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Pharma industry, clinical trials, and regulatory affairs feed
Key Pharmacogenomics Resource Expanded By NIH
Published Date:
Thu, 09 Sep 2010 05:00:00 -0700
Description:
To help advance research on how genes affect responses to medicines, the National Institutes of Health is spending $15 million over five years to expand a key resource, the Pharmacogenomics Knowledge Base (PharmGKB). The goal of pharmacogenomics is to use information about a patient's genetic make-up to optimize his or her medical treatment. As the field has grown, so has PharmGKB...
Federal Appeals Court Declines To Reconsider 'Pay-For-Delay' On Generic Drugs
Published Date:
Thu, 09 Sep 2010 04:00:00 -0700
Description:
A federal appeals court on Tuesday said it will not revisit its decision to uphold settlements that allow pharmaceutical companies to pay competitors to keep generic versions of their drugs off the market, The Wall Street Journal reports. "In April, the U.S...
MAP Pharmaceuticals Announces All Non-Asthmatic Patients Complete Treatment In Open-Label Trial And Completion Of Treatment In QT Trial For LEVADEXtm
Published Date:
Thu, 09 Sep 2010 03:00:00 -0700
Description:
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that all non-asthmatic patients and a subset of asthmatic patients have completed 12 months of treatment in the open-label safety trial of LEVADEX™. In addition, the Company has completed patient treatment in a thorough QT trial, the last trial necessary to support a New Drug Application (NDA) for LEVADEX...
Enobia Provides Update On Progress With ENB-0040, A Bone-Targeted Enzyme Replacement Therapy For Hypophosphatasia
Published Date:
Thu, 09 Sep 2010 03:00:00 -0700
Description:
Enobia Pharma provided an update on key developments in its comprehensive effort to develop ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy, for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages...
Cylene To Report Recent Advances With First-in-Class CK2 Inhibitor, CX-4945, At International CK2 Conference
Published Date:
Thu, 09 Sep 2010 03:00:00 -0700
Description:
Cylene Pharmaceuticals, Inc. will report recent developments with its first-in-class, oral CK2 inhibitor CX-4945, at the 6th International Conference on Protein Kinase CK2, to be held on September 7-10 in Cologne, Germany, the company announced. CX-4945 is potentially a dynamic anticancer therapeutic, as both a stand-alone drug and for use in combination therapies...
Ariana(R) Pharma Collaborates With The FDA To Facilitate Signature Validation For The Development Of Biomarkers
Published Date:
Thu, 09 Sep 2010 01:00:00 -0700
Description:
Ariana Pharma, a leader in decision support tools and services to accelerate the development and optimal use of drugs and biomarker discovery, announces that it has started a collaboration with the US Food and Drug Administration (FDA)...
UC San Diego To Lead New Pharmacogenomics Project
Published Date:
Wed, 08 Sep 2010 06:00:00 -0700
Description:
An international team, led by University of California, San Diego School of Medicine researchers, has been awarded a $6.5 million grant from the National Institutes of Health (NIH) to study the pharmacogenomics of a key mood-stabilizing drug used to treat bipolar disorder...
Cuts To Public Spending On Research Will Jeopardise Funding For Medical Research From Private And Charitable Sources, UK
Published Date:
Wed, 08 Sep 2010 06:00:00 -0700
Description:
The Academy of Medical Sciences has warned that the UK's competitive advantage in medical science is reliant on a Government commitment to maintaining a thriving publicly funded research base. Any cuts risk damaging the UK's rich landscape of medical research funders and would jeopardise the private and charitable funding leveraged by public spending...
Court Denies Sandoz/Momenta's Summary Judgment Of Invalidity In Copaxone(R) Litigation
Published Date:
Wed, 08 Sep 2010 06:00:00 -0700
Description:
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. District Court for the Southern District of New York has denied a motion for summary judgment filed by Sandoz Inc./Momenta Pharmaceuticals, Inc., that the patents at issue are invalid for indefiniteness. The court has not yet set a trial date...
The Benefits Of Hormone Replacement Therapy Overstated And Harms Downplayed By Ghostwritten Articles
Published Date:
Wed, 08 Sep 2010 05:00:00 -0700
Description:
The first academic analysis of the 1500 documents unsealed in recent litigation against the pharmaceutical giant Wyeth (now part of Pfizer) reveals unprecedented insights into how pharmaceutical companies use ghostwriters to insert marketing messages into articles published in medical journals. Dr...
4th Annual Biomarker Discovery And Development Conference, San Francisco, CA Oct. 20-22, 2010
Published Date:
Wed, 08 Sep 2010 03:00:00 -0700
Description:
The 4th Annual Biomarker Discovery and Development Conference features presentations of novel technologies to discover biomarkers, how they are utilized to streamline the development process by reducing time and costs and minimize drug attrition associated with safety concerns, and highlight their utility in clinical trials and as companion diagnostics in the clinics...
Children's Hospital Boston And Particle Sciences Cooperate On Translational Medicine Efforts
Published Date:
Wed, 08 Sep 2010 03:00:00 -0700
Description:
Particle Sciences Inc. (PSI), a leading pharmaceutical Contract Research Organization (CRO), has been engaged by Children's Hospital Boston to help advance early stage molecules and drug innovations into new therapeutic products for patient care...
TenX Biopharma Reinitiates Enrollment In Pivotal Phase III, CTCL Trial
Published Date:
Wed, 08 Sep 2010 03:00:00 -0700
Description:
TenX Biopharma, Inc. announced that it has re-initiated enrollment in the pivotal Phase III clinical trial assessing zanolimumab treatment for cutaneous T-cell lymphoma (CTCL) patients. The trial enrollment was suspended in October 2008 while Genmab (CO:GEN) was seeking a out-license agreement to further develop the compound...
To Reach, Perchance To Kill The Cancer: A Soliloquy From Epeius Nanotechnologies Opposes That 'Sea Of Troubles'
Published Date:
Wed, 08 Sep 2010 03:00:00 -0700
Description:
Epeius Biotechnologies Corporation, a leader in the emerging field of targeted genetic medicine, reports the publication of a landmark paper in clinical oncology. Following up on its advanced U.S...
BIO India International Partnering Conference Showcases Vibrant And Growing Indian Biotech Industry To Global Leaders
Published Date:
Wed, 08 Sep 2010 01:00:00 -0700
Description:
The Biotechnology Industry Organization (BIO) will be hosting the first-ever BIO India International Partnering Conference in Hyderabad, India on September 21-22. BIO India will bring together biotechnology and pharmaceutical companies from North America, Europe and Asia to meet and explore business opportunities with India's emerging biotech sector...
INL Selects Vistec's Electron-Beam Lithography System EBPG5200 For Nanotechnology Research
Published Date:
Tue, 07 Sep 2010 05:00:00 -0700
Description:
Vistec Lithography, a leading supplier of advanced electron-beam lithography systems has announced today that the International Iberian Nanotechnology Laboratory (INL) in Braga, Portugal has placed an order for Vistec's electron-beam lithography system EBPG5200...
Hans-Joachim Bohm, Mathai Mammen, Tom Novak And Others To Present At 6th Modern Drug Discovery And Development Summit, Oct 20-22, San Francisco
Published Date:
Tue, 07 Sep 2010 03:00:00 -0700
Description:
The at 6th Modern Drug Discovery and Development Summit will feature plenary keynote presentations from Mathai Mammen, Senior Vice President of Research and Early Clinical Development at Theravance; Gilles J. A. Gallant, Vice-President of Clinical Oncology at Human Genome Sciences; Tom Novak, Ph.D,Senior Vice President of Research & Development, Fate Therapeutics; and Hans-Joachim Bohm, Ph.D...
Stephen Turner And Michael R. Jackson To Present At Assay And Drug Discovery Technologies Conference, San Diego, Sept. 20-21, 2010
Published Date:
Tue, 07 Sep 2010 03:00:00 -0700
Description:
Stephen Turner, Founder & Chief Technology Officer of Pacific Biosciences and Michael R. Jackson, Vice President, Drug Discovery and Development of Burnham Medical Research Institute will give a keynote presentation at the 5th Assay and Drug Discovery Technologies Conference to be held this year in San Diego, CA Sept. 20-21, 2010 by GTCbio...
Urgent Action Needed To Ensure UK Patients Get Their Medicines, UK
Published Date:
Tue, 07 Sep 2010 02:00:00 -0700
Description:
Urgent action is needed to tackle the worsening problems UK patients are facing when trying to receive their medicine prescriptions...
Key To Slowing Rise Of Antibiotic-Resistant Infections Is Pharmaceutical Conservation
Published Date:
Tue, 07 Sep 2010 01:00:00 -0700
Description:
The United States must focus on conserving the use of antibacterial drugs, or face a public health crisis from rapidly rising rates of antibiotic-resistant infections, according to an analysis just released...
European Medicines Agency Holds First Scientific Workshop On Nanomedicines
Published Date:
Tue, 07 Sep 2010 00:00:00 -0700
Description:
On 2-3 September 2010, the European Medicines Agency (EMA) hosted the first international scientific workshop on nanomedicines. Some 200 European and international participants from 27 countries including Australia, Canada, India, Japan and the United States discussed benefits and challenges arising from the application of nanotechnologies to medicines...
ThromboGenics Presents Positive Pooled Results From The MIVI-TRUST Phase III Program
Published Date:
Tue, 07 Sep 2010 00:00:00 -0700
Description:
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that the pooled results from the successful microplasmin MIVI-TRUST Phase III program were presented today at the EURETINA (European Society of Retina Specialists) Congress in Paris, France...
LEVITRA 10mg Orodispersible Tablet For The Treatment Of Erectile Dysfunction Approved In Europe
Published Date:
Tue, 07 Sep 2010 00:00:00 -0700
Description:
The European Commission has approved a new formulation of Levitra® (vardenafil HCI). Levitra 10mg orodispersible tablet will be the first erectile dysfunction (ED) medication available in this novel and convenient formulation...
Novartis And Collaborators Discover Novel Antimalarial Drug Candidate
Published Date:
Tue, 07 Sep 2010 00:00:00 -0700
Description:
Novartis announced that scientists at the Novartis Institute for Tropical Diseases (NITD), in collaboration with researchers from the Genomics Institute of the Novartis Research Foundation (GNF), the Swiss Tropical and Public Health Institute and The Scripps Research Institute have discovered a novel compound that shows promise as a next generation treatment for drug resistant malaria...
Concern About Rosiglitazone (Avandia) And How Drugs Are Regulated And Promoted, BMJ
Published Date:
Mon, 06 Sep 2010 11:00:00 -0700
Description:
There is serious concern about top-selling diabetes drug rosiglitazone (Avandia), its safety, as well as the whole system by which medications are regulated, evaluated and promoted worldwide, according to a BMJ (British Medical Journal) investigation. Dr. Fiona Godlee, BMJ Editor-in-Chief, thinks Avandia should not have been licensed; she believes it should be withdrawn...
Team Of Scientists Issues HIV Vaccine Strategy
Published Date:
Thu, 09 Sep 2010 04:00:00 -0700
Description:
The Council of the Global HIV Vaccine Enterprise on Tuesday released a new strategy for HIV vaccine research, which marked "the culmination of an 18-month effort that included the input of 400 scientists worldwide," VOA News reports (DeCapua, 9/7). The strategy, published as a Commentary (...
N30 Pharma Initiates Phase 1 Trials Of Novel Reductase Inhibitor
Published Date:
Thu, 09 Sep 2010 03:00:00 -0700
Description:
N30 Pharmaceuticals, LLC announced it has dosed the first human subject with N6022, a first-in-class inhibitor of s-nitrosoglutathione reductase (GSNOR). N6022 is the first GSNOR inhibitor to be administered to human beings...
MAP Pharmaceuticals Announces All Non-Asthmatic Patients Complete Treatment In Open-Label Trial And Completion Of Treatment In QT Trial For LEVADEXtm
Published Date:
Thu, 09 Sep 2010 03:00:00 -0700
Description:
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that all non-asthmatic patients and a subset of asthmatic patients have completed 12 months of treatment in the open-label safety trial of LEVADEX™. In addition, the Company has completed patient treatment in a thorough QT trial, the last trial necessary to support a New Drug Application (NDA) for LEVADEX...
Enobia Provides Update On Progress With ENB-0040, A Bone-Targeted Enzyme Replacement Therapy For Hypophosphatasia
Published Date:
Thu, 09 Sep 2010 03:00:00 -0700
Description:
Enobia Pharma provided an update on key developments in its comprehensive effort to develop ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy, for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages...
TCT 2010 Late Breaking Trials To Have Impact On Practice Of Interventional Cardiology
Published Date:
Thu, 09 Sep 2010 01:00:00 -0700
Description:
Clinical trials in a variety of areas within interventional cardiovascular medicine that will be presented at TCT 2010 will directly affect the way that people with cardiovascular disease are treated. Breakthroughs in science and medical research, presented exclusively at TCT, will lead to new treatments that are minimally invasive and involve shorter recovery times...
CytRx Initiates Phase 2 Clinical Trial With Bafetinib In Advanced Prostate Cancer
Published Date:
Thu, 09 Sep 2010 01:00:00 -0700
Description:
CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced initiation of the PROstate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer...
AtheroMed, Inc. Announces Launch Of EASE Clinical Trial To Evaluate Peripheral Arterial Disease Treatment
Published Date:
Thu, 09 Sep 2010 01:00:00 -0700
Description:
AtheroMed, Inc. announced the start of enrollment in the EASE study to evaluate the safety and effectiveness of the Phoenix Atherectomy™ catheter, a minimally invasive device for the treatment of peripheral arterial disease (PAD) in the legs...
Promedior Announces Initiation Of Phase 2a Of Anti-Fibrotic Therapeutic, PRM-151, In The Prevention Of Post-Surgical Scarring In Glaucoma Patients
Published Date:
Thu, 09 Sep 2010 01:00:00 -0700
Description:
Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced that it has initiated a Phase 2a clinical study of PRM-151 to evaluate the efficacy, safety, and tolerability of PRM-151 in preventing post-surgical scarring in glaucoma patients following glaucoma filtration surgery...
Can-Fite BioPharma Announces The Initiation Of Phase 3 In Dry Eye Syndrome
Published Date:
Wed, 08 Sep 2010 07:00:00 -0700
Description:
Can-Fite BioPharma Ltd (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened an Investigational New Drug application (IND) with the US-FDA for a Phase 3 study of its lead drug, CF101, in patients with moderate to severe Dry Eye Syndrome...
New Octapharma 10% High Purity Immunoglobulin Enters Phase II/III Study In Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Published Date:
Wed, 08 Sep 2010 06:00:00 -0700
Description:
Octapharma AG announced the imminent start of the biggest ever study of an intravenous immunoglobulin preparation (IVIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)...
PPD Establishes Network Of Sites For Conducting Phase I Trials In Patients
Published Date:
Wed, 08 Sep 2010 05:00:00 -0700
Description:
PPD, Inc. (Nasdaq: PPDI) announced it has established preferred provider relationships with a network of sites across North America for conducting Phase I trials in patients to meet growing client demand for these services. PPD has established relationships with Commonwealth Biomedical Research in Madisonville, Ky...
TenX Biopharma Reinitiates Enrollment In Pivotal Phase III, CTCL Trial
Published Date:
Wed, 08 Sep 2010 03:00:00 -0700
Description:
TenX Biopharma, Inc. announced that it has re-initiated enrollment in the pivotal Phase III clinical trial assessing zanolimumab treatment for cutaneous T-cell lymphoma (CTCL) patients. The trial enrollment was suspended in October 2008 while Genmab (CO:GEN) was seeking a out-license agreement to further develop the compound...
To Reach, Perchance To Kill The Cancer: A Soliloquy From Epeius Nanotechnologies Opposes That 'Sea Of Troubles'
Published Date:
Wed, 08 Sep 2010 03:00:00 -0700
Description:
Epeius Biotechnologies Corporation, a leader in the emerging field of targeted genetic medicine, reports the publication of a landmark paper in clinical oncology. Following up on its advanced U.S...
ThromboGenics Presents Positive Pooled Results From The MIVI-TRUST Phase III Program
Published Date:
Tue, 07 Sep 2010 00:00:00 -0700
Description:
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that the pooled results from the successful microplasmin MIVI-TRUST Phase III program were presented today at the EURETINA (European Society of Retina Specialists) Congress in Paris, France...
Road-Map Agreed For Confirmatory Trials Of Promising Microbicide
Published Date:
Mon, 06 Sep 2010 04:00:00 -0700
Description:
Two further clinical trials are planned to confirm a vaginal gel which has shown potential in reducing the risk of HIV. The results of the first trial of the gel, which were announced in July at the XVIII International AIDS Conference in Vienna, must be confirmed before the product can be made available for general use...
Gynecologic Cancer Patients Should Consider Clinical Trials
Published Date:
Mon, 06 Sep 2010 02:00:00 -0700
Description:
For the estimated 83,000 women who will be diagnosed with a gynecologic cancer in 2010, participation in clinical trials offers an opportunity both to ensure that future patients benefit from the most up-to-date treatments and increased survival rates and to potentially improve the health of current patients...
Successful Completion Of First Clinical Trials On Potent New Hepatitis C Drug
Published Date:
Mon, 06 Sep 2010 01:00:00 -0700
Description:
The first clinical trials on a new investigational drug being developed to treat infections caused by Hepatitis C virus have been successfully completed...
Depression Significantly Improved By Non-Invasive Therapy
Published Date:
Mon, 06 Sep 2010 00:00:00 -0700
Description:
Major depression is a common and disabling brain condition marked not only by the presence of depressed mood but also by its effects on sleep, energy, decision-making, memory and thoughts of death or of suicide. Major depression affects 15 million adults in the U.S...
Merck's Cladribine Tablets For Multiple Sclerosis Approved In Australia
Published Date:
Sun, 05 Sep 2010 01:00:00 -0700
Description:
Merck KGaA announced that the Australian Therapeutic Goods Administration (TGA) has approved Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS)(1). Cladribine Tablets will be registered in Australia under the trade name Movectro®...
HeartWare Receives Second Patient Allotment Under Continued Access Protocol For Pivotal U.S. Bridge-To-Transplant Clinical Trial
Published Date:
Sat, 04 Sep 2010 01:00:00 -0700
Description:
HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S...
Optimer Pharmaceuticals Announces Presentations Of Additional Fidaxomicin Phase 3 Data At Upcoming ICAAC Annual Meeting
Published Date:
Fri, 03 Sep 2010 04:00:00 -0700
Description:
Results from studies related to Optimer Pharmaceuticals, Inc.'s (Nasdaq: OPTR) lead developmental product candidate, fidaxomicin, will be presented at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) to be held at the Boston Convention and Exhibition Center in Boston on September 12-15, 2010...
Transdel Pharmaceuticals Presents Phase 3 Study Data On Ketotransdel® At World Pain Congress In Montreal, Canada
Published Date:
Fri, 03 Sep 2010 02:00:00 -0700
Description:
Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, announced the final data set from its Phase 3 study of Ketotransdel® (TDLP-110) at the 13th World Congress on Pain in Montreal, Canada...
Soligenix Announces Publication Of Article Identifying Domains Within The Ricin Toxin A Subunit As Targets Of Protective Antibodies
Published Date:
Fri, 03 Sep 2010 02:00:00 -0700
Description:
Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced the publication of an article online in Vaccine. The article describes the systematic identification of neutralizing and non-neutralizing B-cell epitopes on ricin toxin's enzymatic A subunit (RTA)...
Inhibitex Successfully Completes Phase 1a Trial Of INX-189
Published Date:
Fri, 03 Sep 2010 02:00:00 -0700
Description:
Inhibitex, Inc. (Nasdaq: INHX), announced that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo...
Halozyme Begins Phase 2 Clinical Trials With Insulin Analogs Lispro And Aspart With RHuPH20 In Type 1 And Type 2 Diabetes
Published Date:
Fri, 03 Sep 2010 02:00:00 -0700
Description:
Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog®, and insulin lispro, the active ingredient in Humalog®...
Electronic Cigarette Distributors Warned By FDA Regarding Unsubstantiated Claims
Published Date:
Thu, 09 Sep 2010 13:00:00 -0700
Description:
Warning letters were sent to five different electronic cigarette distributors by the FDA (Food and Drug Administration) for making unsubstantiated claims, as well as poor manufacturing practices. The FDA also informed the Electronic Cigarette Association that it means to regulate electronic cigarettes and related products "in a manner consistent with its mission of protecting the public health...
Rexahn Pharmaceuticals Submits Serdaxin Phase IIb Protocol To FDA For Major Depressive Disorder (MDD)
Published Date:
Thu, 09 Sep 2010 02:00:00 -0700
Description:
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, announced that it has submitted a Phase IIb protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin for the treatment of major depressive disorder (MDD)...
Ariana(R) Pharma Collaborates With The FDA To Facilitate Signature Validation For The Development Of Biomarkers
Published Date:
Thu, 09 Sep 2010 01:00:00 -0700
Description:
Ariana Pharma, a leader in decision support tools and services to accelerate the development and optimal use of drugs and biomarker discovery, announces that it has started a collaboration with the US Food and Drug Administration (FDA)...
FDA Warns Tea Drink Makers About Unsubstantiated Claims
Published Date:
Wed, 08 Sep 2010 09:00:00 -0700
Description:
Ever heard of tea-flavored beverage makers making health claims for their teas which really should only be made for properly brewed tea? It seems the FDA (Food and Drug Administration, USA) has, and is warning both Dr. Pepper Snapple Group about its Canada Dry Sparkling Green Tea Ginger Ale and Unilever Americas over its website claims and labeling for Lipton Green Tea...
Canadian Food Inspection Agency Seeks Comments On Regulatory Proposal For Imported Food Sector
Published Date:
Wed, 08 Sep 2010 06:00:00 -0700
Description:
The Canadian Food Inspection Agency (CFIA) is seeking input from stakeholders and the Canadian public on the proposed principles that will guide the development of new regulations for certain imported food products. This would include enhanced food safety requirements as well as an importer licensing initiative...
K2M Receives 510(k) Clearance For Its CHESAPEAKE Anterior-Lumbar Stabilization System
Published Date:
Wed, 08 Sep 2010 00:00:00 -0700
Description:
K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new CHESAPEAKE™ Anterior-Lumbar Stabilization System, a unique interbody device designed for stabilization of the spine through an anterior approach...
Medtronic Gains Ce Mark For Enhanced Corevalve(R) Delivery Catheter System With Accutrak Stability Layer
Published Date:
Wed, 08 Sep 2010 00:00:00 -0700
Description:
Medtronic, Inc. (NYSE: MDT) announced CE (Conformité Européenne) Mark approval and the first global use and launch of the Medtronic CoreValve® delivery system with AccuTrak™ Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak's proprietary technology allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValv device...
'Brinavess'™ (Vernakalant) For Infusion Approved In The European Union For Rapid Conversion Of Recent Onset Atrial Fibrillation
Published Date:
Tue, 07 Sep 2010 00:00:00 -0700
Description:
MSD (known in the and as Merck) (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) announced that the intravenous (IV) formulation of 'Brinavess'™ (vernakalant) has been granted marketing approval in the European Union (EU), and for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults...
LEVITRA 10mg Orodispersible Tablet For The Treatment Of Erectile Dysfunction Approved In Europe
Published Date:
Tue, 07 Sep 2010 00:00:00 -0700
Description:
The European Commission has approved a new formulation of Levitra® (vardenafil HCI). Levitra 10mg orodispersible tablet will be the first erectile dysfunction (ED) medication available in this novel and convenient formulation...
Concern About Rosiglitazone (Avandia) And How Drugs Are Regulated And Promoted, BMJ
Published Date:
Mon, 06 Sep 2010 11:00:00 -0700
Description:
There is serious concern about top-selling diabetes drug rosiglitazone (Avandia), its safety, as well as the whole system by which medications are regulated, evaluated and promoted worldwide, according to a BMJ (British Medical Journal) investigation. Dr. Fiona Godlee, BMJ Editor-in-Chief, thinks Avandia should not have been licensed; she believes it should be withdrawn...
FDA Cautions Consumers About Estrella Family Creamery Cheeses
Published Date:
Mon, 06 Sep 2010 05:00:00 -0700
Description:
What is the Problem? The U.S. Food and Drug Administration is warning consumers to discard cheeses from Estrella Family Creamery of Montesano, Wash., because they may be contaminated with Listeria monocytogenes. Environmental samples and one product sample collected by the FDA during an August 2010 inspection at the facility have tested positive for L. mono...
Celgene Officially Notified Of ANDA Filing For REVLIMID(R)
Published Date:
Mon, 06 Sep 2010 04:00:00 -0700
Description:
Celgene Corporation (NASDAQ: CELG) announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA)...
PIP (Poly Implant Prosthese) Breast Implants - UK Test Results
Published Date:
Mon, 06 Sep 2010 03:00:00 -0700
Description:
The Medicines and Healthcare products Regulatory Agency (MHRA) has received encouraging results of UK testing on the silicone gel breast implants manufactured by the French company Poly Implant Prosthese (PIP). The tests found no evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material in the implants...
Food Industry, USDA Criticized For Recent Salmonella Outbreak, Egg Recall
Published Date:
Mon, 06 Sep 2010 01:00:00 -0700
Description:
USA Today reports that food safety groups are slamming how well U.S. Department of Agriculture regulated the farms implicated in the salmonella outbreak...
European Commission Issues Positive Decision For Approval Of Seroquel XR As An Add-On Treatment Of Major Depressive Disorder
Published Date:
Sun, 05 Sep 2010 01:00:00 -0700
Description:
AstraZeneca announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy...
Merck's Cladribine Tablets For Multiple Sclerosis Approved In Australia
Published Date:
Sun, 05 Sep 2010 01:00:00 -0700
Description:
Merck KGaA announced that the Australian Therapeutic Goods Administration (TGA) has approved Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS)(1). Cladribine Tablets will be registered in Australia under the trade name Movectro®...
Gilead Sciences Submits European Marketing Application For Once-Daily Single-Tablet Regimen Of Truvada® And TMC278 For The Treatment Of HIV Infect
Published Date:
Sun, 05 Sep 2010 00:00:00 -0700
Description:
Gilead Sciences, Inc...
BioDelivery Sciences Announces Positive Meeting With FDA On A Streamlined ONSOLIS REMS With Broadened Distribution
Published Date:
Sun, 05 Sep 2010 00:00:00 -0700
Description:
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) announced a positive meeting with the U.S. Food and Drug Administration (FDA), Meda and BDSI that occurred on Wednesday, July 21, 2010 to discuss significant modifications to the existing Risk Evaluation and Mitigation Strategy (REMS) program for ONSOLIS (fentanyl buccal soluble film)...
MSD Receives European Approval Of Its Atypical Antipsychotic Medication SYCREST(R) For The Treatment Of Manic Episodes In Bipolar I Disorder
Published Date:
Sun, 05 Sep 2010 00:00:00 -0700
Description:
MSD (MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A). announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults...
HeartWare Receives Second Patient Allotment Under Continued Access Protocol For Pivotal U.S. Bridge-To-Transplant Clinical Trial
Published Date:
Sat, 04 Sep 2010 01:00:00 -0700
Description:
HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S...
Egg Recall, Drug Approval Time Raise Questions About FDA Resources
Published Date:
Fri, 03 Sep 2010 05:00:00 -0700
Description:
The recent salmonella outbreak/egg recall is raising questions about whether the FDA is fulfilling its regulatory role, PBS' NewsHour reports. "For the past few years, it's been one food safety scare after another. There was E. coli-laced spinach, salmonella-tainted peppers. ... There have also been problems with drugs. The ingredients in a contaminated blood thinner came from China...
BRINAVESS™ (vernakalant) For Infusion Approved In The European Union For Rapid Conversion Of Recent Onset Atrial Fibrillation
Published Date:
Fri, 03 Sep 2010 02:00:00 -0700
Description:
MSD (known in the US and Canada as Merck) (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults...
Ascension Orthopedics Receives FDA Approval For TITAN™ Modular Total Shoulder System
Published Date:
Fri, 03 Sep 2010 02:00:00 -0700
Description:
Ascension Orthopedics, Inc., the world leader in PyroCarbon orthopedic devices, announces FDA approval to market the TITAN™ Modular Total Shoulder System. This newly designed system redefines modularity by providing multiple surgical solutions for shoulder arthroplasty with one implant system. The TITAN Modular Total Shoulder System was developed in collaboration with Joseph Abboud, M...
California Firm Recalls Cooked Shredded Pork Skin Products Produced Without Inspection
Published Date:
Thu, 02 Sep 2010 06:00:00 -0700
Description:
Trinh Company, a San Jose, Calif., establishment, is recalling approximately 2,070 pounds of cooked shredded pork skin products because the products were produced without the benefit of federal inspection, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today...
BRINAVESS™ (vernakalant) For Infusion Approved In The European Union For Rapid Conversion Of Recent Onset Atrial Fibrillation
Published Date:
Thu, 02 Sep 2010 04:00:00 -0700
Description:
Merck (known as MSD outside the United States and Canada) (NYSE:MRK) and Cardiome Pharma Corp...
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