Codexis and Chemtex Achieve Key Milestone in Commercial Development of Bio-Based Chemicals from Non-Food Cellulosic Biomass
Codexis (CDXS), a developer of engineered enzymes for pharmaceutical, biofuel and chemical production, and Chemtex, a leader in chemical engineering and renewable processes, today announced the successful scale-up in the production of CodeXol® detergent alcohols using cellulosic sugars. The scale-up was achieved at a 1,500 liter demonstration facility at Chemtex’s R&D complex in Tortona, Italy and is a key milestone in the ongoing effort initiated by the two companies to develop a fully integrated biomass to detergent alcohols technology. A combination of Chemtex’s commercially proven PROESA® cellulosic sugar technology and Codexis’ CodeXyme® 4X cellulase enzymes was used to produce cellulosic sugars from non-food biomass, while the CodeXol® detergent alcohol fermentation process technology – which includes Codexis’ proprietary microorganism strain – converted these cellulosic sugars to detergent alcohols.
Verastem Receives Orphan Medicinal Product Designation from the European Commission for VS-6063 in Mesothelioma
Verastem, Inc., (VSTM) focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced that VS-6063 has received orphan medicinal product designation from the European Commission for use in mesothelioma. The designation is to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.
“We are pleased that the EMA recognizes the significant unmet medical need in mesothelioma,” said Christoph Westphal, M.D., Ph.D., Verastem Chairman and Chief Executive Officer. “This orphan drug designation provides us with a number of benefits in the development of VS-6063.”
Amgen and Cytokinetics Announce Expansion of License for Omecamtiv Mecarbil
Amgen (AMGN) and Cytokinetics Incorporated (CYTK) today announced an expansion of their strategic collaboration to include Japan. In 2006, Cytokinetics and Amgen entered into a collaboration to discover, develop and commercialize novel small-molecule therapeutics that activate cardiac muscle contractility for potential applications in the treatment of heart failure. Omecamtiv mecarbil is the most advanced drug candidate in this collaboration. Initially, Cytokinetics` license to Amgen for omecamtiv mecarbil excluded Japan. Under the amendment to the collaboration announced today, the companies have agreed on terms expanding Amgen`s license for omecamtiv mecarbil and related compounds to include Japan.
Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder
Data presented as a late breaking abstract at SLEEP 2013, the 27th Annual Meeting of Associated Professional Sleep Societies
Vanda Pharmaceuticals Inc. (Vanda) (VNDA) presented additional entrainment and patient-level clinical data at SLEEP 2013, the 27th Annual Meeting of Associated Professional Sleep Societies in Baltimore, from its SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder) Phase III studies of tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in totally blind individuals. Non-24 is a serious, rare and chronic circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (synchronize) their master body clock to the 24-hour day. Currently there is no approved FDA treatment for Non-24.
Salix and Progenics Announce FDA Advisory Committee to Review Relistor sNDA for Opioid-Induced Constipation in Patients with Chronic Pain
Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) today announced that the FDA is seeking input from an Advisory Committee on Salix's Supplemental New Drug Application (sNDA) for RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain.
The FDA's action to convene an Advisory Committee was taken in response to the formal appeal by Salix of the complete response action taken by the FDA on July 27, 2012 regarding the RELISTOR sNDA for chronic pain. The FDA has said that it will take action under the appeal after receiving input from the Advisory Committee. The FDA will notify the Company once the Advisory Committee meeting date has been determined.
CardioNet, Inc. Enters Into Agreement with UnitedHealthcare Insurance Company
Provides Coverage for CardioNet MCOTTM
CardioNet, Inc. (BEAT) (“CardioNet”), the leading wireless medical technology company focused on diagnosing and monitoring cardiac arrhythmias, announced today that the Company has entered into a three-year National Provider Agreement with UnitedHealthcare Insurance Company, covering all of CardioNet’s monitoring modalities, including Mobile Cardiac Outpatient Telemetry (MCOTTM). The Agreement is effective July 1, 2013 and applies to all UnitedHealthcare affiliated entities, including managed Medicare and managed Medicaid plans. UnitedHealthcare provides coverage to more than 70 million members in the United States.
ImmunoCellular Therapeutics Announces Recommendation of Data Monitoring Committee to Continue ICT-107 Phase II Trial Following Interim Analysis
Study Completion Anticipated by Year-End 2013
ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) announced that the Data Monitoring Committee (DMC) has completed a pre-specified interim analysis of the ICT-107 phase II clinical trial in patients with newly diagnosed glioblastoma and recommended that the company continue the trial to completion.
The trial design for the ICT-107 study provides for the interim analysis to be conducted by the independent DMC after 32 events (patient deaths) are reached.
Rosetta Genomics Executes Credentialing Agreement with Three Rivers Provider Network
Preferred Provider Organization network has more than 10 million covered lives; one-in-five Americans now covered for the Rosetta Cancer Origin Test™
Rosetta Genomics Ltd. (ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that the Company has executed a credentialing agreement with Three Rivers Provider Network, Inc. (TRPN) of Chula Vista, Calif., for the Rosetta Cancer Origin Test. TRPN is one of the largest supplemental Preferred Provider Organizations (PPO) in the U.S., providing healthcare benefits to more than 10 million members nationwide.
Medicago is First in the World to Report Positive Interim Results for its H7N9 Pre-Clinical Trial
- The H7 VLP vaccine candidate induces an antibody response after a single dose in mice-
Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a preclinical trial for an H7N9 Avian Influenza VLP vaccine candidate ("H7 vaccine"). The data show that three micrograms of the H7 vaccine administered with and without adjuvant induced high antibody titers after one dose.
Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting with FDA
Expedited Development Path will Allow Seamless Integration of AVP-786 into ongoing Clinical Programs
Avanir Pharmaceuticals, Inc. (AVNR) today announced that the U.S. Food and Drug Administration (FDA) has agreed to an expedited development pathway for their next-generation compound, AVP-786, requiring only a limited pre-clinical package as part of the Investigational New Drug (IND) application. Upon completion of these preclinical studies the company intends to proceed directly into human clinical trials.
Infinity Reports Updated Phase 1 Data Showing Encouraging Clinical Activity of IPI-145 in B-Cell and T-Cell Lymphomas at ASCO Annual Meeting and Announces Initiation of Phase 2 Clinical Study in Indolent Non-Hodgkin Lymphoma
– Early Data Show that IPI-145 Is Well Tolerated and Has Activity in a Broad Range of B-Cell and T-Cell Lymphomas, with a 68 Percent Response Rate in Indolent Non-Hodgkin Lymphoma – – Rapid Onset of Clinical Activity Observed, with a Median Time to Response of 1.8 Months –
Infinity Pharmaceuticals, Inc. (INFI) today announced updated Phase 1 data from an ongoing study of IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma in patients with relapsed/refractory lymphoma, a group of potentially fatal hematologic malignancies, or blood cancers.
Flamel Technologies Announces FDA Approval of Bloxiverz
Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Bloxiverz™ (neostigmine methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch Bloxiverz™ in July 2013 in 0.5 and 1.0 mg/mL strengths.
"We are extremely excited and pleased to receive this FDA approval for Bloxiverz™, the first product from the portfolio of Éclat products acquired in March 2012," said Mike Anderson, Chief Executive Officer of Flamel.
TESARO, Breast International Group (BIG), and the European Organization for Research and Treatment of Cancer (EORTC) Announce Collaboration for Niraparib Clinical Development in Breast Cancer
TESARO, Inc. (TSRO), an oncology-focused biopharmaceutical company, Breast International Group (BIG), a non-profit organization for academic breast cancer research groups from around the world, and the European Organization for Research and Treatment of Cancer (EORTC), an international, independent, multidisciplinary non-profit research organization, today announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor.
Clovis Oncology’s Rucaparib Demonstrates Encouraging Results from Ongoing Phase I/II Monotherapy Study in Patients with Solid Tumors
Objective responses seen in BRCA-mutant ovarian, breast and pancreatic cancer patients 89% clinical benefit rate in ovarian cancer patients across all doses Rucaparib well-tolerated at doses studied Consistent therapeutic drug exposures observed with BID dosing Phase II dose not yet defined; MTD not yet reached
Clovis Oncology (CLVS) today announced initial findings from an ongoing Phase I/II monotherapy study of rucaparib, the Company’s oral, potent, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for the treatment of ovarian cancer.
Aegerion Pharmaceuticals Receives Positive European CHMP Opinion for LOJUXTA(TM) (lomitapide) to Treat Homozygous Familial Hypercholesterolemia (HoFH)
Aegerion Pharmaceuticals, Inc. (AEGR), a biopharmaceutical company dedicated to the development and commercialization of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, announced today that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion with a unanimous vote recommending a marketing authorization for LOJUXTA(TM) (lomitapide) hard capsules. If approved, LOJUXTA will be indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH).
Uroplasty Announces Positive Coverage Decision For Percutaneous Tibial Nerve Stimulation By Wisconsin Physicians Services
Uroplasty, Inc. (UPI), a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today announced that effective June 1, 2013, Wisconsin Physicians Services (WPS) will begin coverage for Posterior Tibial Nerve Stimulation (PTNS) for treatment of overactive bladder (OAB) and associated symptoms of urinary urgency, urinary frequency and urge incontinence.
WPS, a Medicare Administrative Contractor, provides medical and drug benefits to approximately 8.7 million Medicare beneficiaries in the States of Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska and Wisconsin.
Medtronic Garners First-Of-Its-Kind FDA Approval for 'AUI' Device with Endurant II AAA Stent Graft System
Global Market-Leader in Medical Technology for Endovascular Aortic Repair Also Receives 510(k) Clearance for Sentrant Introducer Sheath
MINNEAPOLIS -- May 30, 2013 -- Medtronic, Inc. (MDT) is expanding its market-leading portfolio of products for endovascular aortic repair in the United States with two new medical devices: the company recently received approval from the U.S. Food and Drug Administration (FDA) for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA`s 510(k) clearance for the Sentrant Introducer Sheath; both devices will be on exhibit at the Medtronic booth during the Society for Vascular Surgery`s "Vascular Annual Meeting," which runs May 30-June 2 in San Francisco.
NovaBay Pharmaceuticals and Virbac Enter Into a Collaboration and License Agreement for Animal Health
Virbac Exercises Option to Develop Auriclosene for Use in Global Veterinary Markets
NovaBay Pharmaceuticals, Inc., (NBY), a clinical-stage biotechnology company focused on the topical, anti-infective market, today entered into a collaboration and license agreement with Virbac (NYSE Euronext:VIRP), a global veterinary product company. Virbac exercised its March 2012 Feasibility and Option Agreement, thereby acquiring exclusive worldwide rights to develop NovaBay's proprietary compound, auriclosene (NVC-422), for global veterinary markets. NovaBay will receive an option exercise fee as well as development and pre-commercial milestone payments as a result of the collaboration. NovaBay also expects to receive royalties on the sale of any commercial products in the companion animal field. Virbac's option exercise follows its extensive testing of auriclosene for veterinary uses during the 12-month option period.
BG Medicine Announces Late-Breaker Oral Presentation of New Data on the BGM Galectin-3(R) Test in Heart Failure
European Society of Cardiology Heart Failure Congress Features 15 Presentations and Two Symposia on Galectin-3
BG Medicine, Inc. (Nasdaq:BGMD) today announced the presentation of new clinical research data on the BGM Galectin-3® test in heart disease at the 2013 European Society of Cardiology Heart Failure Congress (ESC-HF) in Lisbon, Portugal. Among the highlights was a late-breaking oral presentation of results from the Aldo-DHF Biomarker Substudy which demonstrated the usefulness of galectin-3 testing for assessing functional capacity and clinical prognosis in patients diagnosed with a form of heart failure known as Heart Failure with Preserved Ejection Fraction (HFpEF).i Heart Failure with Preserved Ejection Fraction is the fastest growing type of clinical heart failure in the United States and Europe, disproportionately affecting women and accounting for one-third to one-half of all hospital admissions for heart failure.ii
Omthera Pharmaceuticals Announces First Quarter 2013 Financial Results
Omthera Pharmaceuticals, Inc. (OMTH), an emerging specialty pharmaceutical company, today announced its financial results for the first quarter of 2013.
Omthera Pharmaceuticals also announced today that it had entered into a definitive merger agreement with AstraZeneca pursuant to which AstraZeneca will acquire Omthera for $12.70 per share, or approximately $323 million. In addition to the cash payment, each Omthera stockholder will receive one Contingent Value Right (CVR) of up to approximately $4.70 for each share they own, equating to $120 million, if specified milestones related to Epanova are achieved, or if a milestone related to global net sales is achieved. This will bring the total potential acquisition value to $443 million.