Category Archives: UK Pharma

According to a study published on May 1, 2016 in the journal Cancer Research, Hsp90 inhibitor could provide useful treatment for advanced prostate cancers that have become resistant to hormone treatment.

It will work by decreasing the production of androgen receptor modification by using latest and new method of action.

Basically prostate tumors depends on androgens to grow and extend, depriving androgen receptors of these hormones can be an efficient and successful treatment

Base on this study, researchers targeted the one of this androgen receptor alternative, AR-V7. They produced the cancer cells in the lab and injected them into mice. Then they administered a drug (onalespib) that inhibits Hsp90, a chaperone molecule involved in the transcriptional action of these receptors.

According to the study co-leader Johann de Bono, MD, PhD, MSc, Professor of Experimental Cancer Medicine at the Institute of Cancer Research (ICR), in London, United Kingdom, “We have established for the first time that Hsp90 inhibitors that can obstruct the growth of the most common abnormal androgen receptors that cause many prostate cancers to stop responding to existing treatments. The researchers revealed that inhibiting Hsp90 decreased the production of AR-V7, but not by disrupted its known chaperone function”.

According to the opinion of study co-leader Paul Workman, PhD, Chief Executive of the ICR, “Our study has found that Hsp90 inhibition can particularly stop resistance to hormone treatments in prostate cancer through a totally new method linking the dispensation of messenger RNA.”

Dr. Workman explained, ‘We identify Hsp90 inhibitors ‘network drugs’ because they deal with several of the signals that are hijacked in cancer all at once, across a complex network rather than just a single way,”.

Hsp90 inhibitors are already in clinical trials for numerous types of cancer.

2^nd May 2016

http://www.mdlinx.com/pharmacy/article/414

The European Medicines Agency (EMA) has recommended conceding a marketing authorization in the European Union (EU) for Zavicefta (ceftazidime/avibactam), a new treatment against multi-drug resistant bacteria.

Due to lack of availability of medicines to treat patients with infections by resistant bacteria has become a major problem in past years. It is predictable that 25,000 patients in the EU die each year from infections due to bacteria that are resistant to many medicines.

Zavicefta is a fixed combination of avibactam, a new beta-lactamase inhibitor, and ceftazidime, an antibiotic belonging to the class of third generation cephalosporins that is already accepted for use in the EU. Resistance to cephalosporins and to another class of antibiotics, carbapenems, has been increasing lately, in particular in Gram-negative bacteria, and is of major concern. Beta-lactamases are enzymes implicated in bacterial resistance to these antibiotics. By restrain the action of these enzymes, avibactam restores the activity of ceftazidime against ceftazidime-resistant pathogens. This antibacterial agent also has activity against many of the carbapenem-resistant Enterobacteriaceae, where there is presently an unmet medical need as patients have very few options available due to resistance to treatment.

The medicine is to be used in adult patients with intra-abdominal infection, urinary tract infection, as well as pneumonia acquired in a hospital setting. It is also indicated for the treatment of adult patients with infections caused by certain Gram-negative bacteria, for which there are only restricted treatment options.

The effectiveness of Zavicefta against certain Gram-negative bacteria has been verified in the clinical trials that strengthen the authorization of the indications of intra-abdominal and urinary tract infections, and hospital-acquired pneumonia. The Committee for Medicinal Products for Human use (CHMP) considered that it is helpful to make Zavicefta accessible for patients with infections caused by Gram-negative bacteria, when they have few or no therapeutic options to fight the disease, and suggested to include treatment of these patients in the product information on the basis of a limited set of data.

EMA contributes to the European and global attempt to tackle antimicrobial resistance. A major area of activity is to generate an environment that encourages and facilitates the progress of new antimicrobials.

The outlook adopted by the CHMP at its April 2016 meeting is a conciliator step on Zavicefta’s path to patient access. Once a marketing authorization has been approved, decisions about price and repayment will take place at the level of each Member State, taking into account the potential role of this medicine in the circumstance of the national health system of that country.

Date: 29/04/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002523.jsp&mid=WC0b01ac058004d5c1

The European Medicines Agency (EMA) has suggested broaden the authorized use of Gazyvaro (obinutuzumab) to treat patients with follicular lymphoma. The medicine is to be used in amalgamation with bendamustine in patients who were treated before with chemotherapy.

Gazyvaro was first certified in the European Union (EU) in July 2014 for use in combination with chlorambucil in patients having chronic lymphocytic leukaemi and previously untreated.

Follicular lymphoma and chronic lymphocytic leukaemia are both rare types of cancer that affect certain white blood cells that fight infection, called B-lymphocytes. In follicular lymphoma, the body generates abnormal B cells that build up in lymph nodes.

Though useful treatments exist for follicular lymphoma, the disease often comes back and becomes ever more insistent and resistant to existing treatment options. Patients whose disease has become aggressive often die after one to two years.

The active substance in Gazyvaro is a monoclonal antibody that targets B-lymphocytes and triggers the death of cancer cells through the activation of the immune system.

The recommendation from EMA’s Committee for Medicinal Products for Human Use(CHMP) is based on the results of a phase III trial that compared the possessions of Gazyvaro given in permutation with bendamustine and followed by Gazyvaro as a preservation treatment, with the effects of bendamustine alone, in 321 patients with follicular lymphoma who did not respond to or whose disease grow with chemotherapy.

According to the study, patients treated with Gazyvaro in combination with bendamustine lived longer without their disease progressing as compare to patients treated with bendamustine alone.

The general side effects reported with the combination of Gazyvaro and bendamustine were constant with the known safety profiles of the individual medicines.

Because follicular lymphoma is rare, Gazyvaro was nominated as an orphan medicine in 2015. Orphan-designated medicines meet the criteria for ten years’ market exceptionalit.

The outlook adopted by the CHMP at its April 2016 meeting is an intermediary step on Gazyvaro’s path to patient contact. The CHMP opinion will now be sent to the European Commission for the acceptance of a decision on EU-wide marketing authorizations. Once the expansion of suggestion has been granted, a decision about price and compensation will take place at the level of each Member State considering the potential role/use of this medicine in the context of the national health system of that country.

Date: 29/04/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002522.jsp&mid=WC0b01ac058004d5c1

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has adopted the final rules of procedure for public hearings to be held by the Committee. The rules of procedure depict the process and useful provisions for the groundwork, conduct and follow-up of public hearings.

For execution of these regulations, the European Medicines Agency (EMA) will arrange a domestic dry run exercise just to check the progression and trial of public hearings. The dry run is scheduled to take place at the PRAC meeting in July 2016. Public hearings could arrange as early as the fourth quarter of 2016, as soon as a significant topic is decided.

Public hearings are a new contrivance for EMA to connect European Union (EU) citizens in the regulation of medicines and to listen to their analysis, views, visions and practices. The pharmacovigilance legislation has given the PRAC the opportunity to hold public hearings as part of definite and useful reviews of medicines, mainly relevant to their therapeutic effects and available therapeutic substitutes, as well as the possibility and approval of planned and projected risk management.

According to Noël Wathion, EMA’s Deputy Executive Director, “Public hearings will improve the scientific decision-making process on the safety of medicines.”

Public hearings will be held on a case-by-case basis, where the Committee determines that assembling the outlook of the public would bring added value to its review.

Date: 15/04/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002512.jsp&mid=WC0b01ac058004d5c1

8th annual workshop of The European Network of Pediatric Research at the European Medicines Agency will be held  on 2nd June 2016 at the premises of the European Medicines Agency (EMA) in London, UK. The basic objective of the workshop is to support high-quality clinical studies in children.

The basic objective of the research work is to assist the conduct of pediatric studies just to raise the accessibility of medicines approved for children.

It’s the platform for all stakeholders including patients/parents organizations, regulators, Enpr-EMA network representatives, academia, clinical investigators and representatives from the pharmaceutical industry for pediatric studies. All will participate in this workshop and give their views about Enpr-EMA’s activities to promote high-quality research in pediatric medicine.

The main agenda of the workshop is a panel debate on how ethical aspects in relation to clinical studies in children will be handled in the context of the implementation of the new European Union Clinical Trial Regulation. Registration for the first day of the workshop is open until 24 May. The main purpose of the workshop is to:

• Promote high-quality, ethical research on the quality, safety and effectiveness of medicines for use in children
• Helping the conscription of patients for clinical trials
• Facilitating partnership between networks and stakeholders
• Evading gratuitous replication of studies
• Developing scientific and administrative capability at a European level
• Endorsing European Commission framework program applications

Date: 14^th April, 2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002511.jsp&mid=WC0b01ac058004d5c1

EMA launches public consultation on ESVAC strategy for 2016-2020. The draft ‘Vision and Strategy of the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)’, for 2016-2020, published today for a three-month public consultation and the main objective is to strengthen this prospective by further sustaining the compilation and study of robust data.

Accessibility of reliable and intent data on the use of antimicrobials in animals is necessary to update European countries in establishing efficient policies to fight antimicrobial resistance.

Every year, the European Medicines Agency (EMA) publishes a report with sales figures of antimicrobials in animals collected by the ESVAC activity.

From 2016-20, ESVAC will keep on collecting and publishing overall sales data from as many EU/EEA countries as possible. With the addition of data from Croatia, Romania and Switzerland in the report to be published in 2016, the purpose to comprise data from all EEA countries is already close to being achieved.

ESVAC has an objective to bring together the best available European proficiency and capability to promote coordination in the methodologies used to collect and evaluate data on utilization of antimicrobials in animals. It will also give guidance to sustain the collection of data on the use of antimicrobials per species, with an explicit focus on the three major food-producing species (pigs, poultry and cattle).

ESVAC is establishing Defined Daily Doses for animals (DDDvet) and Defined Course Doses for animals (DCDvet) for more precise estimation of the disclosure to antimicrobials by animal species and thus strengthen the strength of the analysis of the data.

This will also helpful for policymakers in making evidence-based policies to reduce the risks from use of antimicrobials based on data on the definite use of antimicrobials in animals.

Antimicrobial resistance is progressively main and vital apprehension for both human and animal health. EMA works with its EU and international partners on a number of initiatives intended to limit the growth of resistance. EMA also works to maintain the expansion of new treatments and to support responsible use of antimicrobials.

7^th April 2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002507.jsp&mid=WC0b01ac058004d5c1

According to new statistics from the Association of the British Pharmaceutical Industry, show that the pharmaceutical industry has contributed over £1 billion to the Department of Health towards the cost of new medicines as part of the voluntary Pharmaceutical Payment Regulation Scheme (PPRS).

This will be helpful for production of new medicines as the latest treatments inexpensive for NHS patients and give UK patients the same approach to new medicines as other EU countries.

The pharmaceutical industry is now willing to advance the stream of new medicines into the NHS. The new statistics also demonstrate that the total spending of NHS on branded medicines that is from £2,136million in 2014/15 to £2,146 million in 2015/16.

According to Executive Director Commercial at ABPI, Richard Torbett, “Since 2014 our members have paid over £1billion towards a plan that they hoped would develop the stream of new medicines into the NHS patients, allowing patients to get access to treatments that are broadly available in other European countries.”

This recent PPRS plan runs for five years and offers a significant prospect to make sure that more NHS patients can take advantage from NICE standard medicines.

Dated: 9^th March 2016

http://www.abpi.org.uk/media-centre/newsreleases/2016/Pages/090316.aspx

The Association of British Pharmaceutical industry has been arranging a conference on a very important topic, “Adoption of new medicines to deliver better patient outcomes?’’ on 21 April2016 at 155 Bishopsgate, London.

The major industry names, key stakeholders across government, different companies, the NHS and patient organizations will join this forum. The basic agenda of this conference is to explore:

• A new model of medicine development
• The vision of accelerated access of new medicines
• Working in partnership for better results
• Development of new medicines
• Chances and opportunities for patients to interact with new medicines in this development process

http://www.cvent.com/events/abpi-annual-conference-dinner-2016/event-summary-d150acf384394fa69c84eef074f57e5d.aspx?RefID=ABPIWebsite

According to the publication Clinical Trials in the United Kingdom from the Department of Health, a report providing a synopsis of development being made by the UK and the National Institute for Health Research (NIHR) in England to make  UK a leading destination for clinical trials.

This is the tremendous development as the results from clinical research offer imperative substantiation and verification that are basically required for new medicines to be licensed. These trials also help to give more and more access to the latest medicines for patients across the NHS.

According to this report the patients in UK are in a good position within Europe for opportunities to take part in clinical research and ultimately take advantage of health outcomes. According to the research, UK is the top country in Europe for phase 1 clinical trial, is breaking at the heels of Germany for phase 2 clinical trials, and is third behind Germany and Spain for phasing 3 clinical trials.

Dated: 24^th March 2016

Source:

http://www.abpi.org.uk/media-centre/newsreleases/2016/Pages/240316.aspx