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Approvals in Medical News

Biostar Pharmaceuticals, Inc. Receives Government Approvals for Three New Products

XIANYANG, China, July 16 /PRNewswire-Asia-FirstCall/ -- Biostar Pharmaceuticals, Inc. (OTC Bulletin Board: BSPM) ("Biostar" or "the Company"), a Xianyang-based developer, manufacturer and supplier of pharmaceutical products and medical nutrients addressing a variety of diseases and conditions,...

RainEarth Obtains Patent Approvals for Its Core Technology

BEIJING, June 26 /PRNewswire-Asia/ -- RainEarth Inc. (OTC Bulletin Board: RNER; "the Company"), announced that its contractual partner in China, Beijing RainEarth Technology Co. Ltd., ("China RainEarth"), has obtained patent approvals for its core technology, which consists of products that ai...

Microsoft to Showcase Clinical Trial Solutions From Discovery to Approvals at Drug Information Association's 2009 Annual Meeting

Demos will focus on scientist collaboration and streamlining the drug discovery process. SAN DIEGO, June 18 /PRNewswire-FirstCall/ -- What: At the Drug Information Association's (DIA) 45th Annual Meeting in San Diego, Microsoft Corp. will showcase Microsoft ...

Mylan Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept(R)

PITTSBURGH, May 7 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Mycophenolate Mofetil Tablets, 500 ...

CTI Focuses on Late-Stage Drug Approvals and Commercialization and Cuts Operating Costs: to Close Bresso Research Center

SEATTLE, Feb. 27 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it has started a collective dismissal procedure pursuant to Law 223/1991 concerning its Bresso, Italy, (CTE) employees. The collective dismissal will involve a total of 62 employee...

Priligy(TM) (Dapoxetine) Receives First Regulatory Approvals for the Treatment of Premature Ejaculation (PE) in Finland and Sweden

BEERSE, Belgium, February 10 /PRNewswire-FirstCall/ -- Janssen-Cilag EMEA, a division of Janssen Pharmaceutica N. V., announced today that Priligy(TM) (dapoxetine) has received marketing authorisation in Finland and Sweden for the on-demand treatment of premature ejaculation (PE) in men 18-64 ...

ProAssurance Receives Regulatory Approvals for Transactions with the PICA Group and Georgia Lawyers Insurance Company

BIRMINGHAM, Ala., Jan. 28 /PRNewswire-FirstCall/ -- ProAssurance Corporation (NYSE: PRA ) announced today that all required regulatory approvals have been granted in connection with its proposed sponsored demutualization of the PICA Group (PICA), the nation's leading provider of professional...

Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets and Lamictal(R) CD

PITTSBURGH, Jan. 28 /PRNewswire-FirstCall/ --Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine T...

LifeSecure Insurance Company Strengthens National Footprint with Partnership Program Approvals in Six States

BRIGHTON, Mich., Jan. 12 /PRNewswire/ -- LifeSecure Insurance Company, a Michigan-based long-term care insurance industry leader, is strengthening its national service offerings through Partnership Program approvals secured in six states, including: Ohio, Florida, Colorado, South Dakota, Oregon ...

Cell Therapeutics, Inc. (CTI) Cuts Net Operating Expenses 35% and Expands Commercial Team to Support Zevalin(R) Sales and Applications Seeking Two Product Approvals in 2009

2008 Projected Financial Highlights and Potential Milestones include: - Grow Zevalin sales - XYOTAX(TM) Marketing Authorization Application submission in Q1 - Pixantrone phase III results and New Drug Application submission - Brostallicin phase II interim results SEATTLE, Jan. 30 /...
Approvals in Medical Technology

Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV Compounds

- Not Intended for Journalists in the UK or Ireland - New Findings From ARTEMIS and TITAN Studies Demonstrate Growth of the Tibotec Virology Franchise GLASGOW, Scotland, Nov. 12 /PRNewswire/ -- New data on PREZISTA(R) (darunavir), a protease inhibitor from Tib...

The Leukemia & Lymphoma Society and Cleveland Clinic Taussig Cancer Institute Announce Groundbreaking Partnership to Accelerate Drug Approvals

WHITE PLAINS, N.Y., Oct. 9 /PRNewswire/ -- In an effort to increase access and participation in clinical trials among adult blood cancer patients, The Leukemia & Lymphoma Society and Cleveland Clinic Taussig Cancer Institute have launched a groundbreaking partnership, The Clinical Trial Center...

Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program

...uth Korea to finalize development plans in that territory. Access believes that three ProLindac combination trials will start shortly upon regulatory approvals of protocols in both China and Korea. Further, Access has reported receipt of additional milestone payments from its Far East partners in the ordinar...

Cyberonics Provides Update on Depression Post-Approval Study

...ellectual property protection and potential infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new indications; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the acc...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

...ent to obtain FDA approval; the FDA may request additional clinical trials or other information prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to certain indications; NeurogesX' product candidates may have unexpected adverse side effects or inadequate therape...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

...orothiazide: 150 mg/12.5 mg tablets, 150 mg/25 mg tablets, 300 mg/12.5 mg tablets and 300 mg/25 mg tablets. Study details The FDA approvals of Tekturna HCT were based on a clinical trial program involving over 6,200 patients and evaluated more than 2,700 patients exposed to combinations of...

University of Michigan Study Shows SEQUENOM's MassARRAY Technology Identifies HPV Infections Missed by Standard Hybridization Test

...from cervical smears and tissue biopsy samples. The AttoSense test is currently available for Research Use Only. SEQUENOM intends to seek FDA and EU approvals as soon as practical. SEQUENOM will continue to collaborate with major medical centers to further validate and demonstrate the performance and value ...

ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients

...treat bronchial asthma in an innovative dry powder inhaler device," Koestler added. "Schering-Plough K.K. has received eight total new chemical entity approvals in Japan during the past two years, underscoring Schering-Plough's commitment to improving health and well being for patients in Japan." Importa...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

...during or after preclinical and clinical testing of our product candidates; (vi) the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; (vii) our dependence on the success of our lead product candidate; (viii) our inability to predict the extent of our fut...

Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

...arties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to...
Approvals in Medical Products

STAR S4 IR Excimer Laser System

Description:...signed to bring CustomVue individualized laser vision correction to life and provide the flexibility to treat patients with the broadest range of FDA approvals to date. Technologies like Active Trak 3-D eye tracking, automatic centering, Variable Spot Scanning (VSS), Variable Repetition Rate (VRR), and...
Company:Advanced Medical Optics, Inc.

Permacol surgical implant

Features:...y gamma irradiation. Permacol surgical implant is non allergenic and resistant to collagenase attack. Permacol surgical implant has both CE and FDA approvals for use in the EU and USA as a permanent surgical implant in humans and is indicated for the reconstruction, recontouring and reformation of soft conn...
Company:Tissue Science Laboratories Inc.

Physician's Drug Handbook, 10th Ed

Features:...eding, pediatric, and geriatric patients A patient teaching section is also included This 10th edition is thoroughly updated with dozens of new FDA approvals and new indications and an updated appendix on herbal medicines Other appendices include guidelines for use of selected antimicrobials, selected anal...
Company:Skyscape, Inc.
Approvals in Biological News

New clinical trial results show how personalized medicine will alter treatment of genetic disorders

.... Though this particular treatment remains in its early stages, within the foreseeable future the now-standard Phase I, II, and III pathway to drug approvals may need to be re-evaluated. How can DNA-like drugs specific to a single patients mutation go through the existing approval process" Are the curr...

Shell Provides Consumers Gasoline Industry's First Pay By Touch Technology at the Pump

...ecategorisation of reserves, economic and financial market conditions in various countries and regions, political risks, project delay or advancement, approvals and cost estimates. Please refer to the Annual Report on Form 20-F for the year ended December 31, 2006 (as amended) for a description of certain imp...

No carrier necessary: This drug delivers itself

... have been considered imperfect solutions. “Unlike formulations that require separate delivery systems, once this drug is approved, no additional approvals will be needed,?said Prasad. “Our published data in animal models demonstrate no difference in drug activity with the nanocrystal formulation,?s...

Technique speeds up detecting, treating wound bacteria

... to get good funding so that we could make some headway in this important area." Finegold's study is a four-year project, and his team is awaiting approvals to test the real-time PCR detection method on actual patients. As his work progresses, he hopes to publish early results that may be put to use in bot...

New licensing agreement to maximize AIDS drug development

...lTM (testosterone gel), branded Tostrex® outside the United States, is marketed in Sweden for the treatment of male hypogonadism also by ProStrakan. approvals of Rectogesic and Tostrex by the other member states of the European Union are being sought through the Mutual Recognition Procedure. ...

OneWorld Health drug receives 'Orphan' designation from U.S. and European regulatory agencies

... as exemption from certain registration fees, and may help pave the way for approvals in other countries. OneWorld Health will file for approval of paromomyci... the rigorous standards of either agency, we will be prepared to accelerate approvals in countries that have a critical need to treat VL." Paromomycin is an o...
Approvals in Biological Technology

China Sky One Medical, Inc. Obtains SFDA Approvals for Geranium Ointment and Musk Liniment for Pain Relief

HARBIN, China, April 23 /PRNewswire-Asia-FirstCall/ -- China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI ), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that it...

Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009

SEATTLE, Jan. 14 /PRNewswire-FirstCall/ -- In meetings held in association with the JP Morgan Healthcare Conference in San Francisco, Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reviewed 2009 targeted milestones and 2008 accomplishments. CTI is seeking to obtain two new drug approvals...

Monsanto Announces Key Regulatory Approvals for Roundup Ready 2 Yield(TM) Soybeans; Product Remains on Track for 2009 Launch

ST. LOUIS, July 24 /PRNewswire-FirstCall/ -- Monsanto Company (NYSE: MON) announced today that it has received regulatory approvals for Roundup Ready 2 Yield(TM) soybeans in Mexico, Australia and New Zealand. In addition, the company noted the European Food Safety Authority (EFSA) has issued a...

Off-Label Stent Use: How Important Are FDA Approvals to Physicians?

Millennium Research Group survey finds that physicians place importance on indication-specific FDA approval WALTHAM, Mass., April 2, 2008 /PRNewswire/ -- Given the recent investigation by the US Department of Justice into the marketing of biliary stents for off-label uses in ...

Boston Scientific Announces Three FDA Product Approvals for Its Cardiac Rhythm Management Business

Approvals include CONFIENT(TM) ICD, LIVIAN(TM) CRT-D and upgraded LATITUDE(R) Patient Management System NATICK, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced U.S. Food and Drug Administration (FDA) approval for three pro...

AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II

MINNEAPOLIS, Aug. 24 /PRNewswire/ -- AGA Medical Corporation ("AGA") announced today that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II"). The AMPLATZER Vascular Plug II expands the AGA family of oc...

KV Pharmaceutical Announces Stockholder Action to Amend By-Laws is Invalid

...culty of predicting FDA approvals, including timing, and that any period of exclusivity may not be realized; (4) the possibility of not obtaining FDA approvals or delay in obtaining FDA approvals; (5) acceptance and demand for new pharmaceutical products; (6) the introduction and impact of competitive product...

Schering-Plough Shareholders Approve Merger With Merck

...d products or pipeline projects; media and societal reaction to such developments; and the ability of Schering-Plough and Merck to obtain governmental approvals of the merger on the proposed terms and schedule. For further details of these and other risks and uncertainties that may impact forward-looking stat...

NeurogesX Reports Second Quarter 2009 Results

...ent to obtain FDA approval; the FDA may request additional clinical trials or other information prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to certain indications; NeurogesX' product candidates may have unexpected adverse side effects or inadequate therape...

Curis and Debiopharm Sign an Exclusive License Agreement Covering the HSP90 Inhibitor CUDC-305

...UDC-305 into clinical trials as planned. - Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations. - Curis may not be able to obtain or maintain the intellectua...
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