Uloric Dosing Updated to Include Patients with Severe Renal Impairment

The new labeling now recommends patients with severe renal impairment be limited to a dose of 40mg once daily.

FDA: More Data Needed for Sirukumab for Active RA

The CRL indicated a request for additional clinical data in order to evaluate the safety of sirukumab in the treatment of RA.

UTI Treatment Gains Qualified Infectious Disease Product Designation

"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.

Long-Term Effectiveness of Adalimumab Examined in RA

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).

Romosozumab Followed by Alendronate Superior in Reducing Fracture Risk

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.

Fracture Risk Reduced with Abaloparatide Followed by Alendronate

The data showed a statistically significant fracture risk reduction through 3.5 years.

Durolane Approved to Treat Knee Osteoarthritis Pain

In clinical trials, treatment with Durolane effectively relieved pain and restored function for up to six months in patients with knee osteoarthritis.

Limiting Sedentary Time 'Necessary' to Avoid Mobility Loss

At the study's end, 29% of participants were either unable to walk or had difficulty doing so.

FDA Reveals Stem Cell Policy Plans Amid Clinic Crackdowns

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.

Biosimilar Cyltezo Gets FDA Approval for Multiple Indications

This marks the second approval of a biosimilar for adalimumab.

Fixed-Dose Combo Tx Duzallo Approved for Uncontrolled Gout

This fixed-dose combination product combines lesinurad, a uric acid transporter 1 (URAT1) inhibitor, with allopurinol, a xanthine oxidase inhibitor in one tablet.

Psoriatic Arthritis Treatment Trends Investigated

Researchers used claims data between 2004-2015 from a large commercial database to identify patients with psoriatic arthritis who were initiated on DMARDs.

Are OTC Lidocaine Patches as Effective as Rx for Localized Pain?

Study authors sought to compare OTC lidocaine 3.6% with menthol 1.25% patches vs. Rx lidocaine 5% as well as to placebo.

Osteoporosis Drugs Assessed for Secondary Fracture Prevention

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).

FDA Panel Recommends Approval of Tofacitinib for Psoriatic Arthritis

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.

FDA Clears Non-Invasive Device to Treat Chronic Intractable Pain

The Stimpod NMS460 includes a nerve-mapping pen-like probe which allows practitioners to locate nerves and evaluate the treatment progress.

FDA Committee Votes Against RA Drug Candidate Approval

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.

Xatmep Now Available for Pediatric ALL, pJIA

Methotrexate works by inhibiting dihydrofolic acid reductase, which interferes with DNA synthesis, repair, and cellular replication.

Mislabeled Muscle Spasm, Parkinson's Drugs Prompt Recall

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.

Septic Arthritis Outbreak Highlights Need for Better Infection Prevention in Outpatient Settings

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.

Biosimilar Renflexis Now Available

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.

FDA Requests More Data for Unique Osteoporosis Drug Candidate

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% Gains Orphan Drug Status for Rare Muscle, Skin Disorder

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.

Alendronate May Lower Hip Fracture Risk for Patients on Oral Glucocorticoids

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.

Orencia Approved to Treat Active Psoriatic Arthritis

A greater response to Orencia was observed in the trial regardless of prior anti-TNF treatment and other non-biologic DMARD therapy.

Is Radiofrequency Denervation Effective for Chronic Low Back Pain?

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.

Rituxan Biosimilar BLA Accepted for FDA Review

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.

Early ART Start Linked to Bone Loss in HIV Patients

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).

Intensive Use of Hand-Held Devices May Up Carpal Tunnel Risk

The researchers found that intensive electronics users had significantly more discomfort, and more severe discomfort, in their wrist and hand.

Upadacitinib Meets Endpoints for Phase 3 Study in RA

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%).

Opioid Use Patterns Among RA Patients Examined

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."

FDA Expands Dysport Use for Lower Limb Spasticity in Adults

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.

First-in-Class Drug Candidate Fast Tracked for Chronic Pain

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.

Pooled Safety Analysis Finds Jardiance Well Tolerated

The proportion of study patients with lower limb amputations were similar for Jardiance (1.9%) and placebo groups (1.8%).

Vitamin D, Omega-3s May Boost DMARD Response in Early RA

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.

Drug Combo Effective for Tophaceous Gout

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).

FDA Approves New Administration Option for Orencia in pJIA

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).

Higher Alcohol Intake May Up Muscle Loss, Function for Some Women

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).

Case: Inhaled Corticosteroid-Induced Myopathy in HIV Patient

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.

Recall: CV Meds Found to Contain Gout Pills

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 Available for the Treatment of Rheumatoid Arthritis

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.

Giant Cell Arteritis Treatment Gets FDA Approval

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.

AACE/ACE: New ACP Osteoporosis Guidelines 'Fall Short'

Five important differences were identified by AACE/ACE involving pharmacotherapy choice as well as treatment duration and reevaluation.

Fast Track Status Granted to Tideglusib for Myotonic Dystrophy

In preclinical studies, AMO-02 has shown efficacy in transgenic models and reversal of muscle cell differentiation deficits in ex vivo tissue samples.

Are Corticosteroid Injections Beneficial for Knee Osteoarthritis?

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.

Xeljanz Under FDA Review for Psoriatic Arthritis

An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.

Are Statin Users at Greater Risk for Back Disorders?

Previous research has demonstrated a link between statin use and use-related injury and arthropathies.

Bone Building Drug Gets FDA Approval for Osteoporosis

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.

Powder Form of Ilaris Permanently Discontinued

Ilaris for Injection will be replaced by Ilaris Injection (solution) for subcutaneous use.

FDA to Review BLA Resubmission of Rheumatoid Arthritis Biologic

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.

Report Sheds Light on Physician Compensation by Location, Gender

Which cities report the highest physician compensation?

Xatmep Approved for Pediatric Patients with pJIA, ALL

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.

Spinraza Beneficial in Later-Onset Spinal Muscular Atrophy

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.

Biosimilar Renflexis Gets FDA Approval

A biosimilar product must demonstrate no clinically meaningful differences in safety or efficacy from the reference product.

Movement Disorders Examined in Current, Past Stimulant Drug Users

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.

Second-Line Tx Options Explored for RA Patients with MTX Failure

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.

FDA Requires More Data Before Baricitinib Approval

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.

Do Uric Acid Lowering Drugs Reduce BP in Hypertensive Patients?

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.

First Drug for Tardive Dyskinesia Gains Approval

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.

Postmenopausal Osteoporosis Drug Shows Long-Term Safety

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.

Amgen Looks to Expand Xgeva Use to Multiple Myeloma Patients

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).

Amount of Vitamin D Needed May Be Less than What's Recommended

"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.

Experimental Device Helps Paralyzed Man Feed Himself

Researchers utilized functional electric stimulation intracortical brain-computer interface system

SSRI Use Tied to Improved Joint Replacement Sx Outcomes

SSRIs users had significantly lower risk of revisions and aseptic revisions compared to those who were not administered an SSRI.

Alexion Seeks Eculizumab Approval for Ultra-Rare Neuromuscular Disease

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.

Study Investigates Transfer of TNFi Therapy to Breast Milk

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.

Pain Management Goals Differ for Physicians, Patients

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.

Does Tocilizumab Raise CV Risk in RA Patients?

Tocilizumab is known to raise LDL cholesterol levels but it is unclear whether the drug raises CV risk in RA patients.

Resolaris Granted Orphan Drug Status for Rare Genetic Myopathy

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 Goes Head-to-Head with Adalimumab in RA Study

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.

Low Back Pain Treatment Guidelines Released

The recommendations are intended for all clinicians treating adult patients with acute, suabcute, or chronic low back pain.

Is Diazepam Beneficial in Acute 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.

Can Yoga Improve Nonspecific Low Back Pain, Function?

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.

Emflaza Approved for Duchenne Muscular Dystrophy

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.

Shift in Bisphosphonate Use with Revised Osteoporosis Recommendations

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.

Etanercept vs. Monoclonal Antibody Tx Assessed in Rheumatoid Arthritis

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.

FDA Accepts Zilretta NDA for Osteoarthritis Knee Pain

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.

Polypharmacy and Frailty: What's the Link?

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.

Many Factors Involved in High Rate of Low Back Pain Among Children

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.

New Position Paper on Screening for Osteoporosis Therapy Adherence Published

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.

High-Inflammation Diets May Impact Fracture Risk

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).

Tocilizumab Gets Priority Review for Treatment of Giant Cell Arteritis

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 May Cut Opioid Use in Chronic Pain

Spinal cord stimulation was found to help decrease or stabilize opioid use in patients with chronic pain.

New Point-of-Care Device Helps to Detect Osteoporosis

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.

How Behavior Could Quicken DNA Aging by 8-Years

A sedentary lifestyle may accelerate biological aging, according to a study published online January 18 in the American Journal of Epidemiology.

Body Dysmorphic Disorder Often Not ID'd by Plastic Surgeons

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.

Muscular Dystrophy Treatment Gets Fast Track Designation

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.

First-of-its-Kind Muscle Activation Therapy Cleared by FDA

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.

Intervention vs. Usual Care for Osteoarthritis Outcomes

Patient- and provider-based interventions do not improve osteoarthritis outcomes, according to a study published online January 17 in the Annals of Internal Medicine.

Spinraza Shown to Cut Risk of Permanent Ventilation, Death in SMA

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.

Do Concomitant Neuropathic Pain Meds Impact Pregabalin Efficacy?

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.

Can Being a 'Weekend Warrior' Reduce Mortality Risk?

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.

Chondroitin Sulfate vs. Celecoxib Data Announced for Knee OA

Bioberica announced positive results from the MOSAIC Study that evaluated the use of chondroitin sulfate for knee osteoarthritis.

Soliris Application Seeks Ultra-Rare Neuromuscular Disease Indication

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.

Do Bisphosphonates Cause Atypical Femur Fractures in OI?

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.

Dual-Mechanism Gout Treatment Under FDA Review

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.

First Treatment for Spinal Muscular Atrophy Gets FDA Approval

The approval was based on positive data from multiple clinical studies involving >170 patients.

BD Introduces New 2.25mL Prefillable Glass Syringes for Biologics

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.

FDA Approves Unique Treatment for Knee Cartilage Repair

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.

NDA Submitted for Novel Knee Osteoarthritis Pain Treatment

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.