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May31
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 My interview today (the third one this week) is with a person I come a long way with. She was a former colleague, an old time friend who introduced me to the wonders of blogging and problogging.
She too is a colleague (not to mention friend) in the science blogosphere and is also my sister at the former About Weblogs Network.
In addition, Ruth has been witness to major events in my life and I was maid of honor at her wedding.
Have I mentioned already that we’ve come a long long way? He he.
Anyway, back to business…here’s Ruth Schaffer:
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May31
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Naltrexone, an FDA approved drug to ease symptoms of alcohol and drug addiction has been found in a Penn State College of Medicine pilot study to bring relief to people with Crohn’s disease. Crohns’s disease is a chronic inflammatory disorder...
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The USFDA recently approved Duramed Pharmaceuticals, Inc. and Barr Pharmaceuticals, Inc.’s New Drug Application (NDA) for SEASONIQUE™ (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive for the prevention of pregnancy. In July 2006,...
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According to the results of a Phase IIIb clinical trial, Shire plc’s methylphenidate transdermal system (MTS), DAYTRANA™, is significantly efficient in reducing the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years during shorter wear...
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The USFDA recently granted accelerated approval to Celgene Corporation’s Supplemental New Drug Application (sNDA) for THALOMID (thalidomide) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma. In the United States (affecting approximately 50,000 people) multiple myeloma is...
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May30
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My second interview is with the beauty blogger, Christina Jones. Christina is also a sister in the former About Weblogs Network. (you see it pays to have ‘sisters" in the blogosphere, they will agree to any interview even with their...
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Lupin Pharmaceuticals, Inc.’s Abbreviated New Drug Application (ANDA) for its Cefdinir Capsules, 300 mg has been granted final approval by the USFDA. Cefdinir Capsules, an extended-spectrum semisynthetic cephalosporin used to treat or prevent infections that are proven or strongly suspected...
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Wyeth Pharmaceutical’s (a Wyeth Division) investigational drug for major depressive disorder (MDD) -desvenlafaxine succinate (DVS-233), passed its Phase 3 clinical trial. The data and results of the study involving this novel serotonin-norepinephrine reuptake inhibitor (SNRI) have been presented at the...
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Angiotension converting enzyme (ACE) inhibitors are medication type commonly used to lower blood pressure. In a study presented at the recent Digestive Disease Week® 2006, researchers found that ACE inhibitors may be doing more that treating the patients’ hypertension but...
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May29
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This is interview week at Know More Media and here at The Pharm Voice, I will be posting interviews from people that are either connected or experts in the Pharmaceutical Industry, as well as seasoned probloggers in various fields of...
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Vocal Fold Insufficiency is a common voice-altering condition that is a serious form of voice loss where one or both vocal folds (and chords) lack the physical capacity to properly vibrate. Treatment of such a condition with Radiesse™ has been...
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SSc or systemic sclerosis is generally considered and treated as an autoimmune inflammatory disorder which cause and cure is yet to be found. Also known as scleroderma, SSc is an uncommon, mysterious disease by which excessive fibrous are formed including...
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The cells in the anus, when infected by ‘high risk” forms of HPV (the virus that causes warts) is a pre-cancerous condition called AIN (anal intraepithelial neoplasia). This condition which is not easily treated even by antiretroviral therapy is more...
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Gaucher's (pronounced go-SHAYZ) disease is a rare but a most common lysosomal storage disorder and genetic disorder affecting Jewish people of Eastern European ancestry. Gaucher's disease is fatal condition wherein a defective form of GC is produced. GC is a...
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May27
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ProEthic Pharmaceuticals announced that it has initiated Phase III clinical trials for PRO-513, the company's drug candidate for migraine headaches. PRO-513 is a formulation of diclofenac potassium powder for oral solution, which utilizes a unique, patented Dynamic Buffering Technology (DBT)...
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French biopharmaceutical bioMerieux is selling its hemostasis range of products to Trinity Biotech plc for a total value nearing $60 million, including collectibles. The operations sold include the automated and semi-automated hemostasis analyzers, as well as a comprehensive range of...
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May26
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As reported recently at boston.com, Novartis AG will launch an anti-malaria project in search of a one-dose cure for the most dangerous type of malaria. The research will be undertaken by the company’s tropical disease institute in Singapore, utilizing $20...
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Treatment with the investigational drug lisdexamfetamine dimesylate (NRP104) showed a statistically significant reduction in the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 years as demonstrated by the results oaf a Phase III Clinical Trial recently presented...
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A generic version of the antidepressant Lexapro (escitalopram oxalate) has been approved by the US FDA. The generic tablets, manufactured by Israel-based Teva Pharmaceuticals, will be available in three doses: 5 mg, 10 mg, and 20 mg. The drug is...
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May25
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The proton pump inhibitor (PPI) NEXIUM® (esomeprazole magnesium) maintained normal gastric (stomach) acid levels in patients with Zollinger-Ellison syndrome or idiopathic gastric acid hypersecretion (IGH), according to the results of a 12-month multi-center study which were presented at the annual...
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The USFDA approved Remicade (infliximab) for treatment of children with active Crohn's disease. Crohn’s disease is a chronic, inflammatory condition of the bowel that can be severely debilitating. Remicade which was initially approved in 1998 for treatment of Chron’d disease...
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Early this year, patient recruitment for the clinical trial of Roche's post-surgical colon cancer adjuvant therapeutic, AVANT, were suspended following the death of 6 patients involved in the study. However, Roche announced that it will now resume recruitment, upon clearance...
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Pharmacopeia and Cephalon, Inc. have formed a partnership to discover, develop and commercialize new drugs. Under the terms of agreement, the "division of labor" between the two firms are clear: 1. Cephalon will be responsible for identifying promising compounds. 2....
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SkyePharma PLC and First Horizon Pharmaceutical Corporation will co-develop a novel controlled-release version of Sular (nisoldipine), First Horizon's antihypertensive product. Nisoldipine is a calcium channel blocker that prevents calcium from entering certain types of muscle cells. Because muscle cells need...
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May24
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According to a study that was presented at the American Thoracic Society International Conference on May 22nd, lung transplant patients who received the inhaled form of the anti-rejection drug cyclosporine had significantly better lung function. "Many lung transplant patients develop...
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Researchers at the University of Georgia have provided vaccine developers with a new tool that could lead to the development of novel vaccines that will protect against a wider range of diseases or work against diseases that are currently hard...
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GeoVax, Inc. has started its HIV/AIDS human clinical trials in different sites around the United States. The culmination of this study is in lieu of the recently received "Safe to Proceed" status for a new Investigational New Drug (IND) from...
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According to an animal model study conducted by University of Pittsburgh School of Medicine researchers whose results have been presented at the annual meeting of the American Urological Association, IP 751, a potent synthetic analog of a metabolite of THC...
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As reported last week at CNN, FDA has approved a new drug, Azilect (also called rasagiline), which helps block the breakdown of a chemical that contributes to problems with movement and coordination (dopamine) that marks Parkinson’s disease. Azilect has been...
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May23
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Lentigen Corporation went into an exclusive, worldwide licensing agreement with the University of Pennsylvania , relating to lentiviral vector technology. Lentiviral vectors ( LV ) are vehicles that can deliver genes or RNAi into cells with up to 100% efficiency...
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Corgentech Inc. recently announced the positive results of one of its two pivotal Phase 3 studies of its lead product candidate, 3268 (a fast-acting local anesthetic) which showed statistically significant reduction in pain when administered just one to three minutes...
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Codeine, a standard ingredient in cough remedies may not be effective in treating cough, according to scientists at the University of Manchester's North West Lung Centre. Lead researcher Dr. Jacyln Smith said: "Codeine has long been considered the standard anti-cough...
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The US FDA granted tentative approval to abacavir sulfate tablets, the first generic anti-HIV medication manufactured by Hyderabad-based Aurobindo Pharma LTD. This product will now be available for consideration for purchase under the government's Emergency Plan for AIDS Relief. "FDA's...
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Vertex Pharmaceuticals Incorporated announced that, in Phase II clinical studies, in combination with pegylated interferon alfa-2a (Pegasys®; peg-IFN) and ribavirin (RBV), the company's lead candidate against hepatitis C virus (HCV), VX-950 reduced HCV RNA to undetectable levels in 100% of...
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May22
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Carrington Laboratories, Inc. has received a U.S. Patent describing the pharmacological compositions that expand the company's technology base and help protect the antigen sparing influenza vaccines which DelSite Biotechnologies, Inc. (Carrington's wholly-owned subsidiary) is developing and commercializing. Because of vaccine...
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Pharsight Corporation, a leading provider of software and strategic services for optimizing clinical drug development, has recently been awarded a patent for interactively building pharmacokinetic and pharmacodynamic ("PK/PD") models using a graphical interface (U.S. Application No. 7,043,415). This patented graphical...
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HemoBiotech, Inc. recently announced that Texas Tech University has filed a patent application for induction of erythropoiesis (red blood cell production) by HemoTech™, a novel chemically modified hemoglobin that is being developed as a blood substitute, which HemoBiotech has worldwide...
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An affiliate of Harvard Medical School, Schepens Eye Research Institute is the first to discover a switch inside blood vessel cells that controls angiogenesis (new blood vessel growth), which is turned on and off by the balance between two enzymes...
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Baxter AG and Jerini AG recently announced the progress of their collaborative research program that aims to develop a non-intravenous therapy for the treatment of hemophilia, in which extensive in vitro and in vivo analyses have identified several synthetic lead...
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May21
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The June 1 issue of G&D reported a novel animal model developed by Drs. Katerina Politi, Harold Varmus and colleagues at the Memorial Sloan Kettering Cancer Center in New York, of lung adenocarcinoma that will be of great use in...
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Valeant Pharmaceuticals International announced last week that the US FDA has given marketing approval for Cesamet (CII) (nabilone) oral capsules, a synthetic cannabinoid for treating nausea and vomiting associated with cancer chemotherapy in patients with whom anti-emetic treatments have failed....
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Nutrition 21, developer and marketer of chromium-based nutritional supplements, announced Friday that it has raised $10 million in private placements, with more than 5.5 million shares of common stock at $1.80 per share. Paul Intlekofer, President and Chief Executive Officer...
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Novavax, Inc. and Esprit Pharma entered into a definitive agreement to co-develop, supply and commercialize Novavax's testosterone lotion currently under Phase 2 clinical trials for female hypoactive sexual desire disorder (HSDD). Under terms of the License Agreement, Esprit will receive...
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Alfacell Corporation will lead a groundbreaking program to be conducted in Turkey to evaluate the potential of ONCONASE® (ranpirnase) and other medications to prevent mesothelioma. "Our hypothesis is that ONCONASE®, with its proven affinity for rapidly-dividing cancerous cells, inhibition of...
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May20
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Inverness Medical Innovations, Inc. has acquired a newly-constructed manufacturing facility in Hangzhou, China, as part of its acquisition of ACON Laboratories' business of researching, developing, manufacturing, marketing and selling lateral flow immunoassay products in the United States, Canada, Western Europe,...
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Shire Laboratories Inc., a subsidiary of Shire plc has filed a lawsuit in the U.S. District Court for the District of New Jersey against Corepharma LLC for infringement of Shire Laboratories' U.S. Patent Nos. 5,326,570 ("'570 Patent") and 5,912,013 ("'013...
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The International Clinical Trials Registry Platform is a major initiative aimed at standardizing the way information on medical studies is made available to the public through a process called registration. In lieu of this, the World Health Organization (WHO)...
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A recent report published at the Journal of the National Cancer Institute showed that women who are on statins (the widely used cholesterol-lowering drugs) are not on increased risk of breast cancer, contradicting what has been reported in previous studies....
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Brittle bone disorder or osteogenesis imperfecta (OI) is an inherited disorder characterized by weak bones that break easily and people inflicted with the most severe form of this disorder have short stature, can suffer hundreds if not thousands of fractures...
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May19
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The USFDA recently issued a warning letter to young adults who are using the antidepressant Paxil, stating that this drug may increase the risk of suicidal behavior in young adults. The warning letter came with the changes in labeling of...
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The University of Central Florida researchers have recently discovered a gene known as MCPIP could provide scientists with the key to developing treatments for preventing inflammation that can cause heart disease. A research team led by Pappachan Kolattukudy, dean of...
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Coreg CR™ (carvedilol phosphate controlled-release capsules) is a controlled-release beta blocker that reduced blood pressure over a full 24-hour dosing interval according to the data presented at the recent American Society for Hypertension 21st Annual Scientific Meeting and Exposition in...
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Targacept Inc.’s TC-1734 (AZD3480) passed its Phase II clinical trial in age associated memory impairment (AAMI). TC-1734 (AZD3480) is a highly selective alpha4 beta2 neuronal nicotinic receptor (NNR) agonist which was discovered using Pentad™, a sophisticated computer-based molecular design platform...
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VX—770, Vertex Pharmaceuticals Inc.’s novel oral drug candidate that specifically targets a key mechanism underlying cystic fibrosis (CF) has been granted Fast Track Designation by the USFDA. The company recently announced that it has started the Phase I clinical study...
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May18
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Neotropix™, Inc.’s Investigational New Drug (IND) application for its very first cancer drug candidate called Seneca Valley Virus (SVV-001), has been approved by the USFDA. The approval means that Neotropix™, Inc. (biotechnology company developing oncolytic viruses for the treatment of...
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The USFDA granted Fast Track Status to Coley Pharmaceutical Group, Inc.’s ACTILON™ (CPG 10101) for use in treatment-refractory patients chronically infected with the Hepatitis C Virus (HCV). "A Fast Track designation for our ACTILON™ development program allows Coley to work...
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Amarin Corporation plc acquired the global rights to a novel formulation of apomorphine for the treatment of "off" episodes in patients with advanced Parkinson's disease. The novel oral formulation provides rapid absorption of apomorphine directly into the bloodstream after sublingual...
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A joint collaboration has been developed between Families of Spinal Muscular Atrophy (FSMA) and Paratex Pharmaceuticals, Inc. in developing a promising drug candidate for the treatment of Spinal Muscular Atrophy (SMA). SMA is the leading genetically inherited cause of death...
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A study headed by Mayo Clinic found that rheumatoid arthritis (RA) patients taking the drugs Humira® or Remicade have thrice the risk of developing several kinds or cancer and double the risk of getting serious infections. Humira® is made by...
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May17
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Rockville, MD-based biopharmaceutical firm MacroGenics has raised $45 million in its third round of venture capital financing round. In addition to all precious investors, this round, led by Ventures West, brings in a new set of VCs: Caisse de dépôt...
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According to University of Cincinnati researchers, a cell-signaling pathway in the brain that is linked to the development of cancer and diabetes is also a key part of networks that regulate food intake. This finding will one day lead to...
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According to a study published at the British Medical Journal website, some ethnic groups may be more susceptible to adverse drug reactions (ADRs), which are an important cause if illness and death. Genetic make-up, age, sex and even diet are...
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May16
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Bristol-Myers Squibb’s ORENCIA®, selective modulator of a co- stimulatory signal required for full T-cell activation, for the treatment of rheumatoid arthritis (RA), has been approved by the USFDA in December 2005. Following this approval, the company recently announced the USFDA...
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Evamist™ is VIVUS, Inc.’s investigational estradiol metered dose transdermal spray that is being developed for the treatment of vasomotor symptoms associated with menopause. VIVUS, Inc. recently announced the positive results from the pivotal Phase 3 clinical trial of Evamist™ which...
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Remoxy™ is DURECT Corporation’s abuse-resistant pain medicine under development based on the company’s patented ORADUR™ technology incorporating the opioid oxycodone. Remoxy™ is currently undergoing a pivotal Phase III program as announced by DURECT recently which was spearheaded by Pain Therapeutics,...
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Paliperidone Prolonged Release Tablets is Janssen-Cilag International NV’s investigational prolonged release, once daily, oral medication for the treatment of schizophrenia that uses OROS technology, which releases drug into the bloodstream steadily over a 24-hour period. "Enhancing patient care for people...
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Phase 3 clinical trial of FEBT or fentanyl effervescent buccal tablet in all measures of pain control assessed in a chronic cancer pain population showed positive results. The study data were presented by Cephalon, Inc. at the annual meeting of...
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May15
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The New York Times recently reported that Doctors are objecting to drug data gathering, a compilation of data showing which physicians are prescribing what drugs. Considered as the most potent weapon in pharmaceutical sales, once drug sales representatives knew of...
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The anticancer drug Taxol (paclitaxel) is derived from the bark of the Pacific yew, one of the slowest growing trees in the world. Reliance to this tree alone can have supply problems with the production of Taxol. Michigan State University researchers...
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Hepsera is an antiviral that Hepatitis B patients are currently taking. Its “nucleotide analog”, an investigational drug called Tenofovir is the same as Hepsera in helping stop the Hepatitis B virus from propagating. Hepatitis B is a disease passed down...
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Europe's third-biggest drugmaker AstraZeneca is buying off its research and development partner, Cambridge Antibody Technology Group Plc, for $1.32 billion. Investors in the Cambridge, England-based company will get 1,320 pence for each of their shares, AstraZeneca said today. That's 67...
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