New study finds fake, low-quality medicines prevalent in the developing world

A new study from the University of North Carolina at Chapel Hill found that substandard and falsified medicines, including medicines to treat malaria, are a serious problem in much of the world. In low- and middle-income countries, more than 13 percent of the essential medicines that satisfy the priority health care needs of the population fall in this category. When looking specifically at African countries, the portion of substandard and falsified medicines rises to almost 19 percent.

Falsified medicines are medical products that deliberately and fraudulently misrepresent their identity, composition or source. Substandard medicines are real medical products that fail to meet quality standards or specifications for a variety of reasons, including poor manufacturing, shipping or storage conditions, or because the drug is sold beyond its expiration date.

Researchers analyzed 96 previous studies of falsified and substandard medicines and each of the studies tested more than 50 medications. The team found that antimalarials and antibiotics were the medicines most commonly sold in substandard or falsified conditions. In low- and middle-income countries, 19 percent of antimalarials and 12 percent of antibiotics are substandard or falsified.

Sachiko Ozawa, an associate professor at the UNC Eshelman School of Pharmacy, led the research along with collaborators. The paper published in the journal JAMA Network Open on August 10.

“The prevalence of substandard and falsified medicines is a substantial public health problem because these medicines can be ineffective or harmful and can prolong illnesses, cause poisoning or lead to dangerous drug interactions,” said Ozawa. “Our study shows that a concerted global effort is needed to improve supply chain management for medicines and to identify solutions to this understudied issue.”

The researchers searched five databases for studies related to substandard and falsified medicines. They reviewed 256 studies and included 96 studies in their analysis.

“We need more global collaboration to implement laws on drug quality, increase quality control capacity, and improve surveillance and data sharing,” said James Herrington, a professor in the UNC Gillings School of Global Public Health and a co-author of the study. “This can strengthen the global supply chain against poor quality medicines, improve health outcomes by reducing antimicrobial and anti-parasitic resistance and, ultimately, help governments, businesses and patients save money.”

The team’s analysis found limited information on the economic impact of poor quality medicines, with the estimates of market size ranging widely from $10 billion to $200 billion. Substandard and falsified medicines can burden health systems by diverting resources to ineffective or harmful therapies and cause additional treatment costs and reduced worker productivity due to treatable illnesses, but these effects have not been measured.


Mushrooms of the Far East hold promise for the anti-cancer therapy

Mushrooms from the Far East area contain the natural chemical compounds, which could be used for the design of the novel drugs with highly specific anti-tumor activities and low-toxicity. These compounds may offer new avenues for oncology, providing us with either stand-alone alternatives to chemotherapy, chemopreventive medicines, or drugs to be used in combination with other therapies.

The international team of scientists from the Far Eastern Federal University (FEFU), University of Lausanne, and Federal Scientific Center of the East Asia Terrestrial Biodiversity FEB RAS describes the available body of research on four fungi species with high anti-cancer potential. The article is published in Oncotarget and contains the list of tumors, which were reported to be promising targets of the fungal compounds. Among them sarcoma, leukemia, rectum and colon cancer, stomach cancer, liver cancer, colon carcinoma and others.

For the purpose of the current study scientists chose mushrooms widely used in Asian and Far Eastern folk medicine: Fomitopsis pinicola, Hericium erinaceus, Inonotus obliquus, and Trametes versicolor. These species of fungi were shown to selectively target certain malignant tumors. The desired effect is achieved thanks to the various bioactive compounds contained in the mushrooms: polyphenols, polysaccharides, glucans, terpenoids, steroids, cerebrosides, and proteins. These substances are not only capable to hit different critical targets within cancer cells levels but also in certain cases to synergistically boost the chemo. Scientists emphasize that four species of fungi were chosen due to the fact that their medicinal properties are relatively well described. Some of them are already actively used for the anti-cancer drugs manufacturing in certain countires. Undoubtedly, there are many other species of fungi that contain chemical compounds to defeat cancer cells.

“In ancient China mushrooms were considered as the most effective treatment for the various types of tumors. Contemporary fungotherapy (treatment by means of mushrooms) represents a promising field for scientific research. The natural chemical compounds contained in fungi have a huge therapeutic and particularly the anti-cancer potential that has not been yet fully studied”, says Professor Vladimir Katanaev, Dr.Habil, Ph.D., Head of the Laboratory of Pharmacology of Natural Compounds of the Department of Pharmacology and Pharmacy of the School of Biomedicine, FEFU.

Another co-PI and corresponding author of this work, director of the center for genomic and regenerative medicine of the School of Biomedicine, FEFU, Alexander Kagansky, notes that despite that the interest in mushrooms studying has been growing exponentially over the past 60 years, about 90% of the fungal species have never been analyzed for their antibiotic and antitumor activities.

“Moreover, the significant part of cancer-related research of fungi deals merely with their toxicity to cancer cells, and the ability to stop the growth and development of cancer cells. The point is that such properties of the fungi compounds are equally detrimental to the healthy cells of the body”, comments on A. Kagansky. According to the scientist, it is necessary to research fungi for the chemical compounds capable of selective, targeted impact on cancer cells.

Vladimir Katanaev notes the importance of further research the immunomodulatory effect of fungi enriched with polysaccharides. According to him, immunomodulation can be attributed to indirect but effective methods of defeating cancer.

The first generation of natural medical compounds from mushrooms’ extracts wasn’t specific and has been applying widely for the therapy of all cancer types without consideration of tumor type properties. Such therapy damaged not only tumor cells but also healthy cells of the body. There were lots of heavy side-effects at times leading to the death of the patient due to the overdose.

Modern approaches to anti-cancer therapy are based on the targeted treatment with minimal or no consequences to the healthy cells and tissues. For this purpose, not only the general therapeutic properties of fungal chemical compounds are investigated but also the ways they differ in their action on different tumours.

The scientists hope that the high potential of the fungi for the anti-cancer therapy showcased in their article will encourage the further research at the junction of oncology and mycology. Currently in the laboratories of the School of Biomedicine (FEFU) led by Vladimir Katanaev and Alexander Kagansky,the new experiments are conducted to reveal the anti-cancer activities of the mushrooms extracts. This work is aimed at creating the new generation of highly specific low-toxic drugs, which could be specifically targeted on different tumor types.



First EMA publication on the results of transparency policy on the publication of clinical data

The European Medicines Agency (EMA) has recently published the results of their transparency policy on the publication of clinical data which they started implementing almost 3 years ago. According to this policy (Policy 0070), reports on clinical trials where efficacy and safety of new drugs were studied are now open to public including scientists and academics. The Agency have been given the direct access to all reports which were submitted to them as a part of marketing authorisation applications since 1 January 2015.

The published report consists of the data and statistics which cover only one year from 20 October 2016 – a milestone when the EMA’s website on medicines and corresponding clinical data was launched. Therefore, this report contains 54 regulatory dossiers and information on 50 medicines for which dossiers were submitted to the EMA. Amongst these medicines there are orphan, paediatric, biosimilar and generic drugs. The statistics is impressive: there were 80537 of downloads and 22164 document ‘views’ (all for noncommercial objectives).

The report also reveals some information on the overall quantity of published documents and the number of documents which were redacted for the purpose of anonymisation and hiding commercially confidential information (CCI). Interestingly that the EMA has accepted only 24% of CCI redactions proposed by the pharmaceutical companies which led to the fact that only 0,01% of 1,3 million published pages had CCI corrections. The report also tells about the anonymisation techniques which were used to protect CCI and the influence of these techniques on final data quality.

The other part of the statistics is also fairly interesting. The vast majority of users work in the pharmaceutical business, 14% were academics and only 8% of healthcare professional and 8% of ordinary patients accessed this website. The report also analyzes people attitude to the new EMA policy. It turned out that most of the responders totally support it and think that such policy may increase public trust to the EMA activity.


The cure for Alzheimer’s is preparing to blow up the market

Chinese scientists from the Ocean University of China, Shanghai Institute of medicine, the Materia Medica at the Chinese Academy of Sciences and of the company Green Valley Pharmaceutical Co., Ltd reported its success in the field of drug creation against Alzheimer’s disease, reports Xinhua. The tool is known as GV-971, and work on it is already 21 years.

The last stage of clinical trials is required before entering the market. It is known that in the study patients were given oral 450 milligrams of GV-971 twice a day for 36 weeks. And the tool significantly improved the condition of people. Experiments with animals were also successful.

The basis of the drug – an extract of brown algae. It can regulate the immune system, reduce inflammation in the nervous system and improve perception. All of this is critical for Alzheimer’s patients. To date, the disease has been diagnosed in approximately 48 million people worldwide. And there is still no effective drug on the market.



Pfizer and Lilly claim win for NGF pain drug in osteoarthritis

Pfizer and Eli Lilly’s nerve growth factor (NGF) inhibitor tanezumab has inched closer to becoming the first alternative to opioid analgesics for severe pain after hitting the mark in a phase 3 trial.

Two subcutaneous doses of tanezumab—given eight weeks apart—met all the objectives in the trial in patients with osteoarthritis pain, significantly improving pain, physical function and patients’ assessment of their symptoms compared to placebo over the 16-week study.

It’s an important win for the drug, which was held back for years in development by concerns over NGF inhibitor safety, and particularly accelerated joint destruction that required replacement surgery in some cases. That resulted in the FDA applying a clinical hold on NGF drugs in 2012 that wasn’t relaxed until 2015.

Pfizer and Lilly say safety data from the phase 3 trial showed that rapidly progressive osteoarthritis was seen in “less than 1.5%” of tanezumab-treated patients and wasn’t observed in the placebo group, and there were no cases of bone destruction or osteonecrosis—another toxicity previously linked to NGF drugs.

The results keep the two partners on course for a filing in 2019 and represent an important milestone for the NGF field given that Regeneron halted some arms in its phase 3 program for NGF rival fasinumab in osteoarthritis in May after the independent data monitoring committee called the risk-benefit profile of the drug at higher doses unfavorable.

Meantime, another NGF inhibitor—Amgen’s fulranumab—seems to have been shelved after former partners Johnson & Johnson and Takeda both handed rights to the drug back in 2016, while AbbVie also gave up on its candidate earlier in the decade.

Pfizer and Lilly’s persistence with the project over many years may be about to pay off, assuming their big phase 3 program, including six studies across osteoarthritis, chronic low back pain and cancer pain, continues to deliver results. The high-risk gamble has a big prize in the offing, given the pressing need for nonopioid drugs for severe and chronic pain without the addictive properties and side effects of opioid painkillers. The U.S. is currently in the grip of an opioid addiction epidemic, with an estimated 11.5 million people misusing these drugs, according to Department of Health and Human Services (DHHS) data. It’s widely thought that an effective nonopioid drug for severe, chronic pain could quickly become a blockbuster and, prior to the FDA’s clinical hold, analysts had predicted that NGF inhibitors could become an $11 billion product category in their own right.

Pricing will of course be an issue given that current opioid analgesics are very cheap; however, it’s worth noting that opioids often don’t work very well in challenging indications like osteoarthritis. That’s one reason Pfizer and Lilly picked up fast-track status from the FDA for tanezumab last year for osteoarthritis and chronic low back pain.


The European Federation of Pharmaceutical Industries and Associations statement on antimicrobial resistance problem

The European Federation of Pharmaceutical Industries and Associations (EFPIA) strongly welcomes the approval of their own initiative report on “A European One Health Action Plan against Antimicrobial Resistance” by the Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament on the 20th June 2018.

The Committee of the European Parliament appeals to the European Commission and the Member States encouraging them to support and adopt new economic models and experimental pilot projects so that to stimulate the development of new antimicrobials, vaccines and rapid diagnostic tests. These aspects are the main measures that should be taken to effectively combat with antimicrobial resistance.

Therefore, EFPIA and its’ members especially support any activities which aim to boost the development of new antimicrobial drugs, vaccines and rapid diagnostic tools. The Federation is positive that European policy makers should work in conjunction with public and private researchers in order to find ways to increase the number of antimicrobials under development.

It is pointed out in the report that correct and prudent use of antimicrobials is crucial for controlling the resistance. They also do believe that the European Commission should manage and share practical guidelines among Member States and stimulate EU countries to implement resolute national strategies against antimicrobial resistance.

The ENVI Committee is calling the European Commission and EU members to join their efforts together and coordinate monitoring and reporting of any new information on antimicrobial resistance problem.



In Europe withdraw some drugs valsartan because of security issues

The European medicines Agency (EMA) is examining medicines containing valsartan supplied by one of the companies in China, after they have been detected by an impurity that potentially causes cancer, according to PharmaTimes.

Chinese company Zhejiang Huahai was found N-nitrosodimethylamine (NDMA) in some batches of the active substance (API) valsartan, supplied to a number of manufacturers of valsartan drugs, circulating in the EU market.

These drugs are used in patients with high blood pressure to prevent heart attack and stroke, as well as in patients with heart failure or who have experienced acute coronary syndrome.

According to the EMA experts, the presence of NDMA in the active substance, which is a potential carcinogen, was a surprise. The reason for the appearance is associated with a change in the production process of API.

Currently, drugs delivered by the company Zhejiang Huahai containing valsartan, Supervisory authorities revoked Tran the EU. In parallel with this, analyzes of the NDMA content in the drugs begin.


X7 Research takes part in the DIA 2018

Colleagues, X7 Research company takes part in the five-day conference “DIA 2018 Global Annual Meeting”, which will be held from June 24 to 28, 2018, in Boston Convention & Exhibition Center, 415 Summer Street, Boston, USA.

Designed to drive insights into action by connecting key policy discussions to real-world knowledge that you need to do your job every day, your attendance will accelerate your growth and your organization’s performance in the development ecosystem. Sessions will include distinguished speakers and expert panelists from regulatory, industry, patient advocacy, and academia. Engage with global decision-makers and influencers in the biotechnology hub of 2018 that you would not otherwise have access to. Advance healthcare product development globally and grow your career while doing so.

More information you can find by clicking on the link on the official website.

Contact us by email We will be glad to see you at this event!

X7 Research cooperates with universities, providing internships to foreign students

Colleagues, X7 Research has been having international students of Moscow International University and The Herzen State Pedagogical University of Russia interning at our offices in Saint Petersburg and Moscow.

At our offices, interns are having hands on experience in training, medical writing, consulting and marketing. During their time at X7 Research interns are an integral part of our daily business by being put in a position where their past knowledge and experience are being put at work while simultaneously gaining a valuable work experience in a different language and culture. Student-interns excel in their knowledge of business Russian language and all other fields of our services that they are interested in.

Moscow International University was opened in the capital of Russia in 1991 and is an established educational institution for many domestic and international students pursuing a degree in law, journalism, languages and management to name a few.

The Herzen State Pedagogical University of Russia (Herzen University) is one of the oldest educational institutions in the country, located in the heart of Saint Petersburg. Founded in 1797 by Emperor Paul I, today the university welcomes students to 57 educational programs from all over the world.

Thus, X7 Research team through internships helps to develop the necessary practical skills, which will later be useful for graduates in their work and promotion on the career ladder. We are happy to continue being a great place for all international students looking for a valuable experience while studying at one of the top Russian universities.

Development of a universal shot against influenza

Imutex has reported their phase 2b data of their universal flu shot “FLU-v” showing strong signs of boosting immune responses while simultaneously lowering rate of infection. This true “universal” shot is designed to protect against all influenza A and influenza B strains in humans and animals.

Imutex, now a well established joint venture between clinical research specialist “hVIVO” and drug development organization “SEEK Group” has their team working on its universal flu vaccine candidate for the past 14 years, as Gregory Stoloff CEO of “SEEK Group” reported to FiercePharma. Giving the urgency for better flu shots, U.S. and Europe have helped fund this phase 2 work, and at this pace, the vaccine should be on the market in 2 years. Before that, testing needs to proceed to phase 3, for which Stoloff added their team is ready to head into and are in discussions with Big Pharma players seeking a partnership for a more efficient testing giving that a large drug maker would already have late-stage testing capabilities well established.

Such a vaccine would create quite a market, as it would serve as a global vaccine for a target population of 7 billion people generating $10 billion to $20 billion annually over a period of 20 years. After the reported 2b data results hVIVO share prices have doubled, which comes at no surprise giving that many other companies including global giants Sanofi and Johnson & Johnson, are also working on advancing flu vaccine technology.

Source: Fiercepharma.