Pentec Health is recalling unused nutritional prescriptions for renal patients compounded on or before May 2, 2013.
The FDA has granted Janssen R&D's NDA priority review for simeprevir in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults.
Apotex, on behalf of Hospira, is recalling an additional 21 lots of Piperacillin/Tazobactam for Injection due to possible precipitation and crystallization in IV bag or line after reconstitution.
Mainly affecting eastern China, the number of bird flu cases has risen to 102, including 20 deaths. This is the first time that this flu subtype, influenza A (H7N9) virus, has been found in people.
Since April 2012, a novel coronavirus (NCoV) has infected 31 adults in six countries.
Possible microbial contamination in sterile compounds from The Compounding Shop poses a risk of serious infection to patients.
For preterm infants, administration of the monoclonal antibody palivizumab for prevention of respiratory syncytial virus (RSV) infection is associated with a significant reduction in the number of days of wheezing during the first year of life.
Antibiotic candidate, ceftolozane/tazobactam, has been granted Fast Track Status for the treatment of hospital-acquired bacterial pneumonia/ acquired bacterial pneumonia and complicated urinary tract infections.
AbbVie was granted Breakthrough Therapy designation for it's direct-acting antiviral combination regimen with and without ribavirin for the treatment of genotype 1 HCV.
The FDA approved an sNDA for Sustiva expanding the age and weight based dosing recommendations for HIV-1 infected pediatric patients. This new approval also provides a "capsule sprinkle" administration method.
A voluntary nationwide recall has been issued for 15 lots of Piperacillin and Tazobactam for Injection 40.5g. Administration of precipitated Piperacillin/Tazobactam in an IV bag or IV line may result in phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis.
Gilead Sciences announced that it has received Complete Response Letters from the FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.
Fumaric acid or fumarate-induced lymphopenia may contribute to the development of progressive multifocal encephalopathy.
New data has been released from an interim analysis of the exploratory global Phase 3b CONCISE study evaluating the potential to shorten total treatment with telaprevir combination therapy to 12 weeks in certain people with genotype 1 chronic hepatitis C virus infection who have the IL28B CC genotype.
Boehringer Ingelheim announced results from the pivotal Phase 3 STARTVerso 1 trial of faldaprevir in combination with pegylated interferon and ribavirin. Faldaprevir is an oral protease inhibitor that is designed to target viral replication in the liver.
The FDA has fast-tracked the investigation of Sanofi Pasteur's KB001A, an antibody fragment intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa in mechanically-ventilated patients. Phase 1 trial of KB001A in underway in the U.S.; planning for a Phase 2b study has begun.
Between January 2011 and January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress. Damaged and soiled mattresses can be a source of contamination during infection outbreaks.
Echosens' FibroScan device, used in the clinical management of patients with liver disease such as chronic viral hepatitis C and B and fatty liver diseases, has received clearance from the FDA.
BioAlliance Pharma has received marketing authorization from the FDA for Sitavig in the treatment of recurring Herpes labialis. Sitavig is a nucleoside analog that comes in the form of a mucoadhesive tablet.
U.S. outpatient antibiotic prescribing in 2010 varied with patient age, geographically, and according to provider specialty.
The FDA will review Merck's New Drug Application for an investigational tablet formulation of the company's antifungal agent, Noxafil. Merck seeks approval to indicate Noxafil tablets for once-daily administration, following a twice-daily loading dose on the first day of therapy.
Gilead has submitted a New Drug Application to the FDA for sofosbuvir, a once-daily oral nucleotide analog for the treatment of chronic hepatitis C virus infection. If approved, sofosbuvir would shorten HCV therapy to 12-16 weeks.
Janssen Research & Development has submitted a New Drug Application to the FDA for simeprevir, a treatment for genotype 1 chronic hepatitis C in adult patients.
Trovagene has released a urine-based molecular human papillomavirus (HPV) test designed to identify the presence or absence of 15 known high-risk HPV strains using proprietary DNA sequences.
Macrolide antibiotics are effective in reducing exacerbations in patients with non-cystic fibrosis bronchiectasis, although the resistance rate increases.
In an important announcement, the FDA has approved Botulism Antitoxin Heptavalent (Cangene). This antitoxin, which contains a mixture of antibody fragments that neutralize all seven serotypes known to cause botulism, is the only product available for the treatment of botulism in adults, and for infant botulism caused by nerve toxins other than types A and B.
Novartis' TOBI Podhaler, indicated for the management of cystic fibrosis in patients with Pseudomonas aeruginosa bacteria in the lungs, has received FDA approval. TOBI Podhaler delivers tobramycin into the patient's lungs via a pocket-sized dry powder inhaler.
After reports surfaced of five intraocular infections at a physician's office, Clinical Specialties is undertaking a voluntary recall of Avastin unit dose syringes. The sterile syringes were being used solely for an off-label indication by an ophthalmologist for macular degeneration.
Eritoran, a synthetic analog of lipid A and a toll-like receptor 4 antagonist, is no better than placebo in reducing mortality in patients with severe sepsis.
The FDA is warning the public that azithromycin (Zithromax or Zmax), a macrolide antibiotic, can cause abnormal changes in the electrical activity of the heart that may lead to potentially fatal arrhythmias.
Having completed Phase 2 development, the FDA has granted Fast Track designation for Chimerix Inc.'s CMX001 for the prevention of cytomegalovirus infection. Phase 3 is expected to begin in 2013.
Boehringer Ingelheim announced the first interim results in HCV/HIV co-infected patients from its ongoing Phase 3 hepatitis C (HCV) clinical trial program (HCVerso).
Cubist Pharmaceuticals announced that the FDA has designated its late-stage antibiotic candidate, ceftolozane/tazobactam, as a Qualified Infectious Disease Product (QIDP) for the indications of hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) and complicated urinary tract infections (cUTI).
Anacor Pharmaceuticals announced positive preliminary results from the second of two Phase 3 studies of tavaborole (Study 302).
Furiex Pharmaceuticals announced that the FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for avarofloxacin (JNJ-Q2).
The American Academy of Pediatrics (AAP) recently published revisions to the 2004 acute otitis media guidelines in the March issue of Pediatrics.
Lupin announced that the FDA has approved Suprax (Cefixime) for Oral Suspension 500mg/5mL.
The CDC is alerting clinicians about the need for additional prevention steps regarding carbapenem-resistant Enterobacteriaceae (CRE).
Gilead Sciences announced topline results from the Phase 3 FUSION study which evaluated 12- and 16-week courses of once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment.
Gilead Sciences announced a voluntary recall of Vistide (cidofovir injection) due to the presence of particulate matter found in some vials of a lot.
Community-associated strains of methicillin-resistant Staphylococcus aureus (CA-MRSA), commonly found in hospitals, are common in nursing homes.
Gilead announced topline results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patents with chronic hepatitis C virus (HCV) infection.
Anacor Pharmaceuticals announced positive preliminary results from the first of two Phase 3 trials of tavaborole, its topical anti-fungal for onychomycosis, a fungal infection of the nail and nail bed.
Pfizer announced that the FDA has approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) for use in vaccine-naïve children and adolescents aged 6-17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine.
Protein Sciences announced that the FDA has approved Flublok (trivalent recombinant hemagglutinin [rHA] influenza vaccine) for use in adults 18-49 years old.
Currently available evidence indicates the safety of the U.S. childhood immunization schedule, with no indication of major safety concerns.
Pandemic influenza A (H1N1) infection in pregnancy is associated with an increased risk of fetal death, and vaccination is associated with a non-significant reduction in the risk of fetal death.
The use of first-line, generic-based antiretroviral (ART) HIV treatment in the United States could potentially save almost $1 billion in the first year of implementation.
Luminex announced that it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), a comprehensive molecular diagnostic assay that tests for >90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay.
Artesunate, a drug used in the treatment of severe malaria, may or may not be associated with hemolytic anemia, so the U.S. Centers for Disease Control and Prevention recommends close monitoring of patients treated with the drug for four weeks after administration of the agent.
AdvanDx announced the launch of Enterococcus QuickFISH BC, a rapid molecular diagnostic test that identifies potentially life threatening bloodstream infections caused by Enterococcus.
For Neisseria gonorrhoeae (N. gonorrhoeae) infections, the rate of clinical treatment failure with cefixime is 6.77%, and is associated with minimum inhibitory concentrations (MICs) of ≥0.12µg/mL.
Aptalis announced the results of a global Phase 3 study of Aeroquin (levofloxacin inhalation solution) conducted in cystic fibrosis patients with stable chronic lung infection with Pseudomonas aeruginosa.
The national prevalence of three doses of human papillomavirus (HPV) vaccination among adolescent girls is about 32%, and incidence rates for some HPV-associated cancers are increasing.
HIV-infected adults achieve higher rates of seroprotection when immunized with a high-dose of the influenza trivalent vaccine compared to the standard dose.
Paratek Pharmaceuticals announced that the FDA has designated omadacycline (formerly known as PTK 0796) as a Qualified Infectious Disease Product (QIDP) for both IV and oral formulations in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
For untreated patients with hepatitis C virus (HCV), treatment with an oral nucleotide inhibitor of HCV polymerase, sofosbuvir, plus ribavirin seems effective for genotypes 1, 2, and 3; and the HCV NS3 protease inhibitor ABT-450, combined with low-dose ritonavir (ABT-450/r) plus the nonnucleoside NS5B polymerase inhibitor ABT-333 and ribavirin, seems effective for genotype 1.
Cepheid announced that it has received clearance from the FDA to market Xpert CT/NG, an in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).
The FDA has approved Varizig (varicella zoster immune globulin [human]; Cangene) for reducing the severity of chicken pox (varicella zoster virus [VZV]) infections in high-risk individuals when given within four days after exposure.
Genentech announced that the FDA has expanded the approval of Tamiflu (oseltamivir phosphate) for the treatment of acute, uncomplicated influenza to include infants 2 weeks or older.
Klebsiella pneumoniae (K. pneumoniae) isolates from U.S. inpatients are becoming increasingly resistant to antimicrobial agents.
In cases of lower-respiratory-tract infection when pneumonia is not suspected, amoxicillin provides little symptomatic benefit.
Vertex Pharmaceuticals announced that the Incivek (telaprevir) label has been updated to include a boxed warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking Incivek combination treatment.
In response to the United Nations (UN) Environmental Program international treaty, which seeks to reduce mercury exposure from different sources, the American Academy of Pediatrics (AAP) has joined the World Health Organization (WHO) in urging the UN to reconsider their stance on thimerosal (ethyl mercury).
GlaxoSmithKline announced that the FDA has approved Fluarix Quadrivalent (quadrivalent influenza vaccine [types A and B]) for the immunization of children 3 years old and older, and adults to prevent disease caused by seasonal influenza virus subtypes A and B.
ConvaTec announced that its Aquacel foam dressings can now be used as part of a comprehensive protocol to protect patients from skin breakdown tied to friction and moisture.
GlaxoSmithKline announced that the FDA has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis when alternative therapies are not available or are not appropriate.
In adolescents infected with hepatitis B virus (HBV), once-daily tenofovir treatment for 72 weeks effectively suppresses HBV DNA and normalizes alanine aminotransferase (ALT) values, regardless of prior HBV treatment exposure.
Benzodiazepine use is associated with an increased risk of developing pneumonia as well as increased mortality following pneumonia.
Janssen announced that the FDA has approved a prescribing information update for Edurant (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies.
Cubist Pharmaceuticals announced that the FDA has designated two of the company's antibiotic candidates, CXA-201 (ceftolozane/tazobactam) and CB-315, as Qualified Infectious Disease Products (QIDP); CXA-201 has been designated for the treatment of complicated intra-abdominal infections, while CB-315 has been designated for Clostridium difficile-associated diarrhea (CDAD).
Recent reports linking outbreaks of infection to antiseptic products have prompted the U.S. Food and Drug Administration to evaluate the need for sterile manufacture of such products.
Significant increases in flu activity in the United States have occurred in the last two weeks.
There has been a significant increase in adverse drug reactions (ADRs) associated with use of trimethoprim-sulfamethoxazole (TMP-SMX) for treatment of skin and soft tissue infection (SSTI) in children.
The odds of contracting whooping cough increase with time since the final diphtheria, tetanus, and acellular pertussis (DTaP) vaccine dose.
Recent testing by the FDA on steroid medications produced by the New England Compounding Center (NECC) has found more contaminants in the steroids Triamcinolone Acetonide and Betamethasone Acetate.
Gilead announced topline results from the Phase 3 POSITRON study examining a 12-week course of once-daily sofosbuvir plus ribavirin (RBV) in patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who are not candidates to take interferon (IFN).
Novartis announced that the FDA has approved the use of Flucelvax (inactivated influenza vaccine [Types A and B]) for active immunization in the prevention of influenza in patients ≥18 years old.
GlaxoSmithKline announced that the FDA has approved Promacta (eltrombopag tablets) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
The pneumococcal conjugate vaccine containing 10 serotype-specific polysaccharides conjugated to Haemophilus influenza protein D, tetanus toxoid, and diphtheria toxoid as the carrier proteins (PHiD-CV10) is effective against invasive pneumococcal disease, including in infants using a 2+1 schedule.
The Associates of Cape Cod (ACC) announced that the FDA has given clearance for the Fungitell assay, a highly sensitive, rapid diagnostic test to detect (1,3)-b-D-glucan in blood serum.
ViiV Healthcare announced 24-week data from the VIKING-3 Phase 3 study evaluating the investigational integrase inhibitor dolutegravir in HIV-1 infected adults with multiple class antiretroviral resistance.
Savara Pharmaceuticals announced that the FDA has granted orphan drug status to AeroVanc (vancomycin hydrochloride inhalation powder) for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF) patients.
For patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) who undergo curative liver resection, treatment with nucleoside analogues correlates with a reduced risk of HCC recurrence or death.
Janssen announced that the FDA has approved a new 800mg tablet of Prezista (darunavir) for the treatment of HIV-1 in treatment-naïve and treatment-experienced adult patients with no darunavir resistance-associated mutations.
For infants, vaccination with the RTS,S/AS01 vaccine, coadministered with Expanded Program on Immunization (EPI) vaccines, is associated with modest protection against clinical and severe malaria.
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).
Antiviral treatment does significantly reduce the risk of developing liver cancer for patients with chronic hepatitis C infection, particularly in virological responders.
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.
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.
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.
High-dose vitamin supplementation does not reduce HIV disease progression or death among HIV patients initiating highly active antiretroviral therapy (HAART) in Tanzania.
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.
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.
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.
For girls, receipt of human papillomavirus (HPV) vaccination at the recommended ages (11-12 years) does not correlate with an increase in sexual activity-related outcomes.
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.
Despite more extensive disease and more adverse prognostic factors, HIV-positive patients with Hodgkin's lymphoma (HL) do not have worse outcomes when treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
For patients with hepatitis C virus (HCV) treated with pegylated interferon-alpha and ribavirin (P/R), drinking patterns and the amount of alcohol consumed before treatment do not impact treatment success.