March 2nd, 2010
Biodel Inc. (Nasdaq: BIOD) announced today that the U.S. Food and Drug Administration has accepted for review the company’s new drug application (NDA) seeking approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel’s proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It has been tested in more than 875 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel submitted its marketing application to the FDA on December 30, 2009 and expects the Prescription Drug User Fee Act (PDUFA) action date for this NDA to be October 30, 2010.
Tags: Prescription Drug
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February 9th, 2010
Important Safety Information about Feraheme
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.
In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects receiving Feraheme, including three patients with serious hypotensive reactions. Serious hypersensitivity reactions were reported in 0.2% (3/1726) of patients. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when treatment for hypersensitivity reactions is readily available. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging but will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients were diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema.
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a webcast and conference call today at 4:45 p.m. ET to discuss today’s press release.
The call will be webcast and accessible through the Investors section of the Company’s website at www.amagpharma.com. The webcast replay will be available from approximately 7:45 p.m. ET on February 5, 2010 through midnight February 19, 2010.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. On June 30, 2009, AMAG received approval from the U.S. Food and Drug Administration to market Feraheme? (ferumoxytol) Injection for the treatment of iron deficiency anemia in adult chronic kidney disease patients. For additional company and product information, please visit www.timepharm.com
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February 1st, 2010
Zidovudine or azidothymidine (AZT) is an antiretroviral drug, the first approved for treatment of HIV. Zidovudine was the first drug approved for the treatment of AIDS and HIV infection. Like other reverse transcriptase inhibitors, AZT works by inhibiting the action of reverse transcriptase, the enzyme that HIV uses to make a DNA copy of its RNA. The viral double-stranded DNA is subsequently spliced into the DNA of a target cell, where it is called a provirus. Jerome Horwitz of Barbara Ann Karmanos Cancer Institute and Wayne State University School of Medicine first synthesized AZT in 1964, under a US National Institutes of Health (NIH) grant. It was originally intended to treat cancer, but failed to show efficacy and had an unacceptably high side effect profile. In 1985, when Samuel Broder, Hiroaki Mitsuya, and Robert Yarchoan, three scientists in the National Cancer Institute (NCI), collaborating with Janet Rideout and several other scientists at Burroughs Wellcome (now GlaxoSmithKline), started working on it as an AIDS drug. After showing that this drug was an effective agent against HIV in vitro, the team conducted the initial clinical trial that provided evidence that it could increase CD4 counts in AIDS patients.
AZT does not destroy the HIV infection, but only delays the progression of the disease and the replication of virus, even at very high doses. During prolonged AZT treatment HIV has the ability to gain an increased resistance to AZT by mutation of the reverse transcriptase. A study showed that AZT could not impede the resumption of virus production, and eventually cells treated with AZT produced viruses as much as the untreated cells. So as to slow the development of resistance, it is generally recommended that AZT be given in combination with another reverse transcriptase inhibitor and an antiretroviral from another group, such as a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor.
AZT may be used in combination with other antiretroviral medications to substantially reduce the risk of HIV infection following a significant exposure to the virus (such as a needle-stick injury involving blood or body fluids from an individual known to be infected with HIV). AZT is also recommended as part of a regimen to prevent mother-to-child transmission of HIV during pregnancy, labor and delivery. With no treatment, approximately 25% of infants whose mothers are infected with HIV will become infected. AZT has been shown to reduce this risk to approximately 8% when given in a three-part regimen during pregnancy, delivery and to the infant for 6 weeks after birth. Use of appropriate combinations of antiretroviral medications and cesarean section when necessary can further reduce mother-child transmission of HIV to 1-2%. Common side effects of AZT include nausea, headache, changes in body fat, and discoloration of fingernails and toenails. More severe side effects include anaemia and bone marrow suppression. These unwanted side effects might be caused by the sensitivity of the γ-DNA polymerase in the cell mitochondria. AZT has been shown to work additively or synergistically with many anti-HIV agents; however, acyclovir and ribavirin decrease the antiviral effect of AZT.
Formal Chemical Name (IUPAC)
1-((2R,4S,5S)-4-azido-5-(hydroxymethyl)tetrahydrofuran-2-yl)-5-methylpyrimidine-2,4(1H,3H)-dione
Tags: Zidovudine
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January 26th, 2010
China MEdicine Corporation (OTC Bulletin Board: CHME) (”China Medicine” or “the Company”), primarily a leading distributor and a developer of Western pharmaceuticaLS, traditional Chinese medicines (”TCM”), and other nutriceuticals today announced that it has entered into a Stock Subscription Agreement for an equity private placement (the “Subscription Agreement”) with One Equity Partners (”OEP”), the GLobal private equity investment arm of JPMorgan Chase & Co.
China Medicine is OEP’s first investment in Greater China and refleCTS the firm’s commitment to back aspirational management teams to accelerate the growth of their businesses.
Subject to certain CLosing conditions, OEP has agreed to purchase 4,000,000 of the Company’s common shares at $3.00 per share and 1,920,000 of the Company’s redeemable convertible preferred shares at $30 per share, for an aggregate purchase price of $69.6 million. Each redeemable convertible preferred share is initially convertible into ten common shares. At closing, the Company will receive $12 million in proceeds while the remaining $57.6 million in proceeds will be placed in escrow until released to fund additional capital EXpenditures and acquisition projects.
*qoute from news.chinaventure.com.cn*
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January 16th, 2010
Flu refers to illnesses caused by a number of different influenza viruses. Flu can cause a range of symptoms and effects, from mild to lethal.
Two strains of flu, seasonal flu and the H1N1 (Swine) flu, are currently circulating in the United States. A third, highly lethal H5N1 (Bird) flu is being closely tracked overseas.
Most healthy people recover from the flu without problems, but certain people are at high risk for serious complications.
Extensive efforts are underway to track and monitor the spread of all flu viruses. In the U.S., epidemiologists at the Centers for Disease Control (CDC) are working with states to collect, compile and analyze reports of flu outbreaks. More on the current situation.
Flu symptoms may include fever, coughing, sore throat, runny or stuffy nose, headaches, body aches, chills and fatigue. In H1N1 flu infection, vomiting and diarrhea may also occur.
Annual outbreaks of the seasonal flu usually occur during the late fall through early spring. Most people have natural immunity, and a seasonal flu vaccine is available. In a typical year, approximately 5 to 20 percent of the population gets the seasonal flu and approximately 36,000 flu-related deaths are reported.
This year, the H1N1 flu virus may cause a more dangerous flu season with a lot more people getting sick, being hospitalized and dying than during a regular flu season. H1N1 is a new virus first seen in the United States. It is contagious and spreads from person to person. Like seasonal flu, illness in people with H1N1 can vary from mild to severe.
A flu pandemic occurs when a new influenza A virus emerges for which there is little or no immunity in the human population; the virus causes serious illness and spreads easily from person-to-person worldwide. On June 11, 2009, the World Health Organization (WHO) declared that a global pandemic of H1N1 flu is underway.
H5N1 (Bird) flu is an influenza A virus subtype that is highly contagious among birds. Rare human infections with the H5N1 (Bird) flu virus have occurred. The majority of confirmed cases have occurred in Asia, Africa, the Pacific, Europe and the Near East. Currently, the United States has no confirmed human H5N1 (Bird) flu infections, but H5N1 (Bird) flu remains a serious concern with the potential to cause a deadly pandemic.
*Quote from www.flu.gov*
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January 11th, 2010

An enzyme that normally helps break down stored fats becomes highly active in some cancer cells and makes them more likely to spread, researchers have found.
When the enzyme, called monoacylglycerol lipase (MAGL), goes into overdrive in cancer cells, it breaks down stored fats to produce large amounts of free fatty acids, which are the building blocks of cell membranes and of fatty molecules that serve as signals between cells. These free fatty acids then produce other smaller molecules that promote cancer growth and progression, the study authors noted.
The finding that stored fats in cancer cells can cause them to become more aggressive offers a possible explanation for the reported link between obesity and cancer, according to the researchers at the Scripps Research Institute in California. They also said MAGL may offer a new target for treating aggressive forms of cancer or for preventing cancer progression.
“Historically, research has focused on the mechanisms leading to cancer formation, and therapies have focused on taking out cancer cells. But here we were looking for pathways that lead to cancer aggressiveness,” corresponding author Benjamin Cravatt, chair of the Scripps Research Department of Chemical Physiology, said in a news release.
He noted that people who eat high-fat foods are constantly introducing free fatty acids into their bodies.
“We have shown that cancer cells have their own pathways to produce free fatty acids, which will enable them to become more aggressive. Less malignant cancer cells do not appear to have adopted an autonomous pathway to increase their own pools of free fatty acids. Thus, taking free fatty acids from the diet could assist these cells in developing a more malignant phenotype,” Cravatt said.
The study was published in the Jan. 8 issue of the journal Cell.
Tags: cancer, cancer aggressiveness, cancer cells, cancer formation
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December 31st, 2009


To celebrate the arrival of the Christmas & the New Year’s Day and thank for all the people’ s hard work during the passed year, Mr Cai, the CEO of Time-chem, together with the staff hold a warm party, which touched the hearts of all people, enhanced communication among the various departments and encouraged all people to work hard in the future. Furthermore, it’s showed the best cares for all the employees from the leaders.
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December 25th, 2009
It seems that Christmas time is here once again, and it is time again to bring in the New Year. Time-chem wish the merriest of Christmas to you and your loved ones, and we wish you happiness and prosperity in the year ahead.

Tags: merry christmas
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December 7th, 2009
Adding the drug cetuximab to neoadjuvant chemotherapy can shrink tumors and boost the odds of successful surgery in colorectal cancer patients with inoperable metastatic liver lesions, new research suggests.
Tumors spread to other parts of the body in more than half of patients with colorectal cancer. Most commonly, the cancer spreads to the liver. Removing the tumors in the liver can cure patients, but about 80 percent have inoperable disease and a poor prognosis when they see doctors, the researchers explain in the Nov. 24 online edition of The Lancet Oncology.
Previous research suggests that neoadjuvant treatment with irinotecan- or oxaliplatin-based chemotherapy can make surgery more likely to succeed. The new study aimed to see if addition of the drug cetuximab, also known as Erbitux, would help patients even more.
The study authors, Gunnar Folprecht, from University Hospital Carl Gustav Carus in Dresden, Germany, and colleagues from Germany and Austria found that treatment with cetuximab boosted the proportion of tumors that could be treated with surgery. The treatment, in general, didn’t have serious side effects.
“Our data suggest that treatment with cetuximab and chemotherapy results in high confirmed tumor response rates … leading to … increased respectability,” Folprecht and colleagues wrote. “In the light of recent studies in metastatic colorectal cancer, the value of further treatment intensification will be investigated.”
Tags: cancer
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December 3rd, 2009

aids
While the war against HIV/AIDS is still far from over, 2009 could prove to be a watershed year in terms of advances in prevention and treatment, experts say.The view on this World AIDS Day, Dec. 1, does seem a bit brighter. In fact, just last month a United Nations report found that the number of people infected with HIV globally has remained unchanged, at about 33 million, for the past two years, and may have peaked in the late 1990s.
Why the change? One big reason could be expanded access to antiretroviral drugs. A report released in October by the World Health Organization, UNICEF and UNAIDS found that 42 percent of people in the developing world who carry HIV now have access to life-extending medications. By the end of 2008, more than 4 million people worldwidewere on antiretroviral medicines — 2.9 million of them in sub-Saharan Africa, where the bulk of HIV-positive people live. That’s a tenfold increase in access over the prior five years.Other nonprofit groups — most notably the Clinton Foundation and the Gates Foundation — have also led the charge, helping to broker price-reduction schemes with pharmaceutical companies for the cheap distribution of AIDS drugs in poorer nations.More widespread access to treatment may also pay dividends in prevention, one expert noted.
In fact, the U.S. Centers for Disease Control and Prevention and the U.S. National Institutes of Health are planning major studies in New York City and Washington, D.C., to see if better identification and treatment of HIV-positive people can help keep infection rates down across the community as a whole.There was also promising news this year in terms of the search for an effective AIDS vaccine.
In October, researchers reporting in the New England Journal of Medicine confirmed that a combination of two vaccines brought about a modest, 31 percent reduction in infection rates among a cohort of 16,000 young adult volunteers in Thailand who were tracked for about three years. Analysis of the trial data suggested that the vaccines’ effect faded with time, however, and was less effective in those at highest risk of HIV, such as sex workers or IV drug abusers.
For these reasons, no one is calling the trial a success. However, the reason that we think it is potentially important is that it’s the first time that we’ve ever seen the slightest positive signal” that immunization against HIV might work.
There were also new glimmers of hope in terms of treatment. One major story was reported as a case study in February in the New England Journal of Medicine. The patient in question was both HIV-positive and had leukemia, and received a stem cell transplant to help cure the cancer. The transplant was unique, however, in that the donor carried a rare gene mutation providing virtual immunity to HIV.
The result: post-transplant, the patient now has no detectable level of HIV in his system.Such a therapy could never become a widespread treatment for HIV/AIDS, because the donor pool is so scarce and bone marrow transplants carry a 30 percent risk of death. But the case does offer intriguing possibilities.It’s a proof of concept that maybe you can cure HIV. So, there’s been interest in finding out where you could do something similar with using gene therapy, bypassing the need for dangerous stem cell transplants.
Other advances in HIV/AIDS made headlines as well in 2009. In February, a topical microbicide gel was found to cut the odds of HIV infection in at-risk African women by 30 percent, while in September researchers at the International AIDS Vaccine Initiative said they’d discovered two immune-system antibodies that might become powerful, broad-spectrum targets for vaccine research in the future.
Tags: HIV, HIV-positive, HIV/AIDS
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