Business Club January 12 In 2010, the FDA approved a total of 21 new drugs. It is a year that fewer new drugs have been approved in recent years. Although several new drugs with the potential of “bombshells†were approved, some new drugs that were highly hoped for were delayed until 2011. Reflects the increasing threshold of FDA approval of new drugs, such as diet pills, diabetes drugs, and other types of drugs that have been rejected or delayed for safety reasons.
According to the FDA-approved new drug report, 21 new drugs received FDA approval in 2010 (excluding new components and new indications), which is slightly lower than 25 in 2009 and 24 in 2004, up from 18 in 2007.
Increase security considerations
Newly approved drugs include some important biological agents, such as Amgen's twice-a-year treatment of postmenopausal women with injection-type osteoporosis drug Prolo, and Roche's Genentech intravenous treatment for rheumatoid arthritis. Drug drug Actemra.
Pradaxa of Boehringer Ingelheim received FDA approval on October 19 last year. It is a blood thinner for prevention of stroke in patients with irregular heart rhythms and became a major drug company in the field of alternative medicines for Chinese forestry. Leader.
While Aririzon’s anticoagulant Brilinta suffered a setback in the final month of 2010, the FDA asked for more detailed research information, and Brilinta’s delay caused AstraZeneca’s stock to fall by 5%.
In October, Gilenya, the first oral drug of multiple sclerosis Novartis, was approved by the FDA. At the beginning of the year, the FDA also approved Acorda's Ampyra drug to improve multiple sclerosis.
In August, the FDA approved a new emergency contraceptive ella, which can be taken within 5 days of unprotected sexual intercourse to prevent unwanted pregnancy. The drug is manufactured by HRA Pharma in France and by Watson Pharmaceuticals in the United States.
In April, Provenge, Dendron’s prostate cancer drug that had been denied approval, was approved as a novel anticancer drug that could mobilize the patient’s own immune system against cancer.
However, there were still some promising drugs rejected by the FDA in 2010, and some were asked to withdraw from the market.
The FDA postponed the new long-acting version of Brigantine, Amgen and Eli Lilly’s diabetes drug, Byetta, and requested more clinical data to address cardiovascular safety concerns.
In October, the FDA again rejected two diet pills from Arena Pharmaceuticals and Vivus.
In response to concerns about increased risk of heart attack, in September, the FDA announced that it would greatly limit the clinical use of GlaxoSmithKline.
In October, Abbott’s weight loss drug sibutramine was required to be withdrawn due to an increased risk of heart attack and stroke. The pain killers Darvon and Darvocet also delisted due to increased risk of abnormal heart rhythms.
Also in October, because the benefits to patients did not exceed their potential medication risks, the FDA withdrew the use of Roche Avastin in advanced breast cancer and asked Roche to modify prescription drug labeling information.
Recently, the FDA said it needed more time to evaluate the MannKind inhaled insulin Afrezza. It also required a second ruling in March against Human Genome Sciences Inc. and GlaxoSmithKline's new systemic lupus erythematosus drug, Benlysta.
Pending new drugs
In 2011, there will be more than 20 new drugs (or devices) pending FDA approval.
EMA: The number of new drugs in 2011 is the same as 2010
In 2010, only 14 new drugs were approved by the European Medicines Agency (EMA), a record low for the past few years. However, the EMA expects to receive 97 drug listing applications in 2011, which is basically the same as 95 in 2010.
The EMA Management Committee expects that the drug application for marketing in 2011 will include 40 new drugs for human use (38 in 2010), 12 new drugs for rare diseases (14 in 2010), and 42 generic drugs (41 in 2010).
In 2011, the EMA approved a budget of 208.9 million euros, an increase of 0.23% over 2010, including fee income of 161 million euros (152.8 million euros in 2010) and EU donation of 33.5 million euros (39.1 million euros in 2010). The Special Fund for Rare Drugs provided by the European Union has declined, from 8.2 million euros last year to 4.9 million euros in 2011.
The EMA does not expect to increase staffing this year and stabilize it at the level of 567 "temporary agents" in 2010.
The EMA Management Committee gave up its new strategy to 2015 and stated that “the roadmap for the 2005-2010 roadmap will be solidified first. The new strategy is to focus on EMA's core business, and there are three priority areas for strengthening the EMA's role in public health needs in the future. To promote the safety of drug use."
According to the FDA-approved new drug report, 21 new drugs received FDA approval in 2010 (excluding new components and new indications), which is slightly lower than 25 in 2009 and 24 in 2004, up from 18 in 2007.
Increase security considerations
Newly approved drugs include some important biological agents, such as Amgen's twice-a-year treatment of postmenopausal women with injection-type osteoporosis drug Prolo, and Roche's Genentech intravenous treatment for rheumatoid arthritis. Drug drug Actemra.
Pradaxa of Boehringer Ingelheim received FDA approval on October 19 last year. It is a blood thinner for prevention of stroke in patients with irregular heart rhythms and became a major drug company in the field of alternative medicines for Chinese forestry. Leader.
While Aririzon’s anticoagulant Brilinta suffered a setback in the final month of 2010, the FDA asked for more detailed research information, and Brilinta’s delay caused AstraZeneca’s stock to fall by 5%.
In October, Gilenya, the first oral drug of multiple sclerosis Novartis, was approved by the FDA. At the beginning of the year, the FDA also approved Acorda's Ampyra drug to improve multiple sclerosis.
In August, the FDA approved a new emergency contraceptive ella, which can be taken within 5 days of unprotected sexual intercourse to prevent unwanted pregnancy. The drug is manufactured by HRA Pharma in France and by Watson Pharmaceuticals in the United States.
In April, Provenge, Dendron’s prostate cancer drug that had been denied approval, was approved as a novel anticancer drug that could mobilize the patient’s own immune system against cancer.
However, there were still some promising drugs rejected by the FDA in 2010, and some were asked to withdraw from the market.
The FDA postponed the new long-acting version of Brigantine, Amgen and Eli Lilly’s diabetes drug, Byetta, and requested more clinical data to address cardiovascular safety concerns.
In October, the FDA again rejected two diet pills from Arena Pharmaceuticals and Vivus.
In response to concerns about increased risk of heart attack, in September, the FDA announced that it would greatly limit the clinical use of GlaxoSmithKline.
In October, Abbott’s weight loss drug sibutramine was required to be withdrawn due to an increased risk of heart attack and stroke. The pain killers Darvon and Darvocet also delisted due to increased risk of abnormal heart rhythms.
Also in October, because the benefits to patients did not exceed their potential medication risks, the FDA withdrew the use of Roche Avastin in advanced breast cancer and asked Roche to modify prescription drug labeling information.
Recently, the FDA said it needed more time to evaluate the MannKind inhaled insulin Afrezza. It also required a second ruling in March against Human Genome Sciences Inc. and GlaxoSmithKline's new systemic lupus erythematosus drug, Benlysta.
Pending new drugs
In 2011, there will be more than 20 new drugs (or devices) pending FDA approval.
EMA: The number of new drugs in 2011 is the same as 2010
In 2010, only 14 new drugs were approved by the European Medicines Agency (EMA), a record low for the past few years. However, the EMA expects to receive 97 drug listing applications in 2011, which is basically the same as 95 in 2010.
The EMA Management Committee expects that the drug application for marketing in 2011 will include 40 new drugs for human use (38 in 2010), 12 new drugs for rare diseases (14 in 2010), and 42 generic drugs (41 in 2010).
In 2011, the EMA approved a budget of 208.9 million euros, an increase of 0.23% over 2010, including fee income of 161 million euros (152.8 million euros in 2010) and EU donation of 33.5 million euros (39.1 million euros in 2010). The Special Fund for Rare Drugs provided by the European Union has declined, from 8.2 million euros last year to 4.9 million euros in 2011.
The EMA does not expect to increase staffing this year and stabilize it at the level of 567 "temporary agents" in 2010.
The EMA Management Committee gave up its new strategy to 2015 and stated that “the roadmap for the 2005-2010 roadmap will be solidified first. The new strategy is to focus on EMA's core business, and there are three priority areas for strengthening the EMA's role in public health needs in the future. To promote the safety of drug use."
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