Clinical - Approvals News: Breaking Clinical - Approvals News, Comments and Articles. - Page: 4

Abbott Receives CE Mark for Test to Aid in Diagnosis and Monitoring of Diabetes

Abbott hasannounced CE Marking (Conformité Européenne) for the ARCHITECT clinical chemistry Hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes. Abbott recently filed for 510(k) clearance with the U.S. FDA. As of 2012, more than 371 million people worldwide were living with diabetes and hal...

COPD Foundation Hosts COPD8USA Conference

WASHINGTON & CHICAGO--(BUSINESS WIRE)--The COPD Foundation will host COPD8USA, a multi-disciplinary, Continuing Medical Education (CME) conference, June 14-15, 2013, Hilton Chicago, 720 S. Michigan Ave., Chicago, Ill. The event provides crucial clinical and scientific knowledge for primary care physicians, pulmonologists, registered nurses, physician assistants, respiratory therapist...

Sequestration Funding Cuts Jeopardize TB Clinical Drug Trials

ATS 2013, PHILADELPHIA - Innovative and potentially game-changing clinical trials to develop new drug regimens to prevent and treat tuberculosis (TB), the second leading global infectious disease killer, are in jeopardy due to federal "sequestration" funding cuts. New CDC-funded TB treatment study findings were announced today in Philadelphia at the American Thoracic Society annual meeting where,...

1-Year TAVI Outcomes Post-Approval Showed A Large Treatment Effect In Terms Of Symptom Relief And Improved Quality Of Life

One-year results from SOURCE XT - one of the largest, post-approval transcatheter aortic valve implantation (TAVI) registries to-date - reported today at EuroPCR 2013 show good clinical outcomes in routine clinical practice, with high rates of device...

Socioeconomic Factors Affect Satisfaction Following Knee Replacement Surgery

Knee replacement surgery is a very common procedure. However, it does not always resolve function or pain in all the recipients of new knees. A study by Robert Barrack, MD and his colleagues from the Washington University School of Medicine wanted t...

JCI early table of contents for May 24, 2013

(Journal of Clinical Investigation) The following release contains summaries, links to PDFs, and contact information for the following newsworthy papers to be published online, May 24, 2013, in the JCI: Modulating the immune system to combat metastat...

Modulating the immune system to combat metastatic cancer

(Journal of Clinical Investigation) In this issue of the Journal of Clinical Investigation, researchers led by Ronald Levy at Stanford University found that regulatory T cells that infiltrate tumors express proteins that can be targeted with therapeu...

New fluorescent tools for cancer diagnosis

(Journal of Clinical Investigation) In this issue of the Journal of Clinical Investigation, Thomas Tuschl and colleagues at Rockefeller University developed a multicolor fluorescence labeling method that can be used to visualize miRNAs in tissue sect...

Aveo says partner Astellas will not seek EU nod for kidney cancer drug

(Reuters) - Aveo Pharmaceuticals Inc said it was informed by its partner Astellas Pharma Inc that the Japanese company would not be seeking marketing approval for their experimental kidney cancer drug in Europe.

China FDA Green Channel For Innovative Devices Draws Comment

China FDA’s efforts to speed approval of innovative medical devices and re-registration need clearer definitions of innovative devices, according to industry comments.

Five-days of corticosteroid enough for acute COPD

A five-day course of systemic corticosteroid is enough for most patients with acute exacerbations of chronic obstructive pulmonary disease (COPD), according to the results of a Swiss trial which found that five-day treatment is non-inferior to conv...

Pharmacogenomics of anti-platelet therapy: how much evidence is enough for clinical implementation?

Clinical characteristics of patients with resistant hypertension: the RESIST-POL study

UPDATE 4-New J&J anti-depressant related to 'Special K' party drug

NEW BRUNSWICK, N.J., May 23 (Reuters) - Johnson & Johnson said it plans to seek approvals for 11 new drugs by 2017, including a treatment for patients with depression who have failed to benefit from standard medications.

Taro Provides Results Year Ended March 31, 2013

Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (“Taro” or the “Company”) today provided unaudited financial results for the three months and year ended March 31, 2013. Quarter ended March 31, 2013 Highlights - compared to March 31, 2012 Net sales of $165.1 million, increased $20.0 million, or 13.8%, however, volumes h...

Merck Provides Update on Phase III Clinical Program for Preladenant, the Company’s Investigational Parkinson’s Disease Medicine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today provided an update on the clinical program for preladenant, Merck’s investigational adenosine A2A receptor antagonist for the treatment of Parkinson’s disease (PD). An initial review of data from three separate Phase III trials did not provide evidence of efficacy for preladena...

Anacor Pharmaceuticals to Present at Deutsche Bank’s 38th Annual Healthcare Conference

Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that David Perry, the company’s Chief Executive Officer, will provide a company overview at Deutsche Bank’s 38th Annual Healthcare Conference on Thursday, May 30, 2013 at 2:10 p.m. ET in Boston, Massachusetts. The event will be webcast live and may be accessed under “Events and Presentatio...

Elan Announces Pricing of US$850 Million in Aggregate Principal Amount of Senior Notes Due 2021

Elan Corporation, plc (“Elan”) (NYSE: ELN) today announced the pricing of the offering of US$850 million aggregate principal amount of 6.250% Senior Notes due 2021 (the “Notes”) by its wholly-owned subsidiaries, Elan Finance public limited company and Elan Finance Corp. The Notes will be issued at par. The offering is expected to close on May 31, 2...

Agilent Technologies Announces Cash Dividend of 12 Cents Per Share

Agilent Technologies Inc. (NYSE: A) today announced that a quarterly dividend of 12 cents per share of common stock will be paid on July 24 to all shareholders of record as of the close of business on July 2. Agilent’s board of directors approved the initiation of quarterly cash dividends to its shareholders in January 2012. The timing and amounts of...

Venaxis Announces Pricing of Offering of Common Stock and Warrants

CASTLE ROCK, Colo., May 23, 2013 /PRNewswire/ -- Venaxis, Inc. (Nasdaq:  APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its rapid, protein biomarker-based appendicitis test, APPY1, today announced the pricing of an underwritten public offering of 10,000,000 shares of its common stock and related warrants to purchase 3,500,000 shares of its common...

Series B round brings $48.2mm to [Karyopharm]

[Karyopharm Therapeutics Inc.] (nuclear transport modulators for cancer) plans to use the $48.2mm raised through a Series B round to fund clinical trials of its KPT330, a Phase I compound for advanced, relapsed, or refractory blood and solid tumors....

Series A brings in $8.5mm for [Cardeas Pharma]

[Cardeas Pharma Corp.] (developing inhaled antibiotics for hospital-acquired respiratory infections) raised $8.5mm in its Series A financing led by Novo AS, which was joined by Avalon Ventures, Devon Park Bioventures, WRF Capital, and undisclosed pri...

Peregrine Pharmaceuticals, The Little Biotech With The Golden Goose Of Immunotherapy

By Chris Lacoursiere:The annual conference of The American Society of Clinical Oncology (ASCO) is currently less than a few days away, and what is the buzz for this year's conference? Immunotherapy is the buzz word for this year's conference. Bavituximab is a phosphatidylserine (PS) binding monoclonal antibody (MAB) produced by Peregrine Pharmaceuticals (PPHM), which appears to be "Th...

Dr. Vance Wright-Browne is recognized among Castle Connolly's Top Doctors® for Port Charlotte, FL region in 2013

PORT CHARLOTTE, Fla., May 23, 2013 /PRNewswire-USNewswire/ -- Castle Connolly Medical Ltd., America's trusted source for identifying Top Doctors, has selected Port Charlotte's Medical Oncology specialist Dr. Vance Wright-Browne for inclusion in its highly selective list of Regional Top Doctors this year. (Photo: http://photos.prnewswire.com/prnh/20130523/DC20121) Castle Connolly Medical Ltd. p...

BTG announces fundraising, deals

BTG plc (LSE:BTG) raised L106.3 million ($161.5 million) through the sale of 32.3 million shares at 330p in a placing on Thursday and also announced a pair of deals. BTG will acquire TheraSphere liver cancer therapy from Nordion Inc. (TSX:NDN; NYSE:N...