Pharmaceutical Industry News

Get news by email or subscribe to our news feeds.

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

Posted today 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...

Read more...

Monthly News Roundup - September 2014

Posted yesterday 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...

Read more...

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

Posted 5 days 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...

Read more...

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

Posted 5 days 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...

Read more...

Tekmira Establishes Regulatory Framework for Emergency Use of TKM-Ebola

Posted 8 days 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...

Read more...

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

Posted 3 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...

Read more...

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

Posted 3 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...

Read more...

U.S. Marshals seize drug products from Flawless Beauty

Posted 3 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,...

Read more...

Monthly News Roundup - August 2014

Posted 4 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...

Read more...

FDA takes action against Georgia dietary supplement manufacturer

Posted 5 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...

Read more...

DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

Posted 5 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...

Read more...

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

Posted 5 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...

Read more...

Turkish man pleads guilty to importing illegal cancer drugs

Posted 6 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...

Read more...

FDA Warns Consumers About Fraudulent Ebola Treatment Products

Posted 6 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...

Read more...

Everything You Need to Know About Experimental Ebola Treatment ZMapp

Posted 8 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...

Read more...

Jazz Pharmaceuticals Completes Acquisition Of Rights To Defibrotide

Posted 8 weeks ago in Pharma Industry News

DUBLIN, Aug. 5, 2014 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the closing of its acquisition of rights to defibrotide in the United States (U.S.) and all other countries in the Americas from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau). Jazz Pharmaceuticals now owns worldwide rights to defibrotide. Defibrotide is a novel product that is marketed by Jazz Pharmaceuticals in the European Union (EU) under the name Defitelio® for the treatment of severe hepatic...

Read more...

FDA takes steps to help ensure the reliability of certain diagnostic tests

Posted 8 weeks ago in Pharma Industry News

July 31, 2014 -- Today, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results. First, the FDA is issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are...

Read more...

Monthly News Roundup - July 2014

Posted 8 weeks ago in Pharma Industry News

GSK’s Flonase Allergy Relief Approved for OTC Use Roughly 50 million people in the U.S. suffer from nasal allergies. The U.S. Food and Drug Administration (FDA) has approved Flonase Allergy Relief (fluticasone propionate 50 mcg spray) as an over-the-counter (OTC) nasal spray for the symptoms of hay fever or upper respiratory allergies. Flonase Allergy Relief can be used for nasal and eye-related allergy symptoms, including runny and itchy nose, sneezing, congestion, and itchy and watery...

Read more...

FDA Commissioner's Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer

Posted 9 weeks ago in Pharma Industry News

TUESDAY, July 29, 2014 -- Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun. Over the last few years, the FDA has taken a number of important steps designed to help consumers better understand the harmful effects of exposure from the sun and from indoor tanning. Today, consumers going to a beach or...

Read more...

Boehringer Ingelheim: Benefits and Safety of Pradaxa Repeatedly Confirmed

Posted 9 weeks ago in Pharma Industry News

Ridgefield, CT, July 23, 2014 – Boehringer Ingelheim (BI) wants to set the record straight following misleading statements that the British Medical Journal (BMJ) published today regarding Pradaxa® (dabigatran etexilate mesylate). We are concerned that this publication may alarm patients and prompt them to stop taking Pradaxa, thereby increasing their risk of stroke. To be clear, many of the allegations made by BMJ were reported months ago in the media and have been previously addressed in...

Read more...
Older articles
Hide
(web5)