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Thalidomide received federal approval in May for treatment of bone-marrow cancer, marking the further rehabilitation of a drug originally banned more than 40 years ago after it caused thousands of birth defects. Multiple myeloma is the second most common blood cancer in the United States affecting approximately 50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each year and about 12,000 Americans are expected to die of multiple myeloma in 2006.
Approvals of FDA-Regulated Products: http://www.fda.gov/opacom/7approvl.html
A Quiet Revolution
A typical day in 2010 is unlikely to feel much different to today. We will probably not be teleporting breakfast or using quantum computers, nor will we be watching holographic TV or traveling to work in flying cars1. A lucky few may likely be flying to the edge of space but for the rest of us, change will probably be more subtle, with TMT advances pervading ever more deeply into our daily lives. Indeed the greater ubiquity of TMT – from the car to the classroom, the living room to the office and essentially everywhere in between is likely to be the most noticeable change. According to a DTT TMT survey undertaken for this report, people around the world will probably use a growing number of TMT products and services more often, in more locations, and for more purposes:
Extraterritorial Reach of US Patent Law
The US patent statute provides a basis for extraterritorial reach, and recent decisions of the Court of Appeals for the Federal Circuit (CAFC) have expanded and solidified that reach. In addition, the CAFC has been called upon to decide whether the US District Courts have subject matter jurisdiction over the alleged infringement of a foreign patent. Article by Koos Rasser:
Latest Amendments in the Indian IP Law
The Government of India is trying to develop a user-friendly Intellectual Property Regime to encourage innovation. (See "The Pharmaceutical Industry and the New Patent Regime in The Indian Union: http://www.vepachedu.com/AJIN/indpatregime.pdf for a review of patent law in India)
The Patent (Amendment) Rules, 2006, has prescribed new timelines for various activities by the Patent Offices, e.g., an Examiner has to be assigned within one month of a request for the examination of a patent application, the Controller has to decide on the Examiner's report within a month of its submission, the First Examination Report has to be issued within six months of the date of request for examination of the patent application, and the time for granting permission to file patents abroad has also been reduced to 21 days. Patent applications have to be published within one month after expiry of the statutory period of 18 months and, if a request for an early publication were filed, the patent application would be published within one month of the request date. Filing a request for examination extended from 36 to 48 months, a pre-grant opposition extended from 3 to 6 months, reply to pre-grant opposition extended from 1 to 3 months, meeting the requirements of the First Examination Report extended from 6 to 12 months. An attempt to decentralize the Patent Offices has been made and all patent activities can now be carried on by all the patent offices (Delhi, Mumbai, Kolkata & Chennai) and electronic payment of fees is made available. See for the Indian Government notification:
Almost since the first pill arrived in 1960, women have manipulated birth control to skip periods for events such as a wedding, vacation or sports competition. Female doctors and nurses were among the first to block menstruation long-term to suit their schedules. And many women have been getting extra prescriptions so they could continuously stay on birth control pills, the Ortho Evra patch or the vaginal ring, rather than bleeding every fourth week. The idea gained momentum after Barr Pharmaceuticals launched Seasonale in November 2003. It's a standard birth control pill taken for 12 weeks, with a break for withdrawal bleeding every three months. Pfizer Inc.'s Depo-Provera is a progestin-only contraceptive shot lasting three months, usually women are period-free after a year or two.
Wyeth is waiting to get Food and Drug Administration approval to sell Lybrel, continuous birth control pill. Approval also is pending in Canada and Europe. Also in June, FDA should decide whether to approve Implanon, a single-rod, three-year contraceptive implanted in the upper arm that maker Organon USA has been selling it in Europe for a decade. Berlex Inc. is developing its own birth control pill for menstrual suppression. Barr, aiming to be a leader in extended contraception, last November bought the maker of ParaGard, an intrauterine device that blocks periods in some women. Barr's new product Seasonique, a successor to Seasonale, likely will get federal approval at week's end. Thanks to birth control pills and other hormonal contraceptives, a growing number of women are avoiding the natural phenomenon.
Injunctions in Patent Cases in the US
The Supreme Court, in eBay Inc., et al. v. MercExchange, L.L.C.,
(see http://www.supremecourtus.gov/opinions/05pdf/05-130.pdf), held that "the decision whether to grant or deny injunctive relief rests within the equitable discretion of the district courts," and vacated the judgment of the Federal Circuit and remanded the case so that the District Court can apply the traditional test properly holding that a patent holder must satisfy the four-prong test that:
(1) it has suffered irreparable injury,
(2) remedies available at law, such as monetary damages, are inadequate to compensate for that injury,
(3) considering the balance of hardships between the patent holder and patent infringer, a remedy in equity is warranted; and
(4) the public interest would not be disserved by a permanent injunction.
Anticipation under Section 102
Solicitor General filed an Amicus Brief (http://www.orangebookblog.com/2005_2D0489.pet.ami.inv.pdf) in response to the Supreme Court's invitation in SmithKline Beecham v. Apotex, on whether a compound inherently produced by prior art is inherently anticipated under section 102 supporting the Federal Circuit decision holding that a prior art patent inherently anticipated PHC hemihydrate because "the manufacture of PHC anhydrate according to the [prior art] patent necessarily results in the production of PHC hemihydrate."
Indo-US Symposium on Nanotechnology in Advanced Drug Delivery
05 - 06 October 2006, Punjab, India
This meeting will offer an opportunity to researchers, educators and developers from academic fields and industries to share their research results and exchange ideas in Nanotechnology for Advanced Drug Delivery Technologies. This meeting will serve to demonstrate the intrinsic ability of nanotechnology to drive new paradigm shifts in healthcare. http://www.niper.gov.in/Indo-US-nanotechnologydrugdelivery.html
For other Nanotech Meetings visit:
Shortfall of Physicians in the US
The federal government predicted in May that the supply of doctors who specialize in treating critically ill patients wouldn't keep up with the demand of the country's aging population by 2020.
Carcinogenic Benzene found in Drinks in US
According to a sample of 100 drinks, the FDA found that 5 had benzene levels over the 5 parts per billion limit set for drinking water. Human consumption of benzene is linked to a higher risk of developing leukaemia.
The drinks that exceeded the limit of 5 parts per billion were:
-- AquaCal Strawberry Flavored Water Beverage
-- Crush Pineapple
-- Crystal Light Sunrise Classic Orange
-- Giant Light Cranberry Juice Cocktail
-- Safeway Select Diet Orange
If a soft drink contains Vitamin C (ascorbic acid) plus either sodium benzoate or potassium benzoate, benzene can form in it when exposed to heat and/or light.
Benzene can be found in:
-- synthetic fibers
-- within the petroleum industry
-- many other manmade products
People who work with petroleum-based solvents have to be particularly careful as they may inhale benzene vapors and seriously raise their chances of developing AML leukaemia.
Remicade for Children
Crohn's disease (CD) is a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and, in some sufferers, delayed development and stunted growth. Approximately 100,000 children under the age of 17 suffer from inflammatory bowel diseases (IBD), which include CD and ulcerative colitis (UC). The safety and efficacy of REMICADE in the treatment of IBD in adults are well established. First approved in the United States for the treatment of adult CD in 1998, REMICADE remains the only anti-tumor necrosis factor (TNF-alpha) therapy indicated for the treatment of Crohn's disease in both adults and pediatric patients. The FDA granted orphan drug designation to REMICADE for the treatment of pediatric Crohn's disease on November 12, 2003. In addition, on August 30, 2004, a REMICADE Phase 3 clinical development program for pediatric Crohn's disease was designated Fast Track by the FDA. In September of 2005, REMICADE also was approved for the treatment of UC in adults. In addition to IBD, REMICADE is approved for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. More than 700,000 patients have been treated with REMICADE worldwide. The U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy. This approval establishes REMICADE as the first and only biologic therapy approved for the treatment of pediatric Crohn's disease.
AZILECT® for Parkinson's
AZILECT® is the second product to come out of Teva Pharmaceutical Industries Ltd.'s
substantial pipeline of innovative products, which is derived largely from a close cooperation with Israeli universities and research institutes. It was approved in Europe and Israel in 2005, where it has been successfully launched. In the EU, it is now marketed in 13 countries in collaboration with Lundbeck A/S as part of a long-term strategic alliance between the two companies. The U.S. Food and Drug Administration (FDA) approved in May AZILECT® (rasagiline tablets) as a treatment for Parkinson's disease both as initial monotherapy in early Parkinson's disease patients and as adjunct therapy to levodopa in moderate-to-advanced stages of the disease.
Oracea for Rosacea
The U.S. Food & Drug Administration (FDA) has approved Oracea(TM) for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. Oracea is the first FDA-approved, orally-administered, systemically-delivered drug to treat rosacea, a dermatologic condition that affects an estimated 14 million adults in the U.S. CollaGenex Pharmaceuticals, Inc. will launch Oracea in July 2006.
FDA Approval's in May: http://www.fda.gov/cder/whatsnew.htm
Now You May Disappear
Scientists say they have learned how to hide things from normal view with special wave deflecting materials, in a project funded by the U.S. Defense Department. Researchers at Pratt and the Imperial London claim to develop an invisible cloak that would use metamaterials to guide light and electromagnetic waves around an area to be concealed. The research was published in the May 25 edition of Science Express, an online version of the journal Science. Light rays are bent when they pass between materials with different refractive indices, such as air and water. But bending light so that it passes round a region of space and emerges travelling along the same line as it was initially is a difficult trick, requiring an invisibility cloak made from materials with a 'tunable' refractive index, the so-called metamaterials. (http://www.nature.com/news/2006/060522/full/060522-18.html)
An Inconvenient Truth showcases science of climate change
An Inconvenient Truth, a feature film starring former vice-president Al Gore as Al Gore giving his PowerPoint presentation on climate change, opens in New York and Los Angeles on 24 May and elsewhere throughout the summer.
Green Chemistry: Dry Cleaning
Dry cleaning is the use of a solvent other than water to lift dirt and stains off fabrics. Most dry cleaning is accomplished with the solvent perchloroethylene (Cl2C=CCl2), considered a possible carcinogen by the Environmental Protection Agency, which runs a program to encourage the development of alternative solvents. Perchloroethylene has dominated the field in the U.S. since the late 1930s, when Dow Chemical and other manufacturers introduced it as a replacement for the odiferous and flammable hydrocarbon solvents that were then commonly used. As many as 30,000 dry cleaning establishments operate in the U.S. today. About 80% of these stores rely on perchloroethylene.
Linde, a German company, is launching a new chain of dry cleaners that will use a carbon dioxide-based washing technique (http://pubs.acs.org/cen/news/84/i22/8422notw5.html). It is converting 24 existing Hangers dry-cleaning stores to the new chain called the Fred Butler and plans 10 more stores by the end of the year.
A group of researchers at Lawrence Livermore National Laboratory (LLNL) has demonstrated experimentally (Science 2006, 312, 1034) that carbon nanotubes can act like a Slip 'n Slide for gases and water, hastening the molecules through the nanotube's channel at speeds far greater than would be expected from classical models of transport. The researchers attribute the surprisingly fast transport to the nanotube's atomically smooth surface and to molecular interactions dictated by the nanotube's confined space.
Prof. Merrifield was born in Fort Worth, Texas, on July 15, 1921, and grew up in California. He graduated from the University of California, Los Angeles, with a BA in chemistry in 1943. He stayed at UCLA and completed his Ph.D. in biochemistry in 1949. A year later, he moved to New York City to work as a research assistant at Rockefeller University, which was then known as the Rockefeller Institute of Medical Research. In 1957, Bruce became an assistant professor; by 1966, he was a full professor. He was named John D. Rockefeller Jr. Professor in 1983 and became emeritus nine years later. He won the 1984 Nobel Prize in Chemistry for a method he named solid-phase peptide synthesis. The Nobel committee that bestowed Merrifield’s prize called his method “simple and ingenious” and noted that it has greatly advanced research in biochemistry, molecular biology, pharmacology, and medicine. The Journal of the American Chemical Society listed Prof. Merrifield’s classic 1963 paper, in which he first described the solid-phase-synthesis technique, as the fifth most cited paper in the journal’s 125-year history. In 1998, C&EN named Prof. Merrifield as one of the top 75 contributors to the chemical enterprise during the magazine’s first 75 years of existence. Prof. Merrifield died on May 14 at his home in Cresskill, N.J. He was 84.
Source: The primary sources cited above, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, womenfitness.net etc.
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