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Sunday 17 December 2017
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Topic: *** Editor's Pick

December 13, 2017
Globally, 694,000 people die from bowel cancer and 1.4 million people are diagnosed every year

Almost 332,000 people living in the UK will needlessly lose their lives to bowel cancer – a preventable, treatable and curable disease – between now and 2035 unless urgent action is taken to fill critical research gaps identified in a Bowel Cancer UK report ‘Finding the Key to the Cures: a plan to end bowel cancer by 2050’ launched today. If ignored, the scale of the issue will only grow larger.

The research has been published in the leading international academic journal, Gut.

December 13, 2017
Renal cell carcinoma is the most common type of kidney cancer in adults, with 80% of kidney cancer patients in the UK diagnosed with this type

Eisai Europe Limited has announced that the National Institute for Health and Care Excellence (NICE) has given a positive recommendation for the use of Kisplyx® (lenvatinib) in combination with everolimus for the treatment of adults with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy, if their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1, and the company provides lenvatinib with the discount agreed in the patient access scheme.1

December 13, 2017
Results from the pooled analysis presented at the American Epilepsy Society Annual Meeting 2017 in Washington DC, USA

Bial and Eisai have announced new real-world audit data presented at the American Epilepsy Society (AES) Annual Meeting 2017, which add to the existing clinical trials examining the effectiveness and tolerability of Zebinix® (eslicarbazepine acetate).

December 13, 2017
The analysis was presented in a poster session at the 59th Annual Meeting of the American Society of Hematology

Sobi and Bioverativ Inc have announced the results of a new, post-hoc, longitudinal analysis of the pivotal Phase III A-LONG study and ASPIRE long-term extension study, showing that weekly prophylactic dosing with its extended half-life therapy Elocta® (efmoroctocog alfa) has the potential to provide improved bleed protection over episodic treatment, resolve target joints and reduce the treatment burden associated with more frequent dosing intervals.

December 1, 2017
Combining two different immunotherapy treatments could dramatically improve lymphoma survival, according to a Cancer Research UK funded study published in Cancer Cell

Researchers from the University of Southampton have tested different combinations of antibodies in the lab to see how they interact with each other and what effect this has on how the immune system fights cancer.

They found one combination – anti-CD27 and anti-CD20 – greatly increased life expectancy in mice with cancer. While most of the mice given just one of the antibodies died within 80 days, nearly all mice given both antibodies survived beyond 100 days.

November 30, 2017
Patients with episodic migraine taking erenumab reported significant and meaningful benefits over six months, with reduced migraine days and acute medication use

Novartis has announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as 4 to 14 migraine days per month).1

November 27, 2017
Survey highlights need for improved education and standardised referral pathways for oncofertility

Results of a new survey highlight the need for improved education and standardised guidance for oncologists initiating cancer treatment in women who may want to safeguard their fertility.1

November 17, 2017
Robust analytical, pharmacological, non–clinical and clinical data demonstrated the similarity of Cyltezo® to Humira®

Boehringer Ingelheim has announced that the European Commission has granted marketing authorisation for Cyltezo® a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases in adults and children.

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.