|Dynavax to Initiate Phase 1 Studies For TLR-9 Agonist For Asthma; Biogen and Sobi Announce Positive Top-Line Results from Phase 3 Study|
|By Staff and Wire Reports|
|Wednesday, 31 October 2012 17:53|
Dynavax Technologies Corporation (NASDAQ: DVAX) announced it will advance AZD1419, a proprietary second-generation TLR-9 agonist for asthma, into Phase 1 clinical studies. Development expenses will be fully funded by AstraZeneca under the terms of a collaboration announced in 2006, and Dynavax expects to receive an advance payment of $6 million in the fourth quarter of 2012. Dynavax anticipates the Phase 1 studies will begin in the first half of 2013.
About AZD1419: AZD1419 has been selected to enter formal clinical development based on extensive preclinical studies conducted by Dynavax and AstraZeneca. Under the terms of a previously-announced research collaboration and license agreement, AstraZeneca will provide to Dynavax approximately $20 million in payments to cover the cost of clinical development activities through Phase 2a. If AstraZeneca chooses to advance the program following completion of Phase 2a, Dynavax will receive a $20 million milestone payment, and AstraZeneca will retain its rights to develop the candidate therapy and to commercialize the resulting asthma product. Additional remaining milestone payments to Dynavax amount to approximately $100 million. Dynavax will receive royalties on worldwide sales of approved products and will have the opportunity to co-promote the product in the United States.
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) announced positive results from A-LONG, a clinical study that evaluated a new long-lasting clotting factor candidate in people with hemophilia A. Hemophilia A is a rare inherited disorder that impairs blood coagulation.
Top-line results from A-LONG, a global, multi-center, Phase 3 clinical study of the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc), showed that rFVIIIFc was effective in the control and prevention of bleeding, routine prophylaxis and perioperative management. Recombinant FVIIIFc was generally well-tolerated. Additional analyses of the A-LONG study are ongoing, and the companies anticipate presenting detailed results at a future scientific meeting.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial results for the third quarter ended September 30, 2012.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will host a live webcast of its quarterly conference call at 8:30 a.m. (ET) on Wednesday, November 7, 2012.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products today announced that they have acquired a new cell sorting system from Propel Labs.
Due to complications from the storm affecting the East Coast, Cambrex Corporation (NYSE: CBM) will now report its results of the third quarter ended September 30, 2012 after the market closes Monday, November 5, 2012.
Compugen Ltd. (NASDAQ: CGEN), announced today the discovery and initial validation of two new drug target candidates for monoclonal antibody (mAb) cancer therapy.
Due to the effects of Hurricane Sandy on the Eastern seaboard, CardioNet, Inc. (NASDAQ:BEAT) is postponing the release of its Third Quarter 2012 financial results to Monday, November 5 at 4 PM Eastern Time.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the initiation of the Phase 3 CB-5945 opioid-induced constipation (OIC) Ascent program with the enrollment of the first patient in the long-term safety study, which is one of four registrational studies in patients with chronic non-cancer pain.
DaVita Inc. (NYSE: DVA), a leading provider of kidney care services committed to improving the quality of life for those diagnosed with chronic kidney disease (CKD), will present 13 abstracts at the American Society of Nephrology (ASN) Kidney Week in San Diego, November 1-4.
Emergent BioSolutions Inc. (NYSE: EBS) announced today the initiation of a Phase 1b study (Protocol 16009) of TRU-016 in combination with rituximab for patients with previously untreated chronic lymphocytic leukemia (CLL). TRU-016 is a humanized anti-CD37 mono-specific protein therapeutic in development for the treatment of B-cell malignancies.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate (TAF; formerly referred to as GS-7340), an investigational novel prodrug of tenofovir for the treatment of HIV-1 infection, met its primary objective.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced it has signed an updated license agreement with Intuitive Surgical (NASDAQ: ISRG).
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be participating in the 2012 Brean Capital Life Sciences Summit on November 7, 2012 in New York City.
InterMune, Inc. (NASDAQ: ITMN) today announced that it will release its third quarter and first nine months 2012 financial results at the close of the U.S. markets on Wednesday, November 7, 2012.
Medidata Solutions (NASDAQ: MDSO) has been selected by Sanofi, one of the world’s leading pharmaceutical companies, as the clinical technology standard for clinical data collection, management and reporting and performance-enhancing analytics across its entire R&D organization.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of cloud-based drug development solutions that optimize the efficiency of clinical development, today announced its financial results for the third quarter of 2012, and provided detailed financial guidance for the fourth quarter and full year 2012.
MMRGlobal, Inc. (OTCQB: MMRF) (the "Company" or "MMR") today announced that less than one month before scheduling of court-ordered arbitration proceedings against Surgery Center Management, LLC ("SCM"), the United States Patent and Trademark Office has issued another health information technology patent to MMR.
NeoGenomics, Inc. (NASD OTC QB: NGNM), a leading provider of cancer genetic testing services today reported its results for the third quarter 2012.
NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today reported consolidated financial results for the third quarter of 2012.
Oncothyreon Inc. (Nasdaq: ONTY) today announced that it will conduct a conference call on Wednesday, November 7, 2012 at 4:30 p.m. Eastern Time to discuss its financial results and provide a review of its pipeline of products in development.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, will announce financial results for the third quarter ended September 30, 2012 on Wednesday, November 7, 2012 after the market closes.
Seattle Genetics, Inc. (NASDAQ:SGEN) today announced that its collaborator, Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, announced that the European Commission has granted conditional marketing authorization for ADCETRIS (brentuximab vedotin).
Sionix Corporation (OTCQB: SINX) today announced that Dr. Henry Sullivan has joined its Board of Directors. Dr. Sullivan holds both a Master's degree and Ph.D. in chemical engineering from New York University, and has held senior positions with Huntsman Petrochemical Corporation and Shell Oil Company for a combined 26 years, where his experience included the optimization of refineries and the allocation of hydrocarbons and their processing and movement.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to discuss the third quarter 2012 financial results, provide an update on the Company's business, and discuss expectations for the future.
Verastem, Inc., (NASDAQ: VSTM) a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced the presentation of data at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics on November 6-9, 2012, in Dublin, Ireland.
Zynex, Inc. (OTCQB: ZYXI), a provider of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced today that it will host an investor webcast, Wednesday, November 7, 2012 at 9:00 a.m. Mountain Time - 11:00 a.m. Eastern Time to discuss the Company's third quarter 2012 results.