Lexicon Pharmaceuticals announced updated data from a Phase 2b clinical trial of LX4211 for type 2 diabetes mellitus.
For patients with schizophrenia, adherence to antipsychotic medications, as recommended by the 2009 Schizophrenia Patient Outcomes Research Team (PORT), correlates with reduced mortality.
Treatment with either glucagon-like peptide-1 receptor agonist exenatide (once weekly) or liraglutide (once daily) leads to improvements in glycemic control, with greater improvement seen with liraglutide.
Treatment of lymphoma patients with the gonadotropin-releasing hormone agonist (GnRHa) triptorelin plus norethisterone does not reduce the rate of chemotherapy-induced premature ovarian failure (POF).
Amgen announced that results from the LAPLACE-TIMI 57, MENDEL, and GAUSS Phase 2 studies evaluating AMG 145 in hypercholesterolemic patients with or without statins, respectively, showed that treatment with AMG 145 resulted in a statistically significant reduction in low-density lipoprotein (LDL) cholesterol.
Auxilium Pharmaceuticals announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Xiaflex (collagenase clostridium histolyticum or CCH) for the potential treatment of Peyronie's disease (PD).
Nektar Therapeutics announced that the FDA has designated etirinotecan pegol (NKTR-102) as a Fast Track program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine (ATC).
ImmunoGen, Inc. announced that Genentech, a member of the Roche Group, has disclosed that the FDA has officially accepted the Biologics License Application (BLA) for trastuzumab emtansine and granted it Priority Review; the proposed indication is for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab; Genentech) and a taxane chemotherapy.
Novartis announced that the Phase 3 RELAX-AHF study has shown that investigational RLX030 (serelaxin) improved symptoms and reduced deaths by one-third at the end of six months in patients with acute heart failure (AHF); most of these deaths were due to cardiovascular causes.
Santarus and Pharming Group NV announced that their Phase 3 clinical study of Ruconest (recombinant human C1 esterase inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met its primary endpoint.
Amgen announced that treatment with AMG 145 in combination with statin therapy, with or without ezetimibe (Zetia; Merck), resulted in a reduction in low density lipoprotein cholesterol (LDL-C), by up to 56% in patients with heterozygous familial hypercholesterolemia (HeFH) in the Phase 2 RUTHERFORD study.
Pozen announced positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540, being assessed for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
Pfizer announced that the FDA has approved Xeljanz (tofacitinib citrate) tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had inadequate response or intolerance to methotrexate.
Boehringer Ingelheim announced that it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75mg.
Multivitamins do not reduce the risk of major cardiovascular events.
The U.S. Pharmacopeial Convention (USP) has revised its current standards on heparin labeling requirements to address safety concerns about the expression of drug strength.
Use of sulfonylureas for initial treatment of diabetes is associated with increased cardiovascular events and death compared with metformin.
Noncanonical Hedgehog (Hh) signaling is activated in tamoxifen-resistant tumors, and the phosphoinositide 3-kinase inhibitor/protein kinase B (PI3K/AKT) pathway plays a key role protecting Hh signaling molecules.
The use of a disease-modifying antirheumatic drug (DMARD) during pregnancy is rare and is associated with a nonsignificant increase in the risk for preeclampsia in women with autoimmune disease.
BioMarin Pharmaceuticals announced that the pivotal Phase 3 study of GALNS for the treatment of patients with the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA; also called Morquio A Syndrome) met its primary endpoint.
Intersect ENT announced that the FDA has approved Propel mini (mometasone furoate), a localized steroid-releasing product for patients with chronic sinusitis.
Verinata Health announced that it is expanding the verifi prenatal test capabilities to include detection of the most common sex chromosome abnormalities.
Omeros reported positive data from the second of its two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery.
Omthera Pharmaceuticals announced that Phase 3 results from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) and ESPRIT (Epanova combined with a Statin in Patients with HypertRiglycerIdemia to Reduce Non-HDL CholesTerol) clinical trials for Epanova met all primary and secondary endpoints.
Otsuka announced Phase 3 clinical trial results for tolvaptan, an investigational drug for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
Abbott announced the launch of Ensure Complete shakes, an expansion of their Ensure product line of oral nutrition supplements for adults.
Durata Therapeutics announced that the FDA has designated dalbavancin as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus).
Janssen announced that the FDA has approved Xarelto (rivaroxaban), an oral anticoagulant, for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment.
The FDA evaluated new information about the risk of serious bleeding associated with use of dabigatran (Pradaxa; Boehringer Ingelheim) and warfarin (Coumadin, Jantoven, and generics).
Combination treatment of lapatinib plus capecitabine is active in some patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with progressive brain metastases, and warrants further study.
Overall, oral nonsteroidal anti-inflammatory drugs (NSAIDs) do not have an effect on C-reactive protein (CRP) levels in patients with rheumatoid arthritis (RA).
Combination therapy is an acceptable first-line approach for manic episodes in terms of efficacy and prevention of relapse, with an acceptable safety profile.
A new study published in the journal Human Reproduction is challenging prior practice that it is safe for pregnant women who suffer from depression to take antidepressants.
Rx Response has partnered with the National Council for Prescription Drug Programs (NCPDP), as well as eRx Network and RelayHealth to form the basis of the Emergency Pharmacy Status Reporting tool.
The FDA released a notice to consumers about the importance in having a plan for emergency medication and medical supplies for both people and animals.
A single 10-minute, at-home treatment with topical ivermectin lotion eliminates head lice infestations in nearly all patients by the next day.
For men with osteoporosis, a once-yearly infusion with zoledronic acid is associated with fewer vertebral fractures and improved bone health compared with placebo.
Addition of the fully human serum proprotein convertase subtilisin/kexin 9 monoclonal antibody, SAR236553, to atorvastatin is associated with greater reductions in low-density lipoprotein (LDL) cholesterol levels compared with atorvastatin alone.
Genzyme, a Sanofi company, announced updated results from the Lemtrada (alemtuzumab) Phase 3 CARE-MS I and CARE-MS II pivotal studies in patients with relapsing-remitting multiple sclerosis (MS).
LEO Pharma announced that the FDA has approved Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate), 0.005%/0.064% for the treatment of body plaque psoriasis for up to 8 weeks in patients ≥18 years.
Teva Pharmaceuticals announced that the FDA has approved Synribo (omacetaxine mepesuccinate) for Injection to treat adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
For children undergoing routine anesthesia for medically indicated magnetic resonance imaging (MRI), the metabolic signature varies with use of sevoflurane and propofol.
The FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter (OTC) eye drops used to relieve redness and nasal decongestant sprays can result in serious and fatal adverse events.
For patients with type 2 diabetes, following administration of a subcutaneous injection of a therapeutic dose of insulin glargine, glargine is minimally detectable in blood, and most of the plasma insulin concentration is in the form of its metabolite M1.
Antiviral treatment does significantly reduce the risk of developing liver cancer for patients with chronic hepatitis C infection, particularly in virological responders.
Use of hormone therapy (HT) within five years of menopause is associated with a reduction in the risk of Alzheimer's disease (AD).
The FDA is advising consumers not to purchase or use Ultimate Formula Bee Pollen Capsules by Ultimate Formula, a product promoted and sold for weight loss.
Celgene announced results from a Phase 3 metastatic melanoma study (CA033) of Abraxane (paclitaxel [bound to albumin (human)]).
Celgene announced that its Phase 3, multi-center, randomized, open-label study (MM-003) of pomalidomide plus low-dose dexamethasone or high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma was reviewed by a data safety monitoring board (DSMB), who determined the trial met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis.
Actelion announced results from the SERAPHIN Phase 3 long-term outcome study of macitentan (Opsumit) in patients with pulmonary arterial hypertension (PAH).
Among patients with colorectal cancer (CRC), regular use of aspirin after diagnosis is associated with longer survival for those with the mutated phosphatidylinositol-4,5-bisphosphonate 3-kinase, catalytic subunit alpha polypeptide gene (PIK3CA).
For patients with paroxysmal atrial fibrillation with no history of antiarrhythmic drug use, there is no significant difference in the cumulative burden of atrial fibrillation over two years between the treatment strategies of radiofrequency catheter ablation or antiarrhythmic agents.
ARIAD Pharmaceuticals announced that the FDA has accepted for filing the New Drug Application (NDA) of ponatinib for patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL); the FDA also has granted ARIAD's request for Priority Review.
Teva announced findings from a Phase 3 pivotal trial of Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for the prevention of pregnancy.
Bayer HealthCare announced data from the Phase 3 CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.
Merck announced results from a Phase 3 study of corifollitropin alfa for controlled ovarian stimulation in women participating in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Antihypertensive medication use and blood pressure control are increasing among U.S. adults, but racial disparities still exist.
Teva announced findings from a Phase 3 clinical trial of Milprosa (progesterone) for luteal supplementation in women undergoing in vitro fertilization (IVF).
Ferring Pharmaceuticals announced that the FDA has accepted for review a New Drug Application (NDA) for its controlled release misoprostol vaginal insert (MVI) for decreasing time to vaginal delivery in women with an unfavorable cervix (a cervix that has not yet softened and thinned so that dilation can take place) when used in sequential regimen with oxytocin augmentation (Pitocin; JHP Pharmaceuticals), if needed.
SARcode Bioscience announced topline results from OPUS-1, a pivotal Phase 3 study of lifitegrast ophthalmic solution, 5%, vs. placebo for the treatment of dry eye disease.
Eisai announced that the FDA has approved Fycompa (perampanel tablets) as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy >12 years old.
Bayer HealthCare announced results of a Phase 3 study evaluating two intrauterine systems (IUDs), LNG-IUS12 and LNG-IUS16, for the prevention of pregnancy for up to three years.
Nuvo Research and Galderma Laboratories announced that the FDA has approved a supplemental New Drug Application (sNDA) for Pliaglis (lidocaine/tetracaine) 7%/7% Cream for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures (eg, dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal).
Supernus Pharmaceuticals received approval from the FDA for Oxtellar XR (oxcarbazepine extended-release tablets) for use as adjunctive therapy in the treatment of partial seizures in adults and in children 6-17 years of age.
Quadex Labs announced the release of Viroxyn Professional Use (benzocaine 7.5%, benzalkonium chloride 0.13%), a single application cold sore product available exclusively through healthcare professionals.
Astellas Pharma announced that Myrbetriq (mirabegron) extended-release tablets, indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency, is now available.
DARA BioSciences announced the launch of Soltamox Oral Solution (tamoxifen citrate), an alternative to tamoxifen tablets for breast cancer patients.
Lilly announced positive top-line results of three completed Phase 3 AWARD trials for dulaglutide, being studied as a once-weekly treatment for type 2 diabetes.
Janssen Biotech announced new Phase 3 study findings which showed significantly more patients with moderately to severely active ulcerative colitis (UC) who responded to induction therapy with subcutaneously administered Simponi (golimumab) maintained clinical response through Week 54, the primary endpoint of the study, compared with patients receiving placebo.
Bayer HealthCare announced data from the Phase 3 PATENT-1 pulmonary arterial hypertension (PAH) trial evaluating its investigational drug riociguat in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid.
The CDC and FDA have confirmed the presence of Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/mL) from one of the three implicated lots from New England Compounding Center.
Exposure to selective serotonin reuptake inhibitors (SSRIs) is associated with an increased risk of intracerebral and intracranial hemorrhage.
A new vaccination strategy is effective against genital herpes and possibly other sexually transmitted infections.
Adding linezolid to ongoing background therapy for the treatment of extensively drug-resistant (XDR) pulmonary tuberculosis is effective in achieving culture conversion, but patients must be carefully monitored for adverse events.
Patients with moderate-to-severe Crohn's disease refractory to tumor necrosis factor (TNF) antagonists who receive ustekinumab induction therapy have a higher clinical response rate and, during maintenance therapy, achieve significantly higher response and remission rates compared to patients receiving placebo.
Sanofi Pasteur, the vaccines division of Sanofi, announced that it has filed a Supplemental Biologics License Application (sBLA) with the FDA for a quadrivalent formulation of its Fluzone (Influenza Virus Vaccine); the sBLA file has been accepted by the FDA for full review, and an action date is anticipated in the second quarter of 2013.
Aeterna Zentaris announced that Phase 3 results for AEZS-130 show that it has promise as a safe and simple oral diagnostic test for adult growth hormone deficiency (AGHD), with accuracy comparable to available testing procedures.
Use of hydroxyethyl starch (HES) for fluid resuscitation in the intensive care unit (ICU) is not associated with increased 90-day mortality but does correlate with increased use of renal-replacement therapy.
High-dose vitamin supplementation does not reduce HIV disease progression or death among HIV patients initiating highly active antiretroviral therapy (HAART) in Tanzania.
Vivus announced that it has submitted an amendment to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia (phentermine and topiramate extended-release) capsules CIV.
Emergency room data from 2007 to 2009 indicate that illicit drug abuse is decreasing, while prescription drug abuse is increasing.
The labeling for Baraclude (entecavir; Bristol-Myers Squibb) has been updated to include data on African Americans and liver transplant recipients with chronic hepatitis B infection.
VSL#3 JUNIOR, a once-daily, high-potency probiotic medical food for the dietary management of children who suffer from irritable bowel syndrome (IBS) and ulcerative colitis (UC) has been launched by Sigma-Tau Pharmaceuticals.
The antiepileptic drug zonisamide, at a dosage of 400mg per day, is associated with enhanced weight loss for obese patients when combined with diet and lifestyle counseling, but the incidence of adverse events is high.
Hologic announced that the FDA has approved the Aptima HPV 16 18/45 Genotype Assay for genotyping human papillomavirus (HPV) types 16, 18 and/or 45 on its Tigris instrument system.
A.P. Pharma announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for APF530 for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).
In light of the recent fungal meningitis outbreak and the ongoing investigation at the New England Compounding Center (NECC), the FDA is alerting patients that they have identified a potential association with an additional product, triamcinolone acetonide.
A combination of folic acid and vitamins B6 and B12 supplementation does not reduce the risk of colorectal adenoma among high-risk women.
Depomed announced that its New Drug Application (NDA) for Serada has been accepted for filing by the FDA, seeking approval for the treatment of menopausal hot flashes.
Use of methotrexate for one year or more is associated with a reduction in the risk of mortality for patients with rheumatoid arthritis (RA).
In men with complete erectile dysfunction (ED), tadalafil 2.5mg and 5mg once-daily result an in intercourse success rate of 32.4% and 46.4%, respectively.
Recipients of Medicare Part D benefits have difficulty selecting the most cost-effective plan to cover their medication needs and, consequently, overpay by an average of $368 per year, with one-fifth overspending by $500 or more per year.
Genentech announced that the FDA has expanded the approved indication for Actemra (tocilizumab injection) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
Kidney transplant patients who receive mammalian target of rapamycin (mTOR) inhibitors after transplant have a greater probability of death or transplant failure than patients receiving calcineurin inhibitors.
Leflunomide is effective for the treatment of patients with psoriatic arthritis (PsA) in daily clinical practice.
Mission Pharmacal Company announced that Binosto (alendronate sodium) effervescent tablet for buffered oral solution is now available for the treatment of osteoporosis in postmenopausal women, and to increase bone mass in men with osteoporosis.
Celgene announced that the FDA has approved Abraxane (nanoparticle albumin bound [nab]-paclitaxel for injectable suspension) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
BD Medical announced the launch of BD Vystra Disposable Pen, a self-injection pen designed for use with therapies that require frequent, low-volume injections or variable dosing.
Biogen Idec announced new data from Phase 3 studies evaluating oral BG-12 (dimethyl fumarate), which provide further evidence supporting its clinical and radiological effects in people with relapsing-remitting multiple sclerosis (RRMS).
Even within an integrated Veterans Affairs (VA) system with a uniform national formulary and established criteria for drug use, there is substantial variation in the use of thiazolidinediones and long-acting insulin analogues among veterans with type 2 diabetes mellitus (T2DM).