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.
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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.
FDA approved a new use for ruxolitinib (Jakafi, Incyte) to treat patients with polycythemia vera (PV), a chronic type of bone marrow disease. Jakafi is the first drug approved by FDA for this condition.
Nilotinib (Tasigna) should be considered as a leading option for front-line therapy in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), according to data presented at the 56th ASH Annual Meeting and Exposition in San Francisco.
Actavis Plc has announced that the Infective Drugs Advisory Committee, which makes recommendations to the FDA concerning the safety and effectiveness of drug products for use in the treatment of infectious diseases, has voted to recommend approval of its New Drug Application for ceftazidime-avibactam.
Patients taking statins may be at an increased risk for cataracts, according to a study published in the Canadian Journal of Cardiology.
In patients with opioid dependence, buprenorphine and naloxone (Zubsolv, Orexo) sublingual tablet (CIII) demonstrated comparable patient retention in treatment at days 3 and 15 versus generic buprenorphine and Suboxone film respectively, according to data presented at the 25th Annual Meeting and Symposium of the American Academy of Addiction Psychiatry (AAAP) in Aventura, Fla.
FDA has approved blinatumomab (Blincyto, Amgen) immunotherapy for the treatment of relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia.
This year, the American Heart Association (AHA) Scientific Sessions were held in Chicago, Illinois, from November 15 to 19. Of all of the late-breaking clinical trials presented at AHA 2014, the IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) study of Merck’s low-density lipoprotein cholesterol (LDL-C)-reducing drugs-the statin, Zocor (simvastatin), and the fixed-dose combination, Vytorin (ezetimibe/simvastatin)-stole the show.
Investigational, oral proteasome inhibitor, ixazomib (MLN9708, Takeda) has FDA has granted breakthrough therapy status for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. This is the first proteasome inhibitor and first investigational therapy for AL amyloidosis to receive breakthrough therapy designation.
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