Action in Medical Technology

Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults

... - New antiepileptic drug with novel mechanism of action helps address critical unmet medical need for ... In preclinical studies, the mechanism of action for Vimpat(R) has been shown to involve the ... which may produce a seizure. The mechanism of action for Vimpat(R) is thought to reduce this sodium ...

Shareholder Class Action Filed Against Rigel Pharmaceuticals, Inc. by the Law Firm of Barroway Topaz Kessler Meltzer & Check, LLP

... LLP: Notice is hereby given that a class action lawsuit was filed in the United States District ... "Class Period"). If you wish to discuss this action or have any questions concerning this notice or ... & Check or to sign up to participate in this action online, please visit www.btkmc.com If you ...

Savient Provides Update on Pegloticase BLA

... and Clarify BLA Data FDA Extends PDUFA action Date to July 30, 2009 Company to Host ... that the pegloticase BLA priority review PDUFA action date has been extended by three months to July 30, 2009. Given the extended action date, the FDA has also notified the Company that ...

ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration

... of ten months and has been given a user fee action date of September 12, 2009. ISTA's Phase ... tissues. The compound's primary mechanisms of action are believed to make it an effective treatment ... ISTA's belief the FDA will review and take action on Bepreve within ten months of filing and ISTA's ...

ASGE and The Pancreatic Cancer Action Network Partner to Raise Awareness About Pancreatic Cancer

... Endoscopy (ASGE) and the Pancreatic Cancer action Network are teaming up this November to raise ... Committee and member of the Pancreatic Cancer action Network's Medical Advisory Council. In addition, ... treatable stages. ASGE and the Pancreatic Cancer action Network encourage patients and their families to ...

FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes

... U.S. "We are pleased that the fast onset of action and mealtime dosing flexibility of Apidra(R) will ... Apidra(R) has a rapid onset and short duration of action and should normally be used in combination with a ... a meal. Due to the short duration of action of Apidra(R), patients also require a ...

NVA237 Phase II Results Presented at the European Respiratory Society Annual Meeting Show Promising Efficacy and Tolerability With Potentially Faster Onset Than Tiotropium

... NVA237 showed similar efficacy and duration of action to tiotropium with potentially a more rapid onset ... all doses of NVA237 showed rapid onset of action and sustained 24-hour bronchodilation over the ... spirometry data suggested a more rapid onset of action than tiotropium. During the study, NVA237 was ...

Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber

... in line with the objectives were: - An onset of action starting on the seventh day (statistically ... of Oralair(R) Grasses and the very fast onset of action on the symptoms," said Olivier de Beaumont. 1 ... and watery eyes), to evaluate the onset of action after different treatment durations (1 week, ...

New AVAC Report on Pre-Exposure Prophylaxis Calls for Immediate Planning to Anticipate Study Results of Potential New HIV Prevention Option

... the Results of PrEP Trials, calling for increased action from governments, global health institutions, ... planned PrEP research, and lays out an agenda for action on key issues that must be addressed as research ... 3. Plan now for optimal use of PrEP: A plan of action for using PrEP to maximum public health impact ...

Protein Tomography(TM) Reveals Molecular Mode of Action of Humax-EGFr Published in PNAS

... With Genmab the Molecular Mode of action of Humax- EGFr (Zalutumumab). In This Study Sidec ... that together with Genmab the molecular mode of action of HuMax-EGFr (zalutumumab) has been determined. ... importance of understanding the molecular mode of action and to capture the flexibility of a receptor ...

Shareholder Class Action Filed Against Vertex Pharmaceuticals Incorporated by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP

... LLP: Notice is hereby given that a class action lawsuit was filed in the United States District ... "Class Period"). If you wish to discuss this action or have any questions concerning this notice or ... & Kessler or to sign up to participate in this action online, please visit http://www.sbtklaw.com ...

Kosan Presents Preclinical Data on Nuclear Export Inhibitors, Novel Anticancer Agents, at AACR

... the NEI anticancer mechanism of action correlating inhibition of the target CRM1 with ... including potency, durability of action and a wide therapeutic index. "Kosan's NEI ... Hsp90 inhibitors have a novel mechanism of action targeting multiple pathways involved in cancer ...

Influenza Vaccination Rates Among Health Care Personnel Remain Well Below National Goal

... (NFID) has published two new reports: a Call to action urging health care personnel to receive annual ... vaccination among their employees." Call to action Sheds Light on Vaccination Gaps The Call to ... each other and to patients. Indeed, the Call to action report cites resources suggesting that ...

AIDS Action Council Statement on World AIDS Day 2007: Leadership Needed for a National Strategy to Stop the AIDS Epidemic

... Nov. 29 /PRNewswire-USNewswire/ -- AIDS action Council joins organizations and individuals ... of individuals in the U.S. have signed a Call to action asking all Presidential candidates to commit ... will and leadership needed to stop AIDS. AIDS action commends that Hillary Clinton, John Edwards, ...

Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of Pneumonia

... "Cethromycin's unique mechanism of action allows it to overcome resistance and minimize ... for new antibiotics with unique mechanisms of action that can overcome this emerging resistance. ... bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial ...

38.7 Million People Break Guinness World Record for Stand Up Speak Out on International Day for the Eradication of Poverty

... Millennium Campaign (UNMC) and the Global Call to action against Poverty (GCAP) with a wide range of other ... Kumi Naidoo, Chair of the Global Call to action Against Poverty said: "The confirmation of the ... largest number of people standing up to demand action on poverty. But the record we really want to ...

Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress

... show aclidinium's selectivity, long duration of action and rapid clearance from the plasma.(3,4) When ... and ipratropium, but with a faster onset of action than tiotropium and a significantly longer duration of action versus ipratropium, allowing for 24- hour ...

Trana Discovery and Southern Research Institute Announce the First RNA-RNA High Throughput Drug Screening Assay Platform for HIV Antivirals

... the lifecycle of HIV through a novel mechanism of action -- the inhibition of transfer RNA (tRNA). This ... classes working at just four different sites of action in the HIV replicative cycle. And despite the ... of pathogens through a novel mechanism of action -- the inhibition of transfer RNA (tRNA). The ...

Isis Initiates Phase 1 Study of ISIS 325568 Targeting Glucagon Receptor to Treat Type 2 Diabetes

... that binds glucagon, a hormone that opposes the action of insulin. The Phase 1 trial of ISIS 325568 is ... pancreatic function through a dual mechanism of action in insulin-resistant animal models. Furthermore, ... (GCGR) Glucagon is a hormone that opposes the action of insulin and stimulates the liver to produce ...

CeNeRx BioPharma Obtains Rights to Novel Drug Candidate for Prevention and Treatment of Neurodegeneration Disorders

... studies, our small molecule agent CXB909 has been shown to increase the action of native NGF, but without the pharmacokinetic and administration ... and other conditions. In preclinical studies, CXB909 enhanced the action of NGF in vitro , amplifying its activity almost seven-fold. CXB909 was ...

Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza(TM) (cethromycin)

... ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its ... failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance. About Advanced Life ...

Trubion Announces Positive Data From a Phase 1 / 2 Study of TRU-016 for the Treatment of Chronic Lymphocytic Leukemia (CLL)

... and their physicians need more effective therapies with new mechanisms of action that address new targets. We look forward to presenting additional data on ... advance its clinical development programs and regulatory applications and action at the rate it expects, and such other risks as identified in the ...

Stallergenes S.A.: Positive Results From a Phase IIb/III Clinical Trial on the House Dust Mite Desensitization Tablet

... perennial allergic rhinitis. Furthermore, the unexpected quick onset of action and the good safety profile are addressing the needs of patients with ... the 300 IR tablet has been selected. Furthermore, the onset of action was achieved from the 4th month of treatment, meaning that the difference ...

ImQuest BioSciences Receives Phase I SBIR Grant to Develop a Novel Hepatitis C Virus Therapeutic Agent

... scientists will investigate the therapeutic potential and mechanism of action of ATI-0810 (Formerly PG301029) and a series of related chemical ... potent transcriptional inhibitors of HCV, investigate the mechanism of action of the active molecules and provide additional rationale for the ...

Novel Valortim(R) Mechanism of Action Data Presented at the Keystone Symposia on Molecular and Cellular Biology

... biological and chemical threats, announced today that new mechanism of action data for Valortim(R) were presented at the Keystone Symposia on Molecular ... and treatment of inhalational anthrax. Previous mechanism of action data have shown that in addition to inhibiting anthrax toxin, Valortim(R) ...

FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)

... treatment of male hypogonadism. FDA is targeting September 2, 2009 as the action date for a decision on this application. Endo's president and CEO, David Holveck, stated: "We are pleased with the FDA's action and congratulate the NEBIDO development team on reaching this milestone. ...

Oh, My Aching Back: Give Me a Shot of Ozone

... this treatment abroad over the past five years. The mechanism of action in relieving low back pain is complex; however, the primary effect is a ... Meeting March 7-12, 2009. Abstract 38: "Ozone's Mechanisms of action for Relieving Pain Associated With Herniated Intervertebral Disks," J. ...

Drug Development Program Started Based on CAP(R) Human Cell Line

... in chronic diseases. Based on a the anti-inflammatory mechanism of action of alkaline phosphatase towards e.g. TNFa, IL-6 and IL-8, as shown in both ... COO, Dr Ruud Brands commented: "rhuALP, based on the proposed mechanism of action in innate immune modulation, may enable the application in a wide array of ...

Intellect Neurosciences, Inc. Announces Independent Studies on Copper Binding Properties of its Lead Candidate OXIGON(TM)

... findings, from which we gain additional insight into the mechanism of action of our drug candidate. OXIGON(TM) is considerably more potent than ... can bind metal ions such as copper is highly suggestive of a mode of action in common with other compounds, referred to as metal protein attenuating ...

Access Pharmaceuticals Presents new Combination Data on the Company's Angiolix(R) Therapeutic Monoclonal Antibody

... were comparable to those of Avastin combinations. The mechanism of action of Angiolix is considerably more tumor specific than that of Avastin, ... cells; Alchemix, a chemotherapeutic agent that combines multiple modes of action to overcome drug resistance. Access is also developing Phenylbutyrate ...

Kyowa Hakko Kirin Announces Development Policy for Anti-Parkinson's Disease Drug KW-6002 (Istradefylline)

... a Phase 3 clinical trial in Japan. KW-6002 has a novel mechanism of action that specifically antagonizes the adenosine A2A receptor. Kyowa Hakko ... (FDA) in April 2007. On February 25, 2008, Kyowa received an action letter from the FDA. Subsequent to discussions with FDA, Kyowa decided to ...

Schering-Plough Highlights R&D Pipeline Progress, Innovation and Breadth of Research Projects

... relating to the company's plans; its strategies; its progress under the action Agenda and anticipated timing regarding future performance of the action Agenda; business prospects; anticipated growth; timing and level of ...

GEN Reports on the Trend Toward Predictive Toxicogenomics

... are especially interested in figuring out a new compound's mechanism of action and eventually developing a predictive toxicology technique, according to ... focusing on toxicogenomics primarily as a method to explore mechanisms of action rather than to predict toxicity. Roche, for example, uses toxicogenomics ...

Portola Announces Data Showing Its Anti-Platelet Drug Inhibits Platelets in Clopidogrel (Plavix(R)) Non-Responders

... High-level Platelet Inhibition with Immediate Onset of action - NEW ORLEANS and SOUTH SAN FRANCISCO, Calif., Nov. 12 /PRNewswire/ ... show that this direct-acting anti-platelet agent with a novel mechanism of action may have the potential to fill this significant treatment gap and meet a ...

Topical Treatment for Cold Sores Achieves Efficacy of Oral Drugs; Represents Paradigm Shift in the Treatment of Skin Infections

... founder and chairman of NanoBio Corp. "NB-001 employs a physical mode of action to disrupt the outer membranes of pathogens and prompt viral ... killing on contact." The study also suggests that the physical mode of action of NB-001 significantly reduces the likelihood that pathogens will develop ...

Access Pharmaceuticals Presents New Data on the Company's Angiolix(R) Therapeutic Monoclonal Antibody

... Data Indicate Dual Modes of action and Synergy with Chemotherapy DALLAS, Oct. 2 /PRNewswire-FirstCall/ -- ... cells; Alchemix, a chemotherapeutic agent that combines multiple modes of action to overcome drug resistance. Access is also developing Phenylbutyrate ...

Justice Department Will Not Oppose CEO Roundtable on Cancer's Proposal

... business review procedure, an organization may submit a proposed action to the Antitrust Division and receive a statement as to whether the Division currently intends to challenge the action under the antitrust laws. A file containing the business review request ...

Novo Nordisk New Data From a Phase 3 Study Confirms Clinical Benefits of Once-Daily Liraglutide in the Management of Type 2 Diabetes

... 4 is the last of the five phase 3a LEAD(TM) (Liraglutide Effect and action in Diabetes) studies to be presented. "The complete LEAD(TM) clinical ... in Japan on July 15, 2008. About LEAD(TM) (Liraglutide Effect and action in Diabetes) The LEAD(TM) program includes five randomized, controlled, ...

Modigene Platform Validated in Independent Phase III Trial of CTP Technology

... of Modigene's CTP Technology for Extending the Duration of action of Therapeutic Proteins - NES-ZIONA, Israel, July 10 ... FSH-CTP uses the naturally occurring CTP peptide to extend the duration of action of the hormone. Modigene is using the same naturally occurring CTP peptide ...

Patients Taking Cymbalta(R) Reported Reduced Pain Severity of Osteoarthritis of the Knee in New Study

... medical fellow II, Eli Lilly and Company. "Although the exact mechanism of action is unknown, this study may provide important insights into the treatment ... the central nervous system (brain and spinal cord). While the mechanism of action of Cymbalta is not fully known, scientists believe its effects on ...