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

Posted yesterday 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 3 days 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 4 days 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 13 days 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 3 weeks ago in Pharma Industry News

On Wednesday, January 7th, the FDA Oncologic Drugs Advisory Committee unanimously recommended approval of Sandoz’s EP2006, a biosimilar for filgrastim (Neupogen). EP2006 is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments that deplete these necessary infection-fighting cells. If FDA-approved, this would be the first true biosimilar in the U.S. and would have a brand name of Zarxio. The FDA noted in their briefs that EP2006 was...

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

Posted 3 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 4 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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FDA Approves Fast-Acting Ebola Test

Posted 4 weeks ago in Pharma Industry News

The U.S. Food and Drug Administration has approved Swiss drug maker Roche's fast-acting Ebola test for emergency use. The test - which checks for genetic traces of the often deadly virus - offers results in about three hours, compared to many tests on the market that can take a day to produce results, according to news reports. It's hoped that the test -- called LightMix Ebola Zaire rRT-PCR -- can be used in the field to identify people infected with the strain of Ebola that has been causing...

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FDA approves pathogen reduction system to treat platelets

Posted 5 weeks ago in Pharma Industry News

December 19, 2014 -- The U.S. Food and Drug Administration yesterday approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections. On Dec. 16, the FDA also approved the Intercept Blood System for the preparation of...

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FDA approves first pathogen reduction system to treat plasma

Posted 6 weeks ago in Pharma Industry News

December 16, 2014 -- The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI). “The approval of devices like the Intercept Blood System allows blood establishments to prepare plasma that carries a lower risk of transmitting infectious pathogens through transfusion,” said Karen Midthun,...

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FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency

Posted 6 weeks ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns. According to the Centers for Disease Control and Prevention, approximately 40 to 100 new cases of SCID are identified in newborns in the United States each year. SCID is a group of disorders caused by defects in genes involved in the development and function of T...

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FDA clears test that helps predict the risk of coronary heart disease

Posted 6 weeks ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks. FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women. “A cardiac test that helps better predict future CHD risk in...

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FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis

Posted 6 weeks ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings. According to the U.S. Centers for Disease Control and Prevention (CDC), about 55,000 people in the United States are newly infected with syphilis annually. During the 1990s, syphilis primarily...

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FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies

Posted 6 weeks ago in Pharma Industry News

December 11, 2014 -- The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection...

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FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products

Posted 7 weeks ago in Pharma Industry News

December 3, 2014 -- The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding. The final...

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Monthly News Roundup - November 2014

Posted 8 weeks ago in Pharma Industry News

Purdue Pharma’s Abuse-Deterrent Hysingla ER Approved for Pain The U.S. Food and Drug Administration (FDA) has approved Hysingla ER (hydrocodone bitartrate), an acetaminophen-free, extended-release (ER) opioid for severe pain requiring daily, long-term treatment and for which no alternatives exist. Hysingla ER abuse-deterrent properties may reduce, but not totally prevent, abuse of the drug. The tablet forms a thick gel and cannot be easily prepared for injection, and is difficult to crush,...

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

Posted 9 weeks 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 10 weeks 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 12 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 12 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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