TOP-10 of the most sold drugs in the US over the past 25 years

A list of TOP-10 medicines has been published by the volume of sales in the USA. Over the past 25 years, the largest sales volume was recorded for the mega-blockbuster Lipitor, which is not surprising, the drug of Pfizer brought the company 94.67 billion dollars. In the TOP-10 there are also drugs that do not have such status – for example, Epogen.

Analysts of the company IQVIA ranked ten leading drugs in the US for 1992-2017. In addition to Lipitor and Epogen, Plavix entered the rating, which has long been one of the main sources of revenue for Bristol-Myers Squibb and Sanofi. In the first ten, you can also find three immunotherapeutics led by Humira, which is projected to be the first to overcome the bar of annual sales of $ 20 billion.

So, the first three: Lipitor (Pfizer), Humira of AbbVie company, its sales amounted to 75.72 billion dollars and Nexium (AstraZeneca) – 72.45 billion dollars. The fourth is Advair (GSK) – 69.08 billion dollars. The fifth place is held by Enbrel (Amgen) – 67.78 billion dollars. At the sixth Epogen (Amgen) – 55.63 billion dollars, at the seventh Remicade (Johnson & Johnson) – 54.67 billion dollars, the eighth place is held by Abilify (Otsuka / Bristol-Myers Squibb) – 51.34 billion dollars, the ninth is held by Neulasta (Amgen) – 47.40 billion dollars. Plavix (Sanofi / Bristol-Myers Squibb) сloses rating with sales of $ 46.48 billion.

Source: Pharmvestnik.

X7 Research takes part in the 5th Congress of Russian Pharmacologists

Colleagues, X7 Research takes part in a five-day event “Scientific foundations for the search and development of new drugs”, which will be held on May 14-18, 2018 in Yaroslavl, in the “Millennium” congress center.

The following events are planned for this year’s congress:

  • Organizational meeting of the Russian Scientific Society of Pharmacologists.
  • Roundtable “Scientific and methodical aspects of teaching pharmacology in the university”.
  • Pharmacological quest (business game for young scientists) “Drug research: simple and complex tasks”.
  • Competitions, exhibitions and satellite symposia.

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

Contact us by email info@x7research.ru. We will be glad to see you at this event!

X7 Research participates in the Russian Pharmaceutical forum

Colleagues, X7 Research takes part in a two-day international event “Russian Pharmaceutical forum”, which will be held on May 15-16, 2018 in Corinthia Saint-Petersburg Hotel.

The following key topics will be considered at the event this year:

  • Labelling of medicines in Russia
  • GMP inspections
  • State procurement of pharmaceutical drugs: VED list, price setting & the introduction of an information and analytical monitoring and control system
  • Manufacturing of pharmaceutical drugs in Russia: implementation of the import substitution programme in the pharmaceutical industry, obtaining a special investment contract & contract manufacturing
  • Protection of intellectual property rights for pharmaceutical drugs: issues and international practice
  • Search for innovations through partnerships: analysis of opportunities and challenges in the global market
  • Development of a common pharmaceutical market in the EAEU: problems of formation and future prospects
  • Digitalisation in the pharmaceutical industry: prospects for telemedicine and development of innovative medical technologies
  • Changes in the retail market: consolidation of pharmacy chains, prospects for pharmaceutical sales via the Internet and supermarkets and many more!

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

Contact us by email info@x7research.ru. We will be glad to see you at this event!

FDA has issued a new guidance on clinical trials for neurological disorders

The Food and Drug Administration (FDA) haы released a new guidance on clinical trials for following neurological disorders: Alzheimer’s disease (AD), amyotrophic lateral sclerosis, Duchenne muscular dystrophy, pediatric seizures, and migraine. The purpose of this guideline is to provide sponsors with more specific directives so that to save time and resources.

Instead of publishing any detailed diagnostic criteria for early AD, the FDA claims that criteria should reflect existing understanding of AD pathophysiology and progression. The FDA suggested to concentrate on assessing AD potential treatments in the earliest stages of AD, while diagnostic criteria for early AD must be reliable enough. Moreover, the FDA said that evaluating co-primary endpoints such as functional and cognitive improvement is not clinically significant.

As for amyotrophic lateral sclerosis there has not been many changes apart from pointing out that studies should demonstrate “clinically meaningful benefits in symptoms, function, or survival”. However, to prove drug safety it is necessary to enroll enough patients with different amyotrophic lateral sclerosis variants.

Due to a lack of DMD treatments, the FDA has claimed that they may allow clinical studies on “less than usual” nonclinical testing “if justified”. They have also added that investigating clinical pharmacology “is likely not needed to support a new drug’s approval”.

There has been one major change for clinical trials on pediatric seizures. The FDA has said that it was demonstrated that dose-response results in adults and children are comparable. Therefore, there is no need to conduct trials with children to prove drug efficacy as it is possible to extrapolate the results to children over the age of four years.

With regards to migraine, it is no longer necessary to demonstrate potential drug efficacy on four co-primary endpoints — pain, nausea, photophobia, and phonophobia. Now it will be necessary to show efficacy using only two primary endpoints: pain reduction and effect on a patient’s “most bothersome symptom”.

Source: Neurotodayonline.

Pregnant Women in Clinical Trials

The US Food and Drug Administration (FDA) has issued new draft guidance for industry. It outlines the scientific and ethical issues that should be addressed when considering the dilemma of including pregnant women in clinical trials of medicinal and biological products.

There are more than 60 million women of reproductive age in the United States and nearly 4 million births each year, according to US National Vital Statistics data.

This project is intended to serve as a focus for ongoing discussions among the FDA, drug companies, the research community, institutional review boards, and other parties involved with the conduct of clinical trials in pregnant women.

Some of the information in the guidance refers to medicines indicated for the treatment of pregnancy-specific conditions, such as preterm labor and preeclampsia. However, more emphasis is placed on the drugs indicated for the problems that often occur in young women of reproductive age, explains the FDA.

Experts note several reasons for considering the inclusion of pregnant women in clinical trials. Women need safe and effective treatment during pregnancy, and failure to establish the dose/dosing regimen, safety, and efficacy of treatments during pregnancy may compromise the health of women and their fetuses, they point out. In some settings, enrolling pregnant women in clinical trials may offer the possibility of direct benefit to the woman and/or fetus that is unavailable outside the research setting. Developing accessible treatment options for the pregnant population is a “significant public health issue,” the agency says.

Source: Medscape.

The upcoming amendments in the Federal Law No 61

Recently draft amendments of the Federal Law №61 “On drug circulation” dated 12/04/2010 were published. According to the current Law interchangeable medicines are medicine with proved therapeutic equivalence or bioequivalence when compared with the reference medicines and have equivalent content of active substances, excipients and the same form of administration. The characteristics of interchangeable medicines are listed in the article 27.1. It was suggested to add the aspect that interchangeable medicines (with regard to a certain reference medicine) will be of interchangeable between each other. According to the current review of the Federal Law points listed in this article are not applicable to reference medicines, herb medicines, homeopathic medicines and medicines which have been used in the Russian Federation for more than 20 years and for which it is impossible to study bioequivalence. After the amendments the points listed in this article will not applicable only to reference medicines, herb medicines and homeopathic medicines.

Moreover, it was suggested to add this article with extra aspects. According to the amendments it will be necessary to develop general medicinal product labels for all interchangeable medicines as well as maintenance of registers of typical medicinal product labels and interchangeable medicines. The expert body will determine whether the drugs registered before the effective date of this Law and which were beyond the interchangeability or which were determines as non-interchangeable are now may be considered as interchangeable. To determine whether the drugs for which documents were submitted for market registration before the effective date of this Law will be done by conducting a trial and comparing these drugs with reference medicines.

In the note for these draft amendments it is stated that these changes were prepared in order to implement the article 3 of the decision of the Council of the Eurasian Economic Commission dated 03/11/2016 № 92 about separate issue of drug circulation in order to improve the regulation of drug circulation.

Pharma 2030

The Ministry of Industry and Trade began to elaborate a program for the development of the pharmaceutical industry in the Russian Federation until 2030 – Pharma 2030. By the end of April, it is planned to submit the first draft of documents.

One of the important directions of the strategy is the creation of a full-fledged market of domestic medicines. Currently, Russian drugs on the VED list account for 84.5% of the total number of medicines and have almost reached the target level of 90%. Out of 550 INN, approximately 470 INN are manufactured in the Russian Federation as ready-made dosage forms.

The main result of the “Pharma 2020” strategy was the creation of a powerful production base for reproduced medicines, which is to be re-loaded. Also important is the adoption of a bill authorizing the registration of drugs produced on the same site with the same INN, but different trade names.

The domestic pharmaceutical industry should not be limited to the framework of the Russian Federation, A. Alekhin noted. That is why one of the goals of the 2030 program will be the export orientation. The government will create tools to support exports, which will consider the possibility of conducting clinical experiments abroad. Without this, access to foreign markets is impossible.

Another important trend in the development of domestic pharmaceuticals is the production of substances. Already, several private investors have started implementing projects to create large capacities for the production of biological raw materials for medicines, realizing that their own technological synthesis makes it possible to control drug margins and, in the end, to achieve high economic efficiency.

Source: Lekoboz.

Specialty Vaccines for Infectious Diseases

Developing specialty vaccines for emerging and overlooked infectious diseases is a challenging and rewarding enterprise with specific opportunities and problems. Large companies have not historically prioritized this area and instead have focused on the development and commercialization of routine vaccines and vaccines for diseases with more significant global markets.

There are many problems in developing specialty vaccines for emerging and overlooked infectious diseases, namely in financing and R&D.

Investments in specialty vaccines for overlooked infectious diseases are likely to be labeled as risky. This is due not only to attrition rates in vaccine R&D, but also due to the size, location and severity of outbreaks, which are difficult to predict. Companies have little certainty in regard to the market potential of newly developed vaccines. With that said, there is still a significant unmet need, and specialty vaccines are needed to protect against the public health threat that these overlooked infectious diseases represent.

Unfortunately, there are very few companies that focus only on vaccines and even less, with a fully integrated model covering not only the manufacturing but also the commercialization of the product.

However, although the development of specialty vaccines can be considered a risky enterprise, it also has tangible benefits. Smaller companies, such as PaxVax, have found a niche in the market, developing a scalable infrastructure to stimulate the development of the vaccine. The company’s success points to a largely untapped opportunity for pharma looking to invest in a growing market, which means that there are prerequisites to hope for solving problems in the development and commercialization of specialty vaccines.

Source: Fiercepharma.

A break-through in glucose level monitoring

Researchers from the University of Bath (United Kingdom) have created a non-invasive, adhesive patch which measures blood glucose level without a finger-prick blood test. It means that millions of patients with diabetes all over the globe won’t need to conduct a painful and unpleasant finger-prick blood test anymore.

This system does not penetrate the skin, it just contains several micro sensors and is placed above рair follicles. The patch samples glucose from the interstitial fluid (fluid between cells) via electroosmotic extraction through follicular pathways in the skin. The glucose collects into small reservoirs and is quantified there. The other advantage of this method is the fact that it does not require calibration with a blood sample meaning that finger-prick blood test becomes absolutely unnecessary.

The paper was published in Nature Nanotechnology on the 9th of April. The research team hopes that this patch will become a cheap and convenient device which will measure blood glucose level on a  regular basis and automatically send it to patients’ phone or smartwatch warning them when they need to take urgent actions to normalize glucose concentration.

Sources: MRC, Nature.

X7 Research will participate in the CPHI North America

Colleagues, X7 Research will take part in a three-day international exhibition “CPHI North America”, which will be held on April 24-26, 2018 in Philadelphia, PA, USA.

The event is worth to visit for several reasons:

  1. Highly qualified speakers who focus on innovative, big ideas on everything from manufacturing to outsourcing, R&D, drug delivery, and more.
  2. The opportunity to establish useful contacts and expand the network of professional contacts.
  3. A large number of educational content: master classes, lectures, presentations, etc.

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

Contact us by email info@x7research.ru. We will be glad to see you at this event!