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Federal Judge Enters Consent Decree Against Specialty Compounding LLC

Posted 2 weeks ago in Pharma Industry News

March 11, 2015 -- U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. The U.S. Department of Justice brought...

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Monthly News Roundup - February 2015

Posted 4 weeks ago in Pharma Industry News

Sanofi Receives FDA Approval for Basal Insulin Toujeo The U.S. Food and Drug Administration has approved Sanofi’s Toujeo (insulin glargine [rDNA origin], a once-daily long-acting basal insulin for adults with type 1 or type 2 diabetes. In the clinical trials evaluating Toujeo, all of the primary study endpoints were met by demonstrating similar blood sugar control with Toujeo as compared to Lantus. The most common adverse events (excluding hypoglycemia) reported for Toujeo included...

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Lupin Receives FDA Approval for Generic Lumigan Ophthalmic Solution 0.03%

Posted 4 weeks ago in Pharma Industry News

Mumbai, India and Baltimore, Maryland -- February 23, 2015: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Bimatoprost Ophthalmic Solution, 0.03% from the United States Food and Drugs Administration (FDA) to market a generic version of Allergan Inc.'s Lumigan Ophthalmic Solution, 0.03%. Lupin Pharmaceuticals Inc. (LPI), the company's U.S. subsidiary would commence marketing the product shortly. Lupin's Bimatoprost Ophthalmic Solution, 0.03% is...

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FDA Approves VenaSeal Closure System to Permanently Treat Varicose Veins

Posted 5 weeks ago in Pharma Industry News

February 20, 2015 -- The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. There are two types of veins—deep veins and superficial veins. Superficial veins are those that are close to the skin. Veins contain one-way valves that open to let blood flow through and then shut to keep blood from flowing backward. When valves of the...

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FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome

Posted 5 weeks ago in Pharma Industry News

The U.S. Food and Drug Administration today authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that...

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FDA issues new draft documents related to compounding of human drugs

Posted 6 weeks ago in Pharma Industry News

February 13, 2015 -- Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians. The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal...

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New Minivelle (Estradiol Transdermal System) 0.025 mg/day Dose Now Available

Posted 6 weeks ago in Pharma Industry News

Miami, FL and New York, NY -- February 12, 2015 -- Noven Pharmaceuticals, Inc. today announced that the new 0.025 mg/day dosage strength for Minivelle (estradiol transdermal system) is now available by prescription nationwide for only the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes. In September 2014, the FDA approved a new indication for...

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New data shows test can help physicians remove patients with suspected TB from isolation earlier

Posted 6 weeks ago in Pharma Industry News

February 12, 2015 -- The FDA today cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be kept in a hospital airborne isolation room. TB is caused by Mycobacterium...

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FDA Permits Marketing of Fecal Incontinence Device for Women

Posted 6 weeks ago in Pharma Industry News

February 12, 2015 -- The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women. Fecal incontinence is the inability to control bowel movements and is a common problem, especially among older adults. The most common cause of FI is damage to the muscles around the anus (anal sphincters). Vaginal childbirth can damage the anal sphincters or their nerves, which is why FI impacts women about twice as often as...

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FDA Clears System to Reduce Stroke Risk During Stent and Angioplasty Procedures

Posted 6 weeks ago in Pharma Industry News

February 9, 2015 -- The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure. The carotid arteries...

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United States Enters Consent Decree Prohibiting Illegal Distribution of Luvena Prebiotic Products

Posted 8 weeks ago in Pharma Industry News

January 30, 2015 -- At the request of the U.S. Food and Drug Administration, a federal judge from the U.S. District Court for the Central District of California today entered a consent decree of permanent injunction against Laclede, Inc. of Rancho Dominguez, California, and its president, Michael A. Pellico. Laclede is the manufacturer of Luvena Prebiotic products. The consent decree broadly prohibits Laclede from distributing unapproved or improperly labeled (misbranded) drugs and devices...

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Monthly News Roundup - January 2015

Posted 8 weeks ago in Pharma Industry News

Novartis Wins 1st Approval in Race for New Psoriasis Blockbusters The most common form of psoriasis is plaque psoriasis, in which patients develop thick, reddened skin with white patches called scales. The U.S. Food and Drug Administration has approved Cosentyx (secukinumab), a subcutaneous injection to treat adults with moderate-to-severe plaque psoriasis. Cosentyx is a selective interleukin-17A inhibitor that blocks the psoriasis inflammatory response. In Phase III clinical trials,...

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FDA Takes Steps to Improve Reliability of Automated External Defibrillators

Posted 8 weeks ago in Pharma Industry News

January 28, 2015 -- The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices. The FDA issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these devices in the past. The agency’s strengthened review will focus on the critical...

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Teva Receives FDA Approval for First Generic Nexium Delayed-Release Capsules in the U.S.

Posted 8 weeks ago in Pharma Industry News

January 26, 2014 -- The U.S. Food and Drug Administration has approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules. “Health...

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FDA Permits Marketing of First System of Mobile Medical Apps for Continuous Glucose Monitoring

Posted 9 weeks ago in Pharma Industry News

January 23, 2015 -- The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone. The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows caregivers to a person with diabetes to monitor that individual’s blood sugar levels remotely...

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Second Turkish Man Sentenced for Smuggling Counterfeit Cancer Drugs

Posted 9 weeks ago in Pharma Industry News

January 23, 2015 -- Today, the U.S. District Court of the Eastern District of Missouri sentenced Sabahhadin Akman, an owner of the Turkish firm Ozay Pharmaceuticals, to 30 months imprisonment and a $150,000 fine for smuggling counterfeit, misbranded and adulterated cancer treatment drugs into the U.S., including multiple shipments of Altuzan, the Turkish version of Avastin. In August 2014, Akman pleaded guilty to the same charges. Akman’s sentencing follows that of his business partner,...

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FDA Approves Maestro Rechargeable System Device to Treat Obesity

Posted 10 weeks ago in Pharma Industry News

January 14, 2015 -- The U.S. Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness. The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a...

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Biosimilars in 2015 - What Can We Expect?

Posted 11 weeks ago in Pharma Industry News

On Friday, March 6th the FDA approved Sandoz’s Zarxio, the first approved biosimilar in the U.S. Zarxio is the biosimilar for filgrastim (Amgen's Neupogen). Zarxio is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments that deplete these necessary infection-fighting cells, and is the first true biosimilar approved in the U.S. The FDA noted in their briefs that Zarxio was “highly similar” to the brand biologic and had “no...

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FDA grants first CLIA waiver for nucleic acid-based flu diagnostic test

Posted 11 weeks ago in Pharma Industry News

January 6, 2015 -- The U.S. Food and Drug Administration today granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for use in certain laboratories. Influenza, commonly known as the flu, is a contagious respiratory illness caused by two types of influenza viruses: Type A and Type B. Flu infections can range from mild to severe and can sometimes lead to...

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Monthly News Roundup - December 2014

Posted 12 weeks ago in Pharma Industry News

Opdivo Wins Accelerated Approval for Advanced Melanoma Over 9,700 Americans will die from advanced melanoma in 2014. To combat this life-threatening condition, the U.S. Food and Drug Administration has approved Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor for patients with advanced melanoma or melanoma that cannot be removed surgically and who no longer respond to other drugs. In studies, 32% of participants receiving Opdivo had their tumors shrink with the effect lasting for more...

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