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FDA issues additional guidance for outsourcing facilities that compound sterile human drugs

Posted 5 days ago in Pharma Industry News

November 21, 2014 -- Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013. The DQSA added section 503B to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 503B, a compounder can elect to...

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FDA Concerns About Therapeutic Equivalence with Two Generic Versions of Concerta Tablets

Posted 13 days ago in Pharma Industry News

November 13, 2014 -- Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. As a result, the FDA has changed the...

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Monthly News Roundup - October 2014

Posted 3 weeks ago in Pharma Industry News

AstraZenenca’s Xigduo XR Approved for Type 2 Diabetes Type 2 diabetes is estimated to affect 29.1 million people in America. The U.S. Food and Drug Administration (FDA) has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a combination drug of two agents that work together to lower blood sugar. Dapagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin is a biguanide. Clinical evidence of safety and efficacy for Xigduo...

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Pfizer’s Pristiq Demonstrates Low Potential For Sexual Dysfunction in Adults with Major Depressive Disorder

Posted 4 weeks ago in Pharma Industry News

October 29, 2014 - Pfizer Inc. today announced the publication of a clinical study in the Journal of Clinical Psychiatry showing comparable sexual function in adult patients diagnosed with major depressive disorder (MDD) treated daily with Pristiq (desvenlafaxine) Extended Release Tablets 50mg and 100mg doses versus placebo. Sexual dysfunction is often an issue for patients treated with antidepressants, and Pfizer conducted the study pursuant to a postmarketing requirement by the U.S. Food and...

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Merck Receives FDA Breakthrough Therapy Designation for Keytruda in Advanced Non-Small Cell Lung Cancer

Posted 4 weeks ago in Pharma Industry News

WHITEHOUSE STATION, N.J.-- October 27, 2014 --Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on...

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FDA Approves Edenbridge Pharmaceuticals' Generic Stromectol (Ivermectin Tablets 3mg)

Posted 4 weeks ago in Pharma Industry News

Parsippany, New Jersey, October 24, 2014 -- Edenbridge Pharmaceuticals, LLC today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Merck & Co., Inc.'s Stromectol (ivermectin tablets 3 mg). Prior to today, there have been no FDA approved generic versions of Stromectol and Edenbridge intends to begin shipping its Ivermectin Tablets USP 3mg product shortly. This is Edenbridge's first FDA...

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

Posted 5 weeks 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 5 weeks 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 6 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 7 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 7 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 8 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 8 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 8 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 8 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 9 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 11 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 11 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 11 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 12 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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