New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., July 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced that the New Drug Application
(NDA) for exenatide once weekly has been accepte...
CEL-SCI Files Patent Application to Support Company's Treatment for More Virulent Strain of H1N1 Swine and Other Influenza Viruses
VIENNA, Va., June 24 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (NYSE AMEX: CVM ) announced today that it has filed a provisional U.S. patent application
covering its L.E.A.P.S.(TM) immune therapy drugs (vaccines) for the prevention/treatment of H1N1, swine, bird flu, Influenza A and/or ev...
Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA
WOODCLIFF LAKE, N.J., June 10 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX ), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Applicat...
ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema
- Company Also Granted Expansion of Prophylaxis Therapy Label to Include Patient Labeling for Self-Administration -
EXTON, Pa., June 4 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM ) today announced that it has received a Complete Response letter from the U.S. Food and Dr...
A New Era in the Application of Lab-on-a-Chip to Rapid Point-of-Care Diagnosis
ATLANTA, May 17 /PRNewswire/ -- Hai Kang Life Corporation Limited (HKLife) announces further developments of its patented field-assisted LOAC (Lab-on-a-Chip) system, EFADchip technology at the BIO 2009 International Convention, the Global Event for Biotechnology held in Atlanta, through 18-21 ...
U.S. FDA Accepts Aridol(TM) New Drug Application for Review
SYDNEY, Australia, May 13 /PRNewswire-Asia/ -- Pharmaxis (ASX: PXS;
Nasdaq: PXSL ) today announced it had received notification from the United
States Food and Drug Administration (FDA) that the New Drug Application
for its mannitol bronchial challenge test Aridol(TM) has been accepted...
ZyGEM Releases Application Note Showing its DNA Extraction Kits Rapidly Produce High Yields of Quality DNA
--Highlights prepGEM(TM) Tissue Kit's Rapid, Robust and Reliable DNA Extraction That Generates DNA Templates Outperforming Other Commercial Kits--
-- Samples Prepared from Mouse Tails Using prepGEM(TM) Yielded Over 34 Times the Amount of DNA Produced by Two Commercial Rapid Extraction Kits --...
Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes
SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., May 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced that a New Drug Application
(NDA) for exenatide once weekly has been submitted...
BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for XIAFLEX(TM) for the Treatment of Dupuytren's Disease
LYNBROOK, N.Y., April 28 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC ), a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application
Innocoll, Inc. Files 510 (k) Application for CollaRx Lidocaine Sponge
ASHBURN, Va., March 31 /PRNewswire/ --- Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Pharmaceuticals, has filed a US 510k application
for its CollaRx(TM) Lidocaine Sponge for the management of painful wounds.
It is estimated that each year 13 million patients worldwid...
First Application to Fight High Cholesterol Launches on the iPhone and iPod Touch
Cholesterol Coach allows users to track their cholesterol and, more importantly, lower their cholesterol by putting together an action plan for diet, exercise and smoking, the key modifiable risk factors for high cholesterol.
Melbourne, Australia (PRWEB) March 27, 2009 ...
BioMarin's Clinical Trial Application for GALNS for Morquio A Syndrome Accepted by the MHRA
NOVATO, Calif., March 18 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN ) announced today that its application
for clinical trial authorization (CTA) for BMN 110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucop...
Sirion Therapeutics Supplemental New Drug Application for Durezol(TM) to Treat Uveitis is Accepted for Review by the FDA Application
Includes Data from a Comparative Trial in Anterior Uveitis
TAMPA, Fla., March 16 /PRNewswire/ -- Sirion Therapeutics, Inc. announced today that its supplemental New Drug Application
(sNDA) submitted to the U.S. Food and Drug Administration (FDA) seeking market approval of Durezol(...
FDA Accepts Investigational New Drug (IND) Application for Tigris Pharmaceutical's GGTI-2418
BONITA SPRINGS, Fla., March 4 /PRNewswire/ -- Tigris Pharmaceuticals, Inc., a privately held drug development company, today announced that its Investigational New Drug (IND) application
for the Company's geranylgeranyltransferase inhibitor (GGTI-2418) has been accepted by the U.S. Food and Drug A...
FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab
THOUSAND OAKS, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN ) today announced that the U.S. Food and Drug Administration (FDA) has accepted Amgen's submission and filed a Biologics License Application
(BLA) for denosumab, an investigational RANK Ligand inhibitor. Th...
MaxCyte Introduces the GT(TM) Flow Transfection System for Application with Autologous and Allogeneic Stem Cell Therapies
Technology enhances biological activity (regenerative potential) of stem cells and accelerates development of proprietary enhanced therapeutics
GAITHERSBURG, Md., Feb. 17 /PRNewswire-USNewswire/ -- MaxCyte announces today the introduction of its GT(TM) Flow Transfection System at the 4th Annu...
Vion Pharmaceuticals Submits New Drug Application for Onrigin(TM)
NEW HAVEN, Conn., Feb. 17 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced today that it has filed a New Drug Application
(NDA) with the U.S. Food and Drug Administration (FDA) for its lead oncology therapeutic Onrigin (laromustine) Injection as a single ...
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.
MINRAD Receives Notice That NYSE Alternext Intends to File Delisting Application With Securities and Exchange Commission
ORCHARD PARK, N.Y., Feb. 6 /PRNewswire-FirstCall/ -- MINRAD International,
Inc. (Amex: BUF ) -- On February 2, 2009, the Company received a notice from
NYSE Alternext US LLC (the "Exchange") stating that the Exchange intends to
strike the common stock of the Company from the Exchange by fili...
Tigris Pharmaceuticals Files IND Application for GGTI-2418
BONITA SPRINGS, Fla., Feb. 6 /PRNewswire/ -- Tigris Pharmaceuticals, Inc., a privately held drug development company, announced today that it has filed an Investigational New Drug (IND) application
with the U.S. Food and Drug Administration (FDA) for GGTI-2418, a novel anticancer compound. GGTI-2...
Vasogen Announces Sale of Patent Application and Provides Corporate Update
MISSISSAUGA, ON, Feb. 2 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ: VSGN ; TSX:VAS) today announced that it has sold a United States patent application
and its related foreign counterparts for US$400,000. This device-based intellectual property has not been used to date in the Celacade System;...
Medarex Announces Allowance of Investigational New Drug Application for Company's First Antibody-Drug Conjugate, MDX-1203
PRINCETON, N.J., Jan. 28 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) announced today the allowance of an investigational new drug (IND) application
filed with the U.S. Food & Drug Administration (FDA) for MDX-1203, the Company's first Antibody-Drug Conjugate (ADC) candidate gener...
Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes
TAMPA, Fla., Jan. 26 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application
(NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sir...
FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT(R) 12-Hour Pseudoephedrine
BOTHELL, Wash., Jan. 20 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD ) today announced that the U. S. Food and Drug Administration (FDA) has issued a Complete Response letter for its Abbreviated New Drug Application
(ANDA) for pseudoephedrine. The application, filed by SCOLR on Augus...
GSK and XenoPort Resubmit New Drug Application for Solzira(TM) in Restless Legs Syndrome
LONDON, RESEARCH TRIANGLE PARK, N.C. and SANTA CLARA, Calif., Jan. 9 /PRNewswire-FirstCall/ -- GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira (TM) (gabapentin ...
MicroDose and Nexus6 Announce Collaboration to Evaluate Application of Remote Patient Compliance Monitoring Technology with MicroDose's Electronic Dry Powder Inhaler
MONMOUTH JUNCTION, N.J. and AUCKLAND, New Zealand, Jan. 6 /PRNewswire/ -- MicroDose Technologies, Inc. (MicroDose) and Nexus6 today announced that they have entered into a collaboration to investigate the application
of Nexus6's SmartinhalerLive(TM) technology with MicroDose's next generation elec...
Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo(R)
FDA to review Intermezzo(R) (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings
PT. RICHMOND, Calif., Dec. 16 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical comp...
OmegaGenesis Announces Angiogenesis Application Collaboration
Advances Research and Product Development of Nano-Materials for Angiogenesis Applications
GILROY, Calif. and ROCHESTER, Minn., Dec. 15 /PRNewswire/ -- OmegaGenesis announced today that they have entered into a collaboration with Mayo Clinic for the discovery and validation of nano-materia...
ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve(TM)
IRVINE, Calif., Nov. 13 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals,
Inc. (Nasdaq: ISTA ), today announced the Company filed a New Drug
Application (NDA) with the U.S. Food and Drug Administration (FDA) for
Bepreve(TM) (bepotastine ophthalmic solution). The Company is seeking
approval for ...
Savient Submits Biologics License Application (BLA) for pegloticase
EAST BRUNSWICK, N.J., Oct. 31 /PRNewswire-FirstCall/ -- Savient
Pharmaceuticals, Inc. (Nasdaq: SVNT ) today announced the submission of its
BLA to the U.S. Food and Drug Administration (FDA) seeking approval to
market pegloticase in the United States along with its request for a
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate
Seeks Approval for Use in Epilepsy as Adjunctive Treatment in Partial Onset Seizures
RARITAN, N.J., Oct. 24 /PRNewswire/ -- Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. (J&JPRD) announced today that it has
submitted a New Drug Application
to the ...
FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
OSAKA, Japan, Oct. 10 /PRNewswire/ -- Takeda Pharmaceutical Company
Limited ("Takeda") today announced that Takeda Global Research and
Development Center, Inc., a wholly owned United States (U.S.) subsidiary,
received notification that the U.S. Food and Drug Administration (FDA) will
not be ab...
Cell Therapeutics Submits Supplemental Biologics License Application for Zevalin Use in First-Line Consolidation Therapy
Approval would make Zevalin only Radioimmunotherapy in U.S. to be Indicated for Use in First-Line Therapy
SEATTLE, Oct. 2 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq and MTA: CTIC) announced today that it has submitted a supplemental
Biologics License Appl...
FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma
BROOMFIELD, Colo., Sept. 23 /PRNewswire/ -- ARCA biopharma, Inc.
announced today that the U.S. Food and Drug Administration (FDA) has
accepted a New Drug Application
(NDA) for the company's lead product
candidate, bucindolol, an investigational and pharmacologically unique
beta-blocker and mil...
Inhaled Treprostinil New Drug Application Filed by FDA
SILVER SPRING, Md., Sept. 3 /PRNewswire-FirstCall/ -- United
Therapeutics Corporation (Nasdaq: UTHR ) and its wholly-owned subsidiary
Lung Rx, Inc. announced today that the U.S. Food and Drug Administration
(FDA) has accepted for review the New Drug Application
(NDA) for inhaled
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
LI-COR Updates Product and Application Guide for Summer 2008
LINCOLN, Neb., Aug. 11 /PRNewswire/ -- LI-COR Biosciences announces an
updated Infrared Fluorescent Products Guide offering accessories and
reagent products including infrared-labeled secondary antibodies, protein
labeling kits, Western blotting kits, In-Cell Western(TM) assay kits,
FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
HORSHAM, Pa., Aug. 8 /PRNewswire/ -- Centocor, Inc., today announced
that the U.S. Food and Drug Administration (FDA) has extended the review
timeline for the Biologic License Application
for ustekinumab, a
subcutaneous biologic therapy, by three months to December 2008. The
Pressure BioSciences, Inc. Announces the Market Release of its PCT-Enhanced Trypsin Digestion Application for Proteomics
SOUTH EASTON, Mass., Aug. 6 /PRNewswire-FirstCall/ -- Pressure
BioSciences, Inc. (Nasdaq: PBIO ) ("PBI" or "the Company") today announced
the market release of its pressure cycling technology ("PCT")-enhanced
trypsin digestion application
for proteomics, a major new addition to its
Huifeng Bio-Pharmaceutical (HFGB) Provides Update on COS Application Status
COS Consultants Evaluate Purification Testing, Standards and Procedures
SHAANXI, China, July 29 /Xinhua-PRNewswire-FirstCall/ -- Huifeng Bio-
Pharmaceutical Technology, Inc. (OTC Bulletin Board: HFGB), a leading
developer and producer of plant extracts and raw materials used in the