Our firm has extensive experience working with organisations across the industry, including: proprietary and generic drug manufacturers, specialty drug makers, medical device and diagnostics suppliers, biotechnology companies, wholesalers, pharmacy benefit managers, contract research organisations, and industry associations. We have made a deep commitment to understanding the forces affecting our clients' operations and have aligned our practice with the market to ensure that our people are deeply knowledgeable about the relationships that suppliers have with providers, payers, regulators and patients.
Whether you are an emerging company seeking venture capital to fund research or advice on a collaboration to commercialize a product, or an established company looking to improve or expand operations, you can count on our insight and experience to find the best approaches to achieve your financial, operational and strategic objectives.Tuesday, December 11, 2007
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Over the past decade, pharmaceutical and life sciences companies have entered a difficult period where shareholders, the market and regulators have all created significant pressures for change within the industry. From thinning pipelines and skyrocketing operating costs to calls for lower prices and a greater regulatory burden, the industry is confronting unprecedented challenges that are expected to radically transform the business. Biotechnology companies also face increasingly tougher choices about product development strategy, funding sources, collaboration arrangements and the competition for talent. To overcome these challenges, the industry will require a bold vision and leaders who have the willingness to embrace a fundamentally new approach to their business
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By 2020 the pharmaceutical market is anticipated to more than double to $1.3 trillion, with the E7 countries - Brazil, China, India, Indonesia, Mexico, Russia and Turkey - accounting around one fifth of global pharmaceutical sales. Further, incidence of chronic conditions in the developing world will increasingly resemble those of the developed world. But Pharma 2020: the vision - which path will you take? indicates that the current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets. In order to make the most of these future growth opportunities, the industry must fundamentally change the way it operates.
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KEMSTRO™ (baclofen orally disintegrating tablets) is a muscle relaxant and antispastic. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Its chemical name is 4-amino-3- (4-chlorophenyl)-butanoic acid. The molecular weight of baclofen is 213.66 and the empirical formula is C10H12C1NO2. The structural formula is represented below
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n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.
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n a prepared statement released earlier in the day, the FDA also said: "Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect."
And it added, "FDA recommends that health-care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs."
Dr. Paul O. Katz, chairman of gastroenterology at Albert Einstein Medical Center in Philadelphia, agreed that these drugs are safe and that patients shouldn't hesitate to use them.
"This is altogether good news," Katz said. "It is reassuring to physicians and the public, who are using these drugs on a widespread basis, that this is not deemed to be an issue."
Both drugs are made by the British pharmaceutical company AstraZeneca. In May, the company gave the FDA findings from two small, preliminary trials that were designed to test the effectiveness of the drugs, compared with surgery, for severe gastroesophageal reflux disease (GERD).
During the trials, some cardiac "events" were seen among study participants, hinting that long-term use of Prilosec and Nexium could increase the risk of heart attack, heart failure and heart-related sudden death, the FDA said at the time.
Because of these concerns, AstraZeneca gave the FDA more detailed data from the two initial studies as well as findings from 14 other studies -- one 14 years in length -- that compared the drugs with a placebo.
The more complete data showed that patients taking Prilosec had a lower risk of heart problems than patients taking a placebo. And findings from the ongoing Nexium trial found no difference in heart problems between patients taking the drug and those undergoing surgery for GERD, the FDA statement said.
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MONDAY, Dec. 10 (HealthDay News) -- A U.S. government review of the popular heartburn drugs Prilosec and Nexium found no evidence of increased heart risks, health officials said Monday.
The announcement followed a three-month safety review after reports of possible heart risks emerged from two preliminary studies. But detailed data from both studies, plus another 14 studies, showed no heightened risk associated with long-term use of the drugs, U. S. Food and Drug Administration officials said.
Dr. Paul Seligman, associate director of the FDA's Office of Safety Policy and Communication at the Center for Drug Evaluation and Research, told reporters that the agency "had completed our safety review, and our current assessment is that studies do not show a risk for heart attack or heart-related problems."
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psychoactive drug or psychotropic substance is a chemical substance that acts primarily upon the central nervous system where it alters brain function, resulting in temporary changes in perception, mood, consciousness and behavior. These drugs may be used recreationally to purposefully alter one's consciousness, as for ritual or spiritual purposes, as a tool for studying or augmenting the mind, or therapeutically as
Because psychoactive substances bring about subjective changes in consciousness and mood that the user may find pleasant (e.g. euphoria) or advantageous (e.g. increased alertness), many psychoactive substances are abused, that is, used outside of the guidance of a medical professional and for reasons other than their original purpose. With sustained use, pt. can involve a combination of, support groups and even other psychoactive substances to break the cycle of dependency.
In part because of this potential for abuse and dependency, the ethics of drug use are the subject of a continuing philosophical debate. Many governments worldwide have placed restrictions on drug production and sales in an attempt to control drugad7
The Bulk Actives division has the technology to manufacture 40 products. With facilities that consist of four plants capable of producing a range of bulk actives (APIs), plans are afoot for major expansion over the next five years. The bulk actives division which operates as a Strategic Business Unit - the Chemicals SBU - is headquartered at Ankleshwar, Gujarat and is among the fastest growing manufacturing units with ambitious plans for the future.
This unit is spread on a 42,000 sq. mt. Plot in the GIDC chemicals zone of which 7,200 sq. mt is the constructed area, leaving ample scope for expansion.
The new Multi Purpose Plant, built at a cost of Rs.3 Millions, was executed by internationally renowned consultants - Jacobs H&G, U.K.
The state-of-the-art plant, spread over an area of 30,000 sq. ft. area is equipped to manufacture four different products simultaneously on a campaign basis, under class 100, 000 "Clean room" condition. Besides being a 'closed' plant with forced ventilation system, it also deploys scrubbing system for Acidic and Alkaline vapors, ensuring clean environment.
The APIs manufacturing facility of Cadila Pharma group at Ankleshwar encompasses one of the highest capacities in India to produce Loratadine (Anti-Histaminic), Glibenclamide (Anti-diabetic) and Chloro Hexidine Base (Dis-infectant). The Ethambutol and the Fluoxetine plants at Cadila Pharma, Ankleshwar, are approved by USFDA.
Cadila Pharmaceuticals has an arrangement (DMF) with Mallinckrodt Inc USA, for supplying 8 APIs, including Ethambutol and Fluoxetine to them. Mallinckrodt Inc, in turn, can convert these bulks into formulations.
Fluoxetine is an anti-depressant and Cadila Pharma has a capacity to produce 1000 kgs/month at its Ankleshwar unit. The USFDA approval to Cadila Pharma has come without any 483 comments, which shows the competency of the group in its facilities, documentations etc.
Active Pharmaceutical Ingredients manufactured at CPL- Ankleshwar
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In line with our vision to be significant global player by 2010 A.D., Cadila Pharmaceuticals is fast emerging as a true Indian multinational.
As part of our strategy, we have wholly owned subsidiaries, joint ventures, strategic alliances, contract manufacturing, own marketing offices in 4 countries and have significant presence in over 46 countries across the globe. Our business revolves around the exports of formulations, bulk actives, hospital disposables, veterinary formulations and pharmaceutical machinery manufacturing.
Besides a significant presence in the Americas, CIS Countries, Africa, Central and South-East Asia, Oceanic Countries, Japan, Middle East and Europe, the company has offices in USA, Japan, Kenya, Nigeria, Russia, Kazakhstan and Ukraine. The International SBU plans to expand operations to more than 100 countries by 2010.
The focus is on building brands in the following therapeutic segments
As part of our strategy, we have wholly owned subsidiaries, joint ventures, strategic alliances, contract manufacturing, own marketing offices in 4 countries and have significant presence in over 46 countries across the globe. Our business revolves around the exports of formulations, bulk actives, hospital disposables, veterinary formulations and pharmaceutical machinery manufacturing.
Besides a significant presence in the Americas, CIS Countries, Africa, Central and South-East Asia, Oceanic Countries, Japan, Middle East and Europe, the company has offices in USA, Japan, Kenya, Nigeria, Russia, Kazakhstan and Ukraine. The International SBU plans to expand operations to more than 100 countries by 2010.
The focus is on building brands in the following therapeutic segments
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There has been a growing trend towards natural medicines and the use of dietary supplements for modern healthcare, as people throughout the world are becoming increasingly dissatisfied with the possible side-effects, lack of noticeable long-term results and high cost associated with allopathic drugs. Herbal products have provided a more natural and often more effective alternative.
Cadila Pharmaceuticals uses the ancient Indian medicinal science of Ayurveda to make herbal formulations with clinically proven efficacy. The Company has an experienced phytochemistry research team since 1983 and has developed 30 unique herbal products.
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About half a dozen technologies including diagnostics for HIV, thrombolites for Myocardial infarction and a pro-biotic are planned for launch this year. An equal number of products are in the pipeline for immuno-prophylaxis, diagnosis of hepatitis C, therapeutics for Cancer, Viral hepatitis, diabetes mellitus and anemia. HIV diagnostics include the mandatory ELISA format and highly advanced rapid autologous red blood cells agglutination test referred to as Naked-Eye Visible Agglutination Assay (NEVA) based on a technology developed for the first time. NEVA can be used on the bedside or in the office of the doctor. Results are available in 3-5 minutes as against the mandatory ELISA, which takes significant
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Sodium Hyaluronate, another biotech product was developed on the basis of technology obtained from Center for Biochemical Technology, Delhi. It has been commercialized in pre-filled syringes for Ophthalmic procedures as a surgical aid under the brand name VISIAL. Cadila Pharmaceuticals is the 3rd Company in the world to market it. Besides ophthalmology, it has got applications in osteoarthritis and rheumatism. For Osteoarthritis of the Knee, the product is made available in pre-filled syringe (PFS) under the brand Halonix. Since the product is based on easily available raw material, there is a tremendous price advantage, which would provide Hyaluronic preparations a competitive edge in export market as well.
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Currently about 20 products including conventional and recombinant vacancies, Anti cancer bio-therapeutics, diagnostics using recombinant antigens and natural thrombolites with high market potential are in Cadila Pharmaceuticals' Biotechnology basket. A sterling example is Immuvac, a potent, unique Immunomodulator developed for the first time in the world.
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Biotechnology is a thrust area of research at Cadila Pharmaceuticals Ltd., over the last few years has established a strong R&D base in biotechnology and developed working relations with key R&D Institutes in the country for outsourcing of Research & Development. Presently, 30 scientists, many of them with Doctorates in their respective disciplines, comprise the Biotech R&D team. The R&D team has been further expanded; keeping in view the expansion plans
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