| FDA Says Merck’s Cervical Cancer Vaccine Seems Safe |
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Merck & Co Inc’s experiment-based vaccine to prevent infection from a virus that causes cervical cancer appears to be effective, and studies did not raise major safety concerns, US regulatory staff said on Wednesday in documents released a day ahead of a key review.
The vaccine Gardasil was developed by Australian researcher Professor Ian Frazer, who designed it to prevent infection with certain types of the human papilloma virus, or HPV, which causes warts and most cases of cervical cancer -- the second- biggest cancer killer in women.
Some analysts project annual sales topping US$2 billion if it wins approval. France’s Sanofi-Aventis would market Gardasil in Europe if it wins permission there.
Food and Drug Administration (FDA) officials said they would ask an advisory panel that meets tomorrow to discuss the safety and effectiveness of Gardasil as well as they will present their analysis about the findings that some women and girls who were infected with HPV before they got the vaccine had a higher rate of cervical lesions, on Thursday.
The evaluation of possible side effects in Merck studies “did not demonstrate a safety signal of concern”, the FDA officials also said.
The FDA generally follows the guidance of advisory panels.
A concluding FDA decision on whether to approve Gardasil is expected by June 8, putting Merck ahead of a potential rival vaccine by GlaxoSmithKline Plc.
Gardasil is an important product for Merck as it faces thousands of lawsuits alleging damage from the company’s withdrawn arthritis drug Vioxx.
Merck studied Gardasil in women ages 9 to 26.
Two kinds of sexually transmitted human papilloma virus, types 16 and 18, are causative factors for an estimated 70 % of cervical cancer cases and are the targets of Gardasil. The specified kinds of cancers kill approximately 300,000 women globally each year, including almost 4,000 in the United States, Merck said.
Each year in Australia more than 1000 novel cases of cervical cancer are diagnosed and over 300 women pass away from this disease, according to Australian Government figures.
The vaccine could reduce annual killings from the disease to about 90,000 if it were used worldwide, the company said in a separate analysis also released by the FDA.
Shares of Whitehouse Station, New Jersey-based Merck dropped 28 cents (0.8%), to $34.84 in midday trading on the New York Stock Exchange amid a sharply lower market.
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Despite saying quite recently that it does not support the use of marijuana for medical purposes, the U.S. Food and Drug Administration (FDA) has given marketing approval for a drug which is a synthetic version of the active ingredient in marijuana.
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| Long Sittings can be Fatal for Travelers - May 17, 2006 10:34 IST |
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Researchers in Scotland have ruled out reduced cabin pressure on long-haul flights as a reason of the potentially disastrous condition deep vein thrombosis (DVT). In other words, reduced cabin pressure and low oxygen during long airplane flights does not appear to increase the risk of possibly mortal blood clots in healthy passengers, the study suggests.
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| Working Moms are healthier than the stay-at-home mothers - May 16, 2006 12:12 IST |
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According to new research carried out in Britain, married mothers who also hold jobs, in spite of having to juggle career and home, enjoy better health than their underemployed or childless peers.
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| FDA approves Pfizer’s Smoking Cessation Drug - May 12, 2006 11:28 IST |
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FDA has given a formal approval on Thursday, to the use of Pfizer’s new smoking cessation pill, to help smokers quit by reducing nicotine cravings and lessening withdrawal symptoms once they stop. Around 70 % of the 45 million American smokers want to give up the smoking habits, and for the first time in almost a decade, there is a new prescription option to help them.
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| "Fatal Contact"- a cautionary tale of H5N1 strain - May 10, 2006 16:42 IST |
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An alarmist ABC television network movie "Fatal Contact: Bird Flu in America" aired in the U.S. on Tuesday, May 9 at 8 p.m., has aroused an abdomen-clinching sense of fear among the American public.
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| deCode discovers Genetic Variant Responsible for Prostate Cancer - May 8, 2006 12:12 IST |
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Researchers at deCODE genetics along with fellow academic researchers in Iceland, the US and Sweden today reported the discovery of a common genetic variant that predisposes to prostate cancer.
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| Sanofi-Aventis named in Class Action Suit - May 6, 2006 19:47 IST |
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Sanofi-Aventis, which makes the drug Ambien has been named in a class action lawsuit by Patrick J. Kennedy who claims that the drug cause him to awake in a trance like state, and met with an accident.
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| Vaccine Makers get Federal Funding - May 6, 2006 2:21 IST |
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The US government on Thursday awarded more than US$ 1 billion ($ 1.296 billion) to five drug manufacturers that are developing technology for speedier mass production of better influenza vaccines in case of a pandemic.
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| US Elementary Schools Ban Fizzy Drinks - May 4, 2006 13:7 IST |
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Most fizzy drinks will be cast-out from thousands of primary and secondary schools by the 2009-2010 school year under a beverage-industry agreement brokered by former President Bill Clinton.
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| Britons are healthier than Americans - May 3, 2006 12:52 IST |
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Middle-aged Americans are considerably sicker than their British counterparts even though the United States spends more than twice as much per person on health care as Britain, researchers said Tuesday.
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| Woman with first Partial face transplant has full feeling - May 1, 2006 12:43 IST |
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A resident of Valenciennes, Northern France who received the world’s first partial face transplant five months ago, says she has complete feeling in the new tissue.
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