Ironwood and Forest Announce FDA Approval of LINZESSTM; Clinically Significant Results from Cardiovascular Systems' Calcium 360° Study Print E-mail
By Staff and Wire Reports   
Thursday, 30 August 2012 19:47
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 30, 2012.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
and Forest Laboratories, Inc. (NYSE: FRX) announced LINZESS™ (linaclotide) was approved by the U.S. FDA as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).

IBS-C and CIC are chronic functional gastrointestinal disorders that affect as many as 13 million1 and 35 million2 adult Americans, respectively. Symptoms associated with IBS-C include abdominal pain and constipation; symptoms associated with CIC include constipation (infrequent stools, hard stools and incomplete evacuation). There are few treatment options for these conditions, particularly options that relieve abdominal pain associated with IBS-C.


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Cardiovascular Systems (NASDAQ: CSII)
, a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, announced publication of 12-month results from its CALCIUM 360° study in the Journal of Endovascular Therapy, August 2012.

CALCIUM 360° is a prospective, randomized, multi-center study of 50 patients (64 lesions), comparing one-year safety and efficacy of CSI's Diamondback 360° atherectomy device followed by percutaneous transluminal angioplasty (PTA), versus PTA alone, to treat calcified infrapopliteal lesions in patients with critical limb ischemia.



Also Thursday:



Abaxis, Inc. (NasdaqGS: ABAX)
, a medical products company manufacturing point-of-care blood analysis systems, announced today that Clint Severson, chairman and chief executive officer , will present at the Morgan Stanley Global Healthcare Conference on Tuesday, September 11, 2012 at 4:30 p.m. ET.

Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced the official opening of the Company’s new corporate headquarters at the Ardsley Park life science campus in Ardsley, New York.

Akorn, Inc. (NASDAQ: AKRX)
, a niche generic pharmaceutical company, today reported preliminary financial results for the second quarter of 2012, subject to further review by the Company and its auditors.

Anacor Pharmaceuticals (NASDAQ:ANAC)
announced today that David Perry, the company’s Chief Executive Officer, will provide a company overview at the Stifel Nicolaus 2012 Healthcare Conference on Wednesday, September 5, 2012 at 4:25 p.m. ET in Boston, Massachusetts.

Antares Pharma, Inc. (NASDAQ: ATRS)
today announced that Paul K. Wotton, Ph.D., President and Chief Executive Officer, will present at the Stifel Nicolaus 2012 Healthcare Conference on Thursday, September 6, 2012 at 8:35 am Eastern Time.

Aradigm Corporation (OTCBB:ARDM)
(the “Company”) today announced that Igor Gonda, PhD., Aradigm’s President and CEO, will be a panel member at the U.S. Food and Drug Administration’s public workshop regarding the design of clinical trials of antibacterial drugs for the treatment of non-cystic fibrosis bronchiectasis at the Sheraton Silver Spring Hotel in Silver Spring, MD on Friday, September 7, 2012 from 8:00 am to 3:30 pm Eastern time.

ArQule, Inc. (Nasdaq: ARQL)
today announced that the Company will present at the following upcoming conferences.

Akorn, Inc. (NASDAQ: AKRX)
, a niche generic pharmaceutical company, today announced the appointment of Bruce Kutinsky as its Chief Operating Officer of its US operations effective September 1, 2012.

The Board of Directors of AMERICAND DIVERSIFIED HOLDINGS CORPORATION (PINKSHEETS: ADHC) (http://www.americandiversifiedholdings.com/) has today approved the conversion of the Company's outstanding debt totaling over $500,000 USD into newly authorized Preferred "B" shares with its main secured creditor.

Arrowhead Research Corporation (NASDAQ:ARWR)
today announced that it will report its financial results for the fiscal 2012 third quarter ended June 30, 2012, on Monday, August 13, 2012 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

Avita Medical Ltd. (ASX: AVH), (PINKSHEETS: AVMXF), (OTCQX: AVMXY)
, the regenerative medicine company, announced a brief summary of recent manufacturing improvements, a direct result of the combined efforts of R&D and Operations and implementation of the company's commitment to a Continuous Improvement Model.

AxoGen, Inc. (OTCBB:AXGN)
, a leading regenerative medicine company focused on the development and commercialization of products and technologies for peripheral nerve reconstruction and regeneration, today announced approval by the Rizzoli Orthopaedic Institute of its first commercial shipment of Avance® Nerve Graft to MD for Life, its new distribution partner in Italy.

Axia Group's (PINKSHEETS:AGIJ) (http://www.axiagroup.com/) Collagenna Skin Care Products is pleased to announce that it will open another corporate owned clinic in Ottawa, Canada.

Baxter International Inc. (NYSE:BAX)
today announced that it has entered into a manufacturing services agreement with Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation) in the Netherlands that will provide Baxter up to 1.6 million liters of incremental plasma fractionation capacity annually to support global growth of plasma-derived treatments.

Baxter International Inc. (NYSE:BAX)
today announced that the U.S. Food and Drug Administration (FDA) has approved a new 4000 IU dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]. ADVATE is a full-length recombinant factor VIII (FVIII) product that is indicated for the control and prevention of bleeding episodes in patients with hemophilia A.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
today announced that its second quarter 2012 financial results will be released on Thursday, August 2, 2012.

Bioject Medical Technologies Inc. (Pink Sheets:BJCT)
, an innovative developer and manufacturer of needle-free injection therapy systems, today reported unaudited financial results for the year and quarter ended December 31, 2011 and for the first quarter ended March 31, 2012. The financial results are unaudited and actual results may vary.

Biomerica, Inc. (OTCBB: BMRA)
, a global provider of advanced diagnostic products for the early detection of medical conditions, today reported net income of $548,435, or $0.08 per share, for the fiscal year ended May 31, 2012, compared to net income of $157,447, or $0.02 per share, in fiscal 2011.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
today announced that Stephen M. Simes, BioSante’s president & CEO, will present a corporate update at the Stifel Nicolaus Healthcare Conference and Rodman & Renshaw Global Investment Conferences.

BioTime, Inc. (NYSE MKT:BTX)
announced today that Chief Executive Officer Michael D. West, Ph.D. will present at the 2012 Agora Financial Investment Symposium on Tuesday, July 24, 2012, 4:40 p.m. PDT, at the Fairmont Hotel in Vancouver, British Columbia, Canada.

BrainStorm Cell Therapeutics (OTC:BCLI)
announced today that it has completed the planned interim safety review of its Phase I/II ALS (Amyotrophic Lateral Sclerosis) clinical trial, indicating that autologous transplantation of the Company's cell therapy was well-tolerated, appears to be safe for use, and did not present any undue risks to the study participants.

Cardium Therapeutics (NYSE MKT: CXM)
today announced that Christopher J. Reinhard, Chairman & CEO will present at the Rodman & Renshaw Annual Healthcare Investment Conference on Monday, September 10, 2012 at 3:15 p.m. Eastern Time.

Compugen Ltd. (NASDAQ: CGEN)
today reported financial results for the second quarter ending June 30, 2012.

Covidien plc (NYSE: COV)
today announced that its Board of Directors has declared a quarterly cash dividend of $0.225 per ordinary share.

Celsion Corporation (NASDAQ: CLSN)
, a leading oncology drug development company, today announced that Michael H. Tardugno, Celsion's President and Chief Executive Officer, will be presenting at the following upcoming investor conferences during the month of September.

ChromaDex® Corporation (OTCBB: CDXC)
, an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, animal health, cosmetic and pharmaceutical industries, has been invited to present at the 2012 Gateway Conference being held on September 6th at the W San Francisco Hotel.

Covidien (NYSE: COV)
, a leading global provider of healthcare products, today announced the agenda for its investor meeting on Thursday, September 13, 2012.

Lewisham Healthcare NHS Trust has become one of the first trusts to adopt CSC’s (NYSE: CSC) next-generation laboratory solution under a project to overhaul cellular pathology services across the new organization, formed by the merger of acute and community services in Lewisham.

Celgene Corporation (NASDAQ: CELG)
senior management will host a conference call and live audio webcast on Thursday, July 26, 2012 at 9 a.m. ET to discuss the company’s second quarter 2012 financial and operational results.

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY)
today announced its unaudited consolidated financial results for the quarter ended June 30, 2012 under International Financial Reporting Standards (IFRS).

Dyax Corp. (NASDAQ: DYAX)
announced today that executive management will participate in the Rodman & Renshaw Annual Global Investment Conference, being held September 10-11, 2012 at The Waldorf Astoria in New York City.

EasyMed Services Inc.® (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6)
("EasyMed" or the "Company") today announced the launch of its new global website, www.EasyMedMobile.com, to promote its suite of eHealth and telemedicine applications including International Medical Passport and Easy SmartCare.

Eli Lilly and Company (NYSE: LLY)
today announced that Michael J. Harrington will be promoted to senior vice president and general counsel effective Jan. 1, 2013.

Emerging nutraceuticals provider Neutra Corp. (OTCBB:NTRR) announced today that the company has placed its initial order for two new all-natural male enhancement supplements in order to move forward with clinical trials.

EncounterCare Solutions, Inc. (PINKSHEETS: ECSL)
(or the "Company") today commented on the recent BBC news Article, New BioFuels Offer Hope to Hungry World, published on 8 August 2012.

Exact Sciences Corp. (Nasdaq: EXAS) today announced that it will present at two investor conferences during September.

Exact Sciences Corp. (Nasdaq: EXAS)
today announced that the company will host webcasts and conference calls to discuss its second-quarter 2012 financial results and of its annual meeting of stockholders.

Forest Laboratories, Inc. (NYSE:FRX)
and Almirall, S.A. (ALM.MC) announced today that the U.S. Food and Drug Administration (FDA) has approved Tudorza™ Pressair™ (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced updated results from the Phase III EMILIA study, which showed that trastuzumab emtansine (T-DM1) significantly extended the lives (improved overall survival) of people with HER2-positive metastatic breast cancer (mBC) compared to the combination of lapatinib and Xeloda® (capecitabine).

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY)
, announced it has received a Refuse to File letter from the U.S. Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of LEMTRADA™ (alemtuzumab) as a treatment for relapsing multiple sclerosis.

GlaxoSmithKline plc (LSE: GSK)
and Human Genome Sciences (NASDAQ: HGSI) today announced that the companies have entered into a definitive agreement under which GSK will acquire HGS for US$14.25 per share in cash.

IGSM Group, Inc. (PINKSHEETS: IGSM)
has concluded negotiations with a Biotech Company to commercialize the opportunity presented by a small protein named Crotamine.

Illumina, Inc. (NASDAQ:ILMN)
today launched its real-time PCR reagent portfolio, including a novel, probe-based chemistry for gene expression analysis called NūPCR™.

ImmunoGen, Inc. (Nasdaq: IMGN)
, a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced that Roche has reported that updated results from its EMILIA Phase III trial show that patients treated with trastuzumab emtansine had a significant improvement in OS compared to those randomized to standard-of-care therapy.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
will be presenting at the Stifel Nicolaus Healthcare Conference on September 5, 2012 at 1:30 p.m. ET in Boston.

Insmed Incorporated (Nasdaq CM: INSM)
, a biopharmaceutical company dedicated to the development of innovative inhaled pharmaceuticals for the treatment of serious lung infections, today announced that Timothy Whitten, President and Chief Executive Officer, will be presenting a corporate overview at the Stifel Nicolaus 2012 Healthcare Conference in Boston on Thursday, September 6, 2012, at 8:35 AM ET.

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced today the publication of two papers in the journal Cell demonstrating that single-stranded short interfering RNA (ss-siRNA) molecules distributed broadly, activated the RNA interference (RNAi) pathway and reduced expression of targeted genes in animal models.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
today announced that its licensee, Onyx Pharmaceuticals (Nasdaq: ONXX), received accelerated approval from the U.S. Food and Drug Administration (FDA) for Kyprolis™ (carfilzomib) for Injection, a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Medisafe 1 Technologies Corp. (OTCBB: MFTH)
, a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the company is in advanced negotiations to enter into a non-exclusive perpetual license agreement to transfer rights for the full commercialization, marketing and distribution of its patented medicinal locking mechanism and bar-code matching system.

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, today announced final results from the STARTMRK study – the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adults with HIV-1.

MiMedx Group, Inc. (OTCBB: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane announced today that it will present at the Stifel Nicolaus 2012 Healthcare Conference in Boston, Massachusetts.

NeuroMetrix, Inc. (Nasdaq: NURO)
, www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported today that its Chief Medical Officer was interviewed by KIDELA TV, a financial news network.

Obagi Medical Products, Inc. (Nasdaq:OMPI)
, a leader in topical aesthetic and therapeutic skin health systems, today announced it will report financial results for the second quarter ended June 30, 2012 on Thursday, August 2 after market close, followed by an investor conference call on the same day at 4:30 p.m. EDT (1:30 p.m. PDT).

OPKO Health, Inc. (NYSE:OPK)
is pleased to announce the appointment of Juan F. Rodriguez as its new Senior Vice President and Chief Financial Officer.

Orgenesis Inc. (OTCBB: ORGS)
(“Orgenesis” or “the Company”), a development-stage company with a novel therapeutic technology dedicated to converting a patient’s own liver cells into functioning insulin-producing cells as a treatment for diabetes, was featured in two online publications during the week of June 11.

Osiris Therapeutics, Inc. (NASDAQ: OSIR)
today announced that it will report its financial results for the second quarter ended June 30, 2012, on Monday, July 30, 2012.

PerkinElmer, Inc., (NYSE:PKI)
a global leader focused on improving the health and safety of people and the environment, today announced that on Thursday, August 2, 2012, after market close, the Company will release second quarter 2012 results.

Perrigo Company (Nasdaq: PRGO;TASE)
and Tris Pharma, Inc. today announced the commercial launch of a major new store brand product.

Pfizer Inc. (NYSE: PFE)
today announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for postmenopausal women with a uterus for the treatment of estrogen deficiency symptoms and treatment of osteoporosis in women at risk of fracture.

POZEN Inc. (NASDAQ: POZN)
, a pharmaceutical company committed to transforming medicine that transforms lives, announced today that John R. Plachetka, Pharm.D., the Company’s Chairman, President and Chief Executive Officer, and Liz Cermak, the Company’s Executive Vice President and Chief Commercial Officer, will present at the 2012 Stifel Nicolaus Healthcare Conference on Thursday, September 6, 2012 at 3:15 p.m. (ET), at the Four Seasons Hotel in Boston.

Premier Biomedical, Inc. (OTCBB: BIEI)
has announced the successful outcome of a Proof of Concept Test performed by the University of Texas at El Paso (UTEP).

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX)
(“the Company” or “RegeneRx”) today announced that it has entered into a licensing agreement with Lee’s Pharmaceutical (HK) Limited, headquartered in Hong Kong (“Lee’s”), for the license to Lee’s of RegeneRx's Thymosin Beta 4-based products, including the Company’s RGN-259, RGN-352 and RGN-137 product candidates, in China (including Hong Kong and Macau) and Taiwan. Lee’s previously paid RegeneRx $200,000 upon signing of a term sheet and will pay RegeneRx an additional $200,000 with the completion of this license agreement.

Rite Aid Corporation (NYSE: RAD)
announced today that John Standley, chairman, president and chief executive officer; Frank Vitrano, chief financial and chief administrative officer; and Matt Schroeder, group vice president, strategy, investor relations and treasurer, will address the Goldman Sachs Nineteenth Annual Global Retailing Conference on Sept. 5, 2012. Rite Aid’s presentation is scheduled for approximately 3:45 p.m. EDT.

Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a development stage biopharmaceutical company, announced today the results of a Phase 1B clinical trial of an aluminum hydroxide (Alum) adjuvanted formulation of RiVax™, designed to improve the immunogenicity of the vaccine.

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP)
(“Sucampo”) today announced that its majority shareholder and only holder of its class B common stock, S&R Technology Holdings, LLC (S&R), has converted all of its shares of Sucampo’s class B common stock into shares of its class A common stock.

Taro Pharmaceutical Industries Ltd. (NYSE: TARO)
(“Taro”) announced today that the Special Committee of its Board of Directors unanimously rejected the October 18, 2011 unsolicited, non-binding offer from Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and affiliates, “Sun Pharma”) to purchase all of the issued and outstanding shares of Taro not currently held by Sun Pharma for $24.50 per share as inadequate and not in the best interests of Taro’s minority shareholders.

Teleflex Incorporated (NYSE:TFX)
, a leading global provider of medical devices for critical care and surgery, has announced a full line of Weck® Access Devices, including a broad offering of Weck Vista™ bladeless access ports as well as the Weck EFx™ Endo Fascial Closure System.

University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS)
("University General" or "the Company"), a diversified, integrated multi-specialty health care delivery system, today announced the refinancing of two senior living facilities owned by UGHS Senior Living, Inc., a wholly-owned subsidiary of University General Health System, Inc.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
will announce its second quarter 2012 financial results on Monday, July 30, 2012 after the financial markets close.

ViroPharma Incorporated (Nasdaq: VPHM)
today announced that Charles Rowland, vice president and chief financial officer of ViroPharma, will present at the Stifel Nicolaus 2012 Healthcare Conference at 1:30 P.M. ET on Wednesday, September 5, 2012.

XenoPort, Inc. (Nasdaq: XNPT)
announced today that the first subjects have been dosed in a Phase 1, randomized, double-blind, two-period crossover, food effect comparison study of XP23829 in healthy adults.

MultiCorp International, Inc. /XTend Medical Corporation (PINKSHEETS: XMDC), has finalized the name/symbol change with FINRA and the company will begin trading under the symbol MCIC effective on August 28, 2012.

Xylem Inc. (NYSE: XYL)
, a leading global water technology company focused on addressing the world’s most challenging water issues congratulates Luigi Marshall Cham, Jun Yong Nicholas Lim and Tian Ting Carrie-Anne Ng of Singapore, the winners of the 2012 Stockholm Junior Water Prize (SJWP), the most prestigious international student competition for water-related research.

Zalicus Inc. (NASDAQ: ZLCS)
today reported financial results for the second quarter ended June 30, 2012.

Zynex, Inc. (OTCBB: ZYXI)
, a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it received FDA 510(k) clearance on its InWave medical device.



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