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Angiotech Pharmaceuticals, Inc. announces filing of shelf-registration statement

VANCOUVER, July 23 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI , TSX: ANP) today filed a preliminary short form base shelf prospectus with the securities commissions of British Columbia and Ontario and a corresponding shelf registration statement on Form S-3 with the U...

Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)

PLEASANTON, Calif., April 20 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has filed a PMA (Pre-Market Approval) supplement with the FDA seeki...

Advanced Life Sciences Announces Filing of Shelf Registration Statement

CHICAGO, April 8 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), a biopharmaceutical company developing cethromycin, a novel once-a-day antibiotic, to treat respiratory tract infections and to combat bioterror threats, announced today that it has filed a shelf re...

China Sky One Medical, Inc. Provides Update on Filing Form 10-K

HARBIN, China, April 7 /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 an ...

Cell Therapeutics Announces Filing of Form 10-K

SEATTLE, March 23 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that it has filed its annual report on Form 10-K for the year ended December 31, 2008. This filing is available for review on CTI's website at www.CellTherapeutics.com , or on the Secu...

Victhom announces the filing of a patent application to address sudden unexplained death in epilepsy (SUDEP)

QUEBEC, Feb. 11 /PRNewswire-FirstCall/ - Victhom Human Bionics Inc., "Victhom" (TSX: VHB), announced today the filing of a patent application for the detection and treatment of a physiological disorder that most likely leads to sudden unexplainable death in epileptic patients during seizure. Vic...

Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for the Treatment of Community Acquired Pneumonia

CHICAGO, Dec. 3 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's New Drug Application (NDA) for cethromycin, a novel once-a-day oral antibiotic, for the treatment...

Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules

FRAZER, Pa. and PHILADELPHIA, Oct. 21 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH ) and Eurand NV (Nasdaq: EURX ) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Fo...

ULURU Inc. Announces the Filing of a 510k Submission With the FDA for Altrazeal(TM) Silver

ADDISON, Texas, Sept. 30 /PRNewswire-FirstCall/ -- ULURU Inc. (Amex: ULU) today announced that it has filed a 510k application with the United States Food and Drug Administration (FDA) for Altrazeal(TM) Silver. Preclinical studies conducted to support the filing have shown that superior heal...

FDA Meeting Provides Green Light for Cell Therapeutics Submission of Supplemental Filing for Zevalin(R) Label Expansion

Supplemental Biologics License Application (sBLA) on track for Q4 Submission SEATTLE, Sept. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTICD and MTA: CTIC) announced today that following a meeting with the U.S. Food and Drug Administr...

Lixte Biotechnology Holdings Announces Filing of a New Patent Application for Cancer Therapy Based on Targeting a Biomarker by Novel Investigational Agents

EAST SETAUKET, N.Y., Aug. 19 /PRNewswire-FirstCall/ -- Lixte Biotechnology Holdings, Inc. (OTC Bulletin Board: LIXT) announced today that the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) and Lixte filed a joint patent application identify...

Symmetry Medical Extends 10-K Filing Beyond April 14, 2008 Target

WARSAW, Ind., April 14 /PRNewswire-FirstCall/ -- Symmetry Medical Inc. (NYSE: SMA ), a leading independent provider of products to the global orthopedic device industry and other medical markets, today announced that the filing of its 2007 Annual Report on Form 10-K with the Securities and Ex...

WuXi PharmaTech (Cayman) Inc. Announces Filing of Registration Statement For Follow-On and Secondary Offering

SHANGHAI, China, April 4, 2008 /Xinhua-PRNewswire-FirstCall/ -- WuXi PharmaTech (Cayman) Inc. (NYSE: WX ) ("WuXi PharmaTech"), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, today announce...

Cell Therapeutics, Inc. Announces Filing of Form 10-K

SEATTLE, March 28 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced that the filing of its annual report on Form 10-K for the year ended December 31, 2007 has now been timely completed. This filing is available for review on CTI's Web site at http:...

Genzyme Withdraws Bioenvision's European Filing of Evoltra(R) in Elderly AML Patients

Will Resubmit With New Data from Ongoing Studies CAMBRIDGE, Mass., March 19 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ ) today announced the withdrawal of the European application to extend the Evoltra(R) (clofarabine) product label to include the treatment of elderly p...

Angiotech announces filing of audited financial results for the year ended December 31, 2007 and restatement of results for the year ended December 31, 2006

VANCOUVER, March 13 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI , TSX: ANP), a global specialty pharmaceutical and medical device company, today announced the filing of its audited consolidated financial statements and Management's Discussion and Analysis for the ye...

Schering-Plough Announces Filing of U.S. Application for OTC ZEGERID(R)

KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced a submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for ZEGERID(R) (omeprazole/sodium bicarbonate) in the dosage strength of 20 mg of omeprazol...

PharmAthene Completes Pharmacokinetic Studies of Protexia(R); Program on Target for IND Filing in 2008

ANNAPOLIS, Md., March 6 /PRNewswire-FirstCall/ -- PharmAthene, Inc., a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced today that it has completed the initial pharmacokinetic (PK) testing of ...

PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration

Triggers $15 million milestone payment WILMINGTON, N.C., Feb. 28 /PRNewswire-FirstCall/ -- PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a highly selective DPP-4 inhibitor for the treatment of t...

Duramed's Lo SEASONIQUE(R) NDA Accepted for Filing by FDA

MONTVALE, N.J., Feb. 25 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that its subsidiary, Duramed Pharmaceuticals, Inc., has received notification that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for L...

Addrenex Pharmaceuticals Reaches Milestone with Filing of NDA for First Product, CloniBID, to Treat Hypertension

RESEARCH TRIANGLE PARK, N.C., Feb. 20 /PRNewswire/ -- Addrenex Pharmaceuticals has reached its first milestone accomplishment this year with the filing of a new drug application (NDA) for its first drug, CloniBID, to treat hypertension. Upon approval from the Food and Drug Administration, Addr...

Finkelstein Thompson LLP Announces Filing of Securities Fraud Class Action Against CellCyte Genetics Corporation

WASHINGTON, Feb. 5 /PRNewswire-USNewswire/ -- Notice is hereby given that Finkelstein Thompson LLP has filed a Class Action lawsuit in the United State District Court for the Western District of Washington on behalf of a class (the "Class") consisting of all persons or entities who purchased o...

Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA

HORSHAM, Pa., Feb. 4 /PRNewswire/ -- Centocor, Inc. announced today that the Biologics License Application (BLA) for ustekinumab (CNTO 1275) has been accepted for review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic moderate to severe plaque ps...

Oncolytics Biotech Inc. Announces Filing of Phase 1/2 Clinical Trial with REOLYSIN(R)

CALGARY, Jan. 3 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that the U.S. National Cancer Institute (NCI) has filed a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial for patients with metastatic...

Reliant Pharmaceuticals Announces the Filing of Registration Statement on Form S-1 For an Initial Public Offering

LIBERTY CORNER, N.J., Aug. 10 /PRNewswire/ -- Reliant Pharmaceuticals, Inc. today announced that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission for an initial public offering of its common stock. The registration statement contemplates that Relian...

AMDL Announces Filing of Extension on Third Quarter 2007 Form 10-QSB

TUSTIN, Calif., Nov. 13 /PRNewswire-FirstCall/ -- AMDL, Inc. (Amex: ADL) reported today that it has filed a Form 12b-25 with the Securities and Exchange Commission indicating that its Form 10-QSB for the six months ended September 30, 2007 would not be filed by November 14, 2007. However, AMDL...

Prana Announces Filing of Annual Report

MELBOURNE, Australia, Sept. 28 /PRNewswire-FirstCall/ -- Prana Biotechnology Limited (NasdaqCM: PRAN) (ASX: PBT.AX), a biopharmaceutical company focused on the research and development of treatments for neurodegenerative disorders, today announced it has filed its annual report containing audi...

Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product

WOODCLIFF LAKE, N.J., Aug. 15 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Warner Chilcott (US), Inc. in connection with Warner Chilcott's Femcon(R) FE (norethi...

European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreich's Ataxia by Santhera

LIESTAL, Switzerland and OSAKA, Japan, August 16 /PRNewswire-FirstCall/ -- Santhera Pharmaceuticals (SWX: SANN, "Santhera"), a Swiss specialty pharmaceutical company with a focus on neuromuscular diseases, and Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda"), jointly announced today ...

EESTECH Inc - Release From SEC Filing

LOS ANGELES, Feb. 18 /PRNewswire-FirstCall/ -- The Board of Directors wishes to confirm to Stockholders that at its meeting on February 4, 2009 it resolved to file a Form 15 with effect from February 17, 2009. This initiative does not require the approval of stockholders but in the interests of k...

Encorium Announces Receipt of Letter from Nasdaq Regarding its Third Quarter 2008 Form 10-Q Filing

WAYNE, Pa., Nov. 28 /PRNewswire-FirstCall/ -- Encorium Group, Inc. (Nasdaq: ENCO ), a full service multinational clinical research organization (CRO) conducting studies in over 30 countries for many of the world's leading pharmaceutical and biotechnology companies, today announced that on Novemb...

Cephalon Notified of Generic Fentanyl Buccal Tablet Filing

FRAZER, Pa., April 24 /PRNewswire-FirstCall/ -- Cephalon, Inc., (Nasdaq: CEPH ) today announced its receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Watson Laboratories, Inc...

CardioVascular BioTherapeutics, Inc. Announces Update on Timing of Form 10-K Filing

LAS VEGAS, April 21 /PRNewswire-FirstCall/ -- CardioVascular BioTherapeutics, Inc. (OTC Bulletin Board: CVBT) has announced that the Over the Counter Bulletin Board (OTCBB), on which CVBT's stock is traded, has added a temporary "E" to the end of its ticker symbol. The temporary "E" designates...

U.S. District Court Decision About Eisai's Legal Action Over Aricept ODT(R) ANDA Filing

TOKYO and WOODCLIFF LAKE, N.J., Dec. 27 /PRNewswire/ --- Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu) (collectively "Eisai") filed a lawsuit in August 2006 against Mutual Pharmaceutical Co., In...

FDA Accepts Ranexa(R) sNDA and NDA for Filing

PALO ALTO, Calif., Nov 19 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX ) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that its supplemental new drug application (sNDA) and new drug application (NDA) for Ranexa(R) (ranolazine extend...

Ruling enforces international trademark electronic filing requirements

Businesses could lose important trademark rights by failing to meet the technical filing requirements of the U.S. Patent and Trademark Office and the Trademark Trial and Appeal Board, as demonstrated by an international case of earlier this year. In the case, In re Borlind Gesellschaft for ko...

NeurogesX Reports Second Quarter 2009 Results

... Ltd. In the United States, NeurogesX submitted a new drug application (NDA) for PHN to the Food and Drug Administration (FDA) which was accepted for filing by the FDA in December 2008 and has been given an extended Prescription Drug User Fee Act (PDUFA) date of November 16, 2009. NeurogesX' second ...

Viral Genetics Creates Subsidiary to Develop Cancer Therapy

...opportunity to acquire a 25% stake in the new company. Viral Genetics has taken additional steps to strengthen its place in the marketplace by filing an unaudited financial statement at www.Pink S heets.com . That statement covers the company's financials for the last 18-months through March 31...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

...e balance of 2009 R&D expense is related to the advancement of a named pirfenidone analog compound, ITMN-520, toward an expected IND filing in mid-2010. -- G&A expense: anticipated to be in a range of approximately $35 to $40 million. The G&A guidance range includes ap...

NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application

.... In the United States, NeurogesX submitted a new drug application (NDA) for PHN to the U.S. Food and Drug Administration (FDA) which was accepted for filing by the FDA in December 2008 and has been given an extended Prescription Drug User Fee Act (PDUFA) date of November 16, 2009. NeurogesX' secon...
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