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Contents
Malaria Vaccine Cheaper Female Condom Bailout for Biotech Biosimilars New Drug Test Stem Cells to Help Drug Development Glaxo to buy BMS in Pakistan Prozac for Cancer Therapy Cholinesterase Inhibitors Trilipix Indian Pharmaceutical & Biotech Industry Test for Patentability of Process Claims Patent Practitioner’s Professional Responsibility Generics in US get Cheaper Whooping Cough Vaccine Suicide Warning for Epilepsy Drugs Malaria Vaccine An experimental malaria vaccine is the most promising yet, protecting up to 65 percent of infants from infection in two studies in Africa, researchers reported in the New England Journal of Medicine. While the vaccine is far from perfect, it is the best yet against the mosquito-borne parasite, the researchers agreed. They said they would begin phase III clinical tests, the last stage before seeking regulatory approval, next year. The World Health Organization estimates malaria killed 881,000 people and infected 247 million worldwide in 2006. Some malaria experts say those numbers underestimate the problem. Cheaper Female Condom A new, potentially less expensive version of the female condom is being reviewed by U.S. regulatory when a Food and Drug Administration advisory panel weighs whether they adequately prevent pregnancy, HIV and other sexually transmitted diseases. The FC2 Female Condom, made by Female Health Co, is made with a synthetic rubber using a process similar to male condoms that the company says is less labor intensive and should reduce its current cost. Male condoms, which come in a variety of brands and cost consumers between 50 cents and $2 a piece, are far more widely used than their female counterpart, which costs between $2.80 and $4. Chicago-based Female Health is seeking FDA approval to market the new version. FDA approval could help boost sales in the United States, which make up just 10 percent of the female condom's 34.7 million unit sales in 2008, according to Female Health Co. The female version gives women their own option for protection and allows them to insert a condom before intercourse. Most other countries have already adopted the newer version, the company has said. It also offers other advantages over the male condom, according to the company, including greater protection by covering part of a woman's outer genitals. Bailout for Biotech Representatives from the U.S. biotech industry traveled to Congress to seek a government bailout. Industry execs led by BIO want to exchange future tax credits from future profits in exchange for cash now to support research and development. It could add up to only few hundreds of millions, but not billions of dollars as is the case with auto and financial sectors. The appeal comes at a time that small and medium-sized biotechs are running out of cash, fresh funds are hard to come by, and as the daily carnage continues unabated as developers shed workers and programs in a desperate attempt to stay afloat. In fact, it’s so bad that BIO, the main lobbyist for the industry, is saying that a quarter of the 370 publicly traded U.S. biotech companies have less than six months of cash on hand. And, of course, creating an effective drug can take billions of dollars and decades to accomplish. Not to mention that, if clinical trials go badly, it’s back to the drawing board, making biotech one of the riskiest industries out there. And risk is not something lawmakers are loving these days. Still, the potential health benefits of the drugs biotechs produce are massive, and we do have that whole aging population and health care crisis to contend with. So if we’re already writing $850 billion checks, we may as well throw a little biotech’s way. Biosimilars While making copies of biologic medicines available is not yet possible under U.S. law, President-elect Barack Obama supports biosimilars and Congress is expected to debate next year how to establish a regulatory pathway to get such products on the market. Drugmakers are struggling to find new sources of revenue as regulators approve fewer medicines and patents expire on best-selling products. Merck, based in Whitehouse Station, New Jersey, earlier this month said it will start a new division to copy products based on living proteins and enzymes instead of chemicals. Indianapolis-based Eli Lilly said this month it would also explore making copies of biologics that have lost patent protection. Novartis AG’s generic-drug unit-- Sandoz unit-- two years ago became the first company to have a biosimilar product approved: the growth hormone Omnitrope. The European Commission last August cleared Novartis’s anemia drug that is similar to Johnson & Johnson’s Eprex and Amgen’s Epogen. AstraZeneca is joining the club. Biologic drugs became a key focus for AstraZeneca after the company paid $15.2 billion in cash for MedImmune Inc. in 2007. Biosimilar competition is led by generic companies such as Teva Pharmaceutical Industries Ltd. And Novartis. New Drug Test An international team of scientists has introduced a breakthrough in the use of polymer research that will make it easier to detect drug use and promote faster and more efficient medicines, which was published in the December edition of the Royal Society of Chemistry (RSC) Journal. A polymer is placed onto an electrical probe to detect molecules in the blood. The probe would then send a signal indicating the presence of the drug, allowing the results to be accessed almost instantaneously. The technology will also enable medicines to be directed to specific areas of the body, increasing their effectiveness and reducing side effects. It could take another five to 10 years for the technology to be widely available. Pfizer Gets Trouble over Bextra A Santa Clara County jury ordered Pfizer to pay $38 million to a leading San Bruno medical research firm for stealing trade secrets to develop a pain relief drug that eventually was taken off the market. Concluding a six-week trial, the Superior Court jury also found that Pfizer and a former employee of the research firm could be liable for punitive damages, which could triple the judgment and catapult the verdict beyond $100 million. Judge Gregory Ward, who presided over the trial, will eventually decide the punitive damage amount. The hefty damage award stems from a lawsuit filed by Dr. Dennis Mangano, head of the nonprofit Ischemia Research and Education Foundation, an outfit that has gained national attention in recent years for studies on the risks posed by certain medications during heart bypass surgery. The lawsuit alleged that Pfizer approached the foundation in 2002 to use its renowned database in clinical trials on Bextra, a potential blockbuster drug to treat acute pain caused by arthritis and other maladies. Mangano's data on cardiovascular issues was considered crucial because of concerns the drug might pose heart risks; in fact, Bextra was eventually pulled from the market as a result of those concerns. But according to court documents, Pfizer and the foundation could not agree on terms for use of the database. The lawsuit alleged that Pfizer arranged a side contract with Hsu, a lead statistician who provided the data without approval. The lawsuit further alleged that Pfizer and Hsu destroyed evidence when confronted about stealing the trade secrets, a centerpiece of the trial. Stem Cells to Help Drug Development Drug development is an incredibly expensive and protracted process. Typically, it costs around $1 billion to bring a new drug to market and the whole process usually takes about ten years. Before new drugs can go forward for clinical trials, it's necessary for the chemical compounds which make up a drug to undergo thousands of tests for toxicity before beginning trials on animals -- initially on rodents and then often on dogs. It's here, at this ethically sensitive and very expensive stage, that Professor Mummery believes stem cell research could transform drug development. Stem cell based drug testing is already being promoted in the UK with the public/private initiative "Stem Cells for Safer Medicine" which was set up in 2007. A 2007 sabbatical at the Harvard Stem Cell Institute in Cambridge, Massachusetts gave Mummery first-hand experience of the ethical debates that have engulfed stem cell research debates in the U.S. "I was shocked at the light years we are away from the way people think about embryonic stem cells in the States," she said. "It's very mixed up with the abortion issue. It's put into the same category." "You go into a lab in the States and they say; 'this is our NIH lab, and this is our other lab'. They have to buy one microscope to look at NIH lines and another to look at other lines. They have to administer all the stem cells separately. There are even dotted lines in a lab which you can and cannot cross. It's completely ridiculous," she said. In addition to public outdated thinking, lack of public funding under President George W. Bush has also stymied research in the US. http://www.cnn.com/2008/HEALTH/12/22/stem.cell.drug.tests/ Glaxo to buy BMS in Pakistan Glaxo, like many big pharmaceutical companies, faces a slowing pipeline of drugs from its R&D efforts as well as increased competition from generic drugmakers. In response, continuing a small buying spree in emerging markets, Glaxo has agreed to pick up Bristol-Myers Squibb's Pakistani business for about $36.5 million. Glaxo says it will acquire a portfolio of more than 30 pharmaceutical brands, including antibiotics, vitamins and dermatology products. Total sales of the portfolio in 2007 were about $19 million. Already this year, GSK has purchased a portfolio of drugs from Bristol-Myers Squibb in Egypt. The company also announced a drug commercialization deal with the South African pharmaceutical company Aspen. GlaxoSmithKline, which has headquarters in London, employs more than 5,000 people in Research Triangle. Prozac for Cancer Therapy In animal models, a mild doxorubicin-fluoxetine treatment combination slowed down tumor progression significantly. These results suggest that pairing Prozac with chemotherapeutic drugs to curb drug resistance warrants further clinical study, says Dr. Peer. His research was published in Cancer Letters, and his suggestions are now listed as recommendations in the latest version of Cancer Encyclopedia. . Cholinesterase Inhibitors According to U.S. researchers, a review of nine studies that examined the effectiveness of three popular cholinesterase inhibitors in managing Alzheimer's patients' behavioral and psychological symptoms, found the drugs were effective at the same dosage used to improve cognitive impairment. The study was published in the December issue of Clinical Interventions in Aging. About 90 percent of Alzheimer's patients have behavioral and psychological symptoms. Cholinesterase inhibitors boost levels of a brain chemical called acetylcholine, which assists memory, thought and judgment. Trilipix The U.S. Food and Drug Administration (FDA) approved Abbott's TRILIPIX(TM) (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. TRILIPIX is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. TRILIPIX has not been shown to prevent heart disease or heart attack. Indian Pharmaceutical & Biotech Industry The then Indian Prime Minister Narasimharao Pamulaparti (PVN Rao) opened the Indian economy and started dismantling the license Raj in early 1990s, which had the most significant impact in the area of pharmaceuticals and computer industries. With the new regime and India's Patents (Amendment) Act 2005, the $8 billion Indian pharmaceutical industry has been forced to adapt and recast its business models. The introduction of product patents has provided a reason to start domestic research programs. The pharmaceutical industry has unprecedented opportunities for both foreign and local companies as India remains the second fastest growing emerging economy in the world and pharmaceuticals remain one of the strong sectors of growth. In December 2008, Union Minister of Science and Technology Kapil Sibal announced 20 more biotech parks to be set up throughout the country for promoting research in the field of life sciences. At present, besides Lucknow, there are only three "functional" biotech parks at Hyderabad, Pune and in Punjab. In order to produce "high quality human resource", an agreement would be signed with the Welcome Trust of Britain. The Department of Biotechnology (DBT) will form a 10-year pact with the Welcome Trust for ensuring high quality human resource, which is one of the key elements for scientific leadership. In addition, a regional UNESCO centre would come up in Faridabad in Haryana to help bring academia, industrialists and government officials on a common platform for promoting utility-based research. Expressing concern over the shortage of the number and quality of human resource needed to take the biotechnology revolution forward, Sibal called the scientists to undertake research projects for countering diseases that are considered a "burden for the poor", food security, new varieties of crops, vaccines, and to mitigate industrial pollution. An investment of Rs 15 crore (~ USD 3 million) has been made into the Lucknow Park, which is nothing compared to what biotech industry elsewhere in the world is investing. Cost of developing a new drug is more than USD 1 billion and cost of developing a biologic is even more. Perhaps, the Indian politician forgets that the scientists are not sages living in ashrams in forests, but are professionals who need to be paid for their work and expensive research facilities. The Lucknow Biotech Park is a joint venture of the central and the state governments, with assistance from the Council of Scientific and Industrial Research (CSIR) and the Indian Institute of Technology (IIT), Kanpur, and some other educational institutions and industries. Although set up in 2002, the Lucknow Biotech Park was officially inaugurated in December 2008. This, of course, shows the Indian government’s interest in such projects. Poor people can only hope and vote! Test for Patentability of Process Claims The Federal Circuit in In re Bilski explained that subject matter eligibility is a threshold determination for patentability separate from novelty or non-obviousness. The inquiry begins with determining whether a claim falls into one or more categories of invention listed in § 101: process, machine, article of manufacture or composition of matter. Under the Federal Circuit's previous precedents, including State Street, if a claim fell into one of the four broad categories, it was deemed patentable subject matter unless it fell under one of several exceptions defined by the Supreme Court: laws of nature, natural phenomena and abstract ideas. The Court rejected the State Street test as "inadequate." Under Bilski, "[a] claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." http://www.patentlyo.com/patent/2008/10/in-re-bilski.html http://www.mondaq.com/article.asp?articleid=70794&email_access=on http://www.patentlyo.com/patent/2008/11/ex-parte-hallig.html Patent Practitioner’s Professional Responsibility According to Mr. Moatz, the primary complaints that he receives against patent practitioners: Neglect. Lack of candor (Either to client or the PTO). Failure to make reasonably inquiry. Failure or delay in filing application Failure to respond to OA (even when client has not paid) Misuse of the certificate of mailing Insufficient funds Failure to pay issue fee Failure to revive Failure to turn over files to new attorney Failure to communicate with client Additional reasons for ethical sanction include DUIs; unauthorized taking of prescription meds; and disbarment. http://www.patentlyo.com/patent/law/moatz08.pdf Generics in US get Cheaper American consumers and health insurers saved about $1 billion on generic drugs this year as “fierce” competition among drugmakers and pressure from insurers lowered prices. Total spending on drugs from Teva Pharmaceutical Industries Ltd., Mylan Inc. and other generic-drug makers fell 2.7 percent to $33 billion in the 12 months ended in September, the biggest decline in at least a decade, the health research firm IMS Health Inc. said in a report today. The average price manufacturers charged wholesalers for the copycat pills fell 8 percent while demand increased 5.4 percent, IMS said. The surge in use was driven by a flood of new generic drugs that entered the market this year after patents expired on $16 billion worth of medicines. At the same time, insurers and retail pharmacies are pressuring generics makers to cut prices as they compete against each other. The trends are likely to accelerate through 2012 as half the current 20 top-selling pills get competition from generic copies, which can cost 70 percent less than their brand-name counterparts. In addition, Wal-Mart Stores Inc., the world’s largest retailer, two years ago began selling prescriptions for more than 300 generic drugs for $4 a month. Target Corp., the second-largest U.S. discount retailer, and Safeway Inc., the third-largest U.S. supermarket chain, later followed. Wal-Mart this year reduced the price to $10 for a three-month supply. Whooping Cough Vaccine Whooping cough, also known as pertussis, is a serious and highly contagious respiratory disease characterized by severe coughing fits. Whooping cough may lead to complications such as pneumonia or rib fracture in adolescents and adults. The illness may last for more than 100 days and can lead to lost time at work or school. Babies who have not received all of their shots for whooping cough are at risk of catching the illness. Preteens, teens and adults are often the source of infection for infants. Whooping cough starts off like the common cold, and may include symptoms such as a runny nose, sneezing, mild fever and severe coughing fits. While more than 3,500 cases of whooping cough were reported in U.S. adults ages 20 years and older in 2007, many more cases may go unreported. In fact, it is estimated that over 600,000 cases occur in adults annually. According to the CDC's 2007 National Immunization Survey, an estimated 98 percent of adults aged 18-64 years reported that they have not received the whooping cough booster shot. The U.S. Food and Drug Administration (FDA) has approved GlaxoSmithKline’s BOOSTRIX® [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 19-64 years of age. BOOSTRIX offers protection against tetanus, diphtheria and pertussis (whooping cough) to individuals 10-64 years of age -- the broadest age range for any Tdap vaccine. BOOSTRIX was previously approved as a booster vaccine for preteens and teens. Whooping cough is a highly contagious respiratory disease that can be prevented through vaccination, yet most adolescents and adults have not received the recommended booster shot, according to the Centers for Disease Control and Prevention (CDC). About one in 10 doctors who vaccinate privately insured children are considering dropping that service largely because they are losing money when they do it, according to a new survey. Suicide Warning for Epilepsy Drugs Epilepsy drugs will now carry a warning about an increased risk of suicide among people taking them. The Food and Drug Administration announced the warning this week for 21 medications, citing a slightly higher risk for suicide among people taking epilepsy drugs versus placebos. Manufacturers now will be required to distribute pamphlets describing the risks for patients. The FDA advises monitoring of all patients taking the medications for changes in behavior that could indicate suicidal thoughts or behavior or depression. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, CNN, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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