Supartz FX Injection Launched for Knee Osteoarthritis Pain

Bioventus announced the launch of Supartz FX (hyaluronic acid) for the management of knee osteoarthritis pain.

New Duchenne Muscular Dystrophy Tx Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to TXA127 (angiotensin 1-7; Tarix Orphan) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.

Infants Born to Mothers Exposed to This HIV Drug May Have Lower Bone Mass

According to a National Institutes of Health (NIH) Study, infants exposed in the womb to the HIV drug tenofovir disoproxil fumarate, may have lower bone mineral content than those exposed to other anti-HIV drugs.

Study: Baricitinib Superior to Conventional DMARD

Eli Lilly and Incyte announced positive top-line results of RA-BEGIN, the third Phase 3 study evaluating the safety and efficacy of baricitinib for the treatment of patients with moderately-to-severely active rheumatoid arthritis (RA).

New Recommendations Released for Treating Ankylosing Spondylitis, Spondyloarthritis

The American College of Rheumatology, in conjunction with the Spondylitis Association of America and the Spondyloarthritis Research and Treatment Network, has released new recommendations for both pharmacologic and non-pharmacologic treatment of ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (SpA).

Keveyis Launched for Primary Periodic Paralysis

Taro announced the launch of Keveyis (dichlorphenamide) tablets, the first therapy approved for the treatment of primary hyperkalemic and hypokalemic periodic paralysis and related variants.

ColciGel for Acute Gout Flares Now Available

Gensco Laboratories announced the launch of ColciGel (colchicinum 4X) indicated for the treatment and prophylaxis of acute gout flares in adults, the first prescription transdermal gel approved for this condition.

New PMR Screening, Tx Recs and Gout Classification Criteria

The American College of Rheumatology (ACR), in collaboration with the European League Against Rheumatism, has issued new publications on recommended screening, treatment, and management of polymyalgia rheumatica (PMR) and new classification criteria for gout.

Bone Fracture, Density Warning Issued for SGLT2 Inhibitor

The Food and Drug Administration (FDA) has issued another warning for canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, regarding the risk for bone fractures with new information about decreased bone mineral density.

Exercise May Lower Fracture Risk With Rosiglitazone

Research in the journal Endocrinology indicates that exercise may partially reduce the risk of increased marrow adipose tissue associated with both diabetes and peroxisome proliferator-activated receptor agonists (PPARs) medications for the treatment of type 2 diabetes.

Epidural Steroid Injections May Be Effective for Spinal Stenosis After All

Contrary to a study published in the New England Journal of Medicine (NEJM) which concluded that epidural steroid injections were not helpful in the treatment of lumbar spinal stenosis, a letter in the journal Pain Medicine states that epidural steroid injections may provide good short term benefit, lasting from weeks to months.

Top-Line Results for Investigational Osteoporosis Drug

Amgen and UCB announced top-line results from the STRUCTURE trial evaluating romosozumab in women with postmenopausal osteoporosis at high risk for fracture previously treated with bisphosphonate therapy.

FDA Approves Updated Labeling for Simponi Aria

Janssen Biotech announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the label for Simponi Aria (golimumab for infusion) to include measures in both physical and emotional health in patients being treated for moderately to severely active rheumatoid arthritis (RA).

Novel Drug Granted Orphan Designation for Rare Musculoskeletal Disorder

The Food and Drug Administration (FDA) has granted AT001 (Audentes) Orphan Drug designation for the treatment of X-Linked Myotubular Myopathy (XLMTM).

Tomatoes as Gout Trigger? New Study Adds to Evidence

Patients with gout often self-report foods like tomatoes and tomato products as dietary triggers, but consumption of these foods as a trigger of gout flares may not be supported by empirical evidence. A study in BMC Musculoskeletal Disorders reports on a positive association between tomato consumption and serum urate levels, but suggests that there may be a biological basis.

First Drug Approved for Primary Periodic Paralysis

Taro announced that the Food and Drug Administration (FDA) has approved Keveyis (dichlorphenamide) tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis.

When Supplement Use Becomes an Eating Disorder

Recent research has shown that an increasing number of men are using over-the-counter bodybuilding supplements to the point where it may be characterized as an eating disorder.

Vitamin D May Not Benefit Postmenopausal Women

Postmenopausal women did not experience beneficial effects on bone mineral density, muscle function, muscle mass or falls with high-dose vitamin D, according to a study published in JAMA Internal Medicine.

Do Antibiotics Increase Juvenile Arthritis Risk?

New research in Pediatrics suggests that children who are exposed to antibiotics could have an increased risk of newly diagnosed juvenile idiopathic arthritis (JIA), but that antibiotic use could be a marker for abnormal immunity rather than a direct cause of JIA.

Arthritis Drug May Help Eczema Patients, Too

A drug used to treat rheumatoid arthritis (RA) was effective in patients with moderate to severe eczema, according to a study conducted by researchers from Yale School of Medicine.

Dysport Gains FDA Approval for Upper Limb Spasticity

Ipsen announced that the Food and Drug Administration (FDA) has approved Dysport (abobotulinumtoxinA) injection for the treatment of upper limb spasticity in adults.

Certain Comorbid Disorders May Lower Opioid Efficacy, Up Abuse Risk

Opioids are often prescribed to treat chronic lower back pain, but patients with comorbid psychiatric disorders such as depression and anxiety could experience significantly less pain relief with this therapy and may be more likely to abuse their medication.

Diazepam Sold Online May Actually Be Antipsychotic, FDA Warns

The Food and Drug Administration (FDA) issued a warning about the potential risk of purchasing counterfeit diazepam online.

FDA to Review New Xeljanz Formulation for Rheumatoid Arthritis

Pfizer announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate.

Eteplirsen NDA Submission Completed for Duchenne Muscular Dystrophy

Sarepta Therapeutics announced that it has completed a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for eteplirsen.

Cosentyx Efficacious in Psoriatic Arthritis Study

Novartis announced one year results from the Phase 3 FUTURE 2 study with Cosentyx (secukinumab) in patients with psoriatic arthritis (PsA).

Are Americans Following Physical Activity Guidelines?

Results from the National Health Interview Survey show that between 2008 and 2013, the percentage of people meeting the Department of Health and Human Services 2008 Physical Activity Guidelines for Americans increased for all age groups.

Women Wishing to Conceive May Want to Avoid These Pain Meds, Study Suggests

A study presented at the European League Against Rheumatism Annual Congress (EULAR 2015) indicates that use of some non-steroidal anti-inflammatory drugs (NSAIDs) could have a negative impact on female fertility, even with short-term use.

Mylan Expands Recall of Multiple Injectable Products

Mylan announced that it is expanding a voluntary recall of multiple injectable products to the hospital/user level due to the presence of visible foreign particulate matter.

One-Third of World Population Suffers From More Than Five Illnesses

A third of the world's population, about 2.3 billion people, is experiencing over five ailments, according to a new analysis from the Global Burden of Disease Study (GBD) 2013.

NSAID, Antihistamine Discovered in Joint Pain Supplement

The Food and Drug Administration (FDA) has warning consumers to not buy or use GC Natural's Pyrola Advanced Joint Formula, an herbal supplement marketed for joint pain.

High Heels May Initially Strengthen, Then Weaken Ankle Muscles

Prolonged wearing of high-heeled shoes has been linked to injuries related to the plantarflexor (PF) and dorsiflexor (DF), but a new study in the International Journal of Clinical Practice has also found that it may initially strengthen ankle muscles but eventually can lead to a muscular imbalance, a predictor of ankle injury.

Sarilumab Improves Physical Function in Rheumatoid Arthritis Trial

Regeneron and Sanofi announced results from their Phase 3 SARIL-RA-TARGET trial of sarilumab in patients with rheumatoid arthritis (RA).

Osteo Bi-Flex Now Available in Mini-Tabs

Osteo Bi-Flex announced the launch of Osteo Bi-Flex EASE, a mini-tab supplement that promotes joint comfort through a novel collagen-based formula.

Oral Steroids May Improve More Function than Pain in Sciatica

A short course of oral steroids provided modest improvement in function and no significant improvement in pain for patients with acute radiculopathy (sciatica), a study published in JAMA has shown.

Treating Overactive Bladder May Reduce Fall Risk in Elderly

A new study has shown that treatment for overactive bladder (OAB) may lead to less falls among older adults.

Xiaflex Label Updated With Contracture Recurrence Data

Endo announced that the Food and Drug Administration (FDA) has approved a label update for Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord.

Senza System Offers SCS for Pain Without Paresthesia

Nevro announced that the Food and Drug Administration (FDA) has approved the Senza System, a spinal cord stimulation (SCS) system as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain, and leg pain.

How Common is Vitamin D Toxicity with Supplements?

Toxic levels of vitamin D are rarely seen in people taking supplements, according to Mayo Clinic researchers.

Rare Facial Disorder Drug Designated Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma), a physiocrine-based product for the treatment of facioscapulohumeral muscular dystrophy (FSHD).

Botox Label Expanded, Addition of Two Flexor Muscles

The FDA has approved an expansion of the Botox (onabotulinumtoxinA; Actavis) label for the treatment of adults with upper limb spasticity.

FDA: Topical Flurbiprofen Exposure May Be Fatal for Pets

The FDA is warning pet owners, veterinarians, healthcare providers, and pharmacists that pets are at risk of illness and death when exposed to topical pain medications containing flurbiprofen.

Counterfeit Botox Discovered in the U.S.

The FDA is alerting healthcare providers and the public that counterfeit Botox (onabotulinumtoxin A; Allergan) has been found in the United States and may have been distributed to doctors' offices and clinics.

Ice May Hinder, Not Help, After Muscle Injury

Contrary to popular advice, applying ice after a muscle impact injury may not contribute to angiogenesis and muscle regeneration and could actually delay recovery.

Long-Term Efficacy Data for Otezla in Plaque Psoriasis Announced

Celgene announced results from the ESTEEM Phase 3 clinical program for Otezla (apremilast) in patients with moderate to severe plaque psoriasis.

New Data on Once-Daily Baricitinib for RA From Phase 3 Trial

Eli Lilly and Company and Incyte announced results from a second Phase 3 trial with baricitinib in patients with rheumatoid arthritis.

Smallest Estrogen Patch Now Available for Postmenopausal Osteoporosis

Noven announced the launch of Minivelle (estradiol transdermal system) 0.025mg/day, a new low dosage strength approved for the prevention of postmenopausal osteoporosis.

Adalimumab Biosimilar Effective in Rheumatoid Arthritis Trial

Amgen announced results for its Phase 3 study evaluating the safety and efficacy of biosimilar candidate ABP 501 compared to adalimumab (Humira; AbbVie) in patients with moderate-to-severe rheumatoid arthritis.

FDA: Avoid Bone Grafts with Recombinant Proteins in Patients Under 18

The Food and Drug Administration (FDA) is recommending against the routine use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients under 18 years old.

Deflazacort Designated Fast Track Status for Duchenne Muscular Dystrophy

The Food and Drug Administration (FDA) has granted Fast Track designation to deflazacort (Marathon Pharmaceuticals) for the treatment of patients with Duchenne Muscular Dystrophy (DMD).

Menopausal Symptoms Tied to Hip Fracture Risk

A new study shows that women who experience menopausal symptoms (eg, severe hot flashes, night sweats) tend to have lower bone mineral density and higher rates of hip fractures vs. women who do not have menopausal symptoms.

Infusion Reactions with Krystexxa: New Phase 3 Results Announced

Crealta announced results from two Phase 3 trials and one open-label extension trial on loss of urate-lowering response to Krystexxa (pegloticase) and risk of infusion reactions cited in the product's Food and Drug Administration (FDA)-approved labeling.

Baricitinib Demonstrates Efficacy in Rheumatoid Arthritis

Eli Lilly and Company and Incyte Corp. announced results from the Phase 3 RA-BEACON study of baricitinib in patients with active rheumatoid arthritis (RA).

Experimental Drug May Help Spinal Cord Injury

A new drug could allow the long axons of spinal cord nerve cells to regenerate after paralyzing spinal cord injuries, unlike current treatments that may require touching the healing spinal cord.

40% of Seniors Report Disability, Census Report Shows

According to a U.S. Census Bureau report, almost 40% of people ages ≥65 had at least one disability, of which two-thirds reported difficulty in walking or climbing.

Dysport sBLA Under Review for Upper Limb Spasticity

The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA; Ipsen) for the treatment of upper limb spasticity in adults.

New Clinical Guidelines Issued for Paget's Disease

The Endocrine Society released a Clinical Practice Guideline for the diagnosis and treatment of Paget's disease of the bone.

Duchenne Muscular Dystrophy Therapy Designated Orphan Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CAT-1004 (Catabasis) for the treatment of Duchenne Muscular Dystrophy (DMD).

Hidden NSAIDs Found in Herbal Supplement

The Food and Drug Administration (FDA) is warning consumers not to buy or use "Feng Shi Ling," a product marketed as an herbal drug for pain due to rheumatoid arthritis and osteoporosis.

Otezla Demonstrates Sustained Response in Active Psoriatic Arthritis

Celgene announced results from two PALACE Phase 3 clinical trials with Otezla (apremilast) for the treatment of adults with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Secukinumab Demonstrates Efficacy in Psoriatic Arthritis Trials

Novartis announced results from the Phase 3 FUTURE 1 and FUTURE 2 studies with secukinumab in patients with psoriatic arthritis (PsA).

Combination Therapy Effective in Rheumatoid Arthritis Study

Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase 3b AVERT trial investigating the use of Orencia (abatacept) plus methotrexate (MTX) in biologic and MTX-naïve CCP-positive early moderate to severe rheumatoid arthritis (RA) patients.

Men Rarely Screened for Osteoporosis, Study Suggests

Men are three times less likely to undergo bone mass density (BMD) testing following a distal radial fracture compared to women, reports a new study.

Xiaflex Gains Expanded Dupuytren's Contracture Use

Auxilium announced that the Food and Drug Administration (FDA) has approved Xiaflex (collagenase clostridium histolyticum) for the treatment of up to 2 Dupuytren's contracture joints in the same hand during a single treatment visit.

Rasuvo Autoinjector Launched for RA, pJIA, Psoriasis

Medac Pharma announced the launch of Rasuvo (methotrexate) injection for patients with rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis (pJIA), and psoriasis.

FDA Expands Humira Use for pJIA in Children Aged 2 Years and Up

AbbVie announced that the Food and Drug Administration (FDA) has approved the use of Humira (adalimumab) for moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) to reducing signs and symptoms in patients aged ≥2 years.

Humira Gains Pediatric Crohn's Disease Indication

AbbVie announced that the Food and Drug Administration (FDA) has approved Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease for patients ≥6 years old.

Minivelle Patch Gains New Strength, New Indication

Noven announced that the Food and Drug Administration (FDA) has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis.

Otezla Tabs Gain New Psoriasis Indication

Celgene announced that the Food and Drug Administration (FDA) has approved Otezla (apremilast) for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

Orthopedists Release Choosing Wisely Recommendations

The American Orthopaedic Foot & Ankle Society (AOFAS) has released a list of tests and procedures that are commonly ordered but not always necessary.

Odanacatib Reduces Fracture Risk in Postmenopausal Women

Merck announced results from the Phase 3 LOFT study with odanacatib in postmenopausal women with osteoporosis.

Updated Phase 3 Efficacy Results for Ampio

Ampio announced an update to the Phase 3 multicenter, double-blind STEP study of Ampion for osteoarthritis (OA) of the knee.

Zorvolex Gains New Pain Indication

Iroko announced that the Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules for the management of osteoarthritis pain.

Ryanodex FDA-Approved To Treat Inherited Life-Threatening Condition

Eagle Pharmaceuticals announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension, an antidote for the management of malignant hyperthermia (MH), along with the appropriate supportive measures.

Mislabeling Causes Ibuprofen, Oxcarbazepine Recall

American Health Packaging announced a voluntary recall of Ibuprofen Tablets 600mg and Oxcarbazepine Tables 300mg due to mislabeled inner unit dose blister packaging.

FDA Approves Rasuvo Injection for RA, JIA, Psoriasis

Medac Pharma announced that the FDA has approved Rasuvo (methotrexate) subcutaneous auto-injector for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis.

Contact-Free Vital Signs Monitoring Device Gets FDA Clearance

EarlySense has announced that the FDA has issued clearance for the Chair Sensor Solution, the first automatic contact-free sensor for continuous monitoring of patients' vital signs in a chair.

First Wearable, Motorized Exoskeleton for Paraplegics Cleared by FDA

The FDA has cleared the first motorized device intended to act as an exoskeleton in individuals with paraplegia due to spinal cord injuries for use at home and in the community.

Biomarkers May Predict Long-Term Outcomes in JIA

At EULAR 2014, scientists presented the possibility of using biomarkers to predict disease outcomes at 12 months in children with juvenile idiopathic arthritis (JIA).

Higher Cost Burden Seen With Musculoskeletal Disorders vs. Others

Increased healthcare costs were associated with musculoskeletal disorders compared to other disease states, according to a new study presented at EULAR 2014.

Can Genotyping Determine RA Outcomes?

Positions 11, 71, and 74 of the HLA-DRB1 gene was shown to be strong independent genetic determinants of radiological damage in rheumatoid arthritis (RA).

Biomarkers in RA Patients Linked to Anti-TNF Treatment Response

A potential biomarker of response to anti-TNF therapies in patients with rheumatoid arthritis (RA) has been identified, which could lead to the personalization of RA treatment.

Erectile Dysfunction Often Present in Men with Gout

Erectile dysfunction (ED) is present and frequently severe in most men with gout, reports research presented at the European League Against Rheumatism Annual Congress (EULAR 2014).

Cranial Ultrasound More Sensitive in GCA Diagnosis

Cranial ultrasound is superior in sensitivity and has comparable specificity in the diagnosis of giant cell arteritis (GCA) compared to temporal artery biopsy (TAB), according to a new study.

Monounsaturated Fatty Acids May Suppress RA Activity

At EULAR 2014, two studies shed insight on the relationship between dietary intake of monounsaturated fatty acids and cholesterol with disease activity in rheumatoid arthritis (RA) and osteoarthritis (OA), respectively.

CT-P13 Comparable to Infliximab in Ankylosing Spondylitis Tx

CT-P13, an infliximab biosimilar, achieved statistically similar improvements in disease activity disability, and mobility in patients with ankylosing spondylitis (AS) compared to infliximab, results from the PLANETAS study found at EULAR 2014.

Romosozumab Significantly Increases Bone Mineral Density, Content

Romosozumab was found to significantly increase bone mineral density and bone content in the spine and hip in postmenopausal women compared to baseline and also compared to teriparatide and placebo, as presented at EULAR 2014.

Many Not Receiving Optimal TNF-Alpha Inhibitor Dose in Psoriatic Arthritis

Many patients with psoriatic arthritis were not receiving doses of TNFα inhibitor, adalimumab, to obtain optimal clinical benefit, according to data presented at EULAR 2014.

Saline as Effective as PRP Injections in Epicondylitis Pain

At EULAR 2014, new research showed that ultrasound-guided injections of growth factors-containing platelet-rich plasma (PRP) are no more effective than saline injection sin treating recently developed epicondylitis.

Are BMI and RA Outcomes Inversely Linked?

Obese patients with rheumatoid arthritis (RA) have higher disease activity scores (DAS) than non-obese patients, regardless of their disease stage, scientists presented at EULAR 2014.

MicroRNAs May Help Predict Osteoarthritis

Recent findings identify a correlation between the presence of biomarkers in the blood (micro RNAs [miRNAs]) and the development of severe osteoarthritis of the knee or hip joint, as presented at EULAR 2014.

Stopping Immunosuppressants without Flare Trigger in Lupus Patients

New research showed that it is possible to successfully stop immunosuppressant therapy without triggering a flare for the majority of lupus patients in remission, as presented at EULAR 2014.

Improved Penile Curvature Deformity with Xiaflex

Auxilium Pharmaceuticals announced new data from its Phase 3 IMPRESS trials that evaluated Xiaflex for the treatment of Peyronie's disease at the 2014 Annual Meeting of the AUA.

First-of-Kind Prosthetic Arm Approved by FDA

DEKA Integrated Solutions has received FDA marketing approval for the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrode in individuals with upper extremity amputations occurring at the shoulder joint, mid-upper arm, or mid-lower arm.

Arthritis Supplement Contains 3 Hidden Ingredients

Nano Well-Being Health is issuing a voluntary recall of two lots of Super Arthgold 500mg capsules, a dietary supplement for joint pain and arthritis.

FDA: Corticosteroid Injections Need Label Warning

The FDA is warning patients and healthcare professionals about the potential for rare but serious adverse events associated with injection of corticosteroids into the epidural space of the spine.

Eteplirsen NDA Submission Plans for Rare Neuromuscular Disorder

Sarepta Therapeutics has announced its plans to submit a New Drug Application (NDA) for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

Otrexup Results Published for Rhuematoid Arthritis

Antares Pharma announced the publication of results from its crossover study comparing the relative bioavailability, safety, and tolerability of Otrexup (methotrexate) to oral methotrexate (MTX) in adults with rheumatoid arthritis in the Annals of the Rheumatic Diseases.

First Oral Psoriatic Arthritis Drug Launched in Specialty Pharmacies

ReCept announced that it is one of the specialty pharmacies selected to distribute Otezla (apremilast; Celgene), a recently approved drug for adults with active psoriatic arthritis.

Results Reinforce Ampion Use in OAK

Ampio announced results of the 20 weeks extension of the SPRING study of Ampion for the treatment of osteoarthritis of the knee (OAK).

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