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Pharmaceutical Industry News

FDA approves first absorbable stent for coronary artery disease

Posted 2 weeks ago in Pharma Industry News

July 5, 2016 -- The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years. “The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rat...

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Monthly News Roundup - June 2016

Posted 3 weeks ago in Pharma Industry News

Epclusa: First Approval For All Major Forms of Chronic Hepatitis C Virus The U.S. Food and Drug Administration (FDA) has given the go-ahead to Epclusa (sofosbuvir and velpatasvir), a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) infection in adults. Epclusa is used for HCV genotypes 1 through 6, with or without cirrhosis. In studies, 95 to 99 percent of Epclusa-treated patients without...

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FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens

Posted 3 weeks ago in Pharma Industry News

June 29, 2016 -- The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states...

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FDA approves implantable device that changes the shape of the cornea to correct near vision

Posted 3 weeks ago in Pharma Industry News

June 29, 2016 -- The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision. Presbyopia is the loss of the...

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FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX

Posted 6 weeks ago in Pharma Industry News

June 9, 2016 -- The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. This effort was part of Operation Pangea IX, the Ninth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and...

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FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer

Posted 7 weeks ago in Pharma Industry News

June 1, 2016 -- The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC). Lung cancer is the leading cause of cancer-related...

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Monthly News Roundup - May 2016

Posted 7 weeks ago in Pharma Industry News

FDA Approves Zinbryta for Multiple Sclerosis Multiple sclerosis, a chronic, inflammatory, autoimmune disease of the central nervous system, has been reported as the leading cause of disability in young adults 20 to 40 years of age. The US Food and Drug Administration (FDA) has now approved AbbVie and Biogen’s Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta, a humanized monoclonal antibody, is a long-acting injection that is self- a...

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FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

Posted 11 weeks ago in Pharma Industry News

May 5, 2016 -- Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco...

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FDA reminds health care professionals not to use drug products intended to be sterile from Medaus

Posted 11 weeks ago in Pharma Industry News

May 5, 2016 -- The U.S. Food and Drug Administration is reminding health care professionals and patients not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The FDA has issued a formal request to the Birmingham, Alabama, compounding pharmacy to recall all non-expired lots of drug products intended to be sterile. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening...

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FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults

Posted 11 weeks ago in Pharma Industry News

May 2, 2016 -- The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults ages 18-24. Of the more than 2 million LGBT young adults in the U.S., more than 800,000 smoke occasionally. The “This Free Life” campaign is designed to specifically reach the occasional or “social” smokers in the LGBT community to help prevent tobacco-related disease a...

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Monthly News Roundup - April 2016

Posted 12 weeks ago in Pharma Industry News

First-Time Generic Approved for Statin Crestor High cholesterol, high low-density lipoprotein (LDL) or “bad cholesterol”, and triglycerides increase the risk for serious heart disease and may lead to heart attacks and strokes. The FDA has now approved the first generic version for Crestor, known by the generic name of rosuvastatin. Rosuvastatin was approved for three uses: high triglycerides in addition to diet; primary dysbetalipoproteinemia (improper breakdown of cholesterol and tri...

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FDA Approves First Generic Crestor

Posted 12 weeks ago in Pharma Industry News

April 29, 2016 -- The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses: in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults; in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides; either alone or in combination...

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FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

Posted 13 weeks ago in Pharma Industry News

April 22, 2016 - The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling. The FDA takes the act of banning a device only on rare occasions when it is necessary to protect public health. ESDs administer electrical shocks through electrodes attached...

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FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens

Posted 13 weeks ago in Pharma Industry News

April 19, 2016 -- The U.S. Food and Drug Administration announced today it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highlighted through the placement of advertisements in 35 U.S. markets specifically s...

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FDA approves folic acid fortification of corn masa flour

Posted 14 weeks ago in Pharma Industry News

April 14, 2016 -- The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains. Folic acid, a synthetic form of folate, is a B vitamin that when taken by a pregnant woman may help prevent neural tube defects, which are birth defects affecting the brain, spine, and spinal...

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FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns

Posted 15 weeks ago in Pharma Industry News

April 8, 2016 -- Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue. CVM’s action comes after the center recently reexamined the safety profile of the drug and conducted a preliminary risk characterization that indicated there could be potential risk to human health from ingesting pork, especially pork liv...

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Monthly News Roundup - March 2016

Posted 16 weeks ago in Pharma Industry News

FDA Approves Teva’s Cinqair to Treat Severe Asthma In March, the U.S. Food and Drug Administration (FDA) approved Teva’s Cinqair (reslizumab) as an adjunct for the maintenance treatment of severe asthma in adults not well-controlled on their current asthma medications. Cinqair is an interleukin 5 (IL-5) antagonist monoclonal antibody (IgG4 kappa) given once every four weeks via infusion in a clinical setting. In studies, patients receiving Cinqair had fewer attacks, a longer time to first att...

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FDA allows use of investigational test to screen blood donations for Zika virus

Posted 16 weeks ago in Pharma Industry News

March 30, 2016 -- The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. “The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood sup...

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FDA takes important step to increase the development of, and access to, abuse-deterrent opioids

Posted 17 weeks ago in Pharma Industry News

March 24, 2016 -- The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. Today’s actions are among a number of steps the agency recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing ...

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FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death

Posted 17 weeks ago in Pharma Industry News

March 22, 2016 -- In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to r...

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