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HDCN News Archive -- Clinical Pharmacology
M17	FDA convenes to examine impact of direct-to-consumer pharmaceutical, and now, medical device, advertising.
M13	Texting kids to take their medicine may increase compliance.
M09	Darapladib lowers the activity of inflammatory enzyme associated with vascular plaque.
M05	ASN Renal Week abstract archives 2003-2006 now available on-line in .pdf format.
M02	New ACE 2 activator compounds lower blood pressure in rats and also reduce cardiac and renal fibrosis.
A28	FDA approves Relistor (methylnaltrexone) for opioid-induced constipation.
A25	First ever activator of ENAC sodium channel developed.
A24	GAO says that FDA lacks resources to inspect non-US drug suppliers; only 8% are being inspected now.
A23	Genzyme to build new research and development center in Beijing.
A23	Some compounds in Chinese bitter melon identified with activity against diabetes.
A22	CMS releases standards for e-prescribing of drugs.
A21	Massachusetts Senate unanimously passes a law banning all pharma gifts to doctors.
A19	Democrats propose labeling requirements for food and drugs which would list country of origin.
A10	FDA notice regarding investigation of mycophenolate mofetil regarding progressive multifocal leukoencephalopathy.
A07	New antimicrobial proteins identified in alligator blood
A04	AMAG Pharma presents data on new iron supplement at NKF Spring Clinical Meeting.
A03	New Merck heart failure drug rolofylline gives encouraging results in Phase III trial.
M27	Keryx ends development of sulodexide after negative trial results.
M19	Roche agrees to pay Amgen 22.5 percent royaty on Mircera sales in the U.S.
M13	FDA Oncologic Drug Advisory Panel recommends continued indication of ESAs for cancer patients excluding breast and head and neck.
M12	Keryx diabetes drug sulodexide fails to achieve primary endpoint in phase III clinical trial.
M11	Eli Lilly follows Pfizer and NovoNordisk in discontinuing inhalable insulin.
M10	FDA plans to ease restrictions on dissemination of reprints by pharma involving off-label usage of drugs.
M07	Bill to encourage e-prescribing for Medicare-reimbursed encounters likely to pass this year.
M06	More on the heparin contaminant in Baxter's product line - still unidentified.
M05	Massachusetts may ban drug industry freebies for docs.
M05	Supreme court votes 4 vs. 4 regarding pharma immunity from product liability for FDA-approved prescription drugs.
M05	FDA finds possible contaminant in Baxter heparin.
M05	Sensor necklace and magnetic trace additive to pills might be used to track medication compliance in clinical trials.
F27	Supreme Court hears arguments as to whether pharma companies should be protected from torts when a drug has been approved by the FDA.
F26	FDA: Medication guide must be given to patients with each rosiglitazone (Avandia) prescription.
F20	AMAG submits NDA to FDA for ferumoxytol.
F16	FDA issues draft guidelines for comment to Pharma about distributing reprints describing off-label usage of drugs.
F16	Baxter heparin case calls attention to Chinese chemical companies supplying drug raw materials with minimal regulation.
F16	Promising early data from another prostate cancer vaccine trial.
F15	Some cholesterol synthesis inhibitors also block Staph. aureus pigment synthesis, rendering the germ less pathogenic.
F07	FDA warns on adverse effects due to intravenous colchicine.
F01	Anti-leishmaniasis drug miltefosine kills HIV-infected macrophages, eliminating one protected site of HIV persistence.
J28	Vytorin lowers cholesterol, but does not impact on endpoints; House asks FDA to reconsidering hard vs. soft endpoints in proving drug value.
J25	Cox-2 inhibitors can cause arrhythmias by affecting potassium channels in the heart.
J16	FDA warns of name confusion between two edetate compounds used for chelation.
J11	Gas6 protein may augment the action of erythropoietin
J09	Cannabinoid receptor blocking drug effective in causing weight loss.
J02	Labeling on adrenaline vials in terms of concentration are confusing, lead to errors.
J02	European study could find no link between non-phenacetin pain killers and ESRD
D27	FDA approves synthetic starch-based volume expander fluid.
D27	New orally active cyanide antidotes discovered.
D21	Animal study suggests that EPO may protect hearts against toxicity of anticancer drugs
D20	FDA issues draft guidelines to industry for reporting adverse events linked to OTC drugs and dietary supplements.
D19	Northwestern University gets 700 M royalties for diabetes pain drug patent.
D19	AMAG pharma submits new drug application to FDA for ferumoxytol.
D17	US House Rep Waxman leaks FDA planned guidance to OK drug company promotion of off-label uses of drugs.
D17	Drug that stimulates thyroid hormone beta receptors effective in lowering LDL cholesterol
D15	U.S. FDA considers allowing a new group of -behind the counter- drugs to be dispensed with pharmacist approval only.
D14	FDA warns of serious adverse reactions with iron chelator Exjade.
D08	FDA launches new drug safety newsletter. Here is the first issue (rituximab)
D05	Dennis Quaid sues Baxter over label similarities between low- and high-dose heparin vials.
D04	FDA approves study of iron-containing dialysate additive for hemodialysis patients.
D03	Pharma companies to develop IgA proteases as a potential treatment for IgA nephropathy.
D03	Topical cleaners containing benzethonium chloride bactericidal against MRSA.
N27	FDA: Use of mycophenolate mofetil during pregnancy associated with increased risk of pregnancy loss and congenital malformations.
N26	Nitrosyl cobamide shows promise as an NO-donor type of drug for hypertension or heart disease.
N25	Executives from Genzyme and Johnson and Johnson to sit on FDA foundation board.
N16	CMS pushing e-prescribing for Medicare beneficiaries.
N16	Pramlintide-leptin combination drug induces 13% weight loss in obese patients.
N15	FDA approves Roche ESA anemia drug Mircera
N14	Cattle vaccine shown to be effective in lowering rate of toxigenic E. Coli carriage.
N14	FDA adds black box warning of heart attacks for Avandia (rosiglitazone)
N09	Placenta cloaks its proteins with phosphocholine (as do parasitic worms) to evade immune detection.
N08	FDA modified boxed warnings, indications, for ESA drugs.
N08	Skeletal muscle damage due to statins may operate through atrogin-1 and thus may be preventable.
N06	Shire announces results of Fosrenol trial in stage 3-4 CKD patients.
N05	New vascular function of hemoglobin, as a promoter of nitric oxide synthesis, identified.
N01	Legislation introduced in the House to fight spread of drug-resistant bacteria.
O29	Bacterial use peptides to communicate with each other: extracellular death factor identified.
O25	Bayer issues additional guidance to physicians about Trasylol (aprotinin).
O25	Genzyme launches cholesterol-binding drug (Cholestagel) in Europe for patients with primary hypercholesterolemia.
O25	SQ109, promising anti-tuberculosis drug, given special status by European and U.S. regulators.
O25	Genzyme profits increase tenfold on sales of drugs to treat rare diseases.
O23	Acute pancreatitis associated with exenatide (Byetta) - FDA requires labeling change
O19	Sudden hearing loss associated with erectile dysfunction drugs.
O17	Vaprisol (conivaptan) study shows increase in serum sodium in euvolemic hyponatremia.
O17	FDA advisory committee votes in favor of phosphate binder use for stage 4 CKD.
O16	FDA approves Doribax(tm) - doripenem - for complicated urinary tract infections, including pyelonephritis
O16	Velcade (bortezomib) for multiple myeloma now approved for use in patients with impaired renal function.
O12	FDA advisory meeting next Tuesday to study use of phosphate binders in pre-ESRD - Genzyme, Shire, Fresenius will all be present.
O12	Statins help preserve lung function during aging.
O08	New antibiotic ceftobiprole very effective in curing diabetic foot infections.
O03	Rockwell begins dosing patients with iron (soluble ferric pyrophosphate) - containing dialysate.
S25	New, synthetic version of heparin is patented.
S25	FDA to screen all direct-to-consumer (DTC) television ads if pending law is passed.
S20	Rockwell begins enrollment into Phase IIIb trial of dialysate sodium ferric pyrophosphate for iron therapy.
S11	Nabi to sell its Biologics division, and plans to move its headquarters.
S06	FDA approves first generic versions of carvedilol (Coreg).
A30	New mechanism of action of thiazolidinediones discovered.
A21	Unlike grapefruit juice, pomegranate juice does not appear to affect cytochrome P450-3A activity
A19	Bacteriophage treatments coming back into favor to combat superbugs such as MRSA.
A17	Patients who develop kidney failure after use of phosphate-based laxatives initiate lawsuits.
A17	FDA warning letter issued emphasizing pharmacogenomic variability in warfarin metabolism among patients.
A08	Annals: New study questions the increased heart attack risk with Avandia; original NEJM meta-analysis claimed to have been flawed.
A07	Publix supermarkets to offer up to 14-days of free antibiotics.
J30	FDA Advisory Panel to explore safety and risks of Avandia.
J24	Ferumoxytol Phase III clinical trial results achieve desired endpoints.
J21	New Cochrane analysis focuses on increased side effects in patients taking rosiglitazone (Avandia)
J19	Weight loss pill rimonabant associated with increased suicide risk.
J16	Older, cheaper pills just fine to treat diabetes.
J16	Affymax announces phase 3 development program for Hematide.
J12	Hydroxychloroquine (Plaquenil) may be protective against developing type 2 diabetes.
J09	FDA warning: precipitation when infusing ceftriaxone with calcium-containing solutions.
J27	Amgen makes labeling changes for Sensipar - no longer labeled for use in pre-ESRD patients.
J22	FDA approves pregabalin (Lyrica) for treatment of fibromyalgia.
J22	FDA clears "computerized medication box" (EMMA) for U.S. market.
J19	Randomization complete for phase III trial of sulodexide for diabetic nephropathy.
M23	Diethylene glycol - contaminated toothpaste linked to source in China
M23	Iron-chelating agent defasirox (Exjade) associated with acute renal failure.
M03	NEJM: Drug risks and free speech - can Congress ban direct-to-consumer ads?
A30	Compound from bullfrogs has marked anti-MRSA activity.
A07	Arthritis patients with CVD who take ibuprofen plus aspirin may greatly increase their cardiac risk.
M26	Tolvatptan improves signs and symptoms in patients with CHF.
M26	Nesiritide safety trial shows neutral effect on mortality in CHF patients
M22	FDA moves to limit participation of MDs with ties to pharma companies on its advisory boards.
M12	Azole antifungal drugs found to be active against tuberculosis.
M08	Indian pharma firm Biocon unveils suite of immunosuppressive drugs aimed at the transplant market.
M06	FDA approves aliskiren for treatment of hypertension.
M05	Taking amphotericin B in oil by mouth may result in good efficacy, less renal toxicity.
M02	NEJM: Vancomycin-induced thrombocytopenia: the article link
F28	NEJM: Immune-mediated thrombocytopenia linked to vancomycin use.
F23	MMWR: Nephrogenic fibrosing dermopathy.
F05	FDA approves new dosing recommendations for Rapamune (sirolimus) in high immunologic risk transplant patients.
F01	Biotrends report of Dec 2006 survey on use of ESAs and phosphate binders.
J16	DNA test to be used to determine warfarin dose.
J15	House passes Medicare drug bill.
J09	Two Wisconsin companies get together to develop ingested products for hyperphosphatemia control.
J09	Potential bias in studies funded by the food industry or by pharma in the news.
J04	Genzyme files new drug application with the FDA for sevelamer carbonate.
J03	Renal Advantage completes acquisition of Renalab.
D31	Gene knockout technology creates healthy, prion-protein-free cows
D29	FDA evaluating safety of products from cloned animals; seeks outside comments.
D28	Advanced Magnetics stock surges on hopes for ferumoxytol.
D22	FDA announces that it is still evaluating a possible link between MRA with gadolinium and nephrogenic fibrosing dermopathy.
D22	Multidrug resistant E. coli linked to antibiotic use on farms in the U.K.
D21	Genzyme files for FDA approval of sevelamer carbonbate - Renvela.
D20	FDA to require labeling changes for acetaminophen and for NSAIDs to highlight potential risks.
D16	FDA updates labeling for Trasylol (aprotinin) regarding risk of renal dysfunction, anaphylaxis, and re-exposure.
D12	Phase 3 trial shows Avastin (bevacizumab) improves progression-free survival in renal cancer patients.
D12	FDA campaigns against use of quinine for conditions other than malaria; cautions against use of quinine for leg cramps.
D11	FDA proposes rules overhaul to expand access to experimental drugs.
N30	Dynavax stock rises on news of positive results for Hepatis B vaccine in difficult to immunize patients.
N28	Genzyme researchers show promising results with drug against polycystic kidney disease.
N26	HDCN: Search index updated for audiofiles, slide/audio talks, articles, and abstracts
N18	CMS plans to open up physician-prescribing drug database to researchers
N14	Nabi reaches deal with hedge fund on directors, chairman.
N10	FDA approves pramipexole (Mirapex) for treatment of restless legs syndrome in nonuremics
N10	FDA considers expanding patient access to experimental medications
O30	Pharma supported patient education sites under the microscope.
O26	Phase 3 trial design for belimumab to treat SLE approved by FDA
O23	FDA approves once-a-day Coreg (carvedilol) CR for 3 cardiovascular indications
O18	Cockcroft Gault equation (modified) better than MDRD for adjusting vancomycin dose in the elderly.
O18	Rockwell submits dose ranging study for dialysis solution iron supplement to FDA
O17	FDA approves new treatment for diabetets - Januvia (sitagliptin)
O10	Biodegradable gel stops bleeding promptly
S28	Amgen colon cancer drug gets FDA approval
S28	Meditor working on development of intradialytic hypotension drug.
S27	U.S. House and Senate pass bill allowing purchase of drugs from Canada
S27	La Jolla Pharm announces addition of new sites, reactivation of Riquent (abetimus) study to treat lupus.
S26	Generex develops metformin-containing chewing gum, oral insulin spray, as novel drug-release products.
S19	FDA approves posoconazole to treat Aspergillus and Candida fungal infections.
S18	Food and drugs pass through the stomach very quickly or quite slowly.
S13	More bad news in JAMA paper about CV and kidney risks of COX-2 inhibitors and NSAIDS
S12	New class of pain relievers may help, not hurt, the heart
S11	Advanced Magnetic (ferumoxytol) hires Brenner, Salem, in top positions
S11	Bacterial conversation stoppers may block formation of biofilm
S11	Chitosan (from crabs and shrimp) found to block formation of biofilm.
S11	Want to fight fat? Eat brown seaweed!
S06	Advanced Magnetics completes enrollment for phase 3 trial of ferumoxytol IV iron.
S06	Virtually untreatable type of tuberculosis being identified worldwide
A24	FDA proposes system to systematically register and uniquely identify all drugs sold in the U.S.
A19	Spray on bacteriophages approved to control Listeria on meat; toxigenic E. Coli next on the list.
J31	Survey of FDA scientists documents political interference in drug approval process
J24	Rockwell gearing up to study efficacy of dialysis solution-based iron therapy.
J21	Fresenius to debut calcium-acetate / magnesium-carbonate phosphorus binder in Germany.
J20	New antibiotic tygecycline available in the UK to treat MRSA.
J10	Some drug metabolism / detoxification has a pronounced circadian rhythm.
J02	Cytochroma acquires Proventiv Therapeutics to commercialize new Vitamin D products for CKD market
J28	How to restrict access to your medication prescribing data
J28	Did you know that drug companies have full access to your medication prescribing data?
J20	ISMP and FDA issue medical abbreviation blacklist - QOD, IU, ug, qHS, all likely to cause errors (pdf)
J07	Congenital malformations with first-trimester ACE-inhibitor therapy.
J05	Isis Pharma gets orphan drug status for familial hypercholesterolemia drug.
J02	Heart attack risk with COX-2 broadened to include most NSAIDs
M17	Superbug slain by soil antibiotic
M15	Aspirin may protect against gentamicin-induced hearing loss.
M09	Getting rid of the furanocoumarins in grapefruit juice abolishes the juice's effects on CYP3A drug metabolism
M01	Astellas acquires rights to two new orally-active prolyl hydroxylase inhibitor drugs to treat anemia.
A26	GI hormone oxyntomodulin lowers appetite, increases activity level
A26	FDA approves first generic pravastatin.
A25	University of Michigan to pay for preventive diabetes meds for its employees.
A21	Orally available iron chelating agent desafirox shows promising results.
A20	Roche files with FDA for approval of its anemia drug CERA (continuous erythropoetin receptor activator)
A19	FDA grants priority review to Neurochem for Fibrillex - AA amyloidosis drug.
A13	FDA announces public meeting focusing on regulation of nanotechnology
M21	Nabi to resume development of Staph. vaccine.
M17	New vitamin D anticancer effects may be separable from its bone effects.
M15	Six men in monoclonal antibody drug trial critically ill.
M12	Losartan metabolite activates PPAR-gamma
M09	Nabi's NicVax (smoking cessation vaccine) given fast-track status by US FDA.
M06	Annals: Dramatic recent rise in community-acquired MRSA infections.
M03	Serotonin may play a role in hardening of the arteries.
M02	Hyperglycemia and hypoglycemia associated with use of gatifloxacin.
F24	FDA approves new antifungal drug (Eraxis) effective against serious Candida infections.
F24	Tolvaptan receives FDA fast-track approval status to treat polycystic kidney disease.
F21	Is there a way to avoid the bladder toxicity of cyclophosphamide?
F21	Alginate-encapsulated pancreatic islet cell transplants for diabetes.
F13	Neurochem submits Fibrillex to the FDA for control of AA amyloidosis
F06	Synthetic heparin could replace animal-derived drug.
F01	Nabi announces fast tracking of hepatitis C immune globulin by the FDA to prevent HCV reinfection.
J28	Baxter mourns death of William Graham, pioneer and leader in healthcare.
J28	FDA approves first ever inhaled insulin for the treatment of diabetes.
J26	FDA approves Sutent - new angiostatin treatment for metastatic kidney or stomach cancer.
J26	Aprotinin (Trasylol) linked to increased risk of kidney failure, heart attack and stroke.
J24	Alagebrium (a collagen cross-link breaker) softens arteries - and that's good for you.
J24	Archives: Chronic warfarin use increases risk of bone fracture.
J23	Annals: Liver failure and hepatitis from telithromycin.
J22	AHA review casts doubt on cardiovascular health benefits of soy-based foods.
J21	British study shows that work stress linked to both heart disease and metabolic syndrome.
J21	Medicare Part D changeover leaves some Florida patients without payments for transport to dialysis.
J19	New drug label rule intended to reduce medical errors.
J19	Study of drug resistance among bacteria found in soil can potentially guide new drug development.
J19	Commonly used antidepressants may also affect the immune system.
J19	MMWR: Type A influenza highly resistant to amantadine derivatives
J18	Rockwell Medical Technologies gets rights to market vitamin- and carnitine-supplemented dialysate.
J17	Anti-obesity drug from cannabis really works?
J16	Canadian study suggests higher mortality among diabetics treated with sulfonylurea drugs vs. metformin.
J15	Acetazolamide reduces sleep apnea severity in heart failure patients.
J15	Hypothalamus has a fatty acid sensor that may regulate food intake
J07	CJASN: Diagnostic and Therapeutic Corner: HAART and the Kidney
J07	Brain protein (p11) may play a critical role in depression.
J06	Post-marketing data detects new onset / worsening of macular edema in patients taking Avandia (rosiglitazone).
J05	MRSA patterns in ICUs changing: 64% prevalence rate, hardier, bugs, but less multi-drug resistance.
J04	FDA approves conivaptan (Varprisol) for treatment of euvolemic hyponatremia in hospitalized patients.
J04	Adenosine receptor antagonist completes phase 2 trials for congestive heart failure.
D27	Acetaminophen can cause acute liver failure when usual dose is even slightly exceeded.
D26	Dalbavancin (a vancomycin-like drug) effective in mice against anthrax.
D17	Heteropolymer antibodies - a new approach to treat and prevent? MRSA infections.
D17	CDC recommends new blood test to diagnose TB infection.
D14	Amgen buys Abgenix, maker of panitumumab (colon cancer drug).
D12	Oral endothelial receptor antagonist ambrisentan effective in pulmonary HTN.
D11	Pramexipole for restless legs syndrome in nonuremics.
D10	Encyclopedia of traditional Indian medical knowledge to be on the internet.
D03	Random testing shows high lead levels in some imported Chinese plums.
N28	Higher dose of Fosrenol (lanthanum carbonate) approved by FDA for ESRD patients.
N17	Oralyn, an oral insulin-like drug, to be launched this month in Ecuador.
N17	Tea, cinnamon, buckwheat, and cherries for diabetics.
N17	AHA: CV mortality benefits of diuretics linked to alpha-adducin genotype.
N16	AHA: Aliskiren (renin inhibitor) adds to anti-HTN effects of irbesartan.
N12	Risk-stratified analysis proposed to analyze RCTs to detect harm.
N07	AAKP info sheets on Medicare Part D drug benefit for kidney patients.
N06	More on the new FDA digital drug label submission requirement.
N06	New FDA-supported website lists latest approved drug labels for all meds.
O30	Making sense of the new Medicare Part D drug plan.
O28	FDA delays decision on approving inhalable insulin
O27	New endogenous carbohydrate (INS2) discovered that lowers blood glucose.
O26	ASN Renal Week 2005 abstracts now available on-line.
O24	Shire highlights publication of 1 and 3-year Fosrenol extension study.
O20	Tigecycline may offer promise to treat MRSA and vancomycin-resistant bacteria.
O18	RPA compiles info on Medicare D drug benefit plan on its website.
O12	New defensin-class antibiotic isolated from pine forest fungus.
O05	Generic form of amlodipine approved by the FDA
S29	JASN: Acute phosphate nephropathy following certain bowel preps.
S28	Toprol (metoprolol)/Topamax/Tegretrol look-alike names prompt FDA alert letter.
S28	Nabi sues Ohio company for patent infringement over generic calcium acetate.
S26	Genzyme could see upside if Renagel included in Medicare Part D.
S25	Genes on chromosome 2 linked to resistant hypertension.
S22	Affymax launches phase 2 study of NESA to treat anemia in European CKD patients.
S22	Pharma organization launches global clinical trials database.
S21	Nabi launches study to see if StaphVax will protect dialysis patients long-term.
S20	Novartis oral renin inhibitor aliskiren shows good results in phase III trial.
S13	Pioglitzaone improves cardiovascular outcomes in diabetics.
S11	FDA approves first glitizar-class drug for treatment of type 2 diabetes.
S09	FDA advisory panel recommends approval of inhaled insulin.
A28	Medicate part D to help cover costs for kidney patient drugs.
A25	Ten Canadian pharmacies apply for license to sell Rx drugs in Nevada.
A22	Scios announces recommended use initiative for Natrecor.
A22	Long-acting form of exenatide works in type 2 DM; Amylin shares soar.
A19	Jury awards widow 253 million in Vioxx suit against Merck.
A19	Magnetic nanoparticle MRI used to visualize inflammed pancreas in type 1 DM.
A19	Myogen announces phase 2 trial results of darusentan in resistant hypertension.
A19	Novartis trying to develop alternative phosphate binding drug.
A18	Will FDA approve diabetes-related health claims for chromium picolinate?
A16	Do clinical trial docs leak info about new drugs to stock brokers?
A16	Analgesic drug use linked to high blood pressure in women.
A16	Kidney Drug Coverage website: Teleconference schedule
A11	Following clinical guidelines in elderly can lead to polypharmacy.
A11