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GSK update on current development status of the GSK/NIH Ebola vaccine candidate

Posted 6 days ago in Pharma Industry News

London UK -- 18 October 2014 -- With the Ebola crisis in west Africa continuing, GSK is working closely with the World Health Organization (WHO), regulators and other partners to respond to the outbreak, to accelerate development of our investigational Ebola vaccine and to ramp up production as quickly as possible. Development of the vaccine candidate is progressing at an unprecedented rate, with first phase 1 safety trials with the vaccine candidate underway in the USA, UK and Mali, and...

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Joan Rivers Died from Complications Under Propofol, Coroner Rules

Posted 8 days ago in Pharma Industry News

THURSDAY, Oct. 16, 2014 -- Joan Rivers has died of "therapeutic complications" while undergoing a procedure to evaluate vocal and gastrointestinal issues, according to the New York medical examiner. The death was caused by a lack of oxygen to the brain during a laryngoscopy, a procedure to view the vocal chords, and an upper gastrointestinal endoscopy. She was sedated with the drug propofol, the medical examiner said. The medical examiner ruled that the cause of death was "anoxic...

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FDA Approves Lutonix 035 DCB - First Drug-Coated Angioplasty Balloon Catheter to Treat Vascular Disease

Posted 2 weeks ago in Pharma Industry News

October 10, 2014 -- The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD). PAD occurs when fatty material (plaque) builds up in the arteries that carry blood to the limbs, usually affecting...

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Rescheduling of Hydrocodone Combo Prescriptions: As of Today, Refills Become More Difficult

Posted 2 weeks ago in Pharma Industry News

October 6, 2014 -- Today the final DEA rule on switching hydrocodone combination products like Lortab and Vicodin from schedule III to schedule II comes into effect. This rule has been put into place to help curb abuse and encourage patients and prescribers to consider alternative ways to deal with pain. What does this mean? Until now, hydrocodone combination products were regulated as schedule III drugs. These drugs, used as pain relievers or cough suppressants, contain both hydrocodone...

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Re-scheduling prescription hydrocodone combination drug products: An important step toward controlling misuse and abuse

Posted 2 weeks ago in Pharma Industry News

October 6, 2014 -- Hydrocodone is the most prescribed opioid in the United States, including 137 million prescriptions in 2013. While it is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States. With the aim of curbing this misuse and abuse, new prescribing requirements go into effect today for hydrocodone combination products, which include products such as Anexsia, Lorcet, Vicodin, and some cough...

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CDC and Texas Health Department Confirm First Ebola Case Diagnosed in the U.S.

Posted 3 weeks ago in Pharma Industry News

September 30, 2014 -- The Centers for Disease Control and Prevention (CDC) confirmed today, through laboratory tests, the first case of Ebola to be diagnosed in the United States in a person who had traveled to Dallas, Texas from Liberia. The patient did not have symptoms when leaving West Africa, but developed symptoms approximately four days after arriving in the U.S. on Sept. 20. The person fell ill on Sept. 24 and sought medical care at Texas Health Presbyterian Hospital of Dallas on...

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Monthly News Roundup - September 2014

Posted 3 weeks ago in Pharma Industry News

Orexigen’s Combo Drug Contrave Approved for Weight Loss The U.S. Food and Drug Administration has approved Contrave (bupropion HCl/naltrexone HCl) for chronic weight management in addition to diet and physical activity. Contrave is an extended-release form of two previously approved drugs, naltrexone (ReVia, Vivitrol) and bupropion (Wellbutrin, Zyban). Naltrexone is approved to treat alcohol or opioid dependence, while bupropion is used for depression, seasonal affective disorder and as an...

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U.S. Marshals Seize Botanical Substance Kratom from Southern California Facility

Posted 4 weeks ago in Pharma Industry News

September 25, 2014 -- U.S. Marshals at the request of the U.S. Food and Drug Administration today seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California. Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Kratom is promoted on numerous websites in the United States for its psychoactive and opioid-like analgesic...

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NIH and FDA Win Top Award for Intellectual Property Licensing of Meningitis Vaccine

Posted 4 weeks ago in Pharma Industry News

September 25, 2014 -- The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the Licensing Executives Society at the society’s 50th annual meeting, Oct. 5-8 in...

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Tekmira Establishes Regulatory Framework for Emergency Use of TKM-Ebola

Posted 4 weeks ago in Pharma Industry News

VANCOUVER, British Columbia, Sept. 22, 2014 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, today announced that the FDA has authorized Tekmira to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections. "Tekmira is reporting that an appropriate regulatory and clinical framework is now in place to allow the use of TKM-Ebola in patients. We have worked...

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FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas

Posted 6 weeks ago in Pharma Industry News

September 9, 2014 -- The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in...

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FDA allows marketing of the first test to assess risk of developing acute kidney injury

Posted 7 weeks ago in Pharma Industry News

September 5, 2014 -- Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death. The kidneys...

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U.S. Marshals seize drug products from Flawless Beauty

Posted 7 weeks ago in Pharma Industry News

September 4, 2014 -- Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed to individuals, retail outlets, health spas and clinics. The seized products,...

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Monthly News Roundup - August 2014

Posted 7 weeks ago in Pharma Industry News

Belsomra: Merck’s First-in-Class Insomnia Treatment Approved The U.S. Food and Drug Administration (FDA) approved the long-awaited Belsomra (suvorexant) tablets for difficulty in falling and staying asleep (insomnia). Belsomra, in a new class called orexin receptor antagonists, blocks the action of orexin, a chemical involved in the sleep-wake cycle in the brain. The FDA has approved Belsomra in various 5 to 20 milligram (mg) strengths. Belsomra is taken once 30 minutes before bed with a...

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FDA takes action against Georgia dietary supplement manufacturer

Posted 8 weeks ago in Pharma Industry News

MONDAY August 25, 2014 -- A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber. BioAnue’s products were sold as...

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DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

Posted 9 weeks ago in Pharma Industry News

August 21, 2014 -- On Friday the U. S. Drug Enforcement Administration (DEA) will publish in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA’s own evaluation of relevant data. The Federal Register has made the Final Rule available for preview on its website today at...

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FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes

Posted 9 weeks ago in Pharma Industry News

August 20, 2014 -- Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease. Type 1 diabetes is the most common type of diabetes diagnosed in children and adolescents, but...

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Turkish man pleads guilty to importing illegal cancer drugs

Posted 10 weeks ago in Pharma Industry News

August 15, 2014 -- Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States. Akman pleaded guilty in the U.S. District Court for the Eastern District of Missouri, in St. Louis, Missouri, where he initially shipped his illegal drugs. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States. The FDA’s...

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FDA Warns Consumers About Fraudulent Ebola Treatment Products

Posted 10 weeks ago in Pharma Industry News

August 14, 2014 -- The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection. There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. Although there are experimental Ebola vaccines and...

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Everything You Need to Know About Experimental Ebola Treatment ZMapp

Posted 11 weeks ago in Pharma Industry News

FAQ: Ebola Experimental Treatments & Vaccines This FAQ addresses questions the public has about potential treatments and vaccines for Ebola. This material has been cross posted on the CDC website. What is ZMapp? ZMapp, being developed by Mapp Biopharmaceutical Inc., is an experimental treatment, for use with individuals infected with Ebola virus. It has not yet been tested in humans for safety or effectiveness. The product is a combination of three different monoclonal antibodies that...

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