FDA has approved dapagliflozin tablets (Farxiga, Bristol-Myers Squibb and AstraZeneca) to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. This marks a rebound for the drug, which FDA rejected last year, citing concerns raised by studies linking the drug to bladder cancer and liver toxicity.
A higher cumulative dose of bortezomib (Velcade, Millennium: The Takeda Oncology Company) suggested improved overall survival (OS) in previously untreated multiple myeloma patients, according to results from a retrospective subgroup analysis of the phase 3 VISTA study.
An investigational all-oral proteasome inhibitor-MLN9708 (Millennium: The Takeda Oncology Company)-plus lenalidomide and dexamethasone generated high response rates and increased depth of response with extended treatment duration in newly diagnosed multiple myeloma patients, according to data presented at the American Society of Hematology (ASH) 2013 annual meeting in New Orleans.
Evolocumab (Amgen) may offer a new treatment option for patients with dyslipidemia, according to new data from a phase 3 study.
Baxter International has initiated a voluntary recall in the United States of 2 lots of premixed sterile intravenous (IV) parenteral nutrition products: CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections to the user level because of complaints of particulate matter found in the products.
In the last decade, ICU mortality due to severe pneumococcal pneumonia has significantly decreased. Improved survival is associated with earlier antibiotic prescribing and an increased use of combined antibiotic therapy, according to a study reported online in Chest.
FDA approvals, complete response, fast-track designations, priority review, first-time generic approval
Baxter International has initiated a voluntary recall in the United States of 2 lots of premixed sterile intravenous (IV) parenteral nutrition products: CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections to the user level because of complaints of particulate matter found in the products.
FDA approved 27 new drugs last year, down from 39 new medications in 2012, which was a 15-year high, the Associated Press reported.
In just 1 year, with the rollout of the Affordable Care Act, the healthcare landscape has undergone its most far-reaching change in decades.
Despite some key pieces of federal legislation passed in recent years, most drugs-about 93%-are still not studied in neonates. Of those drugs that researchers have studied in this vulnerable population and that bear labels reflecting the changes in pediatric prescribing information, only about half (54%) are used in the neonatal intensive care unit (NICU).
Ongoing studies may lead FDA to stiffen its bioequivalence rules for generic antiepileptic drugs (AEDs) and others with so-called narrow therapeutic indices, according to research presented at American Epilepsy Society (AES) annual meeting recently in Washington, D.C., according to MedPage Today.
Last week, the New England Compounding Center's owners and insurers agreed to establish a $100 million compensation fund for its creditors, including the victims who were injured after receiving injections of contaminated steroids produced by the now bankrupt NECC. Victims have until Wednesday, January 15 to submit their claims in the case.
FDA has rejected alemtuzumab (Lemtrada, Genzyme, a Sanofi company) for the treatment of relapsing forms of multiple sclerosis.
The newly enrolled individuals to the healthcare exchanges will be faced with higher out-of-pocket costs for their medications than those who receive insurance through their employers, according to an analysis by Avalere Health of more than 600 health plans in the exchanges.
FDA approved umeclidinium and vilanterol inhalation powder (Anoro Ellipta, GlaxoSmithKline and Theravance) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
FDA expanded the indication for Prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure.
Amneal Pharmaceuticals will start shipping its branded Esomeprazole Strontium 49.3 mg delayed-release capsules on December 18 to three major U.S. wholesalers. Its capsules contain the same active ingredient, esomeprazole, in a different salt form as found in Nexium (esomeprazole magnesium).
US life expectancy for people with cancer hit another all-time high, rising over 50 million life-years (LYS) after diagnosis, according to statistics collected through the Value of Medical Innovation initiative, led by the Center for Medicine in the Public Interest (CMPI).
Manufacturers of antibacterial hand soap and body wash will be required to show that their products are more effective than plain soap and water in preventing illness and the spread of infection, under a FDA-proposed rule.
Individuals diagnosed with rheumatoid arthritis (RA) more recently experienced decreased disability and psychological problems than those treated 20 years ago. While treatment strategies have helped, researchers attribute the positive effects to greater physical activity and encouragement of a worthwhile life by healthcare professionals.
Children hospitalized for pneumonia have similar outcomes, including length of stay and costs, regardless of whether they are treated with “big gun” antibiotics such as ceftriaxone or cefotaxime or more narrowly focused antibiotics such as ampicillin or penicillin, according to a Vanderbilt study published in Pediatrics.
CVS Caremark and Cardinal Health are about to become the single biggest supplier of generic drugs in the United States.
Diabetes was associated with an increased risk for developing hepatocellular carcinoma, a type of liver cancer, and this association was highest for Latinos, followed by Hawaiians, African-Americans, and Japanese-Americans, according to results presented here at the Sixth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Dec. 6-9, in Atlanta.
FDA announced that it had given approval to several pharmaceutical companies to market duloxetine delayed-release capsules (Cymbalta, Eli Lilly), for the treatment of depression and other conditions. in various strengths. Companies named were Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd.
On December 6, FDA approved Sovaldi (sofosbuvir) tablets for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
