Health Regulators-Artificial Hips-Hip Implants-Metal Ball

Safety of all-metal hip implants under scrutiny

WASHINGTON (Reuters) - As concerns mount over the safety of metal-on-metal hip implants, health regulators are seeking advice on how best to minimize risks for the more than 500,000 patients who have received the devices. All-metal artificial hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket. Johnson & Johnson is the biggest manufacturer of the all-metal devices, and other device makers include Zimmer Holdings Inc and Wright Medical Group. ... read more..

source:http://yhoo.it/Os5gIx

Food And Drug Administration-Blood Clot Preventer-Bristol-Myers Squibb-Health Regulators

Bristol/Pfizer clot preventer delayed in U.S

(Reuters) - A closely watched blood clot preventer from Bristol-Myers Squibb Co and Pfizer Inc has failed to win approval from U.S. health regulators, the companies said on Monday. Investors have been awaiting a decision on the drug, Eliquis, by the Food And Drug Administration by the end of the month. The FDA notification did not require the companies to complete any new studies, the companies said, which could mean only a short delay before the drug wins approval. Rather, the agency wants more information on data management and verification from a key clinical trial supporting the medicine. ... read more..

source:http://yhoo.it/MmEDll

Food And Drug Administration-Swiss Pharmaceutical Company-Blockbuster Cancer Drug

Roche's breast cancer drug gets FDA nod

Logo of Swiss pharmaceutical company Roche is pictured in Rotkreuz

(Reuters) - U.S. health regulators have approved a new breast cancer drug from Roche Holding AG that the company hopes will become the standard treatment for women with an aggressive, incurable form of cancer. Roche unit Genentech announced Friday that the Food and Drug Administration approved the injectable drug Perjeta for women with a type of breast cancer known as HER-2 positive, which makes up about a quarter of all breast cancers and has no cure. Analysts predict the medicine could be another blockbuster cancer drug for the Swiss company. ... read more..

source:http://yhoo.it/Ms612a

Health Regulators-Hiv Infection

FDA delays decision on first drug to prevent HIV

Federal health regulators have delayed a decision on whether to approve the first pill shown to prevent HIV infection, the drug's manufacturer says. read more..

source:http://yhoo.it/Ms5Q7g

Food And Drug Administration-Drugmaker Novo Nordisk-Health Regulators-Insulin

Novo Nordisk hit by U.S. delay to new insulin drug

The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near Washington

COPENHAGEN (Reuters) - Danish drugmaker Novo Nordisk, the world's biggest insulin maker, said on Friday that U.S. health regulators had extended their review of its new ultra-long-acting insulin Tresiba, or degludec, to consider further data. The unexpected delay is a disappointment since degludec is a pivotal new product with which Novo hopes to consolidate its position in the fast-growing diabetes market. Shares in the group fell 3.1 percent by 0740 GMT. ... read more..

source:http://yhoo.it/KNZYpR

Food And Drug Administration-Salix Pharmaceuticals Ltd-Health Regulators-Full Review

FDA extends review for Salix diarrhea drug

(Reuters) - Salix Pharmaceuticals Ltd said U.S. health regulators have extended the review date by three months for its experimental pill for HIV therapy-related diarrhea. The U.S. Food And Drug Administration was to review the drug, crofelemer, on June 5. The FDA has notified Salix that it requires additional time for a full review but did not seek any additional studies, the company said in a statement. Salix holds the North American and European rights to the drug. ... read more..

source:http://yhoo.it/Jz2Y78

Food And Drug Administration-Birth Control Pills-Health Regulators-Fatal Blood Clots

US adds more on clot risk to some birth control pills

WASHINGTON (Reuters) - U.S. health regulators are adding information to the labels on a popular class of Birth Control pills that includes Bayer AG's Yaz and Yasmin, to show they may raise the risk of blood clots. All common birth control pills increase a woman's chances of getting potentially fatal blood clots. But the U.S. Food And Drug Administration said on Tuesday that some studies showed the danger may be even higher for more recent pills that contain the compound drospirenone, a synthetic hormone. ... read more..

source:http://yhoo.it/IyGjE1

American Cancer Society-Health Regulators-Prostate Cancer-Cancer Therapy-Loud Protests

Insight: New doubts about prostate-cancer vaccine Provenge

NEW YORK (Reuters) - Prostate cancer vaccine Provenge has long incited passions unlike any other cancer therapy. Doctors who raised doubts about it received death threats. Health regulators and lawmakers faced loud protests at their offices. A physician at the American Cancer Society was so intimidated by Provenge partisans that he yanked a skeptical discussion of it from his blog. The vitriol dissipated in April 2010, when the U.S. ... read more..

source:http://yhoo.it/H7SMRY

Food And Drug Administration-Cholesterol Lowering Drugs-Health Regulators-Heart Disease

FDA adds diabetes, memory loss warnings to statins

(Reuters) - U.S. health regulators will add warnings to the labels of widely used cholesterol lowering drugs, such as Lipitor, to indicate that they may raise levels of blood sugar and could cause memory loss. The Food And Drug Administration announced the changes to the safety information on the labels of Statins such as Pfizer Inc's Lipitor, AstraZeneca's Crestor and Merck & Co's Zocor. Statins have been shown to significantly reduce the risk of heart attack and Heart Disease, and the FDA said the new information should not scare people into stopping taking the drugs. ... read more..

source:http://yhoo.it/yrNTZL

Food And Drug Administration-Health Regulators-Neurogesx Inc-Pain

FDA declines to approve NeurogesX patch for HIV pain

(Reuters) - U.S. health regulators declined to approve NeurogesX Inc's patch derived from chili peppers to treat HIV-related Pain and sought new trial data, and the company said it will cut half its workforce to save costs. The U.S. Food And Drug Administration told NeurogesX that to gain approval for the treatment, Qutenza, the company would need to submit additional clinical data from at least one adequate and well-controlled trial. ... read more..

source:http://yhoo.it/AD59du

Food And Drug Administration-Antiretroviral Drugs-Health Regulators-Clinical Trial

Merck gets approval for wider use of HIV drug

(Reuters) - U.S. health regulators have approved an expanded label for Merck & Co's treatment for HIV for use with other antiretroviral drugs in children and adolescents. The safety and effectiveness of the drug was evaluated in a clinical trial of 96 children and adolescents of ages 2-18 years with HIV-1 infection, the U.S. Food And Drug Administration said in a statement. The drug, Isentress, was first approved for use in adult patients in October 2007. (Reporting by Shailesh Kuber in Bangalore; Editing by Don Sebastian) read more..

source:http://yhoo.it/vqE6sK

National Institutes Of Health-Birth Control Pills-Contraceptive Drugs-Health Regulators

FDA favors more risk info on birth control pills

Federal health regulators are leaning toward adding new information about the risk of blood clots to the labels of widely prescribed Birth Control pills such as Yaz, in light of growing evidence that the newer contraceptive drugs may be riskier than older drugs. read more..

source:http://yhoo.it/uYQpFo

Active Surveillance May Benefit Men With Low-Risk Prostate Cancer

WEDNESDAY, Dec. 7 (Healthday News) -- As more men are screened for and diagnosed with low-risk prostate cancer, a new draft report released Wednesday by a U.S. National Institutes of Health panel concluded that research on the safety of "active surveillance" is needed. read more..

source:http://yhoo.it/ru2v7F

Food And Drug Administration-Generic Drugmakers-Health Regulators-Glaxosmithkline

FDA says Merck's HIV drug gets generic threat

(Reuters) - Health regulators said they have received applications from generic drugmakers to make copycat versions of Merck & Co's HIV drug Isentress, GlaxoSmithKline's HIV drug Epivir and Bayer AG's birth control pill Beyaz. However, the U.S. Food and Drug Administration did not disclose the names of the generic drug applicants. Isentress was first approved in 2007 for use in adult patients. Last month, the FDA expanded the label on the drug for use in children and adolescents. Merck shares were trading almost flat at $38.58 on Tuesday on the New York Stock Exchange. ... read more..

source:http://yhoo.it/zwPhxS

Birth Control Pills-Contraceptive Drugs-Health Regulators

FDA favors more risk info on birth control pills

Federal health regulators are leaning toward adding new information about the risk of blood clots to the labels of widely prescribed Birth Control pills such as Yaz, in light of growing evidence suggesting the newer contraceptive drugs may be riskier than older drugs. read more..

source:http://yhoo.it/uYQpFo

FDA favors more risk info on birth control pills

Federal health regulators are leaning toward adding new information about the risk of blood clots to the labels of widely prescribed Birth Control pills such as Yaz, in light of growing evidence that the newer contraceptive drugs may be riskier than older drugs. read more..

source:http://yhoo.it/uYQpFo