical studies, the new approach has generated an enhanced immunity effect when compared with either vaccine component given alone.
The initial Phase I/IIa clinical trial starting this year should produce data within 18 to 24 months and, if successful, will start a lengthy process of follow-up studies.
With thousands of patients needed for later-stage studies, it is likely to be between 2020 and 2025 before GSK and J&J have a viable set of data to submit to regulators for approval.
Allezoe Medical Holdings (OTCBB:ALZM) today announces that, by written consent of the Board of Directors of the Company, the size of the Board of Directors has increased to 5 members and three non-interested, independent new directors have been elected to fill the vacancies.
BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, today announced the opening of its Asian headquarters, BIOLASE Technology Asia Pacific in Shanghai, China, and a direct sales and service office, BIOLASE Technology India Private Limited in Mumbai, India.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced Monday morning that the FDA's clinical hold on the GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been lifted by FDA, but will that news be enough to get investors to buy-in and hold on to shares?
Caliper Life Sciences, Inc. (NASDAQ:CALP), a leading provider of tools and services for drug discovery and life sciences research, today announced the presentation of key findings that validate an automated, digital pathology workflow for faster and more accurate characterization and analysis of tumor samples, during the American Society of Clinical Oncology 2011 Annual Meeting in Chicago, IL.
CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, issued the following letter to shareholders.
Digirad Corporation (NASDAQ: DRAD) and Dilon Diagnostics, the world leader in molecular breast imaging, today announced that Digirad has contributed advanced photodetector technology for use in Dilon's newest gamma camera, the FDA cleared Dilon 6800 Acella®, via a technology development and OEM agreement.
D. Medical Industries Ltd. (NASDAQ:DMED) (TASE:DMED) ("D. Medical"), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, expects to announce its fiscal 2011 first quarter financial results on Monday, June 13, 2011.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced the successful first Chinese implants of the Edwards SAPIEN XT valve.
Genesis Biopharma, Inc. (OTCBB: GNBP), a biotechnology company developing targeted cancer therapies, today announced an expanded clinical focus to include an autologous cell therapy product candidate, Contego™, for the treatment of Stage IV metastatic melanoma.
Given Imaging (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the initiation of and first PillCam® COLON 2 capsule procedures in a large, multi-center, pivotal PillCam® COLON 2 study, which will support the Company's planned 510(k) submission to the U.S. Food and Drug Administration (FDA).
Grifols, (NASDAQ: GRFS) a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain, today announced the establishment of a new Board of Directors for its U.S. operations, including the appointment of Thomas Glanzmann as Chairman of the Board, who previously was president of another leading global plasma therapeutics business, and the reappointment of Gregory Rich as Chief Executive Officer (CEO) of Grifols U.S. operations.
HWI Global, Inc., (OTCBB: HWIC), the Pittsburgh-based clean room design builder, has been contracted to provide USP 797 consultation and interior fit and finish services for the new Central Pharmacy at UNC Hospitals in Chapel Hill, NC.
Kendle (Nasdaq:KNDL) ("Kendle"), a leading, global full-service clinical research organization (CRO), today announced it is commencing a cash tender offer and consent solicitation for any and all of its $142.5 million aggregate principal amount of outstanding 3.375 percent Convertible Senior Notes due 2012 (CUSIP No. 48880LAA5; ISIN No. US48880LAA52) (the "Notes").
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the Jefferies 2011 Global Healthcare Conference, being held in New York City.
NuVim, Inc. (PINKSHEETS: NUVM), a leading provider of nutritional refrigerated and shelf stable ready to drink beverages and powder mixes, filed the quarter financial statements on Friday.
Pharmacyclics, Inc. (Nasdaq:PCYC) today announced data from the oral presentation of the Phase IB/II study of the Btk inhibitor, PCI-32765, in chronic lymphocytic leukemia / small cell lymphocytic lymphoma (CLL/SLL) at the 2011 American Society of Clinical Oncology Annual Meeting.
Thomson Reuters (TSX: TRI) (NYSE: TRI), the world's leading source of intelligent information for businesses and professionals, today announced its intention to divest its Healthcare business, which has been part of the company's Healthcare & Science segment.
UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce it has commenced marketing the "RX Air Plus" Air Purification System, which the Company believes could revolutionize the air purification marketplace.
Waters Corporation (NYSE:WAT) today announced it has entered into a non-exclusive co-marketing and reselling agreement with PREMIER Biosoft International (Palo Alto, CA) to advance lipidomics research.
Waters Corporation (NYSE:WAT) today introduced the SYNAPT® G2-S High Definition Mass Spectrometer, representing a significant step forward in performance for High Definition Mass Spectrometry.