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Friday 24 November 2017
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Topic: Latest News

November 17, 2017
The Declaration highlights the unintended consequences of the release of increasing amounts of pharmaceuticals into the environment on both human and environmental health

A group of twenty organisations – lead by Health Care Without Harm (HCWH) Europe – have sent a Declaration to European Commissioner for Environment, Maritime Affairs and Fisheries, Karmenu Vella, expressing their deep concern about the threat posed by pharmaceuticals in the environment to European citizens, their communities, and the environment.

November 17, 2017
Within the framework of the Innovative Medicines Initiative, EFPIA, EBE and Vaccines Europe are also supporting an extensive framework of European collaborative projects (pharmaceutical industry and academia), which address the challenges of antibiotic resistance

EFPIA, EBE, Vaccines Europe and their member companies and associations have reiterated their commitment to combatting antimicrobial resistance (AMR) across the globe.

November 17, 2017
Trelegy Ellipta is the first once-daily single inhaler triple therapy to be approved in Europe

GlaxoSmithKline and Innoviva, Inc have announced that the European Commission has granted marketing authorisation for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

November 16, 2017
ABP 215 is being developed as a biosimilar to bevacizumab

Amgen and Allergan have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation of ABP 215, a biosimilar to Avastin® (bevacizumab).

November 16, 2017
Ribociclib in combination with an aromatase inhibitor is a new and effective treatment option for women in England and Wales with the most common form of advanced breast cancer

Kisqali® (ribociclib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a cost-effective treatment option for postmenopausal women within England and Wales with advanced breast cancer.

November 16, 2017
Fulvestrant in combination with palbociclib showed progression-free survival improvement of 4.9 months compared to combination of fulvestrant with placebo

AstraZeneca has announced that the European Commission (EC) has approved a new indication for Faslodex (fulvestrant) in combination with a CDK4/6 inhibitor, palbociclib, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.1

November 16, 2017
Adult-onset Still’s disease and systemic juvenile idiopathic arthritis are rare systemic disorders of auto-inflammatory nature

Swedish Orphan Biovitrum AB has announced that the first patient has been randomised in the Phase III study anaSTILLs, to evaluate efficacy and safety of anakinra in the treatment of Still’s disease.

November 16, 2017
For patients undergoing an allogeneic haematopoietic stem cell transplant, complications arising from cytomegalovirus infection can be life threatening

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of letermovir for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).1

November 16, 2017
Positive opinion based on five studies demonstrating Nplate reduces rates of bleeding in children with rare blood disorder

Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for Nplate® (romiplostim) to include the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) for patients one year of age and older who are refractory to other treatments (for example,corticosteroids, immunoglobulins).

November 9, 2017
48-week Phase III data showed Cyltezo® and Humira® have similar efficacy, safety and immunogenicity in people with rheumatoid arthritis

Boehringer Ingelheim has announced one-year data from Voltaire®-RA, a pivotal Phase III clinical trial comparing Cyltezo® (adalimumab-adbm) and reference product Humira®.

November 9, 2017
Ustekinumab showed significant improvements in various disease measures compared with placebo, including musculoskeletal, mucocutaneous, immunological markers and flares

Janssen has announced positive results from a randomised, placebo-controlled Phase II study investigating the anti-interleukin (IL)-12/23 monoclonal antibody Stelara® (ustekinumab) in the treatment of active systemic lupus erythematosus (SLE or lupus).

November 9, 2017
The Johnson & Johnson Institute brings together 26 professional education facilities and a network of online education and collaborative partnerships across multiple specialties to deliver innovative educational programming

Johnson & Johnson has announced that its Family of Companies has formed the Johnson & Johnson Institute to provide comprehensive professional education focused on helping healthcare professionals improve outcomes, increase patient satisfaction and reduce costs in a value based care environment.

November 9, 2017
NICE also recommends use of Merck’s multiple sclerosis therapy cladribine (Mavenclad®) for highly active disease in adults

NHS England has entered into a commercial agreement that allows NHS patients in England immediate access to the innovative new multiple sclerosis (MS) treatment, cladribine tablets (Mavenclad®).1

November 9, 2017
Tolvaptan reduced the rate of decline of kidney function by 35% over a 12-month period, compared to placebo, in patients with autosomal dominant polycystic kidney disease

Otsuka has announced detailed results from the Phase III REPRISE trial of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD).

November 9, 2017
The survey highlighted that medicines used by patients across Europe have integrated supply chains

EFPIA has published results of a survey underlining the sheer scale and importance of the medicines issues that must be addressed as part of the Brexit discussions in order to protect public health.

Commenting on the survey, EFPIA Director General, Nathalie Moll said. “The survey underlines the  scale of the task ahead. For life saving and life improving medicines, the EU and UK cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the UK leaves the EU.”

November 2, 2017
Patients with ‘forgotten cancer’ to access new immunotherapy Tecentriq® (atezolizumab) via Cancer Drugs Fund

The National Institute for Health and Care Excellence (NICE) has recommended the use of a new immunotherapy via the Cancer Drugs Fund.

November 2, 2017
RAM non-invasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, such as Masimo's RAS-125c and now RAS-45, that is applied to the patient's neck area

Masimo has announced the full market release of RAS-45, an adhesive adult and pediatric acoustic respiration sensor for rainbow Acoustic Monitoring® (RAM™). RAS-45 offers the same performance as the currently available RAS-125c sensor but in a smaller size, with more flexible adhesive.

November 2, 2017
BORN Project convenes public health stakeholders to highlight key program successes at three-year mark, reinforcing global call to action to support universal newborn pulse oximetry screening as a tool to significantly reduce newborn mortality and drive treatment infrastructure in low-resource settings

Masimo and the Newborn Foundation has announced that the BORN Project, their joint commitment to the United Nations’ Every Woman Every Child (EWEC) initiative, has now screened 52,000 newborns across 40 delivery sites in China for critical congenital heart disease (CCHD), pneumonia, and sepsis.

November 2, 2017
CT-P13 shown to be comparable in efficacy and safety to reference infliximab in switched inflammatory bowel disease patients

Celltrion Healthcare and Pfizer have jointly announced data from the Phase III, randomised controlled, switching trial comparing CT-P13 and reference infliximab.

The data showed comparable efficacy and safety between all treatment groups (maintained and switched) in patients with moderate to severe Crohn’s disease (CD) up to one year.1

November 2, 2017
Point-of-care ultrasound is proving indispensable in the intensive care unit at Southampton General Hospital

 Intensive care and anaesthesia consultant Dr Max Jonas explained:

November 2, 2017
Late-breaking data demonstrate rapid improvement in patient-reported symptoms in patients intolerant or refractory to anti-TNF treatment

Janssen has presented new late-breaking data from UNITI-1 assessing Crohn's disease symptom improvement in patients during the first 2 weeks after an intravenous (IV) infusion dose of Stelara®(ustekinumab).1

The data presented at the 25th United European Gastroenterology Week (UEGW 2017) showed that patient-reported symptom improvement began as early as day 1 post ustekinumab IV infusion and was observed consistently at day 8 and beyond when compared with placebo.1

November 2, 2017
Trace is the first data visualisation and reporting software compatible with the full capabilities of the Masimo Root Patient Monitoring and Connectivity Platform

Masimo has announced the US release of Trace™, patient data visualisation and reporting software designed for Masimo Root® and Radical-7® monitors.

October 19, 2017
CHMP recommends to broaden indication to include the treatment of men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

Janssen-Cilag International NV has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorisation for Zytiga® (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of prostate cancer than its current indications.

October 12, 2017
Point-of-care ultrasound system plays a key role in an innovative procedure allowing thyroid surgery without the use of general anaesthetic

A Fujifilm SonoSite SII point-of-care ultrasound system recently played a key role in an innovative procedure allowing thyroid surgery without the use of general anaesthetic.