The introduction of international reference pricing has had a moderating effect on Norwegian price levels, and a step-price system for off-patent drugs has ensured that prices for all generics have fallen. Important steps towards cost-containment have also been taken for reimbursable pharmaceuticals, including the use of a first-choice system. These measures ensure the most cost-effective treatment, while reducing costs for the healthcare system, the National Insurance Scheme and patients.
A report by the Business Research Foundation (SNF) has shown that Norwegian pharmaceutical prices are among the lowest in Western Europe. Therefore, market growth is a result of increased consumption, largely due to the ageing population and the introduction of new drugs on the market. Consequently, the market is growing at a moderate rate, tempered by the effects of lower prices.
Saturday, August 7, 2010
US FDA warns pharma firm about Facebook promotion
The U.S. Food and Drug Administration has warned a pharmaceutical company that its use of the Facebook Share button to promote a cancer-fighting medication violates FDA requirements for disclosing information about drugs.
The FDA, in a letter sent to drug-maker Novartis Pharmaceuticals July 29, tells the company that its use of Facebook Share to promote Tasigna is incomplete and misleading.
This is likely the first time the FDA has issued a warning to a pharmaceutical firm for using Facebook to promote its products, said Jeffrey Chester , a privacy advocate and executive director of the Center for Digital Democracy.
The FDA, which posted the warning letter on its website this week, asks Novartis to stop using Facebook Share to promote the leukemia drug.
"The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug," said the FDA letter, signed by Karen Rulli, acting group letter of the agency's Division of Drug Marketing, Advertising, and Communications. "In addition, the shared content inadequately communicates Tasigna's FDA-approved indication and implies superiority over other products."
FDA rules require that most medication promotional pieces contain information about risks associated with taking the drug, the letter said. In addition, promotional materials are misleading if they suggest a "drug is safer or more effective than another drug when this superiority has not been demonstrated by substantial evidence or substantial clinical experience," the letter said.
Novartis also failed to notify the FDA of the Tasigna promotion, as required by the agency, the letter said.
Novartis, in a statement, said it takes the FDA letter "very seriously."
"We have addressed its concerns by taking the direct and immediate action of taking down the widget referenced by the FDA," the company said. "Novartis will continue to have active discussions with the FDA to understand fully all of the concerns. We also will assess all of our Web assets and materials based on these concerns."
The warning letter highlights a problem with Facebook and other websites targeting advertising dollars from pharmaceutical and companies, said Chester, who asked the FDA in March to investigate the online marketing of drugs. Facebook should be responsible for creating safeguards for the marketing of medications and other health products on its site, he said.
Websites "see digital dollars in their bottom lines and are ignoring the health risks confronting consumers who are targeted using social-media marketing," Chester said. "This letter is a wake-up call -- for the pharma industry, Facebook, and social media application companies."
The FDA's letter is appropriate, Chester added. "Risk warnings must be prominently disclosed -- and not purposefully ... hidden by making a consumer click for more information," he said.
A representative of Facebook didn't have an immediate comment on the letter or Chester's perspective.
The FDA, in a letter sent to drug-maker Novartis Pharmaceuticals July 29, tells the company that its use of Facebook Share to promote Tasigna is incomplete and misleading.
This is likely the first time the FDA has issued a warning to a pharmaceutical firm for using Facebook to promote its products, said Jeffrey Chester , a privacy advocate and executive director of the Center for Digital Democracy.
The FDA, which posted the warning letter on its website this week, asks Novartis to stop using Facebook Share to promote the leukemia drug.
"The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug," said the FDA letter, signed by Karen Rulli, acting group letter of the agency's Division of Drug Marketing, Advertising, and Communications. "In addition, the shared content inadequately communicates Tasigna's FDA-approved indication and implies superiority over other products."
FDA rules require that most medication promotional pieces contain information about risks associated with taking the drug, the letter said. In addition, promotional materials are misleading if they suggest a "drug is safer or more effective than another drug when this superiority has not been demonstrated by substantial evidence or substantial clinical experience," the letter said.
Novartis also failed to notify the FDA of the Tasigna promotion, as required by the agency, the letter said.
Novartis, in a statement, said it takes the FDA letter "very seriously."
"We have addressed its concerns by taking the direct and immediate action of taking down the widget referenced by the FDA," the company said. "Novartis will continue to have active discussions with the FDA to understand fully all of the concerns. We also will assess all of our Web assets and materials based on these concerns."
The warning letter highlights a problem with Facebook and other websites targeting advertising dollars from pharmaceutical and companies, said Chester, who asked the FDA in March to investigate the online marketing of drugs. Facebook should be responsible for creating safeguards for the marketing of medications and other health products on its site, he said.
Websites "see digital dollars in their bottom lines and are ignoring the health risks confronting consumers who are targeted using social-media marketing," Chester said. "This letter is a wake-up call -- for the pharma industry, Facebook, and social media application companies."
The FDA's letter is appropriate, Chester added. "Risk warnings must be prominently disclosed -- and not purposefully ... hidden by making a consumer click for more information," he said.
A representative of Facebook didn't have an immediate comment on the letter or Chester's perspective.
Friday, August 6, 2010
Growth in the field of Clinical Research in India
The prime factor for the rise in the field of clinical research is the talent that India can provide. These people are a group of well- trained staff and are technically strong. This is supported by the quantity of the clinical equipments that are available in plenty in India. Secondly, in terms of the infrastructure and cost of commodities, India proves to be cheaper in comparison to other countries. The research and the development process can be done at a more affordable price.
Moreover, India is known for its diverse cultures and traditions. Many alternate medicines like the Siddha, Unani, Ayurvedic, homeopathy etc are in practice with Allopath medicines. This also has a global recognition, which is attracting many foreign medical companies to take up shared outsourcing policy to hit the Indian clinical research market.
As clinical research can help in the development of various hospitals and providing better health care facilities can be improved by means of transfer of knowledge. Many international institutes have now come up in India that is providing curriculum for clinical research studies.
Thursday, August 5, 2010
pharma news
Breaking World Pharma News
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Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced results of two phase 3 studies of mipomersen in patients who had high cholesterol levels while on maximally tolerated lipid-lowering therapy.
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that a Luxembourg incorporated wholly-owned subsidiary of Shire plc will launch a voluntary public takeover offer for all the shares in Movetis NV, the Belgium-based European specialty gastrointestinal (GI) company.
Revenue in the second quarter increased by 1 percent at CER, but was up 3 percent on an actual basis as a result of the positive impact of exchange rate movements.
Sales of the Bayer Group rose by 14.6 percent in the second quarter, to EUR 9,179 million (Q2 2009: EUR 8,009 million). Adjusted for currency and portfolio effects, business grew by 9.2 percent.
Merck KGaA announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS).
Eli Lilly and Company (NYSE: LLY) announced financial results for the second quarter of 2010. In the second quarter of 2010, worldwide total revenue was $5.749 billion, an increase of 9 percent compared with the second quarter of 2009.
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) has reservations on approval by the U.S. Food and Drug Administration (FDA) of another version of enoxaparin sodium.
Sandoz announced the introduction of enoxaparin sodium injection, the first generic version of Lovenox®[1], in the US. Product shipment began immediately following approval by the US Food and Drug Administration (FDA).| Articles In the Current Issue of Pharma Marketing News | ||||
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