FDA has approved sotalol hydrochloride oral solution (Sotylize, Arbor Pharamceuticals) for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter.
Hospital pharmacies play an essential role in the nation’s healthcare system, and these days, are expected to add value to every aspect of a hospital's strategic agenda.
The Ebola outbreak has taught us that the health systems in West Africa are under-resourced and vulnerable. Scaling up capability of local healthcare provision is an important consideration for control of this virus, and drug makers are gearing up to expedite development of Ebola vaccines.
FDA has approved Antihemophilic Factor (Recombinant), Porcine Sequence] (Obizur, Baxter) for the treatment of bleeding episodes in adults with acquired hemophilia A.
Triple-negative breast cancer (TNBC) represents just under 15% of all breast cancer (BC) cases, according to IMS’ epidemiologic analysis. It carries a bleaker prognosis than other forms of BC. These facts are well-known. Much else about the disease is unknown, however; indeed, it’s probably a mistake to think of TNBC cancer as “a” disease at all.
FDA has approved an updated labeling of morphine sulfate/naltrexone hydrochloride (Embeda, Pfizer) extended release capsules, CII, to include abuse-deterrent properties
An FDA advisory committee has voted to keep the boxed warning for varenicline (Chantix, Pfizer) that states that the drug may cause serious neuropsychiatric events.
Breast cancer is the second most common cancer in the world, and the most common cancer in women. In 2013, approximately 261,000 women were diagnosed with this disease in the United States alone.1 When diagnosed in the earliest stages, such as ductal carcinoma in situ and stage 1, the 5-year survival rate is almost 100%. If diagnosed later, or if the disease progresses to advanced breast cancer, survival rapidly decreases. Human epidermal growth factor receptor 2 (HER2)-positive breast cancer represents about 20% of cases, and before the introduction of HER2-targeting therapies, had the worst prognosis of all breast cancer subtypes.
The number of antibiotic-resistant strains continues to rise rapidly. Statistics from the Centers for Disease Control and Prevention (CDC) and the Infectious Diseases Society of America (IDSA) point to alarming trends that are exacerbated by fewer new antibiotics coming into the market and high costs.
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The 13-valent pneumococcal conjugate vaccine (PCV13) not only prevents pneumococcal illness and death, but also dramatically decreases antibiotic-resistant infections in children by as much as 62%, according to a new study presented at IDWeek 2014
The spread of the Ebola virus (EVD) continues to capture world headlines. It has also become of great concern in the United States where 3 cases have now been confirmed.
The biosimilar candidate ABP 501 (Amgen) has proved to be successful in treating patients with moderate-to-severe plaque psoriasis, according to results from an initial phase 3 study. ABP 501 met its primary end point for efficacy.
FDA has approved netupitant/palonosetron (Akynzeo, Eisai Inc.) to treat chemotherapy-induced nausea and vomiting (CINV).
FDA approved bortezomib (Velcade, Millennium: The Takeda Oncology Company) for injection for use in previously untreated patients with mantle cell lymphoma (MCL), making it the first treatment in the United States to be approved for previously untreated patients with MCL.
In recent months, the incidence of enterovirus D68 (EV-D68) infection has markedly increased across the United States, notably affecting young pediatric patients. Hospitalizations of children with severe respiratory illness associated with this non-polio enterovirus have concurrently risen.1,2
FDA’s approval of ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni, Gilead Sciences), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults, may signal that industry is at the forefront of a cure for hepatitis C, according to one industry expert.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices recommends that everybody aged 6 months and older receive an annual flu vaccine.
FDA has designated new ALS stem cell therapy from BrainStorm Cell Therapeutics as a “fast-track” product.
FDA actions in brief, fast-track designations, priority review.
FDA approved the Lutonix 035 Drug Coated Balloon (DCB) Catheter (Bard) for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 mm to 6 mm.
Zykadia (ceritinib) is a tyrosine kinase inhibitor that was approved by FDA on April 29, 2014, as a medication for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib.
Low thyroid stimulating hormone (TSH) can be observed in patients with treated hypothyroidism initiating metformin, especially between 90 and 180 days of use, according to a study published September 22 in the CMJA.
Specialty drugs’ high prices raise questions about whether their cost is worth the clinical benefits they provide, according to a recent study in Health Affairs.
Responding to requests from treating physicians, FDA has okayed brincidofovir for Emergency Investigational New Drug Applications (EIND), allowing it to be used in the treatment of the Ebola virus disease.
Bristol-Myers Squibb (BMS) will not pursue FDA approval of its hepatitis C (HCV) treatment, a dual regimen of daclatasvir and asunaprevir, and has withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.
