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Pharmaceutical Industry News

Califf, FDA top officials call for sweeping review of agency opioids policies

Posted 8 days ago in Pharma Industry News

February 4, 2016 -- In response to the opioid abuse epidemic, today Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. The FDA will: Re-examine the risk-benefit paradigm for opioids and ensure that the age...

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Monthly News Roundup - January 2016

Posted 12 days ago in Pharma Industry News

Merck’s Once-Daily Zepatier for Hepatitis C Wins Approval Hepatitis C virus (HCV) affects over 3 millions Americans, and may lead to liver impairment, cirrhosis or even liver failure. In January, the U.S. Food and Drug Administration (FDA) approved the oral treatment Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 (the most common) and 4 (the least common) infections in adults. Zepatier is a NS5A replication c...

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Federal Judge Enters Consent Decree Against Downing Labs

Posted 4 weeks ago in Pharma Industry News

January 11, 2016 -- On Friday, Jan. 8, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield. According to the complaint filed with the consent decree, Downing Labs (formerly known as NuVision Pharmacy) manufactured and distributed purportedly sterile drug products that w...

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FDA Approves Integra Omnigraft Dermal Regeneration Matrix to Treat Diabetic Foot Ulcers

Posted 5 weeks ago in Pharma Industry News

January 7, 2016 -- The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound. An estimated 29 million people in the United States have been diagnosed with diabetes, according to the Centers...

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US Marshals Seize Dietary Supplements Containing Kratom

Posted 5 weeks ago in Pharma Industry News

January 6, 2016 -- The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000. “We have identified kratom as a botanical substance that could pose a risk to public health and have the potential f...

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Monthly News Roundup - December 2015

Posted 6 weeks ago in Pharma Industry News

Bridion Approval Launches New Drug Class Neuromuscular blocking drugs cause temporary muscle paralysis and are used to prevent movement during surgery, facilitate endotracheal intubation, and in ICU mechanical ventilation. This month, the FDA approved Merck’s Bridion (sugammadex), a novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. In Phase 3 trials, recovery time was faster overall for the Bridion treatment groups c...

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FDA Proposes Tanning Bed Age Restrictions and Other Important Safety Measures

Posted 8 weeks ago in Pharma Industry News

December 18, 2015 -- Today, the U.S. Food and Drug Administration announced important proposed steps ‎to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of using these devices for adults. The FDA is committed to protecting public health by informing consumers of the risks of indoor tanning. “Today’s action is intended to help protect young people from a known and preventable cause of skin cancer and o...

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FDA Permits Marketing of Fecal Continence Restoration System

Posted 8 weeks ago in Pharma Industry News

December 18, 2015 -- The U.S. Food and Drug Administration today approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options. Fecal incontinence is the inability to control bowel movements. It is a common problem that is frequently underreported, especially among older adults. The most common cause of fecal incontinence is damage to the muscles around the anus (anal...

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FDA Approves Wearable Defibrillator for Children at Risk for Sudden Cardiac Arrest

Posted 8 weeks ago in Pharma Industry News

December 17, 2015 -- The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent. While many automated external defibrillators (which require a second person to operate them) have been cleared for use in children, LifeVest is...

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FDA allows marketing of cooling cap to reduce hair loss during chemotherapy

Posted 9 weeks ago in Pharma Industry News

December 8, 2015 -- Today, the U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy. Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of breast cancer. Hair may fall out entirely, gradually, in sections, or may become thin. Hair loss due to cancer treatment is usually temporary, but minimizing or...

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FDA Clears XSTAT 30 Military Traumatic Wound Dressing for Use in the Civilian Population

Posted 9 weeks ago in Pharma Industry News

December 7, 2015 -- Today, the U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication from use by the military only to use in adults and adolescents in the general population. Early control of severe b...

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Sun Pharma Announces FDA Approval for Generic Gleevec

Posted 10 weeks ago in Pharma Industry News

Mumbai, December 04, 2015: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharma) today announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg. Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis’ Gleevec tablets. As per IMS MAT August 2015, these tablets h...

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Monthly News Roundup - November 2015

Posted 10 weeks ago in Pharma Industry News

Lilly’s Portrazza FDA-Approved for Advanced Lung Cancer Lung cancer is the leading cause of cancer death among both U.S. men and women. The FDA has approved Eli Lilly’s Portrazza (necitumumab), an epidermal growth factor receptor (EGFR) antagonist, in combination with gemcitabine and cisplatin for treatment of advanced squamous non-small cell lung cancer. In clinical studies, patients who took the 3-drug combo lived for an average of 11.5 months compared to 9.9 months for those who took only ...

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FDA takes action to protect consumers from potentially dangerous dietary supplements

Posted 12 weeks ago in Pharma Industry News

November 17, 2015 -- The U.S. Food and Drug Administration, in partnership with other government agencies, today announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging...

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Monthly News Roundup - October 2015

Posted 15 weeks ago in Pharma Industry News

Merrimack’s Onivyde Approved for Metastatic Pancreatic Cancer Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan approved for treatment of metastatic (advanced) pancreatic cancer already treated with gemcitabine-based chemotherapy. Onivyde is given in combination with fluorouracil and leucovorin. In clinical trials, patients who received Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for t...

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Monthly News Roundup - September 2015

Posted 19 weeks ago in Pharma Industry News

Two New Insulins Win FDA Approval for Diabetes This month, the U.S. Food and Drug Administration (FDA) approved two new insulins from Novo Nordisk: Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. Tresiba is a long-acting insulin injected once daily, while Ryzodeg is a mixture of long-acting and rapid-acting insulin analogs. Both products are approved for type 1 and...

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FDA Approves Two New Insulin Treatments for Diabetes Mellitus: Tresiba and Ryzodeg 70/30

Posted 20 weeks ago in Pharma Industry News

The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes. Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, nerve and...

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FDA Advisory Panel Provides Advice for the Continued Safe and Appropriate Use of Essure Permanent Birth Control

Posted 20 weeks ago in Pharma Industry News

WHIPPANY, N.J., Sept. 24, 2015 /PRNewswire/ -- Today the U.S. Food and Drug Administration's Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee discussed considerations to help ensure the continued safe and appropriate use of Essure permanent birth control. At the meeting, Bayer presented safety and efficacy data on Essure, as well as information on the need for permanent birth control options. There was agreement among the Panel members that Essure is an important...

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Monthly News Roundup - August 2015

Posted 23 weeks ago in Pharma Industry News

FDA Approves Sprout’s Addyi For Low Libido in Women Addyi (flibanserin) by Sprout Pharmaceuticals has been FDA-approved the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi is the first approved medication for HSDD, and works in the brain as a multifunctional serotonin agonist antagonist (MSAA). While Addyi showed modest benefit in clinical trials, its side effects, including fainting with alcohol use, prompted many labeling r...

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Monthly News Update: July 2015

Posted 28 weeks ago in Pharma Industry News

Praluent: First Approval in New PCSK9 Inhibitor Class Sanofi and Regeneron’s Praluent (alirocumab), the first in a potential blockbuster class of cholesterol-reducing agents known as PCSK9 inhibitors, was FDA-approved on July 24, 2015. Praluent use is approved in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as a heart attack or stroke, who require further LDL lowering. Praluent was evaluated in f...

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