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.
The American Academy of Orthopaedic Surgeons (AAOS) approved new Appropriate Use Criteria (AUC) for the management of carpal tunnel syndrome and the surgical management of osteoarthritis of the knee.
A retrospective chart review found that rates of urate-lowering therapy monitoring among United States veterans with gout were less than optimal. The full findings are published in the Annals of Pharmacotherapy.
The Food and Drug Administration (FDA) has posted a discontinuation notice for Miacalcin Nasal Spray (calcitonin-salmon; Mylan).
Among the pharmacological treatments for osteoporosis studied, teriparatide appeared to be most effective in preventing new non-vertebral fractures, according to new research published in Cell Physiology and Biochemistry.
The researchers identified six key pieces of information that may help clinicians in selecting the optimal patient for successful de-escalation of biologic DMARD.
Women with immune-mediated diseases receiving anti-tumor necrosis factor (TNF)-alpha agents had significantly higher risks of preterm birth, spontaneous abortion, and low birth weight vs. the general population, a study published in the Journal of Autoimmunity found.
Methotrexate (MTX), the anchor drug in rheumatoid arthritis (RA) treatment, is currently being underutilized in the U.S., with suboptimal dosing, inadequate duration of therapy, and failure to use subcutaneous administration.
The analysis focused on comparing the benefits and risks of biologic monotherapy, non-TNF agents, or tofacitinib monotherapy vs. placebo or methotrexate/other DMARDs.
Benzodiazepines and related drugs were found to increase the risk of hip fracture in patients with Alzheimer's disease.
Centrexion announced that the Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975, a novel therapy intended to treat Morton's neuroma.
For osteoarthritis or rheumatoid arthritis patients at high risk for cardiovascular disease (CVD), celecoxib, ibuprofen and naproxen carry a similar CVD risk, according to newly released results from the PRECISION trial.
For women who are former hormone therapy users, risk of fracture is not increased after discontinuing therapy, according to a study published in the The Journal of Clinical Endocrinology & Metabolism.
A new review has found disease-modifying anti-rheumatic drugs (DMARDs) to be effective in halting progressive bone loss in rheumatoid arthritis (RA) patients, and suggests that they should be used early in treatment.
Biogen and Ionis have announced positive results from the Phase 3 study of Spinraza (nusinersen), an investigational treatment for spinal muscular atrophy (SMA) in children.
A treatment review for acute gout attacks and management has found strong evidence that colchicine, NSAIDs, and corticosteroids are effective in relieving pain in acute gout patients.
Adamas announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, to potentially treat levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
Solid Biosciences and Solid GT announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for SGT-001 for the treatment of patients with Duchenne muscular dystrophy (DMD).
ATyr Pharma has announced that Resolaris, an investigational treatment for facioscapulohumeral muscular dystrophy (FSHD), has been granted Fast Track status by the Food and Drug Administration (FDA).
Pfizer announced that Inflectra (infliximab-dyyb) for injection will be shipped to wholesalers in late November 2016.
Heavy cannabis smokers have lesser bone density than cigarette smokers and are prone to more fractures. That's according to a new analysis of 170 regular cannabis smokers and 114 controls who only smoke cigarettes.
Giant cell arteritis is a chronic, potentially life-threatening autoimmune condition that is more likely to affect women than men.
Recent evidence suggests that beta-blockers may have anti-nociceptive properties.
The Food and Drug Administration (FDA) has posted a discontinuation notice for Fortical (calcitonin-salmon [rDNA origin]; Upsher-Smith) Nasal Spray effective September 30, 2016.
Zurampic is now available for combination use with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone.
Biogen and Ionis have completed the rolling submission of a New Drug Application (NDA) to the FDA for the approval of nusinersen, an invesigational treatment for spinal muscular atrophy (SMA), for which there is currently no approved treatment.
Summit Therapeutics announced it has received a Fast Track designation from the Food and Drug Administration (FDA) for Ezutromid in the treatment of Duchenne muscular dystrophy (DMD).
Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adult patients.
The Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto; Amgen) as a biosimilar to Humira (adalimumab; AbbVie) for various inflammatory diseases.
Janssen Biotech announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the approval of sirukumab for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) announced the publication of new clinical guidelines and an accompanying algorithm to help physicians and other healthcare professionals with the diagnosis, fracture risk assessment, and treatment of postmenopausal osteoporosis
A new retrospective study found evidence which suggests that the β-adrenergic blocker propranolol, may be an effective treatment for tardive dyskinesia (TD), for which there are no current approved treatments.
The use of angiotensin receptor blocker (ARBs) in older men with hypertension was associated with a reduced incidence of non-vertebral fracture than angiotensin-converting enzyme (ACE) inhibitors or calcium channel blockers (CCBs), according to a study published in Age and Ageing.
Compared to other bisphosphonates, alendronate was associated with a higher number of Clostridium difficile infection (CDI) adverse drug reactions, as indicated by the Food and Drug Administration (FDA) Adverse Event Reporting System data (FAERS).
The pain conditions included back pain, neck pain, osteoarthritis, fibromyalgia, severe headaches and migraine.
Adding lesinurad to allopurinol provided extra benefit vs. allopurinol alone in lower serum urate (sUA) levels and is an option for patients requiring additional urate-lowering, a study published in Arthritis & Rheumatology reported.
The Food and Drug Administration (FDA) has approved Erelzi (etanercept-szzs; Sandoz) injection, a biosimilar to Enbrel (etanercept; Amgen).
The Food and Drug Administration (FDA) is informing about the permanent discontinuation of Aristospan (triamcinolone hexacetonide injectable suspension; Sandoz).
Researchers from the University of Calgary found moderate to high quality evidence that triple therapy with methotrexate + sulfasalazine + hydroxycholoroquine or combining methotrexate + most biologic disease-modifying antirheumatic drug (DMARDs) or tofacitinib demonstrated similar efficacy in controlling disease activity in methotrexate-naive patients or after an inadequate response to methotrexate.
Amgen announced top-line data from a primary analysis conducted in a Phase 3 study evaluating the safety and efficacy of Prolia (denosumab) vs. risedronate in patients receiving glucocorticoid treatment.
Limited research published in Annals of Pharmacotherapy suggests that use of proton pump inhibitors (PPI) is associated with myopathy-like symptoms without long-term effects after discontinuation.
Ultrasonography can be useful for guiding modification of anti-rheumatic drugs and steroids for patients with inflammatory arthritis (IA), according to a study published online in the International Journal of Rheumatic Diseases.
Mallinckrodt announced that the FDA has granted Fast Track designation to the Investigational New Drug (IND) application of Synacthen Depot (tetracosactide) for the treatment of Duchenne muscular dystrophy (DMD).
Exposure to prescription drugs associated with fracture risk was not consistently reduced after a fragility fracture occurrence, researchers reported in a JAMA Internal Medicine article.
The FDA has granted Orphan Drug designation to dusquetide (SGX942; Soligenix) for the treatment of macrophage activation syndrome (MAS), a life-threatening complication of rheumatic disease.
In postmenopausal women with osteoporosis, an experimental drug appears to reduce the risk of bone fractures better than teriparatide or a placebo, according to a study published in the Journal of the American Medical Association.
The FDA has granted Orphan Drug designation to TVN-102 (Tivorsan), previously referred to as recombinant human Biglycan, for the treatment of Duchenne Muscular Dystrophy (DMD).
A study published in Arthritis & Rheumatology has found that the DASH diet reduced serum uric acid, particularly in patients with hyperuricemia.
Arhalofenate (800mg) is safe and significantly decreases gout flares compared to allopurinol (300mg), according to a study published online July 27 in Arthritis & Rheumatology.
Thymectomy improves clinical outcomes over a three-year period in patients with nonthymomatous myasthenia gravis, according to research published in the Aug. 11 issue of the New England Journal of Medicine.
The FDA has accepted for filing and granted Priority Review to the New Drug Applications (NDA) of deflazacort immediate-release tablet and oral suspension formulations for the treatment of Duchenne Muscular Dystrophy (DMD).
The Food and Drug Administration (FDA) has approved supplemental Biologics License Applications (sBLA) for Amgen's Prolia (denosumab) and Xgeva (denosumab).