BLA for Adalimumab Biosimilar Accepted for Review

Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

Study Shows Majority of Gout Patients Unaware of Treatment Goals

A new study has highlighted a possible knowledge-gap between healthcare professionals and gout patients, concerning their condition.

Botox Gains Lower Limb Spasticity Indication

Allergan announced that the Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adults to decrease the severity of increased muscle stiffness in ankle and toe muscles.

Guidance on Long-Term Bisphosphonate Tx for Osteoporosis Issued

A task force of the American Society for Bone and Mineral Research has issued guidance on the bisphosphonate therapy for osteoporosis with a risk-benefit perspective.

FDA to Review Once-Daily Oral RA Tx

Eli Lilly and Incyte announced that the New Drug Application (NDA) for once-daily oral baricitinib has been submitted to the Food and Drug Administration (FDA) for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

Cosentyx Gains Two New Arthritis Indications

Novartis announced that the Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

FDA Issues Complete Response Letter to Kyndrisa

The Food and Drug Administration (FDA) has issued a Complete Response Letter to the New Drug Application (NDA) for Kyndrisa (drisapersen; Biomarin), for the treatment of Duchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping.

Cancer, RA Biosimilars Demonstrated Efficacy in Phase 3 Trials

Sorrento Therapeutics announced that its partner, MabTech, has successfully completed Phase 3 clinical trials in China for STI-001, a biosimilar antibody for cetuximab (Erbitux).

NDA for First-in-Class DMD Tx Submitted to FDA

PTC Therapeutics announced the completion of its rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

FDA to Review Sarilumab for Moderate-to-Severe RA

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab (Regeneron and Sanofi) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA).

Physicians Advised to Rethink Preference for Osteoporosis 'Drug Holiday'

The International Osteoporosis Foundation (IOF) has advised physicians to make treatment decisions more individualized for patients taking bisphosphonates; a class of drugs used to treat osteoporosis.

Xeomin Approved for Adult Upper Limb Spasticity

Merz North America announced that Xeomin (incobotulinumtoxinA) has been approved by the Food and Drug Administration (FDA) for the treatment of upper limb spasticity in adults.

New Gout Treatment Gets FDA Approval

The FDA has approved Zurampic (lesinurad; AstraZeneca) to treat hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).

For Active Individuals, Higher Vit D Levels May Be Needed

Individuals who participate in higher impact activities may require higher vitamin D levels to reduce their risk of stress fractures, a new study in The Journal of Foot & Ankle Surgery reported.

Lifetime Chronic Pain Can Result From Risks During Adolescence

Adolescents who have affective, anxiety, and behavioral disorders may be at increased risk for developing chronic pain, a new study published in The Journal of Pain has found.

FDA Grants Orphan Drug Designation to new Treatment for Duchenne Muscular Dysptrophy (DMD)

Food and Drug Administration (FDA) has granted Orphan Drug designation and Rare Pediatric Disease designation to ARM210 (also known as S48168) for the treatment of Duchenne Muscular Dystrophy (DMD)

USPSTF Calls for More Research in These 5 Women's Health Issues

The United States Preventive Services Task Force (USPSTF) released its annual Report to Congress reporting on 5 high-priority evidence gaps regarding women's health.

In Knee OA Study, Chondroitin Beats Common First-Line Tx in Disease Progression

Chondroitin sulfate was shown to be more effective in reducing long-term progression of knee OA than celecoxib.

Be on the Lookout for This Early Sign of Lyme Disease, Says Study

According to research published in The Journal of the American Academy of Orthopaedic Surgeons, spontaneous knee effusion can be a primary symptom of Lyme disease even without the presence of a "bull's eye" rash.

Mobic Oral Suspension No Longer Available

The decision to discontinue the product is business-related and not due to product safety or efficacy.

FDA Arthritis Committee Recommends Lesinurad Approval

AstraZeneca announced that the FDA Arthritis Advisory Committee (AAC) has recommended the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.

Vivlodex Approved for Osteoarthritis Pain

Iroko announced that the Food and Drug Administration (FDA) has approved Vivlodex (meloxicam), a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.

New Data on First-in-Class Duchenne Muscular Dystrophy Tx

PTC Therapeutics announced positive results from the Phase 3 ACT DMD trial of Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

Investigational Oral Arthritis Tx Tops Adalimumab in Phase 3 Study

Eli Lilly and Incyte announced positive topline results of RA-BEAM, the fourth Phase 3 study of baricitinib for patients with moderately-to-severely active rheumatoid arthritis (RA).

Long-Term BMD Gain With Prolia Shown in 10-Year Study Data

Amgen announced results from a 7-year, single-arm, open-label extension of the 3-year randomized, double-blind, placebo-controlled, multi-center, international Phase 3 FREEDOM Study.

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.

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