The new labeling now recommends patients with severe renal impairment be limited to a dose of 40mg once daily.
The CRL indicated a request for additional clinical data in order to evaluate the safety of sirukumab in the treatment of RA.
"We expect to begin enrolling patients as early as December in a proof-of-concept Phase 2 study of omadacycline in uUTI, and an indication in this type of infection would broaden the opportunities for oral omadacycline in community-acquired infections," said Evan Loh, MD, COO and CMO of Paratek.
The authors reported that of the patients who continued taking adalimumab for ≥1 year, 67.0% were considered in low disease activity (LDA)/remission (CDAI ≥10).
ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) was a multicenter, international, randomized, double-blind, alendronate-controlled study (n=4,093) in postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.
The data showed a statistically significant fracture risk reduction through 3.5 years.
In clinical trials, treatment with Durolane effectively relieved pain and restored function for up to six months in patients with knee osteoarthritis.
At the study's end, 29% of participants were either unable to walk or had difficulty doing so.
An FDA inspection of the clinic found that adipose tissue was being processed into stromal vascular fraction (stem cells derived from body fat) which was then administered intravenously or directly into the spinal cord of patients.
This marks the second approval of a biosimilar for adalimumab.
This fixed-dose combination product combines lesinurad, a uric acid transporter 1 (URAT1) inhibitor, with allopurinol, a xanthine oxidase inhibitor in one tablet.
Researchers used claims data between 2004-2015 from a large commercial database to identify patients with psoriatic arthritis who were initiated on DMARDs.
Study authors sought to compare OTC lidocaine 3.6% with menthol 1.25% patches vs. Rx lidocaine 5% as well as to placebo.
Results showed a significant reduction in the risk for secondary vertebral fracture with all of the of anti-osteoporotic drugs (risk ratio [RR] 0.38-0.77).
The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program.
The Stimpod NMS460 includes a nerve-mapping pen-like probe which allows practitioners to locate nerves and evaluate the treatment progress.
Sirukumab, a human monoclonal IgG1 kappa antibody, works differently than current IL-6 inhibitors approved to treat RA by targeting the IL-6 cytokine vs. the IL-6 receptor.
Methotrexate works by inhibiting dihydrofolic acid reductase, which interferes with DNA synthesis, repair, and cellular replication.
Accidental dosing with Cyclobenzaprine HCl may potentially lead to life-threatening serotonin syndrome when the drug is taken in combination with selective serotonin reuptake inhibitors.
Recovered organisms included various Streptococcus, Actinomyces, Haemophilus, Neisseria species, among others; all of the pathogens isolated were oral flora. Two patients also exhibited Staphylococcus aureus bacteria in the blood.
Infliximab products work by neutralizing the biological activity of TNF-alpha by binding with high affinity to the soluble and transmembrane forms of TNF-alpha and inhibiting the binding of TNF-alpha with its receptors.
Dr. Pascale Richetta, head of bone and executive vice president, UCB, stated, "With all three pivotal romosozumab Phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures."
Octagam 10% is currently approved to treat chronic immune thrombocytopenic purpura (ITP) in adult patients. It is supplied as 2g, 5g, 10g, or 20g single-use bottles.
Results showed that after a mean follow-up of 1.32 years, there were 27 hip fractures in the alendronate group and 73 in the non-alendronate group; this corresponded to incident rates of 9.5 (95% CI, 6.5-13.9) and 27.2 (95% CI, 21.6-34.2) fractures per 1000 person-years, respectively.
A greater response to Orencia was observed in the trial regardless of prior anti-TNF treatment and other non-biologic DMARD therapy.
Results showed a statistically significantly, but not a clinically important, improvement in two of the trials which evaluated radiofrequency denervation for the sacroiliac joints (−0.71 (95% CI, −1.35 to −0.06) and a combination of the facet joints, sacroiliac joints or intervertebral disks (−0.99 (95% CI, −1.73 to −0.25) at 3 months.
The proposed indications are for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.
Over the 2.2 years mean follow-up, the immediate ART arm demonstrated greater BMD declines vs. the deferred ART arm at the hip (-2.5% vs. -1.0%, 95% CI: -2.2 to -0.8; P<0.001) and at the spine (-1.9% vs. -0.4%, 95% CI: -2.2 to -1.0; P<0.001).
The researchers found that intensive electronics users had significantly more discomfort, and more severe discomfort, in their wrist and hand.
The results from the 12-week period show that both arms of upadacitinib treatment were superior in achieving ACR 20 (64% in 15mg arm, 66% in 30mg arm) vs. placebo (36%).
The authors concluded that "rheumatologists and other clinicians caring for patients with RA face a significant dilemma precisely because the options for care of pain remain problematic."
The FDA approval was based on data from a Phase 3, multi-center, prospective, double-blind, randomized, placebo-controlled study in 381 adults treated with Dysport 1000 Units, Dysport 1500 Units or placebo after a stroke or traumatic brain injury.
Currently, there is a global Phase 3 program comprised of 6 studies involving approximately 7,000 patients with OA, CLBP or cancer pain with inadequate treatment of pain with approved therapies.
The proportion of study patients with lower limb amputations were similar for Jardiance (1.9%) and placebo groups (1.8%).
The researchers aimed to evaluate the association between dietary vitamin D, omega-3 fatty acids, and treatment outcomes with DMARDs in patients with rheumatoid arthritis.
When lesinurad 400mg was added to febuxostat, significantly more patients achieved target sUA by Month 6 (76.1%; P<0.0001) vs. febuxostat alone (46.8%); however, this was not seen with adding lesinurad 200mg (56.6%; P=0.13).
The approval of the prefilled syringe was based on dosing, efficacy, and safety data of SC abatacept in JIA among patients aged 2-17 years with inadequate response to at least one nonbiologic or biologic DMARD (Study JIA-2).
The data showed sarcopenia was 4 times more prevalent for the high-risk alcohol drinking group vs. the low-risk alcohol drinking group (odds ratio 4.29, 95% CI: 1.87, 9.82).
Initially, the team attributed the muscle weakness to either HIV or drug-mediated myopathy but a muscle biopsy later revealed atrophy of type II fibers without necrosis or inflammation.
Accidental patient dosing with Zurampic can potentially cause adverse renal effects such as acute renal failure; this is more common if Zurampic is given alone without a xanthine oxidase inhibitor.
Kevzara (sarilumab) injection has been approved for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.
In the study, Actemra given weekly and bi-weekly combined with a 6-month glucocorticoid regimen, more effectively sustained remission through Week 52 than placebo combined with a 26-week steroid taper and a 52-week steroid taper.
Five important differences were identified by AACE/ACE involving pharmacotherapy choice as well as treatment duration and reevaluation.
In preclinical studies, AMO-02 has shown efficacy in transgenic models and reversal of muscle cell differentiation deficits in ex vivo tissue samples.
The researchers found that at the end of the study, pain levels didn't differ significantly between the patient who received intra-articular triamcinolone or saline.
An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.
Previous research has demonstrated a link between statin use and use-related injury and arthropathies.
Abaloparatide is a parathyroid hormone related peptide [PTHrP(1-34)] analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells.
Ilaris for Injection will be replaced by Ilaris Injection (solution) for subcutaneous use.
The FDA has accepted for review the resubmission of the Biologics License Application (BLA) for Kevzara (sarilumab; Regeneron and Sanofi) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs.
Which cities report the highest physician compensation?
To date, there is no approved oral liquid formulation of methotrexate for pediatric patients who require body surface area (BSA) dosing or who have difficulty swallowing or cannot ingest tablets or those with needle-phobia.
The CHERISH study was a multicenter, randomized, double-blind, sham-procedure controlled study to evaluate the safety and efficacy of Spinraza in children with later-onset SMA (n=126) aged 2-12 years.
A biosimilar product must demonstrate no clinically meaningful differences in safety or efficacy from the reference product.
The researchers concluded that stimulant drug use may result in acute stimulant-induced tremor as well as long-term proprioceptive deficits in terms of arm-droop.
The data overall showed favorable ACR and EULAR response criteria, DAS28, and modified Sharp scores with anti-TNF agents + methotrexate, with no difference with HAQ and rates of adverse events between the treatment groups.
The NDA for baricitinib was submitted in January 2016 and a 3-month extension for time to review additional analyses was announced in January 2017.
In general, there was low quality evidence from three trials indicating no reduction in systolic (-6.2mmHg, 95% CI: -12.8 to 0.5) or diastolic (-3.9mmHg, 95% CI: -9.2 to 1.4) 24-hour ambulatory BP with uric acid lowering drugs vs. placebo.
The FDA approval was based on efficacy data of Ingrezza in a 6-week clinical study (n=234) of patients who received Ingrezza vs. placebo.
Researchers evaluated the incidences of adverse events in women who initially received placebo during the FREEDOM trial and then received denosumab for up to 3 years during the FREEDOM Extension trial.
The study met its primary endpoint of Xgeva non-inferiority versus zoledronic acid in delaying the time to first on-study SRE in multiple myeloma patients (HR=0.98, 95% CI: 0.85, 1.14; P=0.01).
"This has important ramifications for public health recommendations," said Christopher Gallagher, MD, professor and director of the Bone Metabolism Unit in the Division of Endocrinology of Creighton University School of Medicine.
Researchers utilized functional electric stimulation intracortical brain-computer interface system
SSRIs users had significantly lower risk of revisions and aseptic revisions compared to those who were not administered an SSRI.
The submission is supported by data from the Phase 3 REGAIN study, a randomized, double-blind, placebo-controlled trial which enrolled a total of 125 patients with anti-AChR Abs.
A study which assessed concentrations of certolizumab pegol (Cimzia; UCB) in human breast milk found that minimal to no transfer of drug from plasma to breast milk occurs.
Patients and physicians have substantially different goals when it comes to chronic musculoskeletal pain management, however these differences do not predict patient experience or physician-reported visit difficulty.
Tocilizumab is known to raise LDL cholesterol levels but it is unclear whether the drug raises CV risk in RA patients.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma) for the treatment of limb girdle muscular dystrophy (LGMD).
Tofacitinib plus MTX was shown to be non-inferiority vs. adalimumab plus MTX, however, Xeljanz monotherapy did not meet its primary endpoint for non-inferiority vs.adalimumab plus MTX, or vs. Xeljanz plus MTX.
The recommendations are intended for all clinicians treating adult patients with acute, suabcute, or chronic low back pain.
In the U.S., diazepam is prescribed in approximately 300,000 visits for low back pain annually, however the evidence regarding its efficacy is surprisingly lacking.
For patients experiencing low back pain, yoga may be an effective pain reliever, according to a review published online January 12 in The Cochrane Library.
The Food and Drug Administration (FDA) has approved Emflaza (deflazacort; Marathon) tablets and oral suspension for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 5 years and older.
In response to revised osteoporosis recommendations in 2008, there was a shift in age-related trends in oral bisphosphonate (BP) therapy initiation, according to a study published online February 2 in the Journal of the American Geriatrics Society.
For patients with rheumatoid arthritis, etanercept is associated with lower risk for general infections and tuberculosis compared with monoclonal antibody treatment, according to a meta-analysis published online Feb. 3 in the International Journal of Rheumatic Diseases.
The FDA has accepted for review the New Drug Application (NDA) for Zilretta (FX006; Flexion Therapeutics) for the treatment of patients with osteoarthritis (OA) of the knee.
Older adults who take multiple medications may be twice as likely to become frail in a relatively short period of time (3 years) compared to those who take fewer medications.
Low back pain is common in school-age American children, and rates increase with age, according to a study published online January 30 in JAMA Pediatrics.
The International Osteoporosis Foundation and European Calcified Tissue Society Working Group proposed a screening strategy measuring certain bone turnover markers in patients who have initiated oral bisphosphonate therapy for postmenopausal osteoporosis as a practical way to identify low adherence.
An anti-inflammatory diet may protect women against bone density loss and decrease the risk of hip fracture, according to data taken from the Women's Health Initiative (WHI).
Genentech has announced that the Food and Drug Administration (FDA) has accepted the company's Supplmental New Drug Application (sBLA) for Actemra (tocilizumab) to treat giant cell arteritis (GCA).
Spinal cord stimulation was found to help decrease or stabilize opioid use in patients with chronic pain.
Bone Index announced that the Food and Drug Administration (FDA) has granted clearance for the second generation Bindex device model to aid in the diagnosis of osteoporosis.
A sedentary lifestyle may accelerate biological aging, according to a study published online January 18 in the American Journal of Epidemiology.
Nearly one in 10 patients seeking facial plastic surgery suffers from body dysmorphic disorder (BDD), but doctors often don't spot the problem, according to research published online recently in JAMA Facial Plastic Surgery.
aTyr announced that its candidate Resolaris has been granted Fast Track designation for the treatment of limb girdle muscular dystrophy 2B (LGMD2B), by the Food and Drug Administration (FDA). The FDA also removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials.
CyMedica Orthopedics announced that the Food and Drug Administration (FDA) has granted clearance for e-vive, an app-controlled, data-driven muscle activation therapy and patient engagement solution.
Patient- and provider-based interventions do not improve osteoarthritis outcomes, according to a study published online January 17 in the Annals of Internal Medicine.
Biogen announced new data from the Phase 3 ENDEAR study that showed a statistically significant reduction in the risk of death or permanent ventilation in Spinraza (nusinersen)-treated infants with spinal muscular atrophy (SMA) vs. untreated infants.
The therapeutic efficacy of pregabalin in treating two types neuropathic pain (NeP) is not influenced by concomitant NeP medications, according to new research published in the journal Pain Physician.
Weekend warriors may add almost as many years to their life span as those who work out all week long, according to research published online in JAMA Internal Medicine.
Bioberica announced positive results from the MOSAIC Study that evaluated the use of chondroitin sulfate for knee osteoarthritis.
Alexion has submitted a marketing application to the Food and Drug Administration (FDA) to extend the indication for Soliris (eculizumab) to be a treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Data from a retrospective study of children with osteogenesis imperfecta (OI) suggests that atypical femur fractures are related to the severity of OI vs. use of bisphosphonates. Findings from the study are published in the Journal of Bone and Mineral Research.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Duzallo (lesinurad/allopurinol fixed-dose combination; Ironwood) for the treatment of hyperuricemia in patients with uncontrolled gout.
The approval was based on positive data from multiple clinical studies involving >170 patients.
BD announced the launch of BD Neopak 2.25mL prefillable glass syringes intended for biopharmaceutical manufacturers that handle high-value and sensitive biologic agents that require higher quality levels and performance to treat rheumatoid arthritis, psoriasis, lupus, severe asthma, and other chronic conditions.
The Food and Drug Administration (FDA) has approved Maci (autologous cultured chondrocytes on porcine collagen membrane; Vericel) for the repair of symptomatic, full-thickness cartilage defects of the knee in adults.
Flexion has submitted a new drug application (NDA) to the Food and Drug Administration (FDA) for Zilretta (FX006), a potential treatment for patients with osteoarthritis (OA) of the knee.