|Shares of Synta Moving Higher Following News of Ganetespib; MiMedx Says Will Meet with FDA in Mid-October|
|By Staff and Wire Reports|
|Thursday, 12 September 2013 18:55|
Synta Pharmaceuticals Corp. (NASDAQ : SNTA) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of ganetespib, the Company's lead Hsp90 inhibitor drug candidate, to improve overall survival when administered in combination with docetaxel for the treatment of patients with metastatic non-small cell lung adenocarcinoma who have progressed following one prior chemotherapy regimen.
FDA's Fast Track Drug Development Program is designed to facilitate the clinical development and expedite the review of drugs that are intended to treat serious medical conditions and that demonstrate the potential to fill unmet medical needs.
MiMedx Group, Inc. (NASDAQ : MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company has a meeting scheduled with the Food and Drug Administration ("FDA") to discuss the recent Untitled Letter it received from that agency.
The FDA has scheduled the meeting for October 16, 2013. Parker H. Petit, Chairman and CEO , said, "In the meantime, we will continue to communicate with the FDA in preparation for the scheduled meeting. MiMedx has already responded in writing to the FDA regarding the Untitled Letter. In our correspondence, we provided clear support for our position that our micronized products are minimally manipulated, and we reiterated our desire to work with the agency to resolve this issue as quickly as possible."
As the Company gains clarification through interaction with the FDA, MiMedx will communicate updated information to its shareholders.
3D Systems (NYSE:DDD) announced today the immediate availability of Bespoke Modeling™, a cloud-based, easy-to-use, affordable service that allows medical professionals to quickly create, view, share and 3D print full-color 3D anatomical models directly from DICOM data.
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, has received notification from the European Patent Office that an additional European patent for MuGard™ has been granted.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health records (EHR), practice management, and care coordination, today released national childhood obesity rate findings.
Can-Fite BioPharma Ltd.(TASE: CFBI), (OTCQB: CANFY), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that its shares have been approved for trading as a Level II American Depositary Receipt ("ADR") program on the U.S. Over-the-Counter Markets (the "OTC Markets").
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today announced it recently recorded the first commercial sale of its next generation FORE-SIGHT ELITE™ Cerebral Oximetry products.
Champions Oncology Inc. (OTC:CSBR), a company engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, today announced the signing of a new discovery and drug development partnership with Teva Pharmaceutical Industries LTD (NYSE:TEVA) which will utilize Champions TumorGraft™ technology platform to enhance and accelerate the clinical development of several of Teva's oncology compounds.
CytoSorbents Corporation (OTCQB: CTSO), a leading innovator in the use of blood purification to treat critical illnesses such as sepsis, is a proud sponsor of both the Global Sepsis Alliance and the Sepsis Heroes event hosted by the Sepsis Alliance tonight in New York City, in honor of the second annual World Sepsis Day tomorrow.
Esterline Corporation (NYSE: ESL), a leading specialty manufacturer serving global aerospace and defense markets, today announced that Curtis Reusser, President of United Technologies' multi-billion dollar Aircraft Systems business, will succeed Brad Lawrence as Esterline's President and Chief Executive Officer, and be elected to its Board of Directors effective October 28, 2013.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that clinical data from a Phase 1b trial of PEGPH20 (PEGylated recombinant human hyaluronidase) in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer will be presented at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO) in Amsterdam.
Ingen Technologies Inc. (OTC:IGNT), announces today that it has launched a global consumer commercial for its medical division at the same time when 100 Oxyview Units were shipped to the Department of Homeland Security on September 5, 2013; where recently the Department of Homeland Security purchased 100 Oxyview Units for the US Coast Guard and continues to have a serious interest in the patented respiratory products manufactured by Ingen Technologies.
LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, today reported financial results for the fiscal 2013 fourth quarter and the full year ended June 30, 2013.
LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, announced today that it intends to conduct a modified Dutch auction self-tender offer to repurchase up to $40,000,000 of its common stock at a price per share within a range to be determined prior to commencement of the tender offer.
Marrone Bio Innovations, Inc. (Nasdaq:MBII), a provider of bio-based pest management and plant health products, announced today financial results for the second quarter ended June 30, 2013.
Nanosphere, Inc. (NASDAQ: NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, today announced that it intends to offer shares of its common stock in a public offering.
Pernix Therapeutics Holdings, Inc. (NASDAQ MKT: PTX), a specialty pharmaceutical company, today announced that it had completed the previously disclosed sale of certain non-core assets to Breckenridge Pharmaceutical, Inc.
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) announced the pricing of $60 million principal amount of its 4.50% Convertible Notes due 2018 (the "Notes") through a private offering.
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that the U.S. Patent and Trademark Office granted the Company a Notice of Allowance in connection with U.S. Patent Application Number 12/864,424, titled "Methods and Compositions for Diagnosing Complications of Pregnancy."
SK3 Group, Inc.'s (OTC Pink: SKTO) Investor Relations firm, Rubicon Capital Advisors, on behalf of the Company advised its shareholders and the investment community today that the planned investor conference call re-scheduled for the week of September 13, 2013 has been posted on the Company's website, www.medicalgreens.com.
Senesco Technologies, Inc. (OTCQB:SNTI) today announced financial results for the 12 months ended June 30, 2013 (“Fiscal 2013”).
Star Scientific, Inc. (NASDAQ: STSI) announced that the U.S. Patent and Trademark Office ("PTO") issued a Notice of Allowance on September 3, 2013 to Rock Creek Pharmaceuticals, Inc., its wholly owned subsidiary, in Application No. 13,477,295, covering anatabine citrate, the active component in the company's Anatabloc® products.
StemCells, Inc. (Nasdaq:STEM) today announced dosing of the first high-dose patient in the Company's Phase I/II clinical trial in dry age-related macular degeneration (AMD).