The European Medicines Agency (EMA) has commenced a public discussion on revised regulation on the development of new medicines to treat tuberculosis (TB). The regulation is an addition to EMA’s guideline on the assessment of medicines to treat bacterial infections.

TB is caused by a bacterium called Mycobacterium tuberculosis. In Europe, about 340,000 new TB cases and 33,000 deaths were reported in 2014, frequently from eastern and central European countries. While TB is slowly dilapidated worldwide, the trouble of the disease is still very high with just about 1.5 million deaths per year. Moreover, multidrug-resistant tuberculosis (MDR-TB) still poses a serious public health challenge. It often affects people from the most vulnerable communities, including migrant workers, refugees, displaced persons, prisoners or drug users.

Today’s TB treatments cannot efficiently fight the disease because they are long, intricate, and usually show abridged effectiveness against MDR-TB, striking a heavy burden on patients, families and healthcare systems. New TB medicines and regimens that are simpler to administer, are of shorter duration, and can conquer drug resistance are without delay needed.

In modern years, there has been a shift towards rising completely new regimens to treat TB, rather than focusing on single medicines. The revised guidance takes into account this expansion.

The direction also illuminates the European Union’s regulatory chucks with regard to data that should be produced to hold up the endorsement of new medicines and gives direction on the following topics:

• assessment of the effectiveness of entity new medicines and regimens in light of newly standard medicines;
• assessment of new regimens including at least one new medicine;
• Functioning of biomarkers to calculate the effectiveness of the medicine during clinical development.

EMA will arrange a workshop in November 2016 to confer stakeholders’ comments on the revised regulation.

Stakeholders can send their comments to the Agency until 31 January 2017.

Dated: 01/08/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/08/news_detail_002583.jsp&mid=WC0b01ac058004d5c1

The MRHA has permitted Sanofi Pasteur MSD UK’s quadrivalent influenza vaccine, which includes two A strains (A/H1N1 and A/H3N2) and two B strains (B/Victoria and B/Yamagata) of the virus.

The mainstream of seasonal influenza vaccines in the UK are at this time trivalent, means they help out to protect aligned with three strains of the influenza vaccine; two a strains and a single B strain. However, in the UK’s 2015-2016 flu season 94 percent of influenza B cases belonged to the B/Victoria pedigree. This extraction was only incorporated in quadrivalent formulations and not incorporated in the trivalent vaccines suggested by the World Health Organization.

According to Sanofi Pasteur MSD, “Inclusion of the second B strain in quadrivalent influenza vaccines can help to provide broader protection by minimizing the impact of a mismatch of vaccine and disease-causing strains. It is predicted that quadrivalent vaccines will become a new standard in the preclusion of influenza and is devoted to work with healthcare professionals to facilitate and protect adequate populations.”

The company added that if quadrivalent vaccines were used in the UK over the past decade, it has been anticipated that an additional quarter of a million influenza cases could have been evaded, including 5,940 influenza-related hospitalizations and 3,955 influenza-related deaths.

Date: 26^th July’ 2016

http://www.pharmatimes.com/news/sanofi_pasteur_msds_four-strain_flu_vaccine_approved_1081255

The Cancer Research UK-funded study, published in Nature Communications, observe the outcome of the drug atovaquone on tumors with low oxygen levels in mice to notice that it would be helpful to treat cancer. According to research the drug decreases the speed at which cancer cells use oxygen by targeting the mitochondria which is the main powerhouses of the cell that make energy, a method that utilizes oxygen.

As radiotherapy works by damaging the DNA in cells, and a good supply of oxygen decreases the capability of cancer cells to fix broken DNA, tumors with low oxygen levels are more complicated to treat effectively with radiotherapy. By slow down the use of oxygen, atovaquone therefore reverses the low-oxygen levels in almost all of the tumors. The fully-oxygenated tumors are more effortlessly destroyed by radiotherapy.

The drug was revealed to be useful in a extensive range of cancers, including lung, bowel, brain, head and neck cancer.

“This is a stimulating result. We have now started a clinical trial in Oxford to see if we can prove the same results in cancer patients. We expect that this accessible low cost drug will mean that resistant tumors can be re-sensitized to radiotherapy. And we’re using a drug that we already know is safe,” said Lead author, Professor Gillies McKenna, at the Cancer Research UK/Medical Research Council Institute for Radiation Oncology in Oxford.

According to Dr Emma Smith, Cancer Research UK’s science information manager, “The types of cancer that tend to have oxygen dispossessed regions are often more difficult to treat – such as lung, bowel, brain and head and neck cancer. Looking at the cancer-fighting properties of existing medicines is a very important area of research where medical charities can make a big blow and is a main concern for Cancer Research UK. Clinical trials will tell us whether this drug could help recover treatment options for patients with these types of tumor.”

Date: 25^th July 2016

http://www.pharmatimes.com/news/anti-malaria_drug_could_help_fight_cancer_1080660

London, UK-based Cell Medica has received European Commission orphan drug designations for its lead cancer immunotherapy CMD-003.

The title recounts to the treatment for extra nodal NK/T-cell lymphoma, an unusual type of non-Hodgkin lymphoma, and post-transplant lymph proliferative disorder, a state originated by B-cell propagation due to therapeutic immune containment after organ transplantation.

CMD-003 is made of the patient’s immune cells which have been triggered to kill malignant cells expressing antigens linked with the oncogenic Epstein Barr virus (EBV).

This therapy has the likely to address a range of EBV-linked lymphomas, nasopharyngeal carcinoma and gastric cancer; the EU orphan title will provide the firm with dogmatic and financial inducements for growing and marketing CMD-003, along with a ten-year period of marketing inimitability after product endorsement.

According to Gregg Sando, Cell Medica’s chief executive “CMD-003 is a new cellular immune therapy with the prospective to make over the way we treat patients with EBV-associated lymphomas. We are now testing this product in our CITADEL Phase II test for patients with highly developed extra nodal NK/T cell lymphoma and look forward to finishing point of the study next year.

Date: July 21st, 2016

http://www.pharmatimes.com/news/eu_orphan_status_for_cell_medica_drug_1077305

A petition that required routine vaccination for older children reached more than 815,000 signatures subsequent the widely-publicized death of two year old Faye Burdett last year.

The Joint Committee on Vaccination and Immunization (JCVI) said there is inadequate supply to offer it to children in this younger age group without jeopardizing stocks for the in progress immunization program.

But while granting that the Men B vaccine could establish cost effective for children aged between 13 and 24 months.

The Meningitis Research Foundation argues that the possibility of the virus posed to children aged 13 to 24 months is only to some extent less than that for the standard vaccination age (under one year), and that a positive proposal to develop its use.

According to MRF chief executive Vinny Smith “Vaccinating children under two years old against Men B meningitis and septicemia would have made a major, life-saving divergence to susceptible members of our families. This is a major prospect missed to save young lives from this alarming disease this winter”.

According to chief executive Liz Brown, `”We will continue to fight against a system that distinguishes against the health of the nation’s children on an ability to pay basis”.

Both charities are also calling for a national valuation to demonstrate if the vaccine can prevent teenagers carrying the infection, as called for by the JCVI more than two years ago, beside an improvement of the cost effectiveness framework forming the foundation of verdict on vaccines to safe a more level playing field.

Date: 14^th July 2016

http://www.pharmatimes.com/news/uk_officials_reject_calls_to_expand_men_b_vaccination_1071211

More than 300,000 new cases of cancer were diagnosed in the UK in 2013, and roughly half of all people in the UK born after 1960 will be diagnosed with cancer in their lifetime.

Cancer endurance and survival in England is lesser than the European average, which is moderately because patients in the country are being diagnosed at a later stage. However, there are signs of progress

According to data from the National Cancer Intelligence Network, in 2006 almost 25 percent of cancers, one in four, were diagnosed as an emergency, but in 2013 this figure had fallen to 20 percent, or one in five.

The National Institute for Health and Care Excellence has published a new quality standard method just to accelerate cancer diagnosis and save thousands of lives every year.

It is estimated that in England only, 10,000 lives could be saved every year through earlier finding of the disease and the use of more suitable surgery as prime treatment.

The procedure proposes that GPs have straight access to tests to speed up the process such as:

• Endoscopy
• Ultrasound
• MRI
• X-ray
• CT for people with suspected cancer

The solution to secure early diagnosis and reducing waste of resources is improving attendance rates for cancer service referrals, and so the Institute suggests giving patients written information to support them to attend.

The quality standard, which follows updated direction on the detection and recommendation of suspected cancer published last year, sets out clear tables linking signs and symptoms to possible cancers and comprising simple suggestions about which tests to perform and the type of referral to specialist services that should be made.

According to Professor Gillian Leng, deputy chief executive of NICE, “When we published our updated suspected cancer guidance last year we said the best way to successfully treat cancer was to make an early diagnosis,”

Date: 4^th July 2016

http://www.pharmatimes.com/news/nice_quality_standard_to_boost_earlier_cancer_diagnosis_1057206

The European Medicines Agency (EMA) and the European Society for Medical Oncology (ESMO) are co-organizing a workshop on the role of single-arm trials in the approval of new cancer medicines on 30 June 2016.

There is no specific regulatory guidance on cancer medicines development based on such trials and how to manage the remaining uncertainties optimally. In a single-arm trial every patient registered receives the new medicine. These trials have no detached group in which patients are given a placebo or another medicine to permit evaluation.

The workshop will give a platform to regulators, clinicians, academics, patients, medicine developers and health technology assessment specialists to discuss:

• Situations in which the marketing approval application for a cancer medicine could be based on results from a single-arm trial.
• Experience achieved with marketing authorizations based on single-arm trials data, the potency and shortcomings of different perspectives, and chances from data sharing proposals.
• Circumstances in which a medicine shows considerable anti-cancer activity in an area where patients have no treatment option or where the demeanor of standard trials with a relative arm is difficult, such as in rare cancers or selected populations for example, will be measured.
• Look at the views of diverse stakeholders groups and discuss the need for regulatory supervision with the eventual plan of optimizing the progress of new cancer treatments in these situations.

Dated:  27/06/2016

http://www.ema.europa.eu/ema/index.jsp

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have created a new collaboration on patient engagement. It will give an opportunity to share experiences and best practices on the way the two agencies involve patients in progress, assessment and post-authorization actions related to medicines. The first meeting took place by teleconference on 22 June 2016.

According to Guido Rasi, EMA Executive Director, “Our aim as regulators is to make sure that patients have access to safe and effective medicines that improve their lives. It is important to engage to be able to fully understand their needs and priorities and make their voice heard along a medicine’s lifecycle,”

The collaboration established by EMA and regulators outside the European Union focus on definite topic areas where the parties involved could gain an immense exchange of information. The presently offered EMA/FDA collaboration discusses problems correlated to:

• Biosimilars
• Medicines to treat Cancer
• Orphan medicines
• Medicines for children
• Pharmacovigilance

The increased interaction will allocate EMA and FDA to exchange information to extent the future rendezvous with patients. The information exchange is covered by the confidentiality arrangements between the two regulators.

The main discussion topics will comprise:

• The processes for selecting and preparing patients to take part in the agencies’ activities
• How to ensure that patients are independent and representative
• How to report on the impact of patient involvement

It is expected that three to four meetings will be arranged per year via teleconference and will be chaired in cooperation by FDA and EMA.

Dated: 22/06/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002554.jsp&mid=WC0b01ac058004d5c1

In the meeting of the Pharmacovigilance Risk Assessment from 6-9 June 2016,  the Committee paying attention on the extensive range of its tasks and responsibilities which cover all characteristics and features of the risk management of the use of medicines.

The PRAC’s full range of work comprises

• Pre-authorization actions
• Consideration of risk-management plans for medicines under assessment
• Post-authorization activities
• Evaluation of periodic safety update reports(PSURs) to re-assess the benefit-risk balance of a medicine throughout its lifecycle on the basis of new data collected.

The PRAC also estimates safety signals, public-health functions that make sure that latest safety issues are swiftly detected, assess and, when suitable, product-labeling changes or limitations are introduced for the benefit of patients.

Date: 10/06/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002546.jsp&mid=WC0b01ac058004d5c1