|Vertex Says Kalydeco Showed Lung Function Improvement; American Med and Allergan Sign Agreement for JetTouch™/BOTOX® Program|
|By Staff and Wire Reports|
|Thursday, 07 June 2012 20:27|
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced new data from a long-term follow-up study that showed that the improvements in lung function (forced expiratory volume in one second, FEV), respiratory symptoms and weight gain among people who were treated with KALYDECO™ (ivacaftor)for 48 weeks in one of two pivotal studies (STRIVE or ENVISION) were durable for up to 96 total weeks of treatment
American Medical Systems (AMS), an Endo Health Solutions company (Nasdaq: ENDP), announced it has signed a co-development agreement with Allergan, Inc. to jointly develop and seek regulatory approval for the delivery of BOTOX® (onabotulinumtoxinA) using the JetTouch™ system for treatment of overactive bladder (OAB).
AMS' JetTouch™ is a novel injection platform that has the potential to enable needle-free injection into any area of the body reachable by endoscopic or percutaneous access. Needle-free injection with the JetTouch™ system is being evaluated as an innovative means for local drug delivery and may provide treatment administration efficiencies for the physician.
BOTOX® was approved by the U.S. Food and Drug Administration (FDA) in August 2011 for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX® is currently under FDA review as a potential treatment for OAB with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced today that it has completed enrollment of 40 patients in the second of three dose cohorts in Lm-LLO-E7-07, a randomized, single blind, placebo controlled Phase 2 dose escalation study assessing the safety and efficacy of ADXS-HPV for the treatment of cervical intraepithelial neoplasia (CIN) 2/3.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has completed enrollment in its Phase I trial with ALN-TTR02, an RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis (ATTR).
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced the results of its 2012 Annual Meeting of Stockholders that took place on June 7, 2012, at the Company’s headquarters.
Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that the U.S. National Cancer Institute (NCI) presented long-term (median 10-year follow-up) outcomes at the 2012 American Society of Clinical Oncology Annual Meeting (ASCO 2012) from a Phase II BiovaxID® lymphoma vaccine clinical trial.
Bruker Corporation (NASDAQ: BRKR) today announced the appointment of Charles F. Wagner, Jr. as its Executive Vice President (EVP) and new Chief Financial Officer (CFO), effective on or about June 30, 2012.
China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP) ("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and Traditional Chinese Medicines ("TCM") in China, today announced that the Company recently co-sponsored and attended the Second Plenary Meeting of the Science and Technology Committee of the Wild Plant Protection Association of China in Beijing, organized by China's State Forestry Administration.
Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced it will be presenting neonatal AFECTAIR® data at the 11th European Congress on Pediatric and Neonatal Ventilation being held June 6 – 9, 2012 in Montreux, Switzerland.
Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the Company will host the Galectin Science and Therapeutic Applications Symposium, September 17-19, 2012, in Boston, Massachusetts.
GenVec, Inc. (NASDAQ: GNVC) today announced that the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) has issued a conditional license for GenVec's foot-and-mouth disease (FMD) vaccine for use in cattle.
Generex Biotechnology Corporation (OTCBB: GNBT) announced today that an End-of-Phase II meeting has been scheduled with the United States Food and Drug Administration (FDA) in respect of the Phase II clinical trial of the AE37 breast cancer vaccine being undertaken by its wholly-owned subsidiary, Antigen Express, Inc.
GlaxoSmithKline plc (GSK) and XenoPort, Inc. (Nasdaq:XNPT) announced today that the United States (US) Food and Drug Administration (FDA) has approved Horizant® (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults.
The board of directors of Arizona-based algae producer Health Enhancement Products (OTCBB: HEPI) has appointed a new director, Mr. Brian Young, to serve out the remaining term of departed director Dr. John Crissman, and then stand for election when the entire slate of directors is placed before shareholders for a vote in July 2012.
Magellan Health Services Inc. (NASDAQ: MGLN) announced today that President Karen S. Rohan plans to step down later in the month.
Mallinckrodt LLC, the Pharmaceuticals business of Covidien (NYSE: COV), today announced that it has entered into a co-promotion agreement with Zogenix Inc. (NASDAQ: ZGNX) for SUMAVEL® DosePro® (sumatriptan injection), a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches.
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the developer of the novel Biopump™ technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announced today it has initiated its first U.S. Biopump processing facility in Davis, California.
Proteonomix, Inc. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon human cells and their derivatives, announces the oral presentation by Chief Scientific Officer Ian McNiece, Ph.D., of research related to the Company’s UMK-121 technology today at the International Society for Cellular Therapy (ISCT) 18th Annual Meeting underway in Seattle.
The Pulse Beverage Corporation (OTCBB: PLSB) ("Pulse"), makers of Cabana™ 100% Natural Lemonade and Pulse® NutriPurpose™ brand beverages, today announced that it has secured distribution with Drink King Distributing which serves New York City and Long Island including the boroughs of Queens, Bronx, Brooklyn and Staten Island. New York City is recognized as the nation's number one market.
QuantRx® Biomedical Corporation (OTCBB: QTXB) is pleased to announce the completion of several key milestones achieved during 2011 and early 2012.
Rite Aid Corporation (NYSE: RAD) today announced sales results for May.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has filed a 510(k) submission to the U.S. Food and Drug Administration (FDA) for a fully automated TnT-hs assay for use on Roche's full portfolio of laboratory analyzers.* Intended as an aid in the in the diagnosis of myocardial infarction, the electrochemiluminescence (ECL) immunoassay is used for the in vitro quantitative determination of TnT-hs in human serum and plasma.
Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) announced today that Dr. Dennis L. Fowler, MD, MPH has joined the Company as a consultant for the development of the Company's Insertable Robotic Effector Platform ("IREP") for single-site surgery.