Category Archives: UK Pharma

The EU PAS Register gives an affluence of information on the safety and value of authorized medicines. It is a cooperatively available podium with information on post authorization research in medicines already marketed in Europe and comprises study etiquettes, study results, related publications and other appropriate and significant information.

The 1,000^th study has been uploaded in the European Union (EU) electronic Register of Post-Authorization Studies (EU PAS Register).

The information in the EU PAS Register reduces publication bias[i] (A type of bias that occurs when the outcome of a study influences the decision whether to publish or otherwise allocate it) through improved transparency of medicines research, improves the quality of post-authorization studies by enabling peer-review of protocols and results, simplifies association among stakeholders, and ensures passivity with EU pharmacovigilance legislation necessities.

The majority of studies in the EU PAS register are non-interventional, meaning the assignment of the patient to a therapeutic strategy is not decided in advance by a trial protocol but falls within existing medical practice [ii] (The assignment of the patient to a particular therapeutic strategy in a clinical trial is decided in advance and does not fall within normal clinical practice) and the treatment of the medicine is clearly separated from the decision to include the patient in the study.

These studies complement the evidence generated through the clinical development programme supporting the initial marketing consents of a medicine. They provide valuable perception into the use of a medicine in normal clinical practice and are essential in fully characterizing the safety and effectiveness profile once it is marketed and throughout its life span.

Regulators across the EU boost the registration of all non-interventional post-authorizations studies, regardless of who initiates, manages or finances them. Companies must register all non-interventional post-authorizations safety studies (PASS) forced by regulators. They are stimulated to register PASS requested to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures.

The EU PAS Register was developed through the European Network of Centre for Pharmacoepidemiology and Pharmacovigilance

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/02/news_detail_002692.jsp&mid=WC0b01ac058004d5c1

The National Institute for Health Research Efficacy and Mechanism Evaluation (EME) Program is financing and supporting a new £1.5 million trial testing a combination of therapies to prevent rapture in patients with brittle bone disease.

The University of Edinburgh’s six years studies including 25 hospitals in the UK and one in the Republic of Ireland, will evaluate a treatment of teriparatide followed zoledronic acid against placebo in 390 people with osteogenesis imperfecta.

The erratic bone condition is initiated by genetic transmutations that lead to abnormalities in collagen, leaving people with exceedingly fragile bones that break easily.

Both teriparatide and zoledronic acid are recognized treatments for the bone-thinning disease osteoporosis but this is the first time they have been tested in combination as therapies for OI.

According to Professor Stuart Ralston, University of Edinburgh’s Centre for Genomic and Experimental Medicine, “This is possibly a game-changing trial since it is the first study that had been explicitly intended to investigate whether any treatment can stop fractures in osteogenesis imperfect. If the results are positive, it could be the best thing in treatment of this rare but devastating state.”

Date: 16 Jan, 2017

http://www.pharmatimes.com/news/trial_to_test_fracture_prevention_combo_in_brittle_bone_patients_1184248

According to an industry analysis published by Deloitte, the profits on investment in drug research and development (R&D) are attained by the pharmaceutical industry fell to 3.7% in 2016 — the lowest figure in the past six years.

The study found that predictable peak sales per new product have dropped by 11.4% year on year since 2010 to reach an average US$394m.

The findings, published in Deloitte’s report ‘Measuring the profit from pharmaceutical innovation 2016: Balancing the R&D equation’, are based on its 2016 analysis of the R&D spend by the global top 12 research-based life science companies: Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck & Co, Novartis, Pfizer, Roche, Sanofi and Takeda.

The report reveals that the companies have launched 233 products over the past six years and developed another 376 products to reach late stage pipelines, with a total sales estimate of US$1,697bn.

During 2016, the costs of bringing a new drug from discovery to launch have alleviated — from US$1,576m in 2015 to US$1,539m in 2016 — but peak sales per product have continued to fall.

Colin Terry, consulting partner for European life sciences R&D at Deloitte, says the continuing fall in projected return is a “real issue” for the global industry: “As costs per product remain high, sales projections decline, and given it now takes the industry over 14 years to launch a drug, real questions must be elevated about output and revenues on innovation.”

He says drug price is the “most publicized challenge, with political and public scrutiny on the topic intensifying”. The mainstream of companies are struggling to attain historical highest sales in spite of continuing to launch many new products. They are also progressively looking for revenues from treatments in smaller patient groups.”

Date: 4^th Jan 2017

http://www.pharmaceutical-journal.com/news-and-analysis/news-in-brief/return-on-investment-falls-for-pharmaceutical-industry/20202146.article

The High Court has given the Pharmaceutical Services Negotiating Committee (PSNC) permission for a judicial review of the pharmacy funding cuts, the negotiator has confirmed.

According to PSNC, the hearing is planned for the second week of February. Though, the judge “has specified” that if the government asks for a later hearing date, then “the question will rise of whether there should be a postponement in the enactment of the funding cuts although the case is continuing”,

The speaker proclaimed earlier this month that it had sought a judicial review, on the grounds that the Secretary of State “failed to carry out a lawful consultation” on the suggestions for that division.

Two weeks later, the National Pharmacy Association announced that it is also scheduling to take its legal challenge against the cuts to the High Court.

Date: 22 December, 2016

http://www.chemistanddruggist.co.uk/news/high-court-agrees-review-pharmacy-funding-cuts-next-year

Rheumatoid arthritis is an immune system disease causing swelling and damage in the joints. It affects between 0.5% and 1% of people in the EU. Patients with moderate to severe rheumatoid arthritis have chronic inflammation causing tiredness, pain and joint stiffness. The symptoms are reversible with suitable and proper treatment, joint damage and the related disability are permanent.

The European Medicines Agency (EMA) has suggested granting a marketing approval in the European Union (EU) for Olumiant (baricitinib) for the treatment of adults with mild to severe active rheumatoid arthritis. It is to be used to treat patients who have not responded effectively to, or who are incapable to endure one or more disease‑adapting anti-rheumatic drugs (DMARDs). Olumiant, which is taken by mouth, can be used on its own or in combination with methotrexate which is given by injection or infusion. However, even with the most effective treatments available, more than half of patients do not achieve a reasonable response so new treatment options are needed.

Olumiant works by blocking the action of enzymes known as Janus kinases (JAKs). These enzymes play a significant role in the method of immunity and inflammation that occurs in rheumatoid arthritis. By blocking these enzymes, Olumiant is expected to reduce the inflammation and other symptoms of the disease. It would be first JAK inhibitor to be used in the treatment of rheumatoid arthritis in the EU and offers a different mode of action to what is currently available.

The recommendation from EMA’s Committee for Medicinal Products for Human Use(CHMP) is based on results of four randomized controlled trials in 3,100 adults with moderate to severe active rheumatoid arthritis. One trial compared Olumiant to methotrexate, another compared Olumiant to adalimumab, and two compared Olumiant to placebo. Generally, Olumiant was more active at reducing disease activity in patients with moderate to severe rheumatoid arthritis, compared to those treated with methotrexate and adalimumab.

Olumiant showed efficacy in patients who had not responded to biologic DMARDs as well as in patients that had never been treated before. Maintenance of efficiency was demonstrated in 52-week-long trials.

The common side effects with Olumiant in clinical trials were:

• Increased lipid (fat) levels in the blood
• Upper respiratory tract infections
• Nausea

The opinion adopted by the CHMP at its December 2016 meeting is an intermediary step on Olumiant’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. Once a marketing authorization has been approved, a verdict on price and reimbursement will then take place at the level of each Member State considering the potential roleof the medicine in the context of the national health system of that country.

Dated: 16th’ December 2016

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/12/news_detail_002667.jsp&mid=WC0b01ac058004d5c1

Ibuprofen is a medicine usually used to decrease pain and infection, but according to a new study the medicine may also decrease the risk of death from lung cancer among previous and existing smokers.

Study co-author Dr. Marisa Bittoni, of The Ohio State University, and colleagues recently presented their findings at the IASLC 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria.

According to the Centers for Disease Control and Prevention (CDC), people who smoke are 15-30 times more likely to develop lung cancer or die from the disease than nonsmokers.

Previous studies have shown that chronic inflammation is associated with increased risk of lung cancer. Since ibuprofen is a medication that reduces inflammation, Dr. Bittoni and colleagues set out to investigate whether the drug might benefit people with a history of smoking

• Ibuprofen reduced lung cancer death risk by 48 percent

To reach their findings, the team analyzed the data of 10,735 adults who were part of the Third National Health and Nutrition Examination Survey (NHANES III), enrolling between 1988-1994.

Fast facts about smoking

• Smoking is the leading preventable cause of death worldwide
• People who smoke die an average of 10 years earlier than nonsmokers.

Subjects’ smoking status, use of ibuprofen and other no steroidal anti-inflammatory drugs (NSAIDs), and information on other lifestyle factors were gathered at study baseline.

Participants were followed-up for an average of 18 years, and the researchers pinpointed their cause-specific mortality status using data from the National Death Index up until 2006.

The researchers used Cox proportional hazards lapse models to estimate how NSAID use was associated with the risk of lung cancer death.

During follow-up, 269 of the participants died from lung cancer, of whom 252 had a history of smoking.

Because the vast majority of lung cancer cases were among past or current smokers, the team also calculated the effects of NSAIDs in a further sample of 5,882 adults with a history of smoking.

Overall, the team found that former or current smokers who regularly used ibuprofen were 48 percent less likely to die from lung cancer than those who did not use the drug.

The link between lung cancer death risk and the use of aspirin – another common NSAID – was not statistically significant, the authors report.

Quitting smoking and adopting a healthy lifestyle remain the best ways to lower lung cancer risk. However, Dr. Bittoni and colleagues believe their findings suggest regular ibuprofen use might be appreciated for some people.

Dated: 12^th December, 2016

http://www.medicalnewstoday.com/articles/314656.php

According to research published in the British Journal of Clinical Pharmacology, lack of awareness about reporting systems for drug reactions (ADRs) and confusion about how they work are preventing patients from informing medicines safety regulators when something goes wrong.

The patients who do log a report say preventing other patients from having a similar experience and improving medicines safety and health care professional practice are amongst the reasons why they take action.

The results monitor a methodical review of 21 studies published between 2008 and 2014 that consider patient obstructions to reporting ADRs, their perceptions of the current reporting systems and the factors which influence whether they make an official report.

According to the research increasing patient familiarity and providing clear reporting processes, reporting systems could better achieve patients reporting of adverse drug reactions.

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s medicines safety regulator, agrees that some patients are dissuaded from reporting ADRs through its official Yellow Card system.

Dated: 25th November 2016

http://www.pharmaceutical-journal.com/news-and-analysis/news-in-brief/patients-lack-knowledge-on-how-to-report-adverse-drug-reactions/20201995.article

The National Institute for Health and Care Excellence (NICE) issued draft guidance this week reversing its earlier position on Nucala thanks to a price cut and new data on cost-effectiveness succumbed by GSK.

Patients in the UK with asthma are on progression to receive treatment with GlaxoSmithKline’s recently approved Nucala drug.

According to final draft, Nucala can be used as an add-on therapy for treating severe obstinate eosinophilia asthma in adults, provided they have blood eosinophil counts of 300 cells/mL or more and have at least four breakthrough asthma attacks in the last 12 months or have been on continuous oral corticosteroids for six months.

The endorsements also call for treatment with the drug to be stopped after 12 months if there is no substantial development in asthma attacks or the need for corticosteroids.

According to Prof Carole Longson, director of NICE’s centre for health technology evaluation, “Adults with severe asthma have had partial treatment options and most of them end up taking oral corticosteroids for prolonged periods which can cause further problems such as diabetes, high blood pressure and mood swings.”

Nucala was the first in a new class of interleukin-5 (IL-5) inhibitors to be accepted for marketing, getting a green light from the European Medicines Agency (EMA) a year ago. There are thought to be around 100,000 people in the UK who have hysterical asthma. Nucala is anticipated to value from its first-to-market status, with analysts at Credit Suisse predicting sales of $1.54bn in 2020 given the seriousness of uncontrolled asthma. Its dosing – by subcutaneous injection every four weeks – is seen as an advantage over Cinqaero, which has to be delivered intravenously.

Stalling the activity of IL-5 dampens down the activity of eosinophil, a provocative cell known to play an significant role in the asthma disease process. Nucala’s list price in the UK is £840 per dose, but the discount provided to the National Health Service (NHS) is not revealed.

Dated: December 1^st 2016

http://www.pmlive.com/pharma_news/nice_changes_stance_on_gsks_asthma_drug_nucala_1179522

Prime Minister Theresa May has announced that UK research and development will be given an extra £2 billion a year by the end of this parliament. The real terms increase in government investment for R&D will guarantee that British business remains at the cutting edge of scientific and technological sighting to capitalize on the sector’s potential.

It is expected that this will help to make sure that original products developed in the UK are also commercialized here.

It is also announced that a new Industrial Strategy Challenge Fund, overseen by UK Research and Innovation, that will back precedence technologies such as AI, robotics and biotechnology.

According to Research demonstrations each £1 spent on R&D tax credits presently stimulates between £1.53 and £2.35 of additional investment in the UK, but the HM Treasury will look at whether this provision can be made even more operative to energetically boost innovation.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, said the extra £2 billion a year funding for the sector “a hugely welcome and will be well received by everybody involved in UK life-sciences.”

For encouraging these steps, NHS has the infrastructure to become the go-to place for companies to research, develop and use new medicines,” while “the next wave of medical technologies has the potential to bring investment, highly capable jobs and improved healthcare for patients.

Dated: 22nd November 2016

http://www.pharmatimes.com/news/pm_announces_2bn_boon_for_uk_r_and_d_1177925

Mouth cancer is one of a very small number of cancers which are on the rise. In the UK, cases have increased by 39% in the last decade and by 92% since the 1970s. According to Oral Health Foundation, Unfortunately, survival rates have not improved in the last 20 years either, that is why it is vitally important that everyone is more Mouth aware.

Pharmacists are being commended to be responsive to the patients coming in with possible symptoms of mouth cancer after it occurred that one in ten would show these symptoms to their pharmacist over a dentist or doctor.

A research was directed by the Oral Health Foundation as part of Mouth Cancer Action Month. According to Dr Nigel Carter OBE, CEO of the Oral Health Foundation, “Rather than advising a topical ulcer remedy, which could just mask the symptoms, it is important that pharmacy staff recognize that this could potentially be a sign of mouth cancer.”

The most common symptoms of mouth cancer to be shown to a pharmacist is a mouth ulcer that does not heal within two to three weeks and red or white patches in a person’s mouth and any unusual lumps or bumps around their head or neck. Early diagnosis transforms a person’s chances of beating the disease from 50 per cent to 90 percent.

Date: November 11, 2016

http://www.thepharmacist.co.uk/news/latest-news/patients-with-mouth-cancer-may-come-to-pharmacy-for-help/