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Monday, March 31, 2014
More evidence parents should monitor kids' media diet
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Novartis to Seek Heart Drug Approval After Test Ends Early (2) - Businessweek
Novartis AG (NOVN) plans to seek approval of a medicine for chronic heart failure sooner than expected, advancing its effort to build a portfolio of cardiac therapies.
The drugmaker is ending a late-stage clinical trial of an experimental medicine known as LCZ696 early after the results showed patients treated with it lived longer without being hospitalized than a group who got standard treatment, the Basel, Switzerland-based company said in a statement today.
Novartis shares rose as much as 3.5 percent in Zurich, the biggest intraday gain in more than a year. The study results offered reassurance about the company’s plan to introduce new cardiac medicines, five days after another experimental heart-failure product suffered a U.S. regulatory setback.
“Stoppage for efficacy is certainly a positive surprise,” Michael Leuchten, an analyst at Barclays Plc in London, said in an e-mail. He estimates the drug has the potential to earn at least $1 billion in peak annual sales.
Novartis shares traded 2.9 percent higher at 74.55 Swiss francs at 11:56 a.m. in Zurich.
Last week, a U.S. advisory panel recommended against approving Novartis’s serelaxin, a chemical similar to the hormone relaxin that protects the hearts of pregnant women. The Food and Drug Administration, which often follows the advice of its advisers but doesn’t have to, is scheduled to decide whether to clear the medicine for sale by May 17.
The study of LCZ696, known as Paradigm-HF, followed more than 8,000 patients with a certain type of heart failure who received either the Novartis drug or enalapril, the standard treatment.
“Novartis recognizes the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696’s unique mechanism of action could be transformative,” Tim Wright, Novartis’s head of drug development, said in the statement.
The company plans to start discussions with regulators about marketing approval and to present the trial results to a medical conference, according to the release.
Novartis had expected the data at the end of this year, according to a transcript of a presentation at a Cowen & Co. conference in March. The company also said at the meeting it expected both LCZ696 and serelaxin to generate more than $5 billion in annual sales if they won regulatory approval.
Heart failure, in which the heart becomes unable to pump enough blood throughout the body, often occurs in the wake of other ailments such as hypertension. More than 20 million people live with the disease in Europe and the U.S., according to Novartis.
To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Marthe Fourcade, David Risser
The drugmaker is ending a late-stage clinical trial of an experimental medicine known as LCZ696 early after the results showed patients treated with it lived longer without being hospitalized than a group who got standard treatment, the Basel, Switzerland-based company said in a statement today.
Novartis shares rose as much as 3.5 percent in Zurich, the biggest intraday gain in more than a year. The study results offered reassurance about the company’s plan to introduce new cardiac medicines, five days after another experimental heart-failure product suffered a U.S. regulatory setback.
“Stoppage for efficacy is certainly a positive surprise,” Michael Leuchten, an analyst at Barclays Plc in London, said in an e-mail. He estimates the drug has the potential to earn at least $1 billion in peak annual sales.
Novartis shares traded 2.9 percent higher at 74.55 Swiss francs at 11:56 a.m. in Zurich.
Last week, a U.S. advisory panel recommended against approving Novartis’s serelaxin, a chemical similar to the hormone relaxin that protects the hearts of pregnant women. The Food and Drug Administration, which often follows the advice of its advisers but doesn’t have to, is scheduled to decide whether to clear the medicine for sale by May 17.
The study of LCZ696, known as Paradigm-HF, followed more than 8,000 patients with a certain type of heart failure who received either the Novartis drug or enalapril, the standard treatment.
“Novartis recognizes the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696’s unique mechanism of action could be transformative,” Tim Wright, Novartis’s head of drug development, said in the statement.
The company plans to start discussions with regulators about marketing approval and to present the trial results to a medical conference, according to the release.
Novartis had expected the data at the end of this year, according to a transcript of a presentation at a Cowen & Co. conference in March. The company also said at the meeting it expected both LCZ696 and serelaxin to generate more than $5 billion in annual sales if they won regulatory approval.
Heart failure, in which the heart becomes unable to pump enough blood throughout the body, often occurs in the wake of other ailments such as hypertension. More than 20 million people live with the disease in Europe and the U.S., according to Novartis.
To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Marthe Fourcade, David Risser
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Like obesity, being underweight is also tied to earlier death - Medical News Today
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Liberian health authorities confirm 2 cases of Ebola, WHO says - Fox News
The World Health Organization (WHO) said on Sunday that Liberia has confirmed two cases of the deadly Ebola virus that is suspected to have killed at least 70 people in Guinea.
The outbreak of the highly contagious Ebola, which in its more acute phase, causes vomiting, diarrhoea and external bleeding, has sent Guinea's West African neighbors scrambling to contain the spread of the disease.
Eleven deaths in towns in northern Sierra Leone and Liberia, which shares borders with southeastern Guinea where the outbreak was first reported, are suspected to be linked to Ebola.
WHO said that as of March 29, seven clinical samples from adult patients from Foya district in Liberia were tested.
"Two of those samples have tested positive for the ebolavirus," the global health organization said in the statement on its website on Sunday, confirming for the first time the cases in country.
"There have been 2 deaths among the suspected cases; a 35 year old woman who died on 21 March tested positive for ebolavirus while a male patient who died on 27 March tested negative," it said.
An official of Liberia's health ministry who requested anonymity said the government was aware and would issue a statement on Monday.
The suspected spread of disease into Liberia and Sierra Leone has stirred concern that one of the most lethal infectious diseases known to man could spread in a poor corner of West Africa, where health systems are ill-equipped to cope.
Authorities in Guinea's northwestern neighbor Senegal closed its land border on Saturday and suspended weekly markets near the borders where fresh produce from Guinea were sold in order to prevent the spread of the Ebola virus.
Sanitary checks have also been introduced on flights between Dakar and the Guinean capital Conakry. Regional airline Gambia Bird has also announced that it will delay the launch of services to Conakry, due to start on Sunday, because of the outbreak.
The World Health Organization said in the statement it does not recommend any travel or trade restrictions be applied to Liberia, Guinea or Sierra Leone based on the current information available about the outbreak.
Ebola has killed more than 1,500 people since it was first recorded in 1976 in what is now Democratic Republic of Congo, but this is the first fatal outbreak in West Africa.
The outbreak of the highly contagious Ebola, which in its more acute phase, causes vomiting, diarrhoea and external bleeding, has sent Guinea's West African neighbors scrambling to contain the spread of the disease.
Eleven deaths in towns in northern Sierra Leone and Liberia, which shares borders with southeastern Guinea where the outbreak was first reported, are suspected to be linked to Ebola.
WHO said that as of March 29, seven clinical samples from adult patients from Foya district in Liberia were tested.
"Two of those samples have tested positive for the ebolavirus," the global health organization said in the statement on its website on Sunday, confirming for the first time the cases in country.
"There have been 2 deaths among the suspected cases; a 35 year old woman who died on 21 March tested positive for ebolavirus while a male patient who died on 27 March tested negative," it said.
An official of Liberia's health ministry who requested anonymity said the government was aware and would issue a statement on Monday.
The suspected spread of disease into Liberia and Sierra Leone has stirred concern that one of the most lethal infectious diseases known to man could spread in a poor corner of West Africa, where health systems are ill-equipped to cope.
Authorities in Guinea's northwestern neighbor Senegal closed its land border on Saturday and suspended weekly markets near the borders where fresh produce from Guinea were sold in order to prevent the spread of the Ebola virus.
Sanitary checks have also been introduced on flights between Dakar and the Guinean capital Conakry. Regional airline Gambia Bird has also announced that it will delay the launch of services to Conakry, due to start on Sunday, because of the outbreak.
The World Health Organization said in the statement it does not recommend any travel or trade restrictions be applied to Liberia, Guinea or Sierra Leone based on the current information available about the outbreak.
Ebola has killed more than 1,500 people since it was first recorded in 1976 in what is now Democratic Republic of Congo, but this is the first fatal outbreak in West Africa.
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