A federal appeals court lifted an injunction on Maine''s (a province in USA) pioneering prescription drug law. The law, the first of its kind in USA allows the state to negotiate with drug companies for lower prices for approximately 3,25,000 residents who don''t have insurance for prescription drugs. It also allows the state to impose price controls in three years if negotiations don''t lead to steep price reductions.
The Pharmaceutical Research and Manufacturers of America, known as PhRMA, asked for the preliminary injunction, arguing that the law unconstitutionally regulates transactions outside Maine''s state borders and conflicts with federal Medicaid law. ``I am thrilled,'''' Maine Human Services Commissioner Kevin Concannon said. ``And the opinion appears to be very clear on virtually all of the arguments made by PhRMA _ the court of appeals ruled with the state.''''
Brazil to break Nelfinavir''s patent if AIDSs drug prices not reduced.
Brazil will break Nelfinavir''s patent in case Roche does not reduce the price of the drug until next July. Brazil''s plan is to produce the product, used in Aids treatment programs. At the first meeting with the Brazilian government, Roche proposed a 13% price cut, which was considered irrelevant by local authorities. In case Brazil did not produce 8 of the 12 drugs used in Aids treatment, the country would be spending more than US$1bil per year instead of the current US$320mil. Brazilian authorities discarded both importing and exporting Aids drugs.
Mystery of permanent memory revealed
For the first time, scientists have identified a protein in the brain that is required for turning short-term memories into permanent ones. Initial learning takes place in one part of the brain, the hippocampus, but these first experiences become permanent memories only after reinforcement in the brain''s outermost layer, the cortex, according to Dr. Alcino J. Silva from the University of California at Los Angeles. Until now, little was known about the processes involved in making that translation. Using sophisticated measurements of the electrical activity of the brain, the researchers showed that mice deficient in a protein called alpha-CaMKII have disruptions in the type of activity usually associated with the development of memories. ``This information will be essential to design therapies to memory disorders.''''
Altea gets two US patents in Drug Delivery Systems
Altea announced the issuance of two new patents enhancing its proprietary position in drug delivery systems. One patent, No 6,183,434, encompasses mechanical methods and devices for forming tiny openings in the skin to facilitate the delivery of a substance or withdrawal of an analyte. Another patent No. 6,173,202, encompasses delivering an enhancer to increase the flux of a substance through micropores in a tissue. Altea''s patented icroPor technology creates microscopic pores in the outermost dead layer of skin or in other tissues such as m ucosa, opening tiny pathways to access the underlying cells and microcirculation.
Altea has demonstrated delivery of physiologically relevant doses of peptides and proteins in pilot clinical studies. These studies have included insulin, parathyroid hormone (1-34), interferon, other macromolecules larger than 40,000 daltons, and small molecules such as lidocaine. This unique system enables needleless infusion of biotechnology products with delivery profiles that can be tailored as desired for different applications, e.g., a steady infusion of the drug, a bolus or pulsatile delivery, or a combination of basal plus etc.
Washington and 15 other states file a lawsuit against 4 drug mfrs
Washington and 15 other states filed a lawsuit in US District Court in Michigan alleging that four drug manufacturers illegally conspired to keep a cheaper, generic form of a widely prescribed heart medication off the market for at least a year. According to the complaint, drug manufacturers Aventis (formerly Hoechst Marion Roussel), Andrx and others manipulated laws intended to encourage competition and ease the entry of cheaper generic drugs into the market.
The states alleged that Aventis conspired with Andrx to keep a generic form of Cardizem CD -- a time release medication used to treat chest pain, high blood pressure and heart disease -- off the market. That conspiracy, the states allege, forced consumers and taxpayers to pay higher prices for the medication. In exchange for keeping the cheaper version off the market, Andrx received payments of about $100 million per year, according to the complaint. "This behavior was a clear attempt to keep the market from functioning properly and denied consumers access to a cheaper, equally effective product." Cardizem CD is one of the most widely prescribed heart medications, In 1997 alone, Cardizem earned its maker more than $700 million in sales and was the company''s largest revenue producer.
Soil microbe drug "Epothilone" fights cancer
A new cancer treatment more potent than the best-selling cancer drug taxol has produced encouraging results in its first human trials. It could give hope to patients with tumours that have become resistant to taxol. The drug, Epothilone, originally isolated from soil-dwelling micro-organisms called myxobacteria, works in the same way as taxol. Epothilone appears to be more potent than taxol, so patients do not have to take such a high concentration of the drug. It even works on cancer cells that are resistant to taxol or other treatments. Hilary Calvert, head of Newcastle University cancer research unit, and his colleagues carried out a phase I clinical trial involving 36 patients. The disease was halted in about half of the patients, and in five of them, the tumour shrank. . The researchers will use the results of the trial to work out which is the best dose to use, and they hope to start the next phase of trials within months. The drug used in the trial was developed by Novartis. But another version of epothilone has been developed by Bristol Myers Squibb.
New cholesterol guidelines
Guidelines for managing cholesterol got broader. The National Institutes of Health are now recommending more aggressive treatment of high cholesterol in people at risk for heart disease. The new NIH guidelines extend the list of people considered to be at risk for heart disease to include those with diabetes and metabolic syndrome (a combination of obesity, high blood pressure and other conditions Standards for acceptable cholesterol levels change under the new guidelines.The NIH says doctors should consider an optimal level of low-density lipoprotein (LDL, or"bad" cholesterol) to be less than 100 mg per deciliter. For high-density lipoprotein (HDL, or "good" cholesterol), levels should be at least 40 mg/dL. Exercise, losing excess weight and dietary improvements remain the most important lifestyle changes recommended to maintain healthy cholesterol levels, the NIH says.
ANDA for Methylphenidate Extended Release 20 mg tablets, a $100 mio product
Food and Drug Administration approved Abbreviated New Drug Application (ANDA) for Methylphenidate Extended Release 20 mg tablets. The approval followed the FDA''s Division of Bioequivalence''s determination that Able''s Methylphenidate Hydrochloride Extended Release Tablets USP, 20 mg, are bioequivalent and, therefore, therapeutically equivalent to the Ritalin-SR(R) 20 mg Tablets of Novartis Pharmaceutical Corporation. The generic market for DynaGen''s newly approved drug is estimated to be $100 million" DynaGen filed its ANDA for Methylphenidate Extended Release 20 mg tablets in November 2000.
Natural Cox -2 pain reliever to be the ingredient of dietary supplement
Next Pharmaceuticals, USA, has entered into an agreement with Natrol , California, to featur its natural, patent-pending selective COX-2 inhibitor Nexrutine in Natrol''s natural pain management formula called Flexanew. The COX-2 enzyme plays a role in inflammation and accompanying pain. Nexrutine has been shown to selectively inhibit this enzyme without any inhibition of COX-1, a stomach-protecting enzyme. "With Natrol leading the way in the natural pain management category, the company expects Nexrutine to become a major dietary supplement ingredient and natural alternative for people concerned about the potential side effects of OTC anti-inflammatory/pain products."
Compiled from WWW by Dr. Venkat Appaji Padmanabhunie-mail : appajipv@hotmail.com