Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Applied Nanoscience Inc. (ANI) (PINKSHEETS:APNN), a nanotechnology-based filtration company, today issued a progress report to its investors relating to progress in commercializing the disposable NanoFense™ Protective Face Mask, designed to offer superior protection against a broad spectrum of harmful virus, bacteria and fungi.Amarin Corp. (NASDAQ:AMRN), a clinical stage pharmaceutical company with R&D operations based in Mystic, Conn., has joined SAFE-BioPharma Association, the non-profit association that created and manages the global SAFE-BioPharma® digital identity and signature standard for the pharmaceutical and healthcare industries.Adolor Corporation (Nasdaq:ADLR) announced the initiation of clinical testing of ADL7445, its proprietary, oral mu opioid receptor antagonist for the treatment of Opioid Bowel Dysfunction (OBD).Abbott (NYSE:ABT) announced a definitive agreement to acquire the global rights to PanGenetics BV's PG110 fully humanized antibody to Nerve Growth Factor (NGF), expanding the company's pain care portfolio and leveraging its expertise in biologics. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, is providing an update on its RNAi pipeline, platform, and technology at its R&D Day being held in New York today.CellCyte Genetics Corporation (OTC:CCYG) announced the appointment of Dr. Douglas Cerretti as Chief Science Officer and Director of Business Development effective November 1, 2009.DuPont (NYSE:DD) and BSES Limited announced a research, development and commercialization alliance to improve productivity and use of sugarcane varieties.Edwards Lifesciences Corporation (NYSE:EW), the global leader in the science of heart valves and hemodynamic monitoring, announced The Edwards Lifesciences Fund is granting $1.8 million to 107 nonprofit organizations as part of its fifth annual grant cycle. This fund is a donor-advised fund of the Vanguard Charitable Endowment Program.Inovio Biomedical Corporation (NYSE:INO), a leader in DNA vaccine design, development and delivery, announced the company will highlight its technology at two worldwide vaccine conferences next week. Dr. David Weiner, Chair of Inovio’s Scientific Advisory Board, and Niranjan Sardesai, Senior Vice President, SVP, Research and Development will speak on Inovio’s DNA vaccine development.Inhibitex, Inc. (Nasdaq:INHX), announced Russell H. Plumb, president and chief executive officer, will present an overview of the company and its pipeline of differentiated antiviral compounds at the Lazard Capital Markets 6th Annual Healthcare Conference at the St. Regis Hotel in New York City on Tuesday, November 17, 2009 at 1:40 p.m. Eastern Time.Luna Innovations Incorporated (NASDAQ:LUNA), a company focusing on sensing & instrumentation and pharmaceutical nanomedicines, today announced its financial results for the quarter ended September 30, 2009.Medtronic, Inc. (NYSE:MDT) announced the kick-off of an educational campaign aimed at raising awareness among women of overactive bladder (OAB), a serious condition that can severely impact patients’ lives.Mach One Corporation (OTC:MNCN), a rapidly growing, innovative, global wellness solutions company, announced it has completed the first tranche of its investment in PanTheryx, Inc., as stipulated in a recent Letter of Understanding signed in August 2009.Millipore Corporation (NYSE:MIL) a leading provider of technologies, tools and services for the global life science industry has been named “Corporate Citizen of the Year” by the New England Clean Energy Council.NeoGenomics, Inc. (OTC:NGNM) announced it will present at the Lazard Capital Markets 6th Annual Healthcare Conference being held November 17-18, 2009, at the St. Regis, New York Hotel in New York City.Nutra Pharma Corp. (OTC:NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced it plans to begin the drug registration process in Brazil and Colombia for its over-the-counter (OTC) pain reliever.Nile Therapeutics, Inc. (NASDAQ:NLTX), a company focused on the development of novel therapeutics for heart failure patients, announced its third quarter financial results for 2009.For the fiscal year ending June 30th, 2009, PD-Rx (Pink Sheets: PDRX) set record sales of $26.9 million over last year's sales figures of $26.4 million, reporting a net increase in sales of $493,230.PharmAthene, Inc. (NYSE:PIP), a biodefense company developing medical countermeasures against biological and chemical threats, reported financial and operational results for the third quarter and nine months ended September 30, 2009.Repros Therapeutics Inc. (Nasdaq:RPRX) announced it has elected Dr. Jaye Thompson to its Board of Directors, and as a member of the Board’s Audit Committee, effective immediately.Shire plc (Nasdaq:SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®.In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.ULURU Inc. (NYSE:ULU), a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products, announced it has entered into definitive agreements to sell 10,714,467 shares of its common stock at a price per share of $0.14 pursuant to a registered direct offering to institutional investors, resulting in gross proceeds of approximately $1.5 million.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, today announced that it will webcast its upcoming R&D Day live on the "Investors” section of the company’s website at www.alnylam.com.Biogen Idec Inc. (NASDAQ:BIIB) announced today that its presentation at the 2009 Annual Credit Suisse Healthcare Conference will be webcast live via the internet , on Friday, November 13, 2009 at 8:30 a.m. MST, 6:30 a.m. EST.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced its third quarter 2009 financial results.
CEL-SCI Corporation (NYSE:CVM) announced today that Dr. Kenneth S. Rosenthal, Professor of Immunology and Microbiology of Northeastern Ohio Universities College of Medicine and Pharmacy, reported on work conducted in collaboration with scientists at the Cleveland Clinic and CEL-SCI on CEL-SCI's LEAPS vaccine technology.
Clinical Data, Inc. (NASDAQ:CLDA) announced the Company’s operational and financial results for its second fiscal quarter ended September 30, 2009.Compugen Ltd. (NASDAQ:CGEN) announced the discovery and experimental confirmation of a genetic biomarker, CGEN-40001 for predisposition to type 2 diabetes the most common form of diabetes.Commonwealth Biotechnologies, Inc. (NASDAQ:CBTE) is pleased to announce it has completed the divestment of the assets (excluding land and buildings) of its bioanalytical and genetic testing business units, CBI Services and Fairfax Identity Laboratory (FIL) for a cash consideration and an ongoing lease commitment for 5 years.EpiCept Corporation (Nasdaq:EPCT) announced Health Canada has accepted for review the Company’s New Drug Submission (NDS) for Ceplene® (histamine dihydrochloride) for the remission maintenance of acute myeloid leukemia (AML) patients in first complete remission.Global Health Ventures Inc. (OTC:GHLV), or the "Company" a Specialty Pharma is pleased to announce it has completed the prototype manufacturing of the drug "X-Excite" Global's male enhancement drug.Hercules Technology Growth Capital, Inc. (NASDAQ:HTGC), the leading specialty finance company providing venture debt and equity to venture capital and private equity-backed technology and life science companies at all stages of development, announced it has committed to provide Labcyte, Inc. (www.labcyte.com) $5.5 million in credit facilities.Lannett Company, Inc. (NYSE:LCI) reported financial results for the fiscal 2010 first quarter ended September 30, 2009.Mentor Capital, Inc.'s (OTC:MNTR) major investee, Quantum Immunologics, reported significant advances in its recent Quarterly Conference Call. Monsanto Company (NYSE:MON) and Pfizer Inc (NYSE: PFE) announced they have entered into an agreement for Monsanto to acquire Pfizer's Chesterfield Village Research Center located in Chesterfield, Mo.OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) announced OSI Management will present at the Lazard Healthcare Conference in New York, NY on Tuesday, November 17, 2009 at 8:55am (Eastern Time) and will provide an overview on the Company’s product portfolio and business developments.Repros Therapeutics (Nasdaq:RPRX) announced financial results for the third quarter ended September 30, 2009.SuperGen, Inc. (Nasdaq:SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced the acceptance of seven abstracts for poster presentations on November 16, 17 and 18, 2009 at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in Boston, MA.Walgreens (NYSE:WAG)(NASDAQ:WAG), Monthly total increases 185 percent over year ago E-prescribing promotes goals of health care reform as it lowers cost and improves adherence to drug therapy Federal stimulus package further bolsters electronic prescribing.Walgreens (NYSE:WAG)(NASDAQ:WAG), President and CEO Greg Wasson will present during the Morgan Stanley Global Consumer and Retail Conference in New York on Thursday, Nov. 19, 2009 at approximately 8:20 a.m. EST.Yasheng Group (OTC:YHGG), announced an agreement between Yasheng Group's majority shareholder Yasheng Group BVI and Yasheng ECO Trade Corp wherein Yasheng Eco Trade was to acquire 75,000,000 shares of Yasheng Group has been terminated due to a clause in the agreement that either party could terminated if the acquisition was not concluded by the end of September 2009.
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 297 entries as of 8/3/09.. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 8/2/09, Savient Pharma (NASDAQ:SVNT) announced it received a complete response letter (CRL) from the FDA for the Company's Biologics License Application (BLA) seeking approval of Krystexxa (pegloticase) as a treatment for chronic gout patients who do not respond to conventional therapy. The CRL cites deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS).
The Company intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter. Under FDA regulations, the Company believes that this meeting is deemed a "Type A" meeting, meaning that the FDA would meet with the Company within 30 days of its receipt of the meeting request. SVNT stated that it is currently targeting a resubmission for early 2010 and expects to provide more details after meeting with the FDA to discuss the CRL. Resubmissions to the Agency are designated as either Class I (60-day) or Class II (six-month) reviews.
On 8/3/09, Repros Therapeutics (NASDAQ:RPRX) announced that, in the interest of patient safety (elevation of liver enzymes), it is voluntarily suspending dosing of all patients in its clinical trials of Proellex. This decision is based on available information regarding the occurrence of clinically significant increases in liver enzymes with 50 mg and 25 mg doses of Proellex, coupled with recent input from a consulting panel of liver experts.
The Company submitted a meeting request to the FDA on 7/30/09 and, in response, the Agency has proposed to change the topic of the previously scheduled End of Phase II meeting for endometriosis in late September into a discussion about the safety of Proellex and overall direction and scope of the program.The suspension of dosing will involve all ongoing clinical trials with Proellex for the treatment of chronic symptomatic uterine fibroids, anemia associated with this condition, and endometriosis.
On 8/2/09, Transcept Pharma (NASDAQ:TSPT) and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Pending FDA approval, Intermezzo has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. The PDUFA action date for the Intermezzo NDA is 10/30/09 for an expected FDA decision.
Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million based upon the timing of an FDA approval of Intermezzo, which approval and payment are subject to review and acceptance by Purdue. In addition, TSPT is eligible to receive up to an additional $90 million upon reaching future milestones related to achievement of intellectual property and U.S. net sales targets along with double-digit royalties ranging up to the mid-20% level on U.S. net sales.
Shares of TSPT have more than doubled since the stock was featured as an FDA Calendar Extreme Trade on 7/20/09 as one of 20 stocks below $5 with pending FDA decisions or clinical trial results.
On 8/3/09, BVX announced a 510(k) submission to the FDA seeking pre-market clearance for the Company's ICON VS electrosurgical generator. The generator has been designed to work with Bovie's Seal-N-Cut line of vessel sealing instruments providing both monopolar and bipolar energy options to the surgeon. The fully digital ICON VS generator has a user friendly interface allowing the surgeon flexibility to choose the type of effect desired. The monopolar and bipolar functions satisfy a wide variety of surgical demands needed during surgeries including vessel sealing.
On 8/3/09, Keryx Biopharma (NASDAQ:KERX) announced an agreement with the FDA for a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (Velcade). The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.
The study is a double-blinded, placebo-controlled trial comparing the efficacy and safety of KRX-0401 vs. placebo when combined with bortezomib and dexamethasone and will enroll about 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Perifosine is in-licensed by Keryx from Aeterna Zentaris (NASDAQ:AEZS) in the U.S., Canada and Mexico.
On 8/3/09, Icagen (NASDAQ:ICGN) announced that the FDA has lifted the partial clinical hold related to the development of ICA-105665, the Company's novel orally available small molecule KCNQ potassium channel agonist, for the treatment of epilepsy. Accordingly, the Company is planning to initiate a proof-of-concept study in patients with photosensitive epilepsy. The study measures the ability of ICA-105665 to reduce the photic-induced epileptiform EEG responses. The duration of an observed effect will also be measured over time.
A range of doses of ICA-105665 will be studied in successive cohorts, and the response observed in each cohort will determine the subsequent dose for the next cohort. The objective of the study is to determine a potential dose range to study in subsequent, more advanced clinical trials. The study is anticipated to be completed by mid-2010 but interim results may be available earlier. In addition, the Company continues preparations for a proof-of-concept pain study, which is also expected to be initiated during 3Q09 with initial results expected by early 2010.
BloggingStocks: Today was one of those up-days that might be a disappointment to many bulls because the gap-ups were not met by follow-on buying throughout the day. A better weekly joblessness report may have been muted by Asian central banks intervening to protect ... Read more
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