Category Archives: UK Pharma

According to a research from University College London, the first symptoms that present are not a lump in the breast about 17% breast cancer. These findings are presented at the 2016 National Cancer Research Institute (NCRI) Cancer conference in Liverpool. According to the results, women with non-lump symptoms of breast cancer are most probably go to a delay because of no clear symptom found.

At present more than 53,600 women are diagnosed with breast cancer every year, and the earlier the detection the better the chance of survival.

Monica Koo, presenting author based at UCL said that, “Our research shows around one in six women diagnosed with breast cancer have symptoms other than a breast lump, these women are more likely to delay going to the doctor as compare to women with breast lump alone”. Now it’s very important that every woman should aware that a lump is not the only symptom of breast cancer”.

Others possible symptoms of the disease include:

• Nipple abnormalities
• Breast pain,
• Skin abnormalities
• Ulceration
• Shape abnormalities
• Infected or inflamed breast

Experts are now calling for campaigns to raise awareness of all symptoms of the disease because according to Dr Karen Kennedy, Director of the NCRI, it’s essential that breast cancer should be diagnosed as early as possible so that a treatment plan can be settled and started”.

Date: 8th November 2016

http://www.pharmatimes.com/news/nonlump_symptoms_in_17_percent_of_breast_cancers_1175909

The career in academia gives the opportunity to publish research and in this way encourage potential members of the career. Teaching and research-led career progression is possible within universities and other institutions, while pharmacists can still spend more than half their time practicing in hospitals, industry or the community. There are some requirements and deliberations for pharmacists reflecting t the conversion to academia.

Working in academia permits pharmacists to teach and motivate the next generation of healthcare professionals.

According to Margaret Culshaw, deputy head of pharmacy at the University of Huddersfield,  “When people move from the NHS to academia it can be a culture shock because things are less planned. It’s not something you do for the money but for the job satisfaction”.

Date: November 1^st 2016

http://www.pharmaceutical-journal.com/careers/career-feature/how-pharmacists-can-get-into-a-career-in-academia/20201833.article

The competition supervisory body has commenced an inquiry into drug companies alleged of charging the NHS too much prices. The company who has broken the law could face fines of up to 10% of its international earnings.

The investigation relates to suspected unfair pricing by way of charging excessive prices in the supply of certain pharmaceutical products, including to the National Health Service.

The pharmaceutical company Concordia International has revealed that it is part of the inquiry that the Competition and Markets Authority would not disclose how many companies were caught up in the inquiry into suspected undue pricing.

The CMA inquiry into suspected breaches of competition law was commenced on 25 October 2016 and will gather preliminary proof before a decision is made as to whether or not to carry on further by February 2017.

Health secretary Jeremy Hunt called for the CMA to investigate in June 2016 after an investigation by The Times asserted companies were breaking off the NHS by buying the rights to old drugs and dropping existing brand names. The information about the case, set out on the CMA website, states: “The investigation is under Chapter II of the Competition Act 1998 (CA98) and Article 102 of the Treaty on the Functioning of the European Union (TFEU).

Date: 27^th October 2016

http://www.pharmaceutical-journal.com/news-and-analysis/news-in-brief/regulator-to-investigate-drug-companies-that-charge-nhs-excessive-prices/20201874.article

According to a report commissioned by the Association of the British Pharmaceutical Industry (ABPI), the membership organization for UK drug manufacturers, Drug manufacturers in the UK are progressively more working in corporation to develop new medicines as companies move away from the traditional model of in-house research and development.

 According to report, ‘The changing UK drug discovery landscape’, published on 17 October 60% of large biopharmaceutical companies have improved their investment in outsourcing and mutual working with other companies across the sector over the past decade so working with academic circles, medical research charities and bio-tech companies is showing considerable results such as manufacturing new drugs, including immune therapies for the treatment of cancer and others for Alzheimer’s disease.

The report’s findings were based on the results of a survey of 70 organizations as well as interviews with senior drug discovery experts.

But at the same time UK’s drug discovery potential is at risk from competition overseas, where more money is being spent on research and development sector because many organizations generally large firms reported a larger boost in their worldwide discovery investment than that in the UK.

 UK needs to consider how it can best uphold its position as a central player in a vibrant international discovery landscape.

Date: 19^th October 2016

http://www.pharmaceutical-journal.com/news-and-analysis/news-in-brief/uks-drug-discovery-potential-at-risk-warns-industry-body/20201850.article

The European Medicines Agency (EMA) has suggested conceding a provisional marketing approval in the European Union (EU) to Ocaliva (obeticholic acid) for the treatment of patients with major biliary cholangitis. Conditional approval is one of EMA’s main actions to make easy earlier access by patients to medicines that fulfill unmet medical needs. It permits the Agency to suggest a medicine for marketing authorization before the availability of confirmatory clinical trial data.

This is to be used in combination with another medicine, ursodeoxycholic acid (UDCA), in patients who have not responded sufficiently to UDCA, or on its own in adults who are not able to bear treatment with UDCA.

Primary biliary cholangitis is a uncommon and life-threatening disease that causes the steady devastation of the small bile ducts in the liver. These ducts transport fluid called bile from the liver towards the intestines where it is used to help digest fats. Due to the destruction of the ducts, bile builds up in the liver causing damage that may lead to liver cancer.

There are few treatments available for patients with primary biliary cholangitis such as:

• Liver transplantation can considerably get better a patient’s chance of survival; however this is a long and intricate operation only suitable for patients who have advanced liver disease.
• UDCA is the only medicine currently approved to treat primary biliary cholangitis, but up to half of all patients treated with UDCA either fail to respond to the medicine or experience partial benefits. There is therefore a clear unmet medical need for these patients, as well as for patients who are unable to tolerate treatment with UDCA.

The protection and effectiveness of Ocaliva were verified in a phase III study with 216 participants. After 12 months, the amount of patients achieving reductions in levels of their alkaline phosphates was higher in patients treated with Ocaliva.

The most frequent side effects observed with Ocaliva were itching of the skin and weakness.

As part of the conditional marketing authorization, the applicant for Ocaliva has to provide results from two studies. Until availability of full data, the CHMP will review the benefits and risks of Ocaliva yearly to determine whether the conditional marketing authorization can be maintained.

The opinion by the CHMP at its October 2016 meeting is an intermediary step on Ocaliva’s path to patient access. The CHMP opinion will now be sent to the European Commission for the acceptance of a decision on an EU-wide marketing authorization. Once a marketing authorization has been settled, a decision on price and reimbursement will then take place at the level of each Member State considering the possible role in the circumstance of the national health system of that country.

Date: 14/10/2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/10/news_detail_002618.jsp&mid=WC0b01ac058004d5c1

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