Skip to Content

Pharmaceutical Industry News

FDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients

Posted 3 weeks ago in Pharma Industry News

April 7, 2017 -- The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from...

Read more

FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions

Posted 3 weeks ago in Pharma Industry News

April 6, 2017 -- The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional. “Consumers can now have ...

Read more

FDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr

Posted 4 weeks ago in Pharma Industry News

March 31, 2017 -- The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distr...

Read more

Monthly News Roundup - March 2017

Posted 4 weeks ago in Pharma Industry News

Ocrevus Approved for Novel Use Among Multiple Sclerosis Treatments The much anticipated multiple sclerosis (MS) treatment Ocrevus (ocrelizumab) was given the green light from the FDA this month. Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells. It is the first treatment approved for primary progressive multiple sclerosis (PPMS); it’s also indicated for relapsing (RMS). In both forms of MS, Phase III studies demonstrated that Ocrevus slowed d...

Read more

Monthly News Roundup - February 2017

Posted 8 weeks ago in Pharma Industry News

FDA Approves Once-Daily Qtern Tablets for Adults with Type 2 Diabetes The U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor treatment for adults with type 2 diabetes. This new combination agent is to be used alongside diet and exercise in those without adequate blood sugar control with dapagliflozin or who are already treated with dapagliflozin ...

Read more

FDA Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis

Posted 9 weeks ago in Pharma Industry News

February 23, 2017 -- The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with the body’s response to a bacterial infection, as a biomarker to help make a...

Read more

FDA Allows Marketing of Test to Identify Organisms That Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results

Posted 9 weeks ago in Pharma Industry News

February 23, 2017 -- The U.S. Food and Drug Administration today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it takes to provide this important information, which can guide antibiotic treatment recommendations more quickly. "By...

Read more

Louisiana Drug and Dietary Supplement Maker Ordered to Cease Operations Due to Federal Violations

Posted 9 weeks ago in Pharma Industry News

February 21, 2017 -- On Friday, U.S. District Judge Robert G. James for the U.S. District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and distributor of drugs and dietary supplements, and its owner, Anton S. Botha, requiring the business to immediately cease operations until it comes into compliance with federal laws. The complaint, filed by the U.S. Department of Justice, sought a...

Read more

Monthly News Roundup - January 2017

Posted 12 weeks ago in Pharma Industry News

Trulance Cleared by FDA for Chronic Idiopathic Constipation (CIC) The U.S. Food and Drug Administration (FDA) has approved Synergy’s Trulance (plecanatide), a uroguanylin analog for the treatment of chronic idiopathic constipation (CIC). Trulance works by stimulating secretion of bowel fluids. In studies, participants randomly received either 3 or 6 milligram (mg) Trulance tablets once a day for 12 weeks, or placebo. Those receiving Trulance had improvements in the frequency of complete s...

Read more

FDA Approves Xyrem (sodium oxybate) Oral Solution Generic with a REMS Program

Posted 14 weeks ago in Pharma Industry News

January 18, 2017 -- The FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. Cataplexy is a primary symptom of narcolepsy where patients suddenly lose muscle tone, including voluntary muscle control, while awake. Muscle weakness or paralysis associated with cataplexy may cause a person to collapse. Approximately 70 percent of people with...

Read more

Monthly News Roundup - December 2016

Posted 17 weeks ago in Pharma Industry News

Biogen’s Spinraza Approved for Spinal Muscular Atrophy The U.S. Food and Drug Administration (FDA) has cleared Biogen's Spinraza (nusinersen), the first drug for spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is classified as a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide and alters the splicing of the SMN2 gene to yield a more functional protein. In an interim analysis of efficacy, 40% of patients t...

Read more

Monthly News Roundup - November 2016

Posted 21 weeks ago in Pharma Industry News

Novo Nordisk’s Xultophy 100/3.6 FDA-Approved for Type 2 Diabetes This month the U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Xultophy 100/3.6 (insulin degludec and liraglutide), a once-daily injection of insulin degludec (Tresiba), and the glucagon-like peptide-1 (GLP-1) agonist liraglutide (Victoza), used with diet and exercise to improve blood sugar control in type 2 diabetes. Xultophy is used in adults inadequately controlled on less than 50 units of basal insulin daily ...

Read more

Monthly News Roundup - October 2016

Posted 25 weeks ago in Pharma Industry News

Merck’s Zinplava Approved to Fend Off Return of Clostridium Difficile Zinplava (bezlotoxumab) has been FDA-approved to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for CDI and who are at high risk for CDI recurrence. Zinplava is not an antibacterial and does not treat an active CDI infection. Zinplava is a human monoclonal antibody that binds with C. difficile toxin B to prevent its effects on human cells. Common a...

Read more

Monthly News Roundup - September 2016

Posted 30 weeks ago in Pharma Industry News

Amjevita, a Biosimilar to Humira, Wins FDA Approval Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA) and is used for the treatment of seven inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. Amjevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. Amjevita is not approved as an interchangeable product, meaning the pharmacist n...

Read more

Monthly News Roundup - August 2016

Posted 34 weeks ago in Pharma Industry News

FDA Approves Erelzi: Sandoz’s Biosimilar For Enbrel A third U.S. biosimilar has been FDA-approved; this time it’s Erelzi (etanercept-szzs), a biosimilar to Amgen’s tumor necrosis factor (TNF) blocker Enbrel. Sandoz’s Erelzi is the first approved biosimilar for etanercept, and is used for the same five indications found on the reference product Enbrel: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It’s impo...

Read more

FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu

Posted 38 weeks ago in Pharma Industry News

On August 3, 2016, the U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999. The FDA is committed to improving patient access to safe and effective generic drugs. Generic drugs...

Read more

Kratom Seized in California by US Marshals Service

Posted 38 weeks ago in Pharma Industry News

August 4, 2016 -- The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000. The U.S. Department of Justice filed the complaint, on behalf of the FDA, in...

Read more

Monthly News Roundup - July 2016

Posted 39 weeks ago in Pharma Industry News

Injectable Adlyxin FDA-Approved for Type 2 Diabetes The FDA has approved Sanofi’s Adlyxin (lixisenatide), a new once-daily injectable type 2 diabetes medication. Adlyxin is classified as an incretin mimetic/GLP-1 receptor agonist. For maintenance dosing, Adlyxin will be available in a disposable pre-filled pen of 20 micrograms. Adlyxin is given at mealtime and used alongside diet and exercise to improve blood sugar levels. In clinical studies, Adlyxin met the primary endpoint of hemoglobin A...

Read more

FDA Updates Warnings for Fluoroquinolone Antibiotics

Posted 39 weeks ago in Pharma Industry News

July 26, 2016 -- The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. “Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center fo...

Read more

FDA approves first absorbable stent for coronary artery disease

Posted 42 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...

Read more
Older articles

Pharma Industry News Archive

Hide