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.
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).
Bioventus announced the availability of Gelsyn-3 (hyaluronic acid), an injectable indicated for pain associated with osteoarthritis of the knee.
The incidence of hand, hip, and knee osteoarthritis (OA) increases with overweight and obesity, particularly in the knee, according to a study published in Arthritis & Rheumatology.
Significant improvements in patient-reported outcomes (PROs) were seen with ustekinumab vs. placebo in 3 antecedent-exposure populations of patients with psoriatic arthritis, including those with prior methotrexate and anti-tumor-necrosis factor (TNF) use, according to findings from a study published in Arthritis Care & Research.
Preliminary data from a systematic review supported the biosimilarity and interchangeability of biosimilar and reference tumor necrosis factor alpha (TNF-α) inhibitors.
Ipsen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in patients aged ≥2 years. This approval marks Dysport as the first FDA-approved botulinum toxin for this indication.
The European League Against Rheumatism (EULAR) have updated their recommendations on the management of gout to reflect novel treatments and evidence surrounding already established treatments.
An analysis published in Medicine identified hip-joint lesion, prevalence of peripheral arthritis, and antistreptolysin O (ASO) and circulating immune complex (CIC) levels as risk factors that may be tied to higher rates of uveitis in ankylosing spondylitis.
An ultrasonographically (US)-guided percutaneous treatment using a 21-gauge needle is efficacious for trigger finger, according to a study published in the August issue of Radiology.
Amgen and UCB announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Progress has been made toward developing lab-grown cartilage that could postpone or possibly eliminate the need for hip replacement surgery in younger arthritis patients, according to research published online in the Proceedings of the National Academy of Sciences.
Bristol-Myers Squibb announced the launch of Orencia (abatacept) ClickJect Autoinjector, a new autoinjector for adults with moderate to severe rheumatoid arthritis.
Bayer announced the launch of Aleve Direct Therapy, a drug-free, pain relief device.
Electronic stimulation of the vagus nerve may help ease symptoms of rheumatoid arthritis (RA), according to a study published online in the Proceedings of the National Academy of Sciences.
The Food and Drug Administration (FDA) is warning against misleading claims about whole body cryotherapy to treat various diseases or conditions.
The prevalence of arthritis and arthritis-attributable activity limitation is projected to increase in U.S. adults by 2040, according to a study published online in Arthritis & Rheumatology.
Findings from a study published in Acta Diabetologica support that treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors is associated with better vitamin D balance in patients with type 2 diabetes.
In a study published in Clinical Reviews in Allergy & Immunology, researchers found that tumor necrosis factor (TNF inhibitors appeared to have clinical benefits with regard to adverse cardiovascular events in psoriasis and/or psoriatic arthritis.
A new study has shed light on an association between immune checkpoint inhibitors (ICIs) and the onset of inflammatory arthritis and sicca syndrome.
Kitov Pharmaceuticals announced new study data from the Phase 3 study for KIT-302 (amlodipine besylate/celecoxib) in the treatment of osteoarthritis pain and hypertension, suggesting beneficial effects on renal function.
Secukinumab, a human anti-IL-17A monoclonal antibody, was shown to be effective in both tumor necrosis factor inhibitor (TNFi)-naïve and TNFi-exposed psoriatic arthritis patients, however greater improvements were noted in TNFi- naïve patients.
A higher allopurinol dose provided a protective effect against incident renal failure in elderly patients, according to a study published in Annals of the Rheumatic Diseases.
Immediate initiation with tocilizumab with or without methotrexate was more effective than methotrexate alone for patients with newly diagnosed rheumatoid arthritis, researchers concluded in a study published in The Lancet.
Marathon Pharmaceuticals announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for deflazacort for the treatment of patients with Duchenne Muscular Dystrophy (DMD).
Eli Lilly and Incyte announced positive data from the pivotal study, RA-BEYOND, evaluating baricitinib vs. placebo for the treatment of rheumatoid arthritis (RA). Study findings were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London.
Electroacupuncture may be a beneficial treatment option for carpal tunnel syndrome, according to a study published online June 6 in CMAJ, the journal of the Canadian Medical Association.
Janssen announced positive results from the SIRROUND-D study, a pivotal Phase 3 trial evaluating subcutaneous sirukumab (CNTO 136) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
For patients with rheumatoid arthritis (RA), biological interventions of both anti-tumor necrosis factor (anti-TNF) and non-anti-TNF agents may lead to a small to moderate improvement in fatigue.
Pfizer announced top-line results from the OPAL Beyond study, the second Phase 3 trial of Xeljanz (tofacitinib citrate) for the potential treatment of patients with active psoriatic arthritis (PsA).
Cannabinoids may have limited benefits in rheumatic conditions, with some potential benefit in terms of pain relief and effect on sleep, according to a review published in Arthritis Care & Research.
Veterans with rheumatoid arthritis were significantly more likely to be persistent and adherent to a tumor necrosis factor inhibitor (TNFi) plus methotrexate combination therapy than to triple therapy with non-biologic disease-modifying antirheumatic drugs (DMARDs), a study published in Arthritis Care & Research concluded.
Sarepta announced that the Food and Drug Administration (FDA) is continuing the pending New Drug Application (NDA) review for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).
The FDA has accepted for review the Biologics License Application (BLA) for SB2 (Samsung Bioepis), a biosimilar candidate to Remicade (infliximab; Janssen), for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Use of bisphosphonates is associated with adverse drug reactions such as atypical femoral fractures (AFs) and osteonecrosis of the jaw (ONJ).
Given the widespread use of fluoroquinolone antibiotics, clinicians should be aware of factors that may put patients at increased risk for tendinitis or tendon rupture, according to an article published in Pharmacotherapy.
The use of intravenous (IV) or oral iron with or without an erythropoiesis-stimulating agent (ESA) may help prevent post-operative anemia and reduce blood transfusion without significantly raising the risk of adverse events, study authors reported in a study published in Annals of Pharmacotherapy.
The FDA has granted Priority Review for the Biologics License Application (BLA) for olaratumab (Lilly), in combination with doxorubicin, for the potential treatment of advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.
A majority of The Food and Drug Administration's (FDA) Advisory Committee voted against recommending eteplirsen, which in its New Drug Application (NDA), proposes to become the first drug to treat Duchenne muscular dystrophy.