Accelerated approval has been granted by FDA to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients who have unresectable or metastatic melanoma not responding to treatment with other drugs.
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According to a rule proposed by FDA in the Federal Register (December 18, 2014), healthcare providers would receive prescription drug and biologics product labeling information via an electronic system, thus replacing the use of paper to provide such information on the safety and effectiveness of human prescription drugs.
FDA approved the first intravenous influenza treatment, peramivir (Rapivab, BioCryst).
Some anti-inflammatory drugs, including ibuprofen have the potential to prevent the second most common type of skin cancer, according to a study published in the Journal of Investigative Dermatology.
Despite known risks of confusion and falls associated with benzodiazepine use in elderly patients, a study published in JAMA Psychiatry, finds that prescription of benzodiazepines increases as people age. The research offers the first estimates of use patterns in the United States.
One medical center is urging parents to seek non-medical solutions for their children’s anxiety or insomnia, after a recent study found that teens prescribed anti-anxiety or sleep medications are up to 12 times more likely to abuse prescription drugs than those who had never been prescribed them.
The Southeastern Pennsylvania Transportation Authority (SEPTA) recently filed a class action suit in federal court against Gilead Sciences, Inc. over the high cost of its hepatitis C drug, Sovaldi.
FDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria.
FDA has approved finafloxacin (Xtoro, Alcon) otic suspension for the treatment of otitis externa.
FDA has approved olaparib (Lynparza, AstraZeneca) for the treatment of women with advanced ovarian cancer associated with defective BRCA genes, as determined by an FDA-approved test.
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FDA allows marketing of first newborn screening test to help detect Severe Combined Immunodeficiency
FDA has allowed marketing of the EnLite Neonatal TREC kit (PerkinElmer), the first newborn screening test for detection of Severe Combined Immunodeficiency (SCID).
FDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
FDA has approved lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The FDA has granted breakthrough therapy designation for Lucentis (ranibizumab, Genentech) for the treatment of diabetic retinopathy.
FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).
FDA has cleared a new screening test for the prediction of future coronary heart disease (CHD) events, such as myocardial infarction. It is cleared for use in all adults who have no history of CHD.
FDA has granted the first-ever CLIA waiver for the Syphilis Health Check test, a rapid screening test for syphilis.
Bisphosphonates, the most commonly used drugs for osteoporosis may be able to reduce the growth of certain cancers by inhibiting the activity of a cancer-producing family of receptor called the human epidermal growth factor receptor (HER), according to 2 studies published online this week in the Proceedings of the National Academy of Sciences (PNAS).
A price increase for a popular form of the medication, naloxone, threatens the ability of non-profit programs and organizations, including police departments around the country, to provide a medical antidote for drug overdoses.
FDA has approved Cyramza (ramucirumab, Eli Lilly) in combination with docetaxel to treat aggressive non-small cell lung cancer.
A new vaccine, human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9, Merck Sharp & Dohme), has been approved by FDA for the prevention of diseases caused by 9 HPV types. It is effective against 5 additional strains of the virus than is the previous FDA-approved version of the vaccine (Gardasil).
Data from the largest clinical trial of myelofibrosis patients treated with ruxolitinib (Jakavi, Novartis) support its safety profile and efficacy benefit, as measured in primary and secondary end points, according to a study presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco.
MP Diagnostics HTLV Blot 2.4 (MP Biomedicals) has been approved by FDA as the first FDA-licensed supplemental test for human T-cell lymphotropic virus-I/II (HTLV-I/II). It is a qualitative enzyme immunoassay test, which is to be used to confirm the presence of HTLV antibodies as well as to differentiate between HTLV-I and HTLV-II infection.
On the 1-year anniversary of the first G8 summit on dementia, new funding has been announced for a study to research the use of tadalafil (Adcirca, Cialis; Eli Lilly), an erectile dysfunction drug, for the treatment of vascular dementia.
Formulary managers should be alert to the use of opioid painkillers by special populations, such as people with epilepsy, according to findings during a poster session at the American Epilepsy Society annual meeting in Seattle.
Dr OvbiageleFor recent ischemic stroke patients, using an optimal combination of evidence-based secondary prevention medication classes, compared to not doing so, was associated with 61% lower odds of experiencing a recurrent stroke, according to a study published online in Neurology.
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