Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) suggested the marketing approval for VarroMed (oxalic acid dihydrate / formic acid) in the European Union (EU). This anti parasitic medicine will be used for Varroa mite infestation in honey-bee colonies, which is the most considerable parasitic health concern affecting honey bee worldwide.

As Honey bees are vital for pollination of crops and wild plants in Europe. The European Commission estimates that pollinators, including honey bees, bumble bees and wild bees, put in at least 22 billion euro each year to European agriculture and pollinate over 80% of crops and wild plants on the continent.

Though, beekeepers around the world have reported losses of honey-bee colonies, which are measured to be caused by a permutation of different factors:

• Habitat loss
• Climate change
• Pesticide use
• Diseases affecting bee health

The decline of these pollinators could lead to serious biological, agricultural, environmental and economic problems.

The main parasite affecting honey bees is the Varroa mite, an insidious species from Asia that has affected bee colonies worldwide. The Varroa mite feeds on the circulatory fluid of bees and brood (bee larvae) and can also throw in to the increase of viruses and bacteria.

VarroMed is intended to kill Varroa mites and is a liquid which is dripped into bees in the hive. It contains as active substance a fixed mixture of two organic acids, oxalic acid dihydrate and formic acid. Both substances have been known in veterinary medicine for a long time and are either naturally present in foods or accepted for use in foods. The medicine is not expected to pose a risk to human or animal health or the environment, if used according to the product information.

VarroMed is intended to be used as part of an integrated Varroa control program, which includes not only treatment with medicines but also non-chemical techniques like queen trapping or drone brood removal. It can be used either as a single-dose treatment during the brood less period (winter treatment) or in the presence of brood (spring or autumn), which will usually require frequent treatments.

Treatment should only be given at times when honey is not produced by bees.

The effectiveness and safety of the product in the protection of honey bees against Varroa mites was tested in laboratory and field studies in different European climate conditions.

The medicine has been classified as MUMS (minor use minor species/limited market), and, consequently, abridged data rations apply, and these have been considered in the evaluation. EMA’s MUMS policy aims to arouse the development of new veterinary medicines for minor species and for diseases in major species for which the market is limited and that would otherwise not be developed under current market conditions.

Date: 07/10/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/10/news_detail_002614.jsp&mid=WC0b01ac058004d5c1

According to some studies, bicyclic azetidines have the capacity to treat malaria and avoid malaria transmission

Existing antimalarial drugs only treat one stage of the parasite life cycle, and are endangered by the occurrence of resistance.

Researchers curtained 100,000 synthetic compounds with a comprehensive range of 3D features to find out new compounds with action throughout the parasite life cycle, against a multidrug-resistant strain of the malaria parasite Plasmodium falciparum.

The researchers indicated that two compounds in this family could bring a single-dose cure for malaria in mouse models. And one of the compounds, termed BRD7929, was able to remove blood parasites at all stages of the life cycle. The demonstration presented a family of compounds called the bicyclic azetidines.

The findings show that bicyclic azetidines have the potential to both treat malaria and stop malaria transmission as well convenient for prophylaxis in high-risk populations.

Dated: 3^rd October 2016

http://www.pharmaceutical-journal.com/news-and-analysis/research-briefing/newly-identified-compound-could-both-treat-and-prevent-malaria/20201739.article

According to expert recommendations, statins should be the first treatment chosen but by the results of research there is the possibility that other interventions may offer the same clinical advantage.

Data from 49 trials including 312,175 patients indicate that non-statin treatments that lower cholesterol are as beneficial as statins in decreasing risk of heart attack.

According to a large meta-analysis the comparative benefits of non-statin cholesterol-lowering treatments comprising diet, have similar benefits to statins in decreasing the risk of heart attack and stroke.

Researchers found by data from 49 trials involving 312,175 patients covering nine different options for lowering low-density lipoprotein cholesterol (LDL-C) that the use of statin and non-statin therapies have similar risks of major vascular events.

Date: 28^th September 2016

http://www.pharmaceutical-journal.com/news-and-analysis/news/non-statin-cholesterol-lowering-therapies-achieve-same-benefit-as-statins/20201771.article

The exceptional or rare diseases are expected to affect 30 million people in the European Union and approximately the same number in the United States, each disease independently concerns a limited number of patients.

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have new collaboration on exceptional diseases to share experiences and best practices on each other’s regulatory approach to the development of medicines for these diseases.

The international alliance in this area is mainly important to make sure that the limited number of studies that can be conducted to benefit all patients.

The agencies will exchange information on various aspects of the development and scientific assessment of medicines for rare diseases such as:

• Plan of clinical trials in small populations and the use of statistical analysis methods;
• Substantiation of trial endpoints such as outcomes of a trial
• Preclinical proof to carry development programs
• EMA’s conditional marketing authorization and FDA’s accelerated approval
• Risk management strategies for long-term safety issues with medicines for rare diseases.

The existing EMA/FDA alliance discusses issues like:

• Patient engagement
• Bio similar
• Orphan medicines
• Medicines to treat cancer
• Medicines for children
• Pharmaco care

The first meeting of the rare diseases alliance took place by teleconference on 23 September 2016. The alliance will at first meet once a month via teleconference and will be chaired jointly by FDA and EMA.

Date: 26/09/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/09/news_detail_002609.jsp&mid=WC0b01ac058004d5c1

Plasma-derived medicines are prepared from human blood. They are used to treat and prevent serious diseases and include coagulation factors and immunoglobulin. Urine-derived products are made from pooled human urine and include certain hormone-based treatments and urokinase products (medicines used to break up blood clots.

Basic Evaluations conceded out by the European Medicines Agency (EMA) and proficient establishment in the EU Member States have confirmed that there is no increased risk of contamination with the Zika virus for patients who take plasma-derived or urine-derived medicines.

EU regulators sought assurance that there is no risk of the virus contaminating the final product and affecting the patients taking it if the plasma or urine came from donors who had constricted the Zika virus.

EMA’s Committee for Medicinal Products for Human Use (CHMP) has addressed the potential risk from Zika virus for plasma-derived medicinal products. The CMDh has corresponding the assessment by EU Member States on the potential risk from Zika virus for urine-derived medicinal products.

The CHMP concluded at its meeting last week that the manufacturing processes used for plasma-derived products, including for example the solvent method to inactivate viruses, pasteurization and virus filtration inactivate or remove the Zika virus from the finished product.

Relating to urine-derived products, the CMDh concluded that the manufacturing processes for these products contain balancing steps with inactivation ability for enveloped viruses, which are adequate for Zika virus safety of these products.

Date: 21/09/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/09/news_detail_002606.jsp&mid=WC0b01ac058004d5c1

The European Medicines Agency (EMA) has suggested conceding a marketing endorsement in the European Union (EU) for Ibrance for the treatment of women metastatic breast cancer.

This treatment will be effective for cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative. Hormone receptor positive breast cancer accounts for 65% of tumors in women aged 35 to 65 years and 82% of tumors in women older than 65 years.

Breast cancer is the most common cancer in women globally, with almost 1.7 million new cases diagnosed in 2012. In Europe, there were probably 464,000 new cases of breast cancer in 2012 and an anticipated 131,000 deaths from the disease.

The commendation from EMA’s Committee for Medicinal Products for Human Use (CHMP) is based on two main studies:

• One is a Phase III trial comparing treatment with palbociclib and letrozole, an aromatase inhibitor, with letrozole treatment alone. 444 patients who received palbociclib in this testing lived on average 24.8 months without their disease getting worse, compared to 14.5 months in the group of 222 patients that received letrozole alone.
• The other study is a Phase III trial which compared treatment of fulvestrant together with palbociclib to treatment with only fulvestrant. 521 women were registered in this trial, despite of their menopausal condition. Initial results showed that 347 patients who received palbociclib had an average of 11.2 months without their disease getting worse compared to 4.6 months for 174 patients who only received fulvestrant.

The major side effects related with myelosuppression, a state in which the patient’s bone marrow produces less blood cells than normal. Other side effects included:

• Infections
• Fatigue
• Nausea
• Vomiting
• Inflammation of stomatitis
• Diarrhea
• Hair loss

The judgment approved by the CHMP at its September 2016 meeting is a mediator step on Ibrance’s trail to patient access. The CHMP opinion will now be sent to the European Commission for the acceptance and implementation of a decision on an EU-wide marketing authorization.

Date: 16/09/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/09/news_detail_002604.jsp&mid=WC0b01ac058004d5c1

According to a meeting between the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) hosted by EMA on 1-2 September 2016, configuration of data requirements by regulators worldwide can put in to motivate the development of new antibiotics to fight antimicrobial resistance globally and protect worldwide public health.  Conversely, regulatory activities are only one factor of the inclusive and versatile response needed to support and step up development of new antibacterial medicines that meet patient needs.

The conclusions of the meeting will be presented at the G7 Health Ministers’ meeting, organized by the government of Japan in Kobe on 11-12 September 2016.

The three agencies also agreed in the meeting that some flexibility should be applied to the requirements for clinical development programs for antibacterial agents where treatment options for patients are partial due to antimicrobial resistance.

The participants discussed approaches to clinical trial design, including choice of endpoints, as well as post-authorization monitoring activities for antibacterial medicines.

They also recognized areas of closer alliance and harmonization of efforts to support the development of safe and helpful antibacterial treatments.

Date: 07/09/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/09/news_detail_002596.jsp&mid=WC0b01ac058004d5c1

The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) is arranging a workshop on 15 and 16 November 2016 to talk about scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that normally fight off viruses and bacteria).

Immunotherapy is a type of cancer treatment that assembles the body’s own resistance mechanism to fight cancer. Immunotherapy medicines have considerably changed the therapeutic landscape, mainly for the treatment of patients with certain cancers, such as lung cancer or melanoma.

T-cell based immunotherapy is a modern approach where T cells from a patient’s blood are genetically engineered in a laboratory in order to allow them to recognize cancer cells through definite receptor proteins. In the body of a patient, the modified T-cells can then spot and destroy cancer cells.

T-cell immunotherapy medicines are being developed and are now being tested in clinical trials in a variety of cancers. However, there are still many scientific and regulatory challenges to be prevail over before these modern products can be brought to the market for the assistance of patients.

Therefore the open workshop aspires to smooth the progress of dialogue between the CAT and medicine developers from industry and academia on:

• present scientific growth;
• regulatory requirements for product manufacture and testing;
• Non-clinical studies and clinical expansion.

Date: 16/08/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/08/news_detail_002591.jsp&mid=WC0b01ac058004d5c1

The European Medicines Agency (EMA) has implemented a new section to its guidelines on good pharmacovigilance practices (EU-GVP), named “Product- or population-specific considerations II: Biological medicinal products”. Good pharmacovigilance practices are a set of procedures intended to make sure the strength of the system of safety monitoring. The new chapter provides supervision on how to better check and control the safety of biological medicines to optimize the secure and efficient use of these products in Europe.

Biological medicines hold one or more active substances made by or resulting from a biological source, such as blood or plasma. Some of them may be already present in the human body and examples include proteins like insulin and growth hormone. The dynamic substances of biological medicines are larger and more composite than those of non-biological medicines. Only living organisms are able to reproduce such complication. Their density as well as the way they are produced may result in a degree of inconsistency in molecules of the same active substance, particularly in different batches of the medicine.

Therefore the direction seem to support those accountable for monitoring these medicines by:

• highlighting detailed issues and challenges for the pharmacovigilance of biological medicines, e.g. in relation to inconsistency of the active gist or tractability of products;
• providing proposals on how to deal with these specificities and challenges;
• Delineation the roles and responsibilities of the various actors.

The GVP guidance comes into force on 16 August 2016.

Date: 15/08/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/08/news_detail_002590.jsp&mid=WC0b01ac058004d5c1

Publication of evaluation reports in Europe and Australia makes information on medicines simply available.

Today in a joint article published by Drug Discovery, the European Medicines Agency (EMA) and the Therapeutic Goods Administration (TGA) in Australia depict their constructive experiences with the publication of evaluation reports for medicines – known as European public assessment reports (EPARs) in Europe and Australian Public Assessment Reports (AusPARs) in Australia.

According to the authors, growing web traffic depicts the regulators’ success in assisting access to medicines’ information and the validations for medicines’ approval.

By focusing on authenticate, evidence-based, and up-to-date information, EPARs and AusPARs throw in to the propagation of consistent facts on medicines and how they are appraised and guarantee transparency. The reports build on close and reliable interface with a wide range of stakeholders in order to reflect the perceptions of different audiences.

Scientific development and stakeholders’ desire for greater information need a permanent development in the communication of information on medicines. Both regulators widely collect feedback on the value of the published information to evaluate continuously how to best communicate high-quality information on medicines to users and researchers.

Dated: 05/08/2016

http://www.ema.europa.eu/ema/index.jspcurl=pages/news_and_events/news/2016/08/news_detail_002587.jsp&mid=WC0b01ac058004d5c1