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Merck Announces Robust Integrated Pipeline With More Than 20 Medicines And Vaccines In Late-Stage Development

March 3, 2010 Health News No Comments

Merck & Co., Inc. (NYSE: MRK) announced its updated, newly integrated, late-stage pipeline following its recent merger with Schering-Plough. The new pipeline features a broad and diversified portfolio of investigational medicines and vaccines, including more than 20 candidates in Phase III or under regulatory review, and more than 20 candidates in Phase II of development. “The combination of two complementary pipelines has yielded a robust and diversified portfolio to fuel Merck’s future growth,” said Peter S. Kim, Ph.D., president, Merck Research Laboratories…

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International Collaboration: FDA And European Medicines Agency Agree To Accept A Single Orphan Drug Designation Annual Report

March 2, 2010 Health News No Comments

In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Both agencies have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products designated by both the United States and the European Union…

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Health Professionals, Researchers And Government Unite To Improve Safe Use Of Medicines And Vaccines By Pregnant Women

February 26, 2010 Health News No Comments

The American Academy of Allergy, Asthma & Immunology (AAAAI) announced that it is launching a new system to provide information to pregnant women and their doctors about using medications and vaccines safely in pregnancy. The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) unites the resources of two leading research institutions and collaborates with five federal agencies. All share an interest in improving maternal-fetal health…

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America’s Biopharmaceutical Companies Studying 183 New Medicines To Counter Diabetes Growth

February 20, 2010 Health News No Comments

A Stratton Spotlight article recently highlighted a Centers for Disease Control and Prevention (CDC) survey that showed a dramatic rise in the number of diabetes cases during the last 10 years and noted that pharmaceutical research and biotechnology companies are working on nearly 200 new medicines to treat this debilitating disease. The rate of new cases of diabetes increased by more than 90 percent among adults over the last 10 years, and fatalities associated with diabetes increased by 45 percent in two decades, according to the CDC study…

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GSK Statement On FDA’s Proposed Label Revisions For Some Asthma Medicines

February 20, 2010 Health News No Comments

GlaxoSmithKline (NYSE: GSK) is reviewing label changes proposed by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK’s Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted. “We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease,” said Dr…

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European Medicines Agency Updates On Pandemic Influenza

February 20, 2010 Health News No Comments

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a conditional marketing authorisation for Humenza from Sanofi Pasteur SA. This is the fifth pandemic vaccine recommended for use by the Committee, and the second to be assessed using an emergency procedure which fast-tracks the evaluation of new vaccines developed during a pandemic influenza. Information on Humenza was evaluated in an accelerated timeframe using a rolling review which started with the submission of the first available data on 23 June 2009…

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European Medicines Agency Recommends Contraindication For Regranex In Patients With Any Pre-Existing Cancer

February 19, 2010 Health News No Comments

Following a review of the available data on a possible risk of cancer in patients using Regranex (becaplermin), from Janssen-Cilag International N.V., the European Medicines Agency has concluded that the medicine must not be used in patients who have any form of cancer. A similar restriction previously applied, but only for patients who had a skin cancer close to the area where the gel was to be applied. Regranex is a gel that is used together with other wound care measures to treat long-term skin ulcers in people with diabetes…

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Aetna Medicare Members To Have Access To Pharmacists Who Can Help Them Safely And Effectively Take Medicines

February 19, 2010 Health News No Comments

Aetna (NYSE: AET) today announced that members who enroll in its 2010 Medicare plans will have access to enhanced services called medication therapy management (MTM) aimed at helping them safely and effectively take medications prescribed by their physician. MTM, which will be delivered by Mirixa Corporation, brings together pharmacists, patients, physicians and other health care professionals to help patients with their medications. “It is critical for our members with chronic diseases to have the assistance they need to safely take their medications thereby reducing adverse drug events…

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Traditional Chinese Practitioner Found Guilty Of Medicines Act Offences

February 18, 2010 Health News No Comments

A traditional Chinese practitioner today received a two-year conditional discharge at the Old Bailey after pleading guilty to five offences of the Medicines Act 1968. Susan Wu, who worked at the ‘Chinese Herbal Medical Centre’ in Chelmsford, Essex, prescribed and sold a traditional Chinese medicine (TCM), Longdan Xie Gan Wan, to a woman who was suffering from a minor skin complaint in 2003. After five years of treatment, the patient has gone on to suffer kidney failure, developed cancer and suffered a heart attack, all of which doctors attribute to the ingestion of the TCM product…

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Safe Practice And Nursing Care Of Patients Receiving Oral Anticancer Medicines

February 17, 2010 Health News No Comments

Safe practice and nursing care of patients receiving oral anticancer medicines: a position statement from UKONS. A position statement from the UK Oncology Nursing Society (UKONS) on the safe, effective use of oral anticancer medicines was published online on 5 February 2010 by ecancermedicalscience…

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Millennium Announces First Clinical Data For TAK-700 Prostate Molecule At ASCO GU

March 10, 2010

Millennium: The Takeda Oncology Company today announced the presentation of safety, pharmacokinetic and efficacy data from the Phase I portion of a Phase I/II clinical trial evaluating TAK-700 in patients with metastatic castration resistant prostate cancer (mCRPC). These data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), held March 5-7, 2010 in San Francisco, CA…

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ImmunoGen, Inc. Announces Orphan Drug Designation Granted To IMGN901 For Treatment Of Merkel Cell Carcinoma By US FDA And EU COMP

March 10, 2010

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its IMGN901 compound when used for the treatment of Merkel cell carcinoma (MCC). Through a separate process, the European Union (EU) Committee for Orphan Medicinal Products (COMP) concurrently also granted IMGN901 orphan medicinal product designation for the treatment of MCC…

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BG Medicine And Abbott To Develop Galectin-3 Test For The I-STAT(R) System

March 10, 2010

BG Medicine, Inc. announced that it has entered into an agreement with Abbott Laboratories (NYSE: ABT) to extend its current development and commercialization collaboration to include the development of a galectin-3 test for Abbott Point of Care’s i-STAT® System. Galectin-3 is a novel biomarker that may play a role in detecting the development and progression of heart failure…

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Refresher: What’s In The Health Reform Bills

March 10, 2010

Since the Senate passed its version of a health overhaul on Christmas Eve, most of the debate has focused on the politics of the effort. By now, many people have forgotten — if they ever knew — what the bill would actually do.

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So here’s a short refresher. According to the Congressional Budget Office, the Senate-passed bill would expand coverage to roughly 30 million of the 46 million people in the U.S. who lack health insurance. Most of the remaining uninsured would be undocumented immigrants, who would be ineligible for benefits… Continue reading

InterMune’s Lung Drug Gets Backing From FDA Panel

March 10, 2010

Another day, another stock-price jump.
First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.
The FDA is expected to decide by early May whether to go along with the panel’s recommendation on pirfenidone, which is intended to treat patients with idiopathic pulmonary fibrosis. The FDA usually follows the lead of its advisory committees.
This all comes as good news for investors in InterMune, whose shares streaked nearly 60% higher Friday because the questions posed by the FDA staff for today’s… Continue reading

Vets Welcome Extension To UK Pet Travel Protection

March 10, 2010

The European Parliament has voted 618 votes to 17 for an extension to the transitional arrangements contained within the regulation on the non-commercial movement of pet animals (Reg. 998/2003) which afford the UK additional protection against rabies, ticks and tapeworms. The British Veterinary Association (BVA) and British Small Animal Veterinary Association (BSAVA) have been lobbying MEPs to support the extension and have strongly welcomed this decision…

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Baby slings to get safety warning after deaths

March 10, 2010

The U.S. government is preparing a safety warning about baby slings — those popular and fashionable infant carriers that parents can sling around their chests to carry their baby. Go to Source… Continue reading

Britain may force owners to microchip dogs

March 10, 2010

British dog owners may be forced to microchip their pets and take out insurance, part of a proposed crackdown on the country’s dangerous canines. Go to Source… Continue reading

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