RX (prescription) drug news from RX-s.net 2012-05-17T18:54:21+00:00 Patients should consult before stopping Pfizer drug-FDA tag:rx-s.net,2012:/1.1325 U.S. health regulators said patients should not stop taking Pfizer Inc’s Zithromax antibiotic without consulting a doctor, after a study showed a slightly higher rate of death among patients taking the drug compared to those on other antibiotics. The U.S. Food and Drug Administration said it was aware of the study, which was published in the New England Journal of Medicine, comparing Zithromax to Bayer’s Cipro and Johnson & Johnson’s Levaquin. Pfizer’s antibiotic showed a slightly higher rate of death due to heart complications. 2012-05-17T18:53:00+00:00 2012-05-17T18:54:21+00:00 2012-05-17T18:53:00+00:00 U.S. health regulators said patients should not stop taking Pfizer Inc’s Zithromax antibiotic without consulting a doctor, after a study showed a slightly higher rate of death among patients taking the drug compared to those on other antibiotics.

The U.S. Food and Drug Administration said it was aware of the study, which was published in the New England Journal of Medicine, comparing Zithromax to Bayer’s Cipro and Johnson & Johnson’s Levaquin.

Pfizer’s antibiotic showed a slightly higher rate of death due to heart complications.

]]> Zytiga (abiraterone acetate) tag:rx-s.net,2012:/1.1324 Zytiga (abiraterone acetate) is an orally active inhibitor CYP17 a cytochrome p450 complex that is involved in testosterone production. Zytiga is specifically indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. Zytiga is supplied as a tablet for oral administration. The recommended dose is 1,000 mg administered orally once daily in combination with prednisone 5 mg administered orally twice daily. Zytiga must be taken on an empty stomach. 2012-05-17T05:29:00+00:00 2012-05-17T05:31:30+00:00 2012-05-17T05:29:00+00:00 Zytiga (abiraterone acetate) is an orally active inhibitor CYP17 a cytochrome p450 complex that is involved in testosterone production.

Zytiga is specifically indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

Zytiga is supplied as a tablet for oral administration. The recommended dose is 1,000 mg administered orally once daily in combination with prednisone 5 mg administered orally twice daily. Zytiga must be taken on an empty stomach.

]]> Roche melanoma drug extends life more than a yr-study tag:rx-s.net,2012:/1.1323 Roche Holding AG’s new drug for advanced melanoma, Zelboraf, on average helped patients with the deadly disease live for more than a year, according to data from a late-stage trial. The results from an abstract, or brief summary, of the study showed that Zelboraf led to a median overall survival of 13.2 months compared with 9.6 months for those who received dacarbazine chemotherapy. That translates into a 38 percent reduction in the risk of death from the disease, researchers said. The overall survival data, which will be presented at next month’s American Society of Clinical Oncology meeting in Chicago, is a follow-up to a pivotal 675-patient Phase III study that was presented at the meeting last year and led to the drug’s approval. 2012-05-17T05:18:04+00:00 2012-05-17T05:19:33+00:00 2012-05-17T05:18:04+00:00 Roche Holding AG’s new drug for advanced melanoma, Zelboraf, on average helped patients with the deadly disease live for more than a year, according to data from a late-stage trial.

The results from an abstract, or brief summary, of the study showed that Zelboraf led to a median overall survival of 13.2 months compared with 9.6 months for those who received dacarbazine chemotherapy. That translates into a 38 percent reduction in the risk of death from the disease, researchers said.

The overall survival data, which will be presented at next month’s American Society of Clinical Oncology meeting in Chicago, is a follow-up to a pivotal 675-patient Phase III study that was presented at the meeting last year and led to the drug’s approval.

]]> Glaxo melanoma drug combo shows promise in small trial tag:rx-s.net,2012:/1.1322 Two drugs being developed by GlaxoSmithKline Plc - each designed to block different pathways used by cancer cells - have been shown in a small clinical trial to curb melanoma with fewer side effects than current therapies. The experimental drugs are dabrafenib, designed to work in patients with a mutation of a gene known as BRAF, and trametinib, which interferes with a protein known as MEK. The drug combination was tested in patients with advanced melanoma and a mutation in the BRAF gene. About half of all melanomas - the deadliest form of skin cancer - have the genetic aberration. Roche Holding AG’s Zelboraf, or vemurafenib, is the only BRAF inhibitor approved for treating melanoma. It was shown in a pivotal trial to reduce the risk of death by 63 percent, but up to a third of patients who take the pill develop a less-deadly form of skin cancer known as cutaneous squamous cell carcinoma. In addition, most patients eventually develop resistance to the drug. 2012-05-17T04:39:03+00:00 2012-05-17T04:48:28+00:00 2012-05-17T04:39:03+00:00 Two drugs being developed by GlaxoSmithKline Plc - each designed to block different pathways used by cancer cells - have been shown in a small clinical trial to curb melanoma with fewer side effects than current therapies.

The experimental drugs are dabrafenib, designed to work in patients with a mutation of a gene known as BRAF, and trametinib, which interferes with a protein known as MEK. The drug combination was tested in patients with advanced melanoma and a mutation in the BRAF gene. About half of all melanomas - the deadliest form of skin cancer - have the genetic aberration.

Roche Holding AG’s Zelboraf, or vemurafenib, is the only BRAF inhibitor approved for treating melanoma. It was shown in a pivotal trial to reduce the risk of death by 63 percent, but up to a third of patients who take the pill develop a less-deadly form of skin cancer known as cutaneous squamous cell carcinoma. In addition, most patients eventually develop resistance to the drug.

]]> OraSure surges on recommendation for HIV test tag:rx-s.net,2012:/1.1321 Shares of OraSure Technologies Inc. jumped to a six-year high Wednesday after a Food and Drug Administration panel said the company’s at-home HIV test should be approved. THE SPARK: On Tuesday an FDA panel voted unanimously in favor of the OraQuick In-Home HIV Test. The product is designed to return test results in 20 minutes based on a mouth swab. OraSure wants to sell it over the counter. The test appears to be less accurate than tests administered by professionals, but it could help address the relatively large number of people who have HIV and do not know it. The federal government estimates that about 1.2 million people in the U.S. have HIV, and 20 percent, or 240,000, do not know it. 2012-05-16T19:28:00+00:00 2012-05-16T19:28:50+00:00 2012-05-16T19:28:00+00:00 Shares of OraSure Technologies Inc. jumped to a six-year high Wednesday after a Food and Drug Administration panel said the company’s at-home HIV test should be approved.

THE SPARK: On Tuesday an FDA panel voted unanimously in favor of the OraQuick In-Home HIV Test. The product is designed to return test results in 20 minutes based on a mouth swab. OraSure wants to sell it over the counter. The test appears to be less accurate than tests administered by professionals, but it could help address the relatively large number of people who have HIV and do not know it.

The federal government estimates that about 1.2 million people in the U.S. have HIV, and 20 percent, or 240,000, do not know it.

]]> FDA approves 20 minute take-home HIV test tag:rx-s.net,2012:/1.1320 One of the biggest problems in fighting the spread of AIDS has always been convincing people to have themselves tested regularly. Unfortunately, getting someone to take a trip to a clinic isn’t always easy, particularly in areas where there aren’t many options for discrete testing. In a development that could leap right over this privacy hurdle, the U.S. Food and Drug Administration has just unanimously approved an over-the-counter HIV test that enables people to test themselves in their own home and receive results in just 20 minutes. The company behind the test, Orasure, has been distributing its OraQuick HIV test to doctors and medical facilities since 2004. With the stamp of approval from the FDA though, the same test could be as easy for consumers to obtain and use as a pregnancy test. There have been take-home HIV tests before, but those have involved mailing a blood sample off to a lab and then waiting several days for results. 2012-05-16T11:30:00+00:00 2012-05-16T11:31:56+00:00 2012-05-16T11:30:00+00:00 One of the biggest problems in fighting the spread of AIDS has always been convincing people to have themselves tested regularly. Unfortunately, getting someone to take a trip to a clinic isn’t always easy, particularly in areas where there aren’t many options for discrete testing. In a development that could leap right over this privacy hurdle, the U.S. Food and Drug Administration has just unanimously approved an over-the-counter HIV test that enables people to test themselves in their own home and receive results in just 20 minutes.

The company behind the test, Orasure, has been distributing its OraQuick HIV test to doctors and medical facilities since 2004. With the stamp of approval from the FDA though, the same test could be as easy for consumers to obtain and use as a pregnancy test. There have been take-home HIV tests before, but those have involved mailing a blood sample off to a lab and then waiting several days for results.

]]> Achillion’s hepatitis C drug gets FDA fast track tag:rx-s.net,2012:/1.1319 The U.S. Food and Drug Administration granted a fast track designation to Achillion Pharmaceuticals Inc’s experimental hepatitis C drug ACH-3102, currently in an early-stage trial. The fast-track status is designed to expedite the regulatory review of drugs that aim to treat serious diseases and fill unmet medical needs. The New Haven, Connecticut-based company got a fast track designation in January for another of its experimental hepatitis C (HCV) drug ACH-1625, which was in a mid-stage trial. 2012-05-15T19:16:00+00:00 2012-05-15T19:17:33+00:00 2012-05-15T19:16:00+00:00 The U.S. Food and Drug Administration granted a fast track designation to Achillion Pharmaceuticals Inc’s experimental hepatitis C drug ACH-3102, currently in an early-stage trial.

The fast-track status is designed to expedite the regulatory review of drugs that aim to treat serious diseases and fill unmet medical needs.

The New Haven, Connecticut-based company got a fast track designation in January for another of its experimental hepatitis C (HCV) drug ACH-1625, which was in a mid-stage trial.

]]> Roche Alzheimer’s drug picked for major test tag:rx-s.net,2012:/1.1318 Roche Holding AG’s Genentech unit has won the right to try its experimental Alzheimer’s drug crenezumab on people with no signs of dementia - the first such trial to gauge whether early intervention can help prevent or slow the disease. The drug will be tested among members of an extended family of about 5,000 people from the Antioquia region of Colombia. They carry a gene that causes them to develop Alzheimer’s early, with some experiencing symptoms of memory loss in their mid-30s, scientists say. The U.S. Department of Health & Human Services is backing the trial with a $16 million grant as part of the government’s National Alzheimer’s Plan announced on Tuesday, which includes a target to find an effective treatment or prevention by 2025. 2012-05-15T19:15:00+00:00 2012-05-15T19:16:44+00:00 2012-05-15T19:15:00+00:00 Roche Holding AG’s Genentech unit has won the right to try its experimental Alzheimer’s drug crenezumab on people with no signs of dementia - the first such trial to gauge whether early intervention can help prevent or slow the disease.

The drug will be tested among members of an extended family of about 5,000 people from the Antioquia region of Colombia. They carry a gene that causes them to develop Alzheimer’s early, with some experiencing symptoms of memory loss in their mid-30s, scientists say.

The U.S. Department of Health & Human Services is backing the trial with a $16 million grant as part of the government’s National Alzheimer’s Plan announced on Tuesday, which includes a target to find an effective treatment or prevention by 2025.

]]> FDA says unsure if Novartis MS pill caused deaths tag:rx-s.net,2012:/1.1317 The U.S. Food and Drug Administration said it could not conclude that Novartis AG’s multiple sclerosis pill Gilenya was related to unexplained deaths of patients, but it remains concerned about the cardiovascular effects of the drug after the first dose. In recent months, doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment. 2012-05-14T20:42:00+00:00 2012-05-14T20:42:47+00:00 2012-05-14T20:42:00+00:00 The U.S. Food and Drug Administration said it could not conclude that Novartis AG’s multiple sclerosis pill Gilenya was related to unexplained deaths of patients, but it remains concerned about the cardiovascular effects of the drug after the first dose.

In recent months, doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.

]]> French drugmaker on trial over weight-loss pill tag:rx-s.net,2012:/1.1316 French drugmaker Servier and its founder went on trial on Monday accused of misleading patients and authorities about a diabetes drug often prescribed for weight loss that officials blame for at least 500 deaths. The case, one of France’s worst health scandals, has put authorities under scrutiny for allowing the sale of Mediator long after the medicine had been pulled in other European countries. Although licensed as a diabetes treatment, the drug was widely prescribed, with a state subsidy, as an appetite suppressant to help people lose weight. 2012-05-14T20:40:02+00:00 2012-05-14T20:41:55+00:00 2012-05-14T20:40:02+00:00 French drugmaker Servier and its founder went on trial on Monday accused of misleading patients and authorities about a diabetes drug often prescribed for weight loss that officials blame for at least 500 deaths.

The case, one of France’s worst health scandals, has put authorities under scrutiny for allowing the sale of Mediator long after the medicine had been pulled in other European countries.

Although licensed as a diabetes treatment, the drug was widely prescribed, with a state subsidy, as an appetite suppressant to help people lose weight.

]]>