News

CE Mark for ReduX Plier (Medtronic) for use in Osteotomies

Medtronic, Inc.has announced the CE Mark (Conformité Européenne) and the European launch of the ReDuX Plier, a new instrument specially designed for use during osteotomies. With the launch of this first specially-designed surgical instrument in the spinal orthopaedic industry, physicians in the European community may now perform a more controlled osteotomy closure for people with a severe form of ...

Xgeva (Amgen) is FDA approved to treat Giant Cell Tumor of Bone

Amgen has announced that the FDA on 13 June 2013 approved a new indication for Xgeva(denosumab) for the treatment of adults and skeletally mature adolescents with Giant Cell Tumor of Bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.

Xgeva was approved following a priority review by the FDA ,a designation reserved ...

EU approves RoActemra (Roche) for polyarticular Juvenile Idiopathic Arthritis

The EMA has approved RoActemra (tocilizumab), from Roche, to treat children with Polyarticular Juvenile Idiopathic Arthritis (PJIA), a rare, chronic and debilitating form of childhood Arthritis. The medicine can be used to treat patients two years of age and older who have not responded adequately to treatment with methotrexate (MTX). RoActemra can be used alone or in combination with MTX. ...

Phase III study of Sufentanil NanoTab PCA System (AcelRx Pharmaceuticals) meets primary endpoint for Pain relief

Top-line data from a Phase III study of Sufentanil NanoTab PCA System, from AcelRx Pharmaceuticals, shows that the primary efficacy endpoint was achieved. The study evaluated control of Pain intensity compared to baseline during the 48-hour study period immediately following major orthopedic surgery, specifically knee or hip replacement, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline ...

Study of Prolia (Amgen/GSK) plus teriparatide shows significant benefits in Osteoporosis

A randomised, controlled trial of postmenopausal women with Osteoporosis shows that teriparatide and Prolia (denosumab), from Amgen/GSK, increased bone mineral densification (BMD) better than previously reported with any available treatment. Ninety four postmenopausal women were assigned in a 1:1:1 ratio to receive 20 ug teriparatide daily, 60 mg denosumab every 6 months, or both. BMD was measured at 0, 3, ...

EMA Pharmacovigilance Risk Assessment Committee recommends restrictions on Protelos (Servier) as a treatment for Osteoporosis

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended restrictions in the use of Protelos/Osseor (strontium ranelate) from Servier, following the evaluation of data showing an increased risk of heart problems, including heart attacks. It will adopt a final opinion at the next CHMP meeting of 22 to 25 April 2013.

EU approves GelrinC (Regentis Biomaterials) for Cartilage Repair

Regentis Biomaterials has received European CE Mark approval for its GelrinC biodegradable implant, for Cartilage Repair. GelrinC is suitable for patients with traumatic knee injuries. It is inserted as a liquid to fill any shape of cartilage defect and it is then converted into a solid through exposure to ultra-violet light. GelrinC's matrix of synthetic polyethylene glycol diacrylate and denatured ...

EU approves Ilaris (Novartis) to treat Gouty Arthritis

Novartis has announced that the European Commission has approved llaris (canakinumab, ACZ885) in the treatment of patients with acute Gouty Arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options. Ilaris is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication, and is administered ...

SOBI and Savient Pharma to co -promote Kineret in USA

Sobi and Savient Pharmaceuticals, Inc. have entered into an agreement for the co-promotion of Kineret (anakinra) in the U.S. Kineret, a recombinant IL-1 receptor antagonist, is a treatment for rheumatoid arthritis (RA) and indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active RA in patients 18 years of ...

EU approves ApiFix AIS System (ApiFix) for Adolescent Idiopathic Scoliosis

ApiFix has received CE Mark approval for its ApiFix AIS correction system, a minimally invasive treatment system for Adolescent Idiopathic Scoliosis (AIS). ApiFix also reports that it has successfully completed a European pilot clinical trial with positive results.

In the ApiFix system, a small implant is attached to the center of the main spinal curvature using only two screws, resulting ...

FDA approves Sculptor Robotic Guidance Arm (Stanmore Implants) for Surgery

Stanmore Implants has received 510(k) clearance from the FDA to market its Sculptor Robotic Guidance Arm for precision implant placement in unicompartmental knee Surgery, also known as partial knee resurfacing. The Sculptor RGA system is a robotic guide to assist with bone preparation, performed by a high speed cutting burr attached to the robotic arm, which limits the surgeon's operation ...

CHMP recommends extension of indication of Humira(AbbVie) in JIA

The CHMP recommends that Humira (adalimumab) from AbbVie, in combination with methotrexate is to be indicated for the treatment of active Polyarticular Juvenile Idiopathic Arthritis, in children and adolescents aged 2 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to ...

FDA approves the iASSIST Knee (Zimmer) for Knee Replacement surgery

The FDA has given 510(k) clearance to the iASSIST Knee, from Zimmer, which is a personalized guidance system for Knee Replacement procedures. The technology comprises small electronic disposable pod components that are used at the site of knee replacement surgery, providing instantaneous, accurate alignment validation through a simple electronic display.

The disposable pods are manipulated within the surgical field with ...

CHMP recommends Ilaris (Novartis) for treatment of Acute Gouty Arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of llaris (canakinumab, ACZ885) from Novartis, in the treatment of patients with acute Gouty Arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options.

Ilaris is the only available ...

NICE recommends Exogen (Bioventus) for treatment of long bone fractures

NICE has issued guidance on the use of Exogen, an ultrasound bone healing system from Smith & Nephew/Bioventus LLC, that benefits patients and the NHS when used for treating long bone fractures (bone fractures that have failed to heal after nine months). But NICE added that the case for adopting the device routinely for long bone fractures with delayed ...

FDA approves Kineret(SOBI) for NOMID

Sobi- Swedish Orphan has announced that the FDA has approved Kineret (anakinra) for the treatment of children and adults with Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

Kineret is the first and only FDA-approved therapy for NOMID, the most severe form of cryopyrin associated periodic syndromes (CAPS). This is the first approval allowing the use of Kineret in children. Kineret was ...

Phase III trial of OMS 103HP (Omeros Corp) shows pain reduction in patients after arthroscopic Surgery

New results from the first pivotal Phase III clinical trial evaluating OMS 103HP, from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery shows the drug provides significant reduction in pain. The trial's primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) – a patient-reported measure comprised of questions about knee swelling, clicking, catching ...

Luveniq (Isotechnika) fails Phase III trial for treatment of Uveitis

Isotechnika Pharma Inc. announced that the Phase III clinical study using Luveniq (voclosporin) for the treatment of non-infectious Uveitis, conducted by Lux Biosciences, under a license agreement with Isotechnika, did not meet its primary endpoint of change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier. As a result, Lux does ...

Results of Phase III studies show substantial benefits of ACZ 885 (Novartis) in patients with Juvenile Idiopathic Arthritis

Results of two Phase III trials show ACZ 885 (canakinumab), from Novartis, provided substantial symptom relief in young patients with systemic Juvenile Idiopathic Arthritis (SJIA). In addition, ACZ 885 delayed disease flare recurrence and allowed patients to substantially reduce or discontinue use of corticosteroids.

In beta-SPECIFIC 1 (trial-1), 84% of SJIA patients treated with ACZ 885 experienced at least a ...

Positive results in Phase III trial of Jakafi (Incyte Corporation/Novartis) for patients with Myelofibrosis

New results from the Phase III COMFORT-II study shows that Jakafi(ruxolitinib), from Incyte Corporation, reduces splenomegaly and other symptoms commonly associated with Myelofibrosis. In addition, benefits are maintained for at least two years.

In a follow-up of 112 weeks, of patients randomised to receive either oral ruxolitinib or conventional therapy, just under half of patients receiving ruxolitinib achieved better than ...

Study shows benefits for bone growth in infants fed on InFat (Advanced Lipids)

A randomized, double-blind, controlled clinical trial on bone strength in term infants fed InFat, a high beta-palmitate formula, from Advanced Lipids, indicates InFat leads to significantly higher bone-strength parameters compared to a standard vegetable oil control. The trial studied the effect of 12 weeks feeding of infant formula with InFat on bone strength parameters. Bone strength results were measured by ...

FDA approves NavioPFS orthopedic surgical system (Blue Belt Technologies) for Knee Replacement

Blue Belt Technologies has received 510(k) clearance from the FDA to market its NavioPFS orthopedic surgical system. The clearance is for Unicondylar Knee Replacement, commonly known as partial Knee Replacement. The NavioPFS system incorporates technology to provide precision information to surgeons via smart instrumentation with robotic control. It delivers intra-operative navigation and 3D visualization during the surgery based on a ...

FDA approve Coflex (Paradigm Spinal) to treat moderate to severe Stenosis

The FDA has granted a Premarket Approval Order for Coflex, a motion preserving interlaminar stabilization device from Paradigm Spine, for the treatment of moderate To severe Stenosis with or without back pain. The approval is based on comprehensive Level 1 comparative effectiveness study for the treatment of spinal Stenosis. The six year clinical trial demonstrates Coflex provides better or equivalent ...

Phase II success for odanacatib (Merck Inc.) for Post Menopausal Osteoporosis

Merck Inc., has announced results from a Phase II trial for odanacatib, an investigational cathepsin K (cat-K) inhibitor in development for the treatment of Osteoporosis in post-menopausal women. The results were presented at the 34th Annual Meeting of the American Society for Bone and Mineral Research.

In the study, treatment with odanacatib (compared to placebo) significantly increased Bone ...

Aquacell Ag (Convatec) surgical cover success reported in JAMA

A new study looking at infections following joint replacement surgery finds a 78 percent decrease in joint infections when Aquacell Ag SURGICAL cover dressing from ConvaTec was used. The study found that the infection rate for total joint replacement patients dropped to 0.4 percent when Aquacell Ag SURGICAL cover dressing was used as compared to 1.8 percent when gauze ...

FDA expand approval for Healicoil PK (Smith&Nephew) for Joint Repairs

Smith & Nephew has received FDA clearance to expand the indications within the hip for its Healicoil PK suture anchor and Osteoraptor suture anchor. Indications for the Healicoil PK Suture Anchor have been expanded to include abductor repair while those for the Osteoraptor Suture Anchor now include labral reconstruction. Healicoil PK suture anchor differs from conventional solid-core implants by eliminating ...

Assessment finds some benefit of Eliquis (BMS/Pfizer) in patients with hip replacements

The German Institute for Quality and Efficiency in Health Care (IQWiG) has carried out an early benefit assessment of Eliquis (apixaban), from BMS/Pfizer, to detect any added benefits after operations to replace a hip or knee joint. Its studies showed that apixaban was more effective in preventing symptomatic Deep Vein Thrombosis than the comparator therapy: about one in 1000 patients ...

FDA approves Prolia(Amgen) for treatment of Male Osteoporosis

Amgen announced the FDA has approved a new indication for Prolia (denosumab) as a treatment to increase bone mass in men with Osteoporosis at high risk for fracture. Prolia, the first FDA approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months. According to the National Osteoporosis Foundation,two million men in the U.S. ...

FDA approves Lospa Knee System (Corentec America) for Knee Replacement Surgery

The FDA has given clearance to market the Lospa Knee System, from Corentec America in the United States. The innovative Knee Joint Replacement System is available and offers an anatomically featured shape for both a cruciate retaining (CR) and a posterior stabilized (PS) knee within a single system. This ensures successful patient outcomes with natural knee range of motion and ...

Legion HK Hinge Knee implant launched by Smith & Nephew in US and Canada

Smith & Nephew the global medical technology business, announced the launch of its Legion HK Hinge Knee implant to surgeons in the US and Canada. As the first hinged knee to be designed using normal knee kinematics, the implant provides a new option for those patients facing difficult primary or revision knee surgery....

EU Commission approves Jakavi (Novartis) for Myelofibrosis

Novartis received approval from the European Commission for Jakavi (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as Chronic Idiopathic Myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The European Commission's decision was based on positive findings from the COMFORT (COntrolled MyeloFibrosis Study ...

FDA approves WiTouch (Hollywog) for Chronic Back Pain

The FDA has issued two 510(k) clearances allowing Hollywog to market its WiTouch and WiTouch Pro wireless remote controlled devices for Chronic Back Pain. The WiTouch devices are the first wireless remote controlled pain relief device incorporating TENS technology to specifically target back pain. The WiTouch is cleared for over-the-counter, and the WiTouch Pro is cleared for prescription use. An ...

NICE recommends Xgeva for as a treatment for people with bone metastases from most solid cancer tumours including Breast Cancer

The National Institute for Health and Clinical Excellence (NICE) has published final draft guidance recommending Xgeva(denosumab) from Amgen/GSK as a treatment for people with bone metastases from most solid cancer tumours.It provisionally recommends denosumab for the prevention of skeletal-related events in: •people with bone metastases from breast cancer and •people with bone metastases from solid tumours (other than breast or ...

Positive data from Phase III study of Xgeva (Amgen) in Breast Cancer patients

Treatment with Xgeva (denosumab), from Amgen, resulted in a greater reduction in skeletal-related events in patients with Breast Cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a Phase III study published in Clinical Cancer Research. The study randomly assigned 2,046 patients to receive subcutaneous denosumab and ...

Phase III trial for Odanacitib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee ...

Phase III trial for Odanacatib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee ...

Stryker withdraws Rejuvenate Modular and ABG II neck stem Hip Replacements

Patients have encountered Stryker hip replacement problems and developed symptoms similar to those seen in metal-on-metal hip replacement devices. Stryker Orthopaedics will voluntarily remove Rejuvenate and ABG II modular-neck stem hip replacemenrs and terminate global distribution of these products. The decision comes after continued post-market surveillance. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to ...

FDA advisory panel does not recommend metal on metal hip replacement implants

The FDA asked an 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, ...

NICE recomends Xgeva (Amgen) for bone metastases

The latest draft guidance from NICE recommends Xgeva (denosumab)from Amgen: •For adults with bone metastases from breast cancer •For adults with bone metastases from solid tumours other than breast and prostate only if zoledronic acid or disodium pamidronate would otherwise be prescribed for these patients....

ACZ 885 from Novartis success in Systemic Juvenile Idiopathic Arthritis

New data from a trial with ACZ 885 (canakinumab) was announced by Novartis. A pivotal Phase III study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) . SJIA is a rare and serious autoiflammatory disease that usually start in childhood.The study met its primary endpoint, and the results will be presented on 7 June at the annual congress of the ...

FDA reject Taltorvic (Merck Inc) for Sarcomas

The FDA has issued a complete response letter to an application for Sarcoma drug Taltorvic (ridaforolimus), from Merck Inc., saying it cannot approve the application in its present form, and "that additional clinical trial(s) would need to be conducted to further assess safety and efficacy". The rejection follows a vote in March in which the agency's Oncologic Drugs Advisory Committee ...

Successful Phase III study for Signifor for Acromegaly

Results of the largest Phase III study of Acromegaly patients, PASPORT-ACROMEGALY, show the novel therapy Signifor ( pasireotide) long-acting release (LAR) from Novartis, was significantly more effective at inducing full biochemical control compared to the current standard medical therapy, Sandostatin LAR (octreotide/IM injection). These data were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress ...

FDA Complete Response Letter to Xgeva application to treat high risk Prostate Cancer bone metastases

The FDA has issued a Complete Response Letter for the supplemental Biologics License Application for Xgeva (denosumab) from Amgen to treat men with castration-resistant Prostate Cancer at high risk of developing bone metastases.The Complete Response Letter states that the FDA cannot approve the application in its present form. The FDA determined that the effect on bone metastases-free survival was of ...

Cell Therapeutics acquires world rights to pancritinib for Myelofibrosis

Cell Therapeutics has acquired a worldwide licence from Singapore-based S*Bio to develop and manufacture pancritinib, an oral once daily, tyrosine kinase inhibitor with dual activity against JAK 2 (Janus Associated Kinase 2) and FMS-like tyrosine kinase 3 (FLT 3). Pacritinib is in Phase II clinical trials for Myelofibrosis with a Phase III trial planned. The drug has Orphan designation in ...

CHMP recommends Jakavi (Incyte/Novartis)for Myelofibrosis

The CHMP of the European Medicines Agency adopted a positive opinion for Jakavi (INC424, ruxolitinib) from Incyte/Novartis for the treatment of disease-related splenomegaly or symptoms in adult patients with primary Myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Globally, there are few available treatments for myelofibrosis, an uncommon, life-threatening blood cancer characterized by multiple ...

MHRA recalls MITCH TRH hip replacements

The MHRA has advised surgeons to stop using the MITCH TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics, and to closely monitor patients who already have them. The MITCH TRH hip is a metal-on-metal hip replacement system consisting of components which can be used in different combinations to carry out either ...

Medtronic launches Powerease System for Spine Surgery

Medtronic, has announced launched the Powerease System, an innovative system of electronic instruments designed specifically for use in instrumented or reconstructive spine surgery. This system brings new capability to the operating room through compatibility with two of the leading pedicle screw platforms on the market, the CD Horizon Solera Spinal System and the TSRH 3Dx Spinal System, and is integrated ...

CDP7851/AMG 785 (UCB/Amgen) enters Phase III for Osteoporosis

UCB and Amgen have announced the start of their sclerostin antibody (CDP7851/AMG 785) Phase III clinical trial program for the treatment of Post Menopausal Osteoporosis. The Phase III program includes a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 ...

Kiva VCF Treatment System (Benvenue Medical/Zimmer) enters KAST trial

Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair announced that over 250 patients have been enrolled in the landmark KAST (Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial) clinical trial. KAST is evaluating Benvenue Medical's Kiva VCF Treatment System in the largest randomized study to date versus the current standard of ...

NICE recommends Xgeva (Amgen/GSK) for SRE prevention of Solid Tumors

NICE, The National Institute for Health and Clinical Excellence, has issued draft guidance recommending the use of human monoclonal antibody Xgeva (denosumab) from Amgen/GSK for for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) for those with bone metastasis from breast cancer, patients with painful bone metastasis from hormone-refractory prostate cancer ...

Results show Protelos (Servier) slows progression of Osteoarthritis

New results of a Phase III study show that Protelos (strontium ranelate), from Servier, show the drug has beneficial effects for Osteoarthritis as well as offering beneficial effects on pain, function, and mobility. In the study, 1,683 patients with knee Osteoarthritis received either Protelos 2g/day, 1g/day or placebo. The primary endpoint was the measurement of narrowing of the medial-tibio femoral ...

FDA advisors vote against Taltorvic (Merck/Ariad) for Sarcoma patients

The FDA's ODAC voted 13-1 against the use of Taltorvic (ridaforolimus), from Merck / Ariad, as maintenance therapy for patients with metastatic soft-tissue Sarcoma or Bone Sarcoma whose disease has not progressed after at least four cycles of chemotherapy. This was based on data showing patients on Taltorvic had a median progression-free survival of 17.7 weeks compared with 14.6 weeks ...

FDA approves generic Bonviva (Roche)

The FDA has approved the first generic versions of Boniva (ibandronic acid), from Roche, a once-monthly product to treat or prevent Osteoporosis in women after menopause. The manufacturers that have gained FDA approval for generic 150 milligram tablets are Apotex, Orchid Healthcare, and Mylan. The once-monthly Bonviva branded 150 mg tablet was originally approved by the FDA in March 2005....

Protelos(Servier) indication for Osteoporosis to be updated by EMA

The EMA still views Protelos/Osseor (strontium ranelate) from Servier Labs as an "important treatment" for women with Osteoporosis and its benefit: risk profile remains favourable, but it is no longer to be recommended for certain patients,and warnings on serious skin reaction will be updated. Prescribers should no longer prescribe the treatment to patients with current venous thromboembolism (VTE) or a ...

Phase III trial begins of ARX-01 System (AcelRx Pharmaceuticals) for treatment of Post-Operative Pain

Dosing has begun in a Phase III study for ARX-01, the Sufentanil NanoTab PCA System from AcelRx Pharmaceuticals. ARX-01 is a pre-programmed, non-invasive, handheld system that allows post-operative patients to self-dose with sublingual Sufentanil NanoTabs to manage their post-operative pain. This first ARX-01 Phase III study is a randomized, double-blind, placebo-controlled efficacy and safety trial in adults following open abdominal ...

MHRA issues guidance on all metal hip replacement

The MHRA in the UK has issued guidance on hip implants (large head implants) requiring blood tests to check for metal ions and to require a MRI if patients have raised metal levels due to breakup and consquent debris from all metal hips. The MHRA estimates that around 49 000 patients out of 69 000 all metal hip patients fall ...

Actelion acquires rights to Xiaflex/Xiapex from Auxilium Pharma

Actelion will acquire from Auxilium Pharma exclusive rights to commercialise Xiaflex (collagenase Clostridium histolyticum) as a treatment for two rare progressive collagen deposit conditions, Dupuytren’s contracture and Peyronie’s disease, in Canada, Australia, Brazil and Mexico.Xiaflex has already been approved in the US and the EU to treat Dupuytren’s contracture, a fibroproliferative disease in which abnormal collage deposits result in nodules ...

FDA to review Xgeva(Amgen) potential to delay bone metastases in non-metastatic Prostate Cancer

The FDA has invited Amgen to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases. The review results from clinical studies in support of this new indication, including ...

European decentralised approval concluded for Steovess (Takeda) for Osteoporosis

Takeda Pharmaceuticals International GmbH announced that the European decentralised procedure was positively concluded for Steovess (formerly known as EX101), a once-a-week 70mg buffered effervescent alendronate for the treatment of Post-menopausal Osteoporosis. The Company submitted its application for marketing authorization in multiple countries through the DCP on 17 September 2010, with the United Kingdom (MHRA) serving as its Reference Member State ...

NICE recommends RoActemra(Roche) for Systemic Idiopathic Juvenile Arthritis

The National Institute for Health and Clinical Excellence (NICE) has published final guidance that recommends RoActemra (tocilizumab)from Roche for the treatment of Systemic Juvenile Idiopathic Arthritis (sJIA) for use in patients aged two and older who have sJIA in whom specific previous treatments have not produced an adequate response subject to Roche making the drug available with a discount as ...

Jakafi (Incyte/Novartis) is FDA approved for Myelofibrosis

The FDA on 16 November 2011, approved Jakafi(ruxolitinib),from Incyte/Novartis, the first drug approved to specifically treat patients with the bone marrow disease Myelofibrosis. Jakafi is an inhibitor of JAK 1 and 2 (Janus Associated Kinase) that are involved in regulating blood and immunological functioning. The decision was based on two pivotal trials called COMFORT-1 and COMFORT-2....

Xgeva results of '147' trial prevention of bone metastases in Prostate Cancer is published in The Lancet

The'147' Phase III study of Xgeva (denosumab)from Amgen/GSK ) evaluated Xgeva for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer and is published in The Lancet. The study found Xgeva significantly prolonged bone metastasis-free survival, delayed time to bone metastasis and reduced the risk of symptomatic bone metastases. This study is ...

Jakafi (Incyte/Novartis) is FDA approved for Myelofibrosis

The FDA on 16 November 2011, approved Jakafi(ruxolitinib),from Incyte/Novartis, the first drug approved to specifically treat patients with the bone marrow disease Myelofibrosis. Jakafi is an inhibitor of JAK 1 and 2 (Janus Associated Kinase) that are involved in regulating blood and immunological functioning. The decision was based on two pivotal trials called COMFORT-1 and COMFORT-2....

SMC 021 fails Phase III trial for Post Menopausal Osteoporosis

SMC 021, an oral salmon calctonin from Novartis, failed to meet main fracture reduction endpoints in Study 2303 a study of Post Menopausal Osteoporosis and to demonstrate a significant difference between treatment groups at three years for the primary endpoint of reducing new vertebral fractures. Similarly no statistical significant response was observed on key secondary endpoints such as new non-vertebral ...

Juvenile Idiopathic Arthritis patients receiving Enbrel (Amgen/Pfizer) show excellent response

In patients with Juvenile Idiopathic Arthritis (JIA) who initiated treatment with the drug Enbrel (etanercept),from Amgen and Pfizer, one-third achieved an excellent response, and this response was associated with low measures of disability at study entry, younger age at the onset of JIA, and fewer disease-modifying antirheumatic drugs used before initiating etanercept, according to a study appearing in JAMA. The ...

ACZ 885 success in Systemic Juvenile Idiopathic Arthritis

New pivotal Phase III data showing 45% of children with active systemic juvenile idiopathic arthritis (SJIA) were able to substantially reduce their use of oral corticosteroids (often described as steroids) within 28 weeks of commencing treatment with ACZ885 (canakinumab) from Novartis (p<0.0001).These data are very welcome because nearly half of ACZ885-treated patients were able to reduce their steroid use during ...

Lower dose of corticosteroids as effective as higher dose for Shoulder Pain

A study of two common corticosteroid doses administered for Shoulder Pain reveals that lower doses are as effective as higher ones for pain reduction, duration of efficacy and improved range of motion. Investigators led by Seung-Hyun Yoon, from the Department of Physical Medicine and Rehabilitation, Ajou University School of Medicine, Suwon, Republic of Korea, conducted a clinical trial in which ...

NICE recommends Mepact for Osteosarcoma

NICE,the health technology appraisal institute for England and Wales, has published final guidance recommending Mepact (mifamurtide)from Takeda in combination with post-operative multi-agent chemotherapy as an option for treating high-grade resectable non-metastatic osteosarcoma in children, adolescents and young adults. This was a reversal of an earlier decision....

Merck Inc. files ridaforolimus at FDA for Metastatic Sarcomas

Merck Inc. has filed ridaforolimus at the FDA seeking approval of the drug as a treatment for patients with metastatic soft tissue or bone Sarcomas. There have been no new treatments in the US for sarcomas in 20 years. The application is based on results of the SUCCEED trial....

Afssaps refers Protelos to EMA for re-evaluation as a treatment for Post Menopausal Osteoporosis

The French regulatory agency Afssaps has decided not to suspend Protelos (strontium ranelate),the Post Menopausal Osteoporosis drug from Servier Labs. Afssaps has referred the drug to EMA and asked for a re-evaluation. There are safety concerns due to cases of venous thrombo-embolism in patients over 80 years of age (who have additional risk factors) and cases of DRESS (dry rash ...

Xgeva success in Prevention of Bone Metastases in Prostate Cancer

In a phase III study of Zgeva(denosumab), men with castration-resistant prostate cancer and no previous exposure to intravenous bisphosphonate drugs (such as zoledronic acid) were enrolled from 342 centres in 39 countries. Patients were assigned 120 mg subcutaneous denosumab plus intravenous placebo, or 4 mg intravenous zoledronic acid plus subcutaneous placebo, every 4 weeks . Median time to first on-study ...

Xgeva success in Trial "147" for prevention of bone metastases in Prostate Cancer

Amgen reports results of its study "147", which not only confirmed that its 120mg dosage form of denosumab, known as Xgeva, improved median bone metastasis-free survival by 4.2 months in men with castrate-resistant prostate cancer (CRPC) versus placebo – the first time a bone-targeted drug has delayed the spread of prostate cancer to the bones – but new data showed ...

Ostora oral calcitonin safe and effective for Osteoporosis

The Phase III ORACAL trial evaluating Ostora tablets (calcitonin oral), from Tarsa Therapeutics, for the treatment of postmenopausal Osteoporosis, has yielded positive safety and efficacy results, according to data presented at the American Society for Bone and Mineral Research 2011 Annual Meeting. The trial compared Tarsa's oral recombinant salmon calcitonin to placebo and to commercially available, synthetic salmon calcitonin administered ...

SHOTZ study shows Forteo more effective than Zometa in bone remodelling

Data from the SHOTZ study were compared showing the mechanisms of action of Forteo (teriparatide [rDNA origin] injection) from Eli Lilly and zoledronic acid (Zometa) from Novartis that evaluated histomorphometric measurements of bone remodeling in transiliac crest bone biopsies from postmenopausal women with osteoporosis. These data were presented in an oral presentation at the 2011 Annual Meeting of the American ...

Protelos risk benefit profile in PMO questioned

The transparency committee at the French health authority, HASe has been investigating pharmacoviligence data on Protelos( strontium ranelate) from Servier to see if its risk benefit profile needs to change. The drug has been associated with hyperesenitivity reactions such as rash, eosinophilia , systemic syndromes (DRESS)(16 cases) and Stevens Johnson Syndrome. EMA was critical of the Servier pharmacovigilence system and ...

ACZ 885 positive in Phase III Juvenile Idiopathic Arthritis trial

ACZ 885 (canakinumab) from Novartis results are reported of a Phase III trial in patients with systemic juvenile idiopathic arthritis (SJIA), a rare and serious childhood auto-inflammatory disease. The results, presented at the 2011 European Pediatric Rheumatology Congress in Bruges, Belgium, showed all primary and secondary endpoints of the study were met. Most ACZ885 patients (83.7%) experienced at least a ...