Showing posts with label Articles. Show all posts
Showing posts with label Articles. Show all posts

Tuesday, 17 February 2009

Patent Data Value

CI Article

United Kingdon - Intellectual Property Organization have published an article on "Unlocking value of the patent" last year (2008).

The article titled "Unlocking the value of patent data: Patent Informatics services at the UK Intellectual Property Office (UK-IPO)".

Abstract: "The UK-IPO has expanded its range of non-statutory services to include Patent Informatics: the macroscopic analysis of patent data to derive technical information. This article describes the genesis of Patent Informatics at the UK-IPO in line with Government strategy and the potential applications of Patent Informatics including informing policy decision making, horizon-scanning and responding to technology sector enquiries. Patent Informatics is a flexible technique for mining patent data; examples graphically presented include e-paper patent filings over time and a carbon capture and storage technology landscape map. Reference is made to other Patent Informatics work under taken by the UK-IPO and covers the databases, analysis tools and methodology employed. The article concludes that in a knowledge driven economy, unlocking technical information from patent data through Patent Informatics enhances Government and industry strategy, innovation and success."

Source: ScienceDirect

Patents Vs Patenting

An interesting article titled "Patents versus patenting: implications of intellectual property protection for biological research", published in Nature Biotechnology.
The article is based on a new survey showing scientists considering the proliferation of intellectual property protection to have a strongly negative effect on research. Thus, reflecting the current scenario in the patenting system and the controveries & concerns in the U.S.

The article eloberates the survey methodology and detailed various areas including impact fo IP protection, cost of formal agreements, influence of patent ownership, influence of research delays, etc. and finally concludes that "The agricultural biologists we surveyed report that the IP protection of research tools is, on balance, having a negative impact on their research areas."

Article Details
PMID: 19131994
Author: Lei Z, Juneja R, Wright BD.
Source: Nature; Pubmed

Saturday, 9 August 2008

Stem Cells and Patent Dispute in US

Stem cells are cells which have potential to develop into any any kind of cell in the body, in technical term they are characterized by the ability to renew themselves through mitotic cell division and ability to differentiate into diverse range of specilized cell types.

The Wisconsin Alumni Research Foundation (WARF) is the non profit technology transfer office of the University of Wisconsin-Madison, and involved in stem cell research and holds many patents on stem cells. WARF gains income by licensing patented technology to many companies in US and worldwide. WARF holds significant patents on human embryonic stem cells the patents are U.S. Patent Nos. 5,843,780 (claiming primate embryonic stem (pES) cells); 6,200,806 (claiming human embryonic stem cell (hES) cells); and 7,029,913 (hES)

The request for re examination was made by nonprofit organisation the Foundation Taxpayer and Consumer Rights (FTCR) and the Public Patent Foundation (PUBPAT) saying that the work done by university researchers are obivious and works are non-patentable and also impeding scientific progress.
On march 2007, The patents, US Pat. Nos. 5,843,780, 6,200,806, and 7,029,913, cover all embryonic stem cell research in the U.S. The USPTO granted each of the requests in September 2006 and rejected all claims of each of the patents .
In recent decision on re-examination of '913 patent, USPTO has amended claim to narrow down the scope of claim.
For Further reading:
1.http://en.wikipedia.org/wiki/Stem_cell
2.http://en.wikipedia.org/wiki/Wisconsin_Alumni_Research_Foundation
3.http://www.pubpat.org/warfstemcell.htm
4. http://patentbaristas.com/archives/2007/04/03/warf-stem-cell-patents-knocked-down-in-round-one/
5. http://patentdocs.typepad.com/patent_docs/2007/04/warf_stem_cell_.html
6. http://patentbaristas.com/archives/2008/03/03/ding-warf-wins-round-2-as-stem-cell-patent-upheld/
7. www.stemcellpatents.com

Drug Approval Process in US/ EU

In this post, i write about process by which drug approvals are made in big markets like US and Europe. The drugs are being developed over many years and have to cross many barriers to get marketed.
There are regulatory Authorities to regulate drug market to ensure safety and effectiveness of marketed drug.
IN US, Food and Drug Administration (FDA)
IN EU, European agency for the Evaluation of Medicinal products (EMEA)

In brief, key stages of drug development
1. Preclinical studies: to establish drug's merit to progress into clinical trials and it includes animal studies and API related studies and formulation (Tablet, capsule in small scale) Investigational new drug (IND) submitted to FDA CDER and FDA checks preclinical studies are perfomed whether in compliance with GLP or not, when clinical trial commences CDER start to monitor the trial.
2. Phase I: conducted with small group of people, to establish merits to progress into patients trials, for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
3. Phase II: conducted in larger group people, to further evaluate safety
4. Phase III: to provide pivotal trial evidence to prove safety and efficacy and FDA uses this data to decide whether to approve or not.
At the end of Phase III, Innovator/sponsor submit New drug application (NDA) FDA CDER checks and concludes the safety and efficacy established in clinical trials

Brief explanation of how process happeans
(Available at
http://www.fda.gov/cder/handbook/develop.htm)
The NDA is evaluated based on the safety and efficacy established in clinical trials and scientifc dats. and Phase IV, this post marketing studies to access the drug's safety, effectiveness and monitored for unexpected health risks. CDER could put hold at any stage in this development cycle.
The above mentioned processes are when new drugs investigated for marketing approval and what is generic drugs? the generic drug applications are called Abbreviated New drug application (ANDA), No need to establish clinical trial data (safety and efficacy) generic drug manufacturers, generic drugs could enter the market after patent protection on formulation/product expired.
Orange book is FDA CDER's listing of approved products and corresponding patent protection, generic drug applications (ANDA) are evaluated for their bioequivalency with innovator/Sponsor product.
ANDA: FDA approved generic based on
1. contains same active agent as an approved (reference listed drug product)
2. should be identical dose, strength and route of administration
3. have same use/ indications
4. be bioequivalent
ANDA applicant has to file ANDA with any of one or more certifications for patent(s) listed in Orange Book (OB)
paragraph I ceritification: No patent information found in OB for which ANDA submitted,
Paragraph II certification: Listed patents are expired for which ANDA submitted,
Paragraph III: to seek approval after listed patent expiry
Paragraph IV: to challenge listed patent, saying Patent(s) listed are invalid, will not infringe to manufacture, use and sale.
Exclusivity:
Exclusivities are to protect the interest and benefit the innovator or generic applicants
Innovator's:
New Chemical entity: 5 years for first time approval of new chemical molecule
pediatric exclusivity: 6 months added to patent lifetime or existing exclusivity, but it will not stand alone.
3 years exclusivity for any significant changes, if new clinical studies conducted by innovator/ sponsor for new indication/dose etc.
generic applicant:
180 day's exclusivity: On filing ANDA with para IV certification and challenging innovator patent(s) listed in OB. First ANDA filing will get 180 days exclusivity on challenging and wining the case. it prevents other generic players from approval.
In EU, Drug approval process is regulated by European agency for the Evaluation of Medicinal products (EMEA), this agency give marketing authorization (MA) in european union (EU) member countries to market drug products. This is called centralized procedure.
In decentralized procedure/ Mutual reconization procedure: This applies to conventional drugs. Applications are made to individual member states selected by applicant.
In EU, two steps to get marketing Authorization,
1. Clinical trial Application
2. marketing Authorization Application (MAA)
Clinical trial Applications are approved in member state level and MAA approved at centralized level. Innovator/Sponsor submit clinical trial application in each member state where trials are to be conducted. In UK clinical trila applications are to be submited to medicine control agency (MCA).
Upon sucessful completion of clinical trials, MAA is to be submitted to EMEA in centralized procedure, four different MAAs are there, it depends on type of medicinal product.
In Mutual regonization procedure, if Once drug approved by any one member state, it is eligible to file MAA in other EU member states through Mutual regonization procedure.
Reference:
1. Drugs from discovery to approval by Rick Ng, PhD, published by John Wiley & Sons, Inc (2004)
2. Pharmaceutical project management 2nd edition, edited by Tony Kennedy
3. generic drug product development, leon shargel and Isadore Kanfer, Marcel Dekker (2005)
4.
http://www.fda.gov/cder/about/smallbiz/generic_exclusivity.htm (Accessed 9th Aug 2008)
5.
http://clinicaltrials.gov/ct2/info/understand (Accessed 9th Aug 2008)
6.
http://www.fda.gov/cder/handbook/develop.htm (Accessed 9th Aug 2008)
Today i got interest to write many things on drug approval, snice i read first two books listed in reference. Please write comment on mistakes i made.

Thursday, 17 April 2008

Spirulina - a collection

Introduction to Spirulina:

Spirulina is a blue-green algae. It is a simple, one-celled form of algae that thrives in warm, alkaline fresh-water bodies. The name "spirulina" is derived from the Latin word for "helix" or "spiral"; denoting the physical configuration of the organism when it forms swirling, microscopic strands.

Spirulina is being developed as the "food of the future" because of its amazing ability to synthesize high-quality concentrated food more efficiently than any other algae. Most notably, Spirulina is 65 to 71 percent complete protein, with all essential amino acids in perfect balance. In comparison, beef is only 22 percent protein.

Spirulina has a photosynthetic conversion rate of 8 to 10 percent, compared to only 3 percent in such land-growing plants as soybeans.

In addition, Spirulina is one of the few plant sources of vitamin B12, usually found only in animal tissues. A teaspoon of Spirulina supplies 21/2 times the Recommended Daily Allowance of vitamin B12 and contains over twice the amount of this vitamin found in an equivalent serving of liver.

Spirulina also provides high concentrations of many other nutrients - amino acids, chelated minerals, pigmentations, rhamnose sugars (complex natural plant sugars), trace elements, enzymes - that are in an easily assimilable form.

Even though it is single-celled, Spirulina is relatively large, attaining sizes of 0.5 millimeters in length. This is about 100 times the size of most other algae, which makes some individual Spirulina cells visible to the naked eye. Furthermore, the prolific reproductive capacity of the cells and their proclivity to adhere in colonies makes Spirulina a large and easily gathered plant mass.

The algae are differentiated according to predominating colorations, and are divided into blue-green, green, red and brown. Spirulina is one of the blue-green algae due to the presence of both chlorophyll (green) and phycocyanin (blue) pigments in its cellular structure.

Even though Spirulina is distantly related to the kelp algae, it is not a sea plant. However, the fresh-water ponds and lakes it favors are notably more saline - in the range of 8 to 11 pH than ordinary lakes and cannot sustain any other forms of microorganisms. In addition, Spirulina thrives in very warm waters of 32 to 45 degrees C (approximately 85 to 112 degrees F), and has even survived in temperatures of 60 degrees C (140 degrees F)

Certain desert-adapted species will survive when their pond habitats evaporate in the intense sun, drying to a dormant state on rocks as hot as 70 degrees Centigrade (160 degrees F). In this dormant condition, the naturally blue-green algae turns a frosted white and develops a sweet flavor as its 71 percent protein structure is transformed into polysaccharide sugars by the heat.
Some scientists speculate that the "manna" of the wandering Israelites, which appeared miraculously on rocks following a devastating dry spell and was described as tasting "like wafers made with hone" may have been a form of dried, dormant Spirulina.

This ability of Spirulina to grow in hot and alkaline environments ensures its hygienic status, as no other organisms can survive to pollute the waters in which this algae thrives. Unlike the stereotypical association of microorganisms with "germs" and "scum", Spirulina is in fact one of the cleanest, most naturally sterile foods found in nature.

Its adaptation to heat also assures that Spirulina retains its nutritional value when subject to high temperatures during processing and shelf storage, unlike many plant foods that rapidly deteriorate at high temperatures.

Spirulina is also unusual among algae because it is a "nuclear plant" meaning it is on the developmental cusp between plants and animals. It is considered somewhat above plants because it does not have the hard cellulose membranes characteristic of plant cells, nor does it have a well-defined nucleus. Yet its metabolic system is based on photosynthesis, a process of direct food energy production utilizing sunlight and chlorophyll, which is typical of plant life forms.

In essence, Spirulina straddles that fork in evolutionary development when the plant and animal kingdoms differentiated. Thus it embodies the simplest form of life. In contrast, other algae such as Chlorella have developed the hard indigestible walls characteristic of plants.
Source: http://www.naturalways.com/spirul1.htm


General Information on Spirulina:

This tiny aquatic plant offers 60% all-vegetable protein, essential vitamins and phytonutrients such as the antioxidant beta carotene, the rare essential fatty acid GLA, sulfolipids, glycolipids and polysaccharides.

Its deep green color comes from its rainbow of natural pigments - chlorophyll (green), phycocyanin (blue) and carotenoids (orange) - that harvest the sun's energy. Easy-to-digest so nutrients are absorbed quickly.

World's highest beta carotene food reduces long term health risks.Spirulina beta carotene is ten times more concentrated than carrots. So even if you don't eat the recommended 4 to 9 servings of fruits and vegetables every day (most people eat only 1-2, including french fries), get your natural beta carotene insurance from spirulina to help support your body's defenses.

60% easy-to-digest vegetable protein without the fat and cholesterol of meat.People are eating less meat and dairy protein because they want to lower fat, cholesterol, and chemicals in their diet. Spirulina is the highest protein food with all the essential amino acids and has only a few calories to keep your waistline where you want it.

A rare essential fatty acid is a key to health.Gamma-linolenic acid (GLA) in mother's milk helps develop healthy babies. Studies show nutritional deficiencies can block GLA production in your body, so a good dietary source of GLA can be important. Spirulina is the only other whole food with GLA.

Iron for women and children's health.Iron is essential to build a strong system, yet is the most common mineral deficiency. Spirulina is rich in iron, magnesium and trace minerals, and is easier to absorb than iron supplements.

High in Vitamin B-12 and B Complex.Spirulina is the highest source of B-12, essential for healthy nerves and tissue, especially for vegetarians.

Unusual phytonutrients for health and cleansing.Scientists are discovering the benefits of polysaccharides, sulfolipids & glycolipids, and the rainbow of natural pigments that give spirulina a deep green color. Green (chlorophyll), blue (phycocyanin) and orange (carotenoids) colors collect the sun's energy and power growth. Chlorophyll is a natural cleanser and is often referred to as nature's green magic.

Source: http://www.spirulina.com/SPBSpirulina.html


Spirulina Uses and Pharmacology

Clinical trials have investigated spirulina's potential but have failed to indicate any consistent effects.

Allergic rhinitis and asthma
Despite experimental data suggesting that C-phycocyanin can selectively inhibit release of histamine from mast cells and prevent increases in immunoglobulin E, studies demonstrating clinical efficacy are inadequate. A small study in patients with mild to moderate asthma suggested that spirulina supplementation (1 g/day) produced improvement in lung function parameters, while a study evaluating spirulina in allergic rhinitis suggested a positive effect on laboratory values but no clinical outcomes were reported.

Antimicrobial activity
Spirulina and its extracts have been evaluated for antiviral activity. One in vitro study found that calcium spirulan extract interfered with replication of several enveloped viruses, including herpes simplex, cytomegalovirus, mumps and measles viruses, influenza A virus, and HIV-1, while another study described a slightly different range of viruses susceptible to the extract. HIV-1 adsorption and penetration were inhibited by an aqueous extract of spirulina, while a crude hot water extract reduced HIV-1 replication. This type of in vitro activity is common to acidic polysaccharides from a variety of sources. Enterovirus is also susceptible to spirulina. Spirulina demonstrated some in vitro activity against common human bacterial pathogens, but less than the standard comparator.

Cancer
C-phycocyanin showed a dose-dependent inhibition of HeLa and human chronic myeloid leukemia cell growth and proliferation in in vitro experiments. Induction of apoptosis was considered to be one of the mechanisms involved. Survival rates increased in mice with liver cancer treated with C-phycocyanin, and tumor regression has been reported in animals with oral cancer. Spirulina induced lesion regression in tobacco chewers with oral leukoplakia in a study conducted in India.

Diabetes
Two small studies have investigated the effects of spirulina supplementation in type 2 diabetes, with improvement noted in fasting blood sugar and lipid profiles. Suggested mechanisms of action include hypoglycemia caused by fiber content or possible insulin-stimulating action of peptides and polypeptides of spirulina proteins. The actions on lipids have been attributed to gamma linolenic acid content.

Dietary supplement
Spirulina, considered a food item for centuries in many countries, is now popularly thought of as a dietary supplement. Spirulina consumption was purported to aid in weight loss because of its high phenylalanine content, but a Food and Drug Administration review found no evidence to support this claim. Suggestions that spirulina is a valuable source of vitamin B 12 have been similarly disputed.

A study of spirulina supplementation for 8 weeks demonstrated clinical improvement in weight gain and increased hemoglobin levels in malnourished children in the West African nation of Burkina Faso. Similar results have been demonstrated among children who are HIV-positive.

Hyperlipidemia
Experiments in rats suggest that C-phycocyanin exhibits hypercholesterolemic action. Two small clinical studies have examined the role of spirulina in hyperlipidemia secondary to nephrotic syndrome. Both populations showed an improved lipid profile with spirulina supplementation; however, the control group in 1 experiment also showed improvement. The gamma linolenic acid content of spirulina may have played a role in the mechanism of action.

Immune system effects
In vitro and animal experiments suggest that spirulina and its extracts might be immunostimulatory. Activation of monocytes and macrophages, as well as augmentation of interleukin and interferon production, have also been demonstrated. A clinical study in healthy men found that oral administration of spirulina for 3 months resulted in enhanced interferon production and natural killer cell capacity. The clinical importance of these effects has not been determined.

Other uses
In a small, randomized, placebo-controlled trial, spirulina plus zinc increased urinary excretion of arsenic and decreased arsenic hair-content in people with chronic exposure to arsenic.
C-phycocyanin inhibited platelet aggregation in in vitro experiments. In mice with chemically-induced arthritis, phycocyanin exerted a scavenging action against reactive oxygen species and anti-inflammatory activity.

A 5% spirulina-supplemented diet prevented fatty liver in rats. Spirulina decreased cisplatin-induced nephrotoxicity in rats, an effect attributed to an antioxidant action. Other studies suggest that spirulina is an antioxidant, but clinical importance has not been demonstrated. Spirulina also has been reported to reduce gastric secretory activity and protect mouse and human bone marrow cells against gamma radiation.
Dosage

There is insufficient clinical data to guide dosing of spirulina for therapeutic effect. Spirulina has typically been studied in daily dosage of 1 to 10 g.

Pregnancy/Lactation
Information regarding safety and efficacy in pregnancy and lactation is lacking. Spirulina may contain more than 180 mcg of mercury per 20 g of spirulina and should be avoided.

Interactions
None well documented. An antiplatelet effect has been demonstrated in vitro but was not clinically evaluated.

Adverse Reactions
Few reports of adverse reactions are available. Cyanobacteria (blue-green algae) may contain the amino acid phenylalanine; therefore, people with phenylketonuria should avoid spirulina. A case of spirulina-associated hepatotoxicity has been reported. Hepatotoxic microcystins and neurotoxic anatoxin-a are produced by a number of cyanobacteria and have been reported as spirulina contaminants. Other contaminants reported include the heavy metals mercury, cadmium, arsenic, and lead, as well as microbes cultivated on fermented animal waste. Questions have been raised regarding the potential for adverse reactions in persons with autoimmune disorders consuming immunostimulatory herbal preparations.

Toxicology
Spirulina is considered nontoxic to humans at usual levels of consumption; however, information is limited.

Source: http://www.drugs.com/npp/spirulina.html

Monday, 31 March 2008

Patenting Flow Chart

Patenting Procedure Flow chart
simple and very understandable
Web link:www.lexorbis.com/patent-opposition.html





Saturday, 22 March 2008

Pre-Grant Oppositions in Patent Act 1970 (India)

  • Pre-grand opposition is executed u/s 25 (1) before the grant of patent. Any interested person, in writing, could apply to controller of patent on basis of grounds mentioned u/s25(1).
  • This procedure is to prevent:
    a) Wrongfully obtaining patent protection
    b) when Worngful Prior publication / priority date claimed
    c) when claimed invention already published before the priority date
    d) when claimed invention is Prior public knowledge or public use in India
    e) when it is Obvious and lack of inventive step
    f) when the invention is not patentable u/s 3
    g) when Insufficient description in complete specification
    h) when applicant failure to disclose information or furnishing false information relatingto foreign filing
    i) when the Convention application not filed within the prescribed time (12 months fromfirst filing date)
    j) when Incorrect mentioning of source/geographical origin of biological material used ininvetion
    k) when it is anticipated with regard to traditional knowledge of anycommunity , anywhere in the world
  • Application could be filed with proper evidences and statement
  • Controller shall only consider the any such request when the applicant make request to examine the application u/s 11B. Section 11B talks about request to examine the application,No application will be examined unless untill applicant make request within 48 months fromfiling date/priority date whichever is ealier.
  • After consider this statement filed by interested person, if the controller is of opinion that the application shall be refused or the amendment in the application, a notice will besent to applicant with copy of the statement.
  • Applicant could give reply with proper evidences, if he desires, within three months from the date of notice.
  • The Controller shall consider the statement and evidence filed by the applicant and may either refuse the grant of patent or ask for amendment of the complete specification to his satisfaction before the grant of patent.After considering the representation and submission made during the hearing,if so requested, the Controller shall proceed further simultaneously, either rejecting the representation and granting the patent or accepting therepresentation and refusing the grant, ordinarily within one month from the completion of the above proceedings.
Ref: http://ipindia.nic.in/ipr/patent/DraftPatent_Manual_2008.pdf

Friday, 21 March 2008

Software patents in U.K

An interesting case where "Court Orders UK Patent Office to Accept Software Patent"

"The European conditions for granting a patent for computer code are much stricter than in the U.S., where computer programs and business methods can be patented."

Source: CIO (http://www.cio.com/article/199400/Court_Orders_UK_Patent_Office_to_Accept_Software_Patent)

Friday, 1 February 2008

Stock World Wide

Previously, various major countries such as USA, UK were the key players in the stock market. The trend has changed these days providing opportunity to the developing countries.

Adding to this, Peru leads the world wide stocks with 53% up in last one year, according to MSCI Barra. BRIC countries (Brazil, Russia, India & China) are the other toppers in stock market with 40% increase over past 5 years. Following to these countries, Egypt, Colombia, Indonesia, the Czech Republic and Turkey have done a good job in last five years.

Source: Forbes


http://www.forbes.com/personalfinance/funds/2008/01/27/turkcell-ishares-bric-pf-guru-in_jc_0128borderless_inl.html

Thursday, 31 January 2008

Pfizer FDA

FDA Approved drugs of Pfizer

A list of drugs from pfizer for FDA approval that has been taken from orange book

Proprietary name & Active ingredients as follows:

ACCUPRIL - QUINAPRIL HYDROCHLORIDE
ACCURETIC - HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
ANTIVERT - MECLIZINE HYDROCHLORIDE
CADUET - AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
CAMPTOSAR - IRINOTECAN HYDROCHLORIDE
CARDURA - DOXAZOSIN MESYLATE
CARDURA XL - DOXAZOSIN MESYLATE
CEFOBID - CEFOPERAZONE SODIUM
CEFOBID IN PLASTIC CONTAINER - CEFOPERAZONE SODIUM
CHANTIX - VARENICLINE TARTRATE
DIABINESE - CHLORPROPAMIDE
DIFLUCAN - FLUCONAZOLE
DIFLUCAN - FLUCONAZOLE
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER - FLUCONAZOLE
DILANTIN - PHENYTOIN
ELLENCE - EPIRUBICIN HYDROCHLORIDE
EXUBERA - INSULIN RECOMBINANT HUMAN
FELDENE - PIROXICAM
GEOCILLIN - CARBENICILLIN INDANYL SODIUM
GEODON - ZIPRASIDONE MESYLATE
GEODON - ZIPRASIDONE HYDROCHLORIDE
GLUCOTROL - GLIPIZIDE
GLUCOTROL XL - GLIPIZIDE
LIPITOR - ATORVASTATIN CALCIUM
LOPID - GEMFIBROZIL
MINIPRESS XL - PRAZOSIN HYDROCHLORIDE
MINIZIDE - POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE
MITHRACIN - PLICAMYCIN
MODERIL - RESCINNAMINE
NAVANE - THIOTHIXENE HYDROCHLORIDE
NEURONTIN - GABAPENTIN
NICOTROL - NICOTINE
NITROSTAT - NITROGLYCERIN
NORVASC - AMLODIPINE BESYLATE
PENICILLIN G POTASSIUM - PENICILLIN G POTASSIUM
PERMAPEN - PENICILLIN G BENZATHINE
PROCARDIA XL - NIFEDIPINE
RELPAX - ELETRIPTAN HYDROBROMIDE
RENESE - POLYTHIAZIDE
RENESE-R - POLYTHIAZIDE; RESERPINE
REVATIO - SILDENAFIL CITRATE
SELZENTRY - MARAVIROC
SINEQUAN - DOXEPIN HYDROCHLORIDE
STREPTOMYCIN SULFATE - STREPTOMYCIN SULFATE
TERRA-CORTRIL - HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE
TERRAMYCIN - LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE
TERRAMYCIN - OXYTETRACYCLINE HYDROCHLORIDE
TIKOSYN - DOFETILIDE
UNASYN - AMPICILLIN SODIUM; SULBACTAM SODIUM
VFEND - VORICONAZOLE
VIAGRA - SILDENAFIL CITRATE
VIBRAMYCIN - DOXYCYCLINE
VIBRA-TABS - DOXYCYCLINE HYCLATE
VISTARIL - HYDROXYZINE HYDROCHLORIDE
VISTARIL - HYDROXYZINE PAMOATE
ZITHROMAX - AZITHROMYCIN
ZMAX - AZITHROMYCIN
ZOLOFT - SERTRALINE HYDROCHLORIDE
ZYRTEC - CETIRIZINE HYDROCHLORIDE



Source: http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempah.cfm

Friday, 25 January 2008

Product from Novartis

Product Name: Trioptal
Generic Name: Oxcarbazepine
Use: Anti-epileptic (Treatment for Fits/seizures)

Friday, 5 October 2007

Primary Complex

Welcome to our new visitor - Vijay ganesh

Primar Complex

Primary complex is condition where there is a lymph node enlargement in the chest which is seen on X-ray chest with some parenchymal (lung) involvement. Lymph nodes outside chest are not defined as primary complex. Ideal way to confirm the diagnosis of tuberculosis is to document ther tubercular germs either from lymph node or from sputum/secretions obtained from the lungs.

Drugs and its actions

The medication contains three different compounds (below) which act together to kill bacteria that cause tuberculosis (TB).

Rifampicin: Rifampicin is typically used to treat Mycobacterium infections, including tuberculosis and leprosy;

Isoniazid: Isoniazid is a first-line antituberculous medication used in the prevention and treatment of tuberculosis.

Pyrazinamide: Pyrazinamide is a drug used to treat tuberculosis in afflicted patients. The drug is largely bacteriostatic, but can be bacteriocidal on actively replicating tuberculosis bacteria.


Treatment

There are two stages in the treatment of tuberculosis. In the first two months after infection (the initial phase), treatment is aimed at killing as many bacteria as possible. Therefore several anti-TB drugs with different mechanisms of action are used in combination. After this time some of the medications are stopped and the others are continued for a further four months (continuation phase) to kill any remaining bacteria. Rifampicin and isoniazid are used in both stages of treatment whilst pyrazinamide is used in the inital phase of treatment only.

The bacteria that cause TB are difficult to treat. By using medications in combiation, the bacteria can be targeted in different ways and hence treatment is more likely to be effective than a single medicine alone. In addition, using different medications make it less likely that bacteria will develop resistance to treatment.

As the period of treatment is long the combination of the three drugs in one tablet helps compliance with the treatment.

Sample Q&A

Q. This is about our baby who is 13 months old. She was away in Coimbatore for about 3 weeks. When she came back to Chennai she had a very bad cold and cough. Upon checking with our doctor it was confirmed that she had severe chest congestion and due to that she was given medication. But even after this there was no let up and she continued having cough with phlegm coming out when she coughed and vomitted. Our doctor recommended doing a chest x-ray and Mantoux test. When this was done blood test revealed the following: Haemoglobin: 10 g%, Total leucocyte count: 12,400 cells, Polymorphs 42%, Lymphocytes 50%, Eosinophils 8%; Mantoux test +ve. I am unable to describe the x-ray because we did not get a report, but looking at the x-ray one side of the chest looked hazy and the other side quite clear. The doctor confirmed that she had primary complex. Now after medication she is quite better but continues to cough occasionally. My question is will she be cured or will it lead to TB since the doctor has given medication for 1 year?

A. Primary complex is an infection due to the Tuberculosis bacteria. When the full treatment course is completed, she should be completely cured. However, it is possible that at a later stage, the Primary Complex may get re-activated, if he general level of Health or Immunity were to decline in your daughter, for some reason.

SOURCE: http://www.doctorndtv.com/
http://en.wikipedia.org/wiki/Main_Page

Wednesday, 26 September 2007

FDA Reform

Source: Forbes
Author:Matthew Herper

You wouldn't know it from the lack of fanfare, but the Food and Drug Administration is getting its biggest overhaul in a decade in a dramatic coda to Merck's withdrawal of the blockbuster painkiller Vioxx three years ago.
A bill to give the FDA more power passed both houses of Congress with only a handful of no votes, and the president is expected to sign it into law. Because the bill is attached to the re-authorization of an important part of the FDA's funding, a veto is unlikely. If the law doesn't pass soon, FDA head Andrew Von Eschenbach is going to have to start informing staffers that their jobs are no longer funded.
The bill represents a victory for advocates of higher standards for making sure that drug side effects are known and promptly dealt with. Before Vioxx was yanked, some of the changes being made would be unimaginable. Until now the claims drug companies like Merck (nyse: MRK - news - people ) and Pfizer (nyse: PFE - news - people ) made about their medicines were, to a degree, negotiated. Labeling discussions between Merck and the FDA dragged on, and as a result, the agency will now be able to dictate what claims companies can make with much more force.
Another change: The FDA will be able to force drug makers to do clinical trials even after a medicine is approved and fine them if they don't follow through. Previously, many big clinical trials regulators asked for weren't finished. And there will be more money to study side effects of new medicines post-approval. Companies will pay more in fees when they submit drug applications, increasing the amount of money the FDA gets from industry by 25% to $400 million.
One of the farthest-reaching changes may be a new requirement demanding that the drug companies list all of their clinical trials in a registry maintained by the National Institutes of Health accessible to anyone with an Internet browser. After the studies finish, the results will also have to be posted. This will expose drug companies to new levels of scrutiny about the safety of their medicines. (See: Lynch 'Em)
Rough-and-ready analyses of existing data set off the Vioxx controversy and the recent kerfluffle over the diabetes drug Avandia. Such analyses, where researchers try to combine different studies to get a better idea of what kinds of side effects emerge in incredibly large groups, also linked antidepressants like GlaxoSmithKline's (nyse: GSK - news - people ) Paxil to suicide risk and the Johnson & Johnson (nyse: JNJ - news - people ) heart failure medicine Natrecor to kidney problems. In both cases, there are still debates about how real the risks are, but they put a squeeze on sales.
Lots of stuff didn't go into the bill. The Union of Concerned Scientists, while lauding the bill, worried that it didn't do enough to deal with the financial conflicts of FDA advisers. It appears to only increase the FDA's power to regulate direct-to-consumer ads a little bit. Pharmaceutical companies had at one point hoped that the bill would contain language that helped protect products that had been vetted by the FDA from product liability suits.
At one point, it looked as if the bill might address how the FDA should go about approving cheaper copycat versions of biotech protein drugs like insulin and human growth hormone. Right now, there's no mechanism for approving true generics of these products, which can be extremely expensive. Part of the reason: Complex safety issues arise because proteins are far more difficult to manufacture than the simpler chemicals in pills like Vioxx and Lipitor.
But all of these issues were Johnny-come-latelies to the Congressional debate. The focus was creating a more transparent FDA with the power to better study and regulate drug safety. Legislators were probably smart, in the end, to stick with the issues they had debated the most and approve a bill that is uncontroversial now but would have seemed like a radical step three years ago.
Hopefully, the changes will strengthen the FDA, renewing the public's shaken faith in the safety of medicines. Drug makers could wish for nothing more.

Link to this site: Link: http://www.forbes.com/business/healthcare/2007/09/21/drugs-safety-fda-biz-sci-cx_mh_0924fda.html

Thursday, 30 August 2007

Novartis' IMATINIB MESYLATE EMR

India's patent system faces clinical trial

ANTI-CANCER drug imatinib mesylate is having a positive side-effect on the country's patent system. The disputes following the award of an exclusive marketing right (EMR) for the drug to Novartis India, a subsidiary of the $24-billion, Switzerland-based multinational Novartis AG, are showing up the loopholes in the system.The Patent Controller's Office, which is responsible for granting EMRs (and will be responsible for issuing patents from 2005), gave the one for imatinib mesylate to Novartis. Meanwhile, the Drug Controller General of India (DCGI), which only checks whether a drug is fit to market, allowed a number of generics companies to do so. Neither of the two bodies is required to tell the other what it is doing. Therefore, what they ended up doing was create a situation where the two permissions are in conflict. "The current law is a recipe for litigation," says Rajiv Gulati, chairman and managing director, Eli Lilly India, the Indian subsidiary of the US-based drug company Eli Lilly. Lilly has also applied for an EMR for its anti-impotency drug Tadalafil, but the market has been hijacked by Ajanta Pharma and now Ranbaxy Laboratories with permits from DCGI.Moreover, there is no special court to handle patent disputes. Novartis' EMR has been challenged in the Delhi High Court by Hyderabad-based drug company Natco Pharma India, which has DCGI permission to market imatinib mesylate. But Novartis, on the basis of the EMR, filed a suit in the Chennai High court against six generic drug companies and managed to get a stay against them for the same drug. Now if Natco wins in Delhi, the Chennai High Court's stay will conflict with the Delhi High Court's verdict.Meanwhile, Novartis has also filed a case in the Mumbai High Court against Natco Pharma and two others - Shantha Biotechnics and Camlin - for infringing on its EMR. In its petition in Mumbai, Novartis disclosed to the judge that the EMR was disputed and the matter was under consideration by the Delhi High Court. Four hearings have already been held in Mumbai on 4, 12 and 25 February and 11 March, but the final decision is likely to be taken only after the Delhi High Court gives its verdict in the other case between the two companies.Novartis India chief executive officer Ranjit Shahani says the company will defend the EMR. The CEO of another drug firm says that one knew there were loopholes in the law, but "they would have never come to light if the EMR had not been granted (for imatinib mesylate) and challenged".

Source: BusinessWorld (http://www.businessworldindia.com/mar2904/news17.asp)

Tuesday, 14 August 2007

Novozyme buys Biocon!

India's leading biotechnology enterprise, Biocon, has entered into an agreement to sell its enzymes unit to Denmark's Novozymes for $115 million.

The Danish firm will pay $97 million upfront, and $5 million after meeting certain business targets. In addition, $13 million will be paid in service fees and lease payments over a period of up to 10 years.

According to Novozymes, use of enzymes is still in its infancy in India, but awareness of their potential and benefits in food and beverage formulation is growing."The activities of Biocon have a good strategic fit to our existing enzyme business," said Novozymes Chief Executive Steen Riisgaard. "We see several interesting market opportunities combined with synergy potential, making this a very interesting acquisition."

"The acquisition of Biocon's enzyme activities provides an important step for Novozymes in strengthening our position on the Indian market, which we believe has an attractive growth potential," he said.

The acquisition will contribute to Novozyme's R&D strategy and brings Biocon's expertise in solid-state fermentation technology.Biocon's enzyme activities are made up of industrial enzymes, food additives and processing aids.In financial year 2006-7, Biocon's enzyme sales amounted to $25 million - 12 percent of the company's overall revenue.

"Industrial enzymes was our original business when we had started, and over the years became a smaller part of our business. It was a difficult decision to divest the business as it has been with us from the start. But since we wanted to concentrate on bio-pharma, and we got a good valuation for the enzymes business, we decided to sell it," national daily The Times of India (TOI) quoted Biocon Chairman and Managing Director Kiran Mazumdar-Shaw as saying.

Biocon will use the proceeds of the sale, the latest in a wave of cross-border merger and acquisition deals involving Indian firms, to buy companies in Europe, Mazumdar-Shaw said.Novozymes, the world's largest maker of industrial enzymes, said its acquisition was expected to have long-term annual sales growth of more than 15 percent.

Novozymes entered the Indian market in 1987 and is setting up research and development facilities in Bangalore, where Biocon is based.Allegro Capital Advisors advised Biocon, while SEB Enskilda and KPMG Investment Banking advised Novozymes on the deal.

The transaction will be completed by the end of this year.

Source of Information: International Business Times

Thursday, 9 August 2007

Drugs info link.

Dear friends,

This is a very useful site with ample imfo about drugs and drug-related info's.

http://www.coreynahman.com/druginfopage.html

Enjoy.......

Regards,

Prakash

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