Grand opening X7 Clinical Clinical Center

Dear Colleagues!

We are pleased to announce that the X7 Clinical Clinical Center has received accreditation for the right to conduct clinical trials.

The ceremonial opening of the center will take place on November 15th.

X7 Clinical Research is a modern center specializing in conducting clinical trials of bioequivalence phase I, phase II, phase III and post-marketing research of drugs in all therapeutic areas. The main principle of the center is to conduct clinical research at the highest level of quality that complies with local and international legislation, as well as ensuring the safety of research subjects.

The key activities of the center are research of bioequivalence and phase I, as well as conducting studies of therapeutic equivalence and phase III. The work of the center implies strict adherence to the principles of Good Clinical Practice (GCP). The equipment and infrastructure of the center are fully consistent with international standards for clinical research.

Detailed information you can find on the website of the center.

Universal influenza vaccine has successfully passed preclinical studies

The universal influenza vaccine from InvVax showed positive results in preclinical studies. At the moment, the company is preparing to conduct phase I clinical studies, at the same time attracting funding from Series A, the In-Pharma Technologist.

In preclinical studies of influenza vaccine, InvVax targeted 4 invariant regions, each of which induced an immune response in mice.

These invariant regions are vaccine components that can prevent the immune system from evading recognition and overcome viral mutations. Thus, invariant regions ensure the stability of the vaccine and have a protective effect against all strains of the virus without the threat of mutation or resistance of the virus.

Data DKI were obtained by intranasal or subcutaneous administration of the candidate vaccine in mice.

The proportion of survivors in the group of mice that received the vaccine was 100%, whereas in the control group that did not receive the vaccine, this figure was 0%.

According to Arthur Young (Founder and President of InvVax): “We are hoping for a vaccine to be purchased by one of the Big Pharma representatives after the end of the Phase I clinical studies, approximately 2021-2023 We also expect approval of a new experimental drug around 2021.”

Link: pharmvestnik.ru

In the USA the new Pfizer drug for treating a lung cancer was approved

US regulators have approved a new drug, Lorbrena (lorlatibin), developed by Pfizer for the treatment of metastatic lung cancer in patients previously treated with a specific gene mutation, reports PharmaTimes.

Lorbrena is prescribed for ALK-positive metastatic non-small cell lung cancer in patients with disease progression during treatment with crizotinib and at least one ALK inhibitor, or in patients with disease progression during treatment with alectinib or ceritinib as a first-line ALK inhibitor.

The drug was approved by the accelerated procedure on the basis of data on the frequency and duration of responses from the tumor. As noted by the company, further approval may depend on the verification and description of the clinical benefits of therapy during the confirmatory study.

Lorbrena is a 3rd generation ALK tyrosine kinase inhibitor.

Link: pharmvestnik.ru

Amgen reduced the cost of evolocumab in the US by 60%

Amgen decided to reduce the cost of the drug Evolumab (Repat) by 60% (up to $ 5850) in order to increase sales.

Evolumab appeared on the market in 2015, and the annual therapy with this drug was estimated at that time at $ 14,000. The main competitor of evolumab is a drug company Regeneron alirokumab (Pralyuent). Due to the high cost of treatment, insurance companies decided to reduce the availability of this lipid-lowering therapy, despite its high efficiency. According to estimates by Amgen Commercial Director Murdo Gordon (Murdo Gordon), about 3.4 million Americans have indications for EVOLUMAB therapy, but so far only 50,000 people have been receiving the drug worldwide.

Evoluumab, like alirocumab, is a monoclonal antibody inhibiting proprotein convertase subtilisin / kexin type 9 (PCSK9). The drugs prevent PCSK9-mediated breakdown of R-LDL by binding to PCSK9 and inhibiting the binding of circulating PCSK9 to the LDL receptor (R-LDL) on the surface of liver cells. As a result, increased expression of R-LDL in the liver leads to a decrease in serum LDL concentration.

Link: www.remedium.ru

The share of Indian pharmaceutical companies account for 39% of the total number of FDA approvals

India holds an important place in the global pharmaceutical sector. Indian R & D-oriented pharmaceutical companies and their subsidiaries received a large number of approved applications for the Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA).

According to the Pharmabiz study, in the first half of the year (including June 2018), Indian pharmaceutical companies and their subsidiaries received 125 final ANDA approvals out of a total of 323 approvals. Thus, Indian companies accounted for about 39% of the total number of allegations. Similarly, these companies received 22 preliminary approvals (tentative approvals) out of a total of 71 provided by the FDA for this period.

In the first half of 2018, the level of approval was slightly lower compared to the same period in 2017, when the FDA approved a total of 387 applications and issued 85 preliminary approvals. Of these, 137 ANDA statements and 32 preliminary approvals were received by Indian companies.

According to the Pharmabiz study, Aurobindo Pharma is the leader among Indian companies, having received 22 ANDA endorsements. It is followed by Zydus Pharma – 16 approvals, Strides Shasun – 12, Cipla – 11. Lupin, Sun Pharma Global and Taro Pharma also received 8 statements each. This is followed by Dr. Reddy’s Laboratories and Glenmark Pharmaceuticals, each of which received 7 approvals in the first half of 2018. In addition, Aurobindo Pharma also became the leader in the number of preliminary approvals during the first half of this year.

During the 2017-2018 fiscal year, R & D expenses of Aurobindo increased to 91 million dollars. US and accounted for 4% of the company’s revenues (2.248 billion dollars), while sales in the United States increased to 1014 million dollars. in 2018, Lupin, India’s third largest pharmaceutical giant, incurred R & D costs of $ 252 million. during 2017–2018, which corresponds to 11.9% of sales. Dr. Reddy’s Laboratories spent $ 249 million on R & D. in 2017–2018 compared to 266 million dollars. for the previous year, which is 7% less.

Despite fierce competition, Indian pharmaceutical companies continue to grow rapidly. But, according to a Pharmabiz study, there is also a tendency to reduce the cost of R & D by some large companies, which may adversely affect the high rating indicators of Indian companies relative to ANDA. According to analysts, these companies should reverse the trend and invest more in R & D.

Link: gmpnews.ru

What do people know about clinical trials?

In the JAMA Network Open published the results of a new survey on the importance of clinical research.
The survey showed that people are aware of the importance of clinical research (CT), but do not know how they are conducted.
The fact that clinical trials are important for the development of new drugs is considered by 85% of respondents (10,506 people); 90% of respondents (11,182 people) believe that CT are safe.
However, 5,578 out of 12,427 people (44.9%) reported that doctors rarely suggest participation in CT as a possible treatment method.

Ennik Anderson, the head of research and director of research services at the Information and Research Center, believes that one of the main reasons that impede the development of medicines is the difficulty in recruiting clinical trial participants. Increasing the level of knowledge about CT among “ordinary people” can be a good solution to this problem. After all, the ultimate goal of our work is to bring drugs to the market as soon as possible so that new effective treatment methods become available to patients.

The survey involved 12,427 respondents from 68 countries. Among the respondents were 2,200 people who participated in clinical trials. Survey participants were asked what they knew about the clinical study, how they got information about the research and what problems they encountered during their decision to participate in the CT.
Although most participants agreed that clinical research is important for the emergence of new drugs, more than half of them do not know where the research is being conducted. Respondents consider participation in clinical trials as burdensome for them. Among those who did participate in clinical studies, about half stated that this led to changes in their daily lives.

“We want to attract patients and medical staff in order to tell how the research protocol is being developed and to introduce them to the research procedures,” said Anderson. Previous studies have focused on the perspectives of researchers and physicians involved in the research, as well as on the difficulties in clinical trials. .
According to Susan Bartlett from Universtet McGill in Montreal, even today many drug studies do not pay enough attention to the information that patients report, such as fatigue or dyspeptic symptoms.
“In essence, we are conducting clinical trials to improve the lives of patients,” said Susan Bartlett to Reuters Health. “The possibility of conducting CT depends largely on the altruism of patients and their belief that the tests we carry out are safe and important for the development of science.”

Bartlett and colleagues conducted studies in the United States, Canada, and Australia on patients with arthritis. What doctors call “unpleasant side effects,” such as fatigue, diarrhea, and gastrointestinal pain, has been identified. They turned out to be common, permanent and “incapacitating” phenomena.
Even if the medicine helps with arthritis, it no longer matters if the patient is constantly feeling tired.
“Patient-oriented approaches in CT are in the early stages of development,” Bartlett added. “We assume that the cumulative effect of adverse reactions from drug intake has a significant impact on the quality of life of patients and reduces compliance with treatment.”

Methods are being developed to make patient-oriented clinical research. This includes identifying the risks and benefits of participation in CT, from the point of view of patients.
“Feel free to talk,” said Bartlett. “Tell us what we do well and where there is room for improvement.” We will all benefit from this.

Link: jamanetwork.com

120 years since the birth of Zinaida Ermolyeva

Zinaida Yermolyeva saved thousands of people during World War II by developing a new type of antibiotics. Abroad, she is also called the “Penicillin Mistress”.

Zinaida Yermolyeva was born in 1898 in the Region of the Don Cossacks – this is how Volgograd Region was called before. In 1921, she graduated from the Women’s Medical Institute in Rostov.

In the second year of study, Zinaida Yermolyeva became fascinated with microbiology and dedicated her entire life to it. At the same time, a cholera epidemic in 1922 had a great influence on it, which swept across the region like a tornado. At that time, she almost died when she drank a liquid with cholera-like vibrios, which she herself had isolated from tap water. A few hours later, Yermolyeva became seriously ill but was able to overcome the disease. Thus, she proved that vibrios are the causative agents of cholera – it is thanks to her discovery that since then water has been chlorinated in public places.

In 1925, Zinaida Ermolieva moved to Moscow. Up until the epidemic in Afghanistan in 1939 and beyond, she continued to develop methods for diagnosing and fighting cholera, for which she was soon given the title of professor.

During the war, she arrived at the besieged Stalingrad, where a cholera epidemic could begin. Zinaida Yermolyeva, in the most difficult conditions, launched the production of bacteriophage, chlorinated public wells and launched mass vaccination. For this, she was awarded the Stalin Prize.

During World War II, penicillin was developed in the West. Later, Howard Florey won the Nobel Prize. However, no one wanted to immediately share the revolutionary discovery with the USSR, so Zinaida Yermolyeva was instructed to develop a Soviet analog of the antibiotic.

The crustosin was even more effective than its western original. Howard Florey, who arrived in the USSR, was delighted with the work of his Soviet colleague, whom he called “Ms. Penicillin.” This nickname was firmly established for Zinaida Yermolyeva – not only here, but also abroad.

Up until his death in 1974, Zinaida Yermolyeva was engaged in microbiology and antibiotics in particular. Thanks to her discoveries, drugs were created that still do not leave the pharmacy shelves: levomycetin, streptomycin and interferon.

Link: www.5-tv.ru

Ministry of Health is in favor of lifting the ban on the cultivation of opium poppy

The Ministry of Health of Russian Federation supports a bill authorizing the cultivation of narcotic plants in the territory of Russia for the production of domestic anesthetic drugs for the full cycle, reports TASS.

Now Russia buys 100% of APS for the production of narcotic painkillers. However, the Ministry of Industry and Trade has developed a draft amendment providing for the abolition of the ban on the cultivation of narcotic plants in the territory of the Russian Federation.

According to the press service of the Ministry of Health, the list of vital and essential drugs (VED) for 2018 “includes six types of opioid analgesics, which are used in surgical interventions and analgesic therapy.”

The draft law prepared by the Ministry of Industry and Trade also spelled out the procedures for the cultivation of narcotic plants, it is also proposed to determine the plant varieties that are allowed to grow for these purposes, and the requirements for them. In addition, it is proposed to extend rules of the federal law relating to the establishment of state monopoly and requirements for the cultivation of narcotic plants “for use in scientific, educational and expert activities, for the cultivation of narcotic plants for the production of drugs used for medical purposes and (or) veterinary medicine and psychotropic substances. ”

Link: www.remedium.ru

In the United States will build a plant for the production of stem cells

According to the prospectus presented last week, the British company Orchard Therapeutics (Orchad Therapeutics) intends to spend part of the proceeds from the IPO to build a plant for the production of stem cells in the San Francisco area, and the rest for clinical research (CI) three gene therapy drugs and bringing them to the market, according to FiercePharma.

GlaxoSmithKline (GlaxoSmithKline; GSK) owns a significant share of the shares of the British biotechnology company, from which it was not possible to receive comments due to the IPO-related “period of silence”.

It is believed that after acquiring GSK’s product portfolio at the beginning of this year, Orchard owns one of the most extensive portfolios of gene therapy drugs in various phases of CI. It includes, in particular, the EU-approved Strimvelis drug for the treatment of severe combined immunodeficiency (the so-called “boy in a bladder” syndrome) worth 625 thousand dollars, sales of which are minimal, as well as two more development programs and CI. As part of this transaction, GSK received a 19% stake in Orchard’s charter capital, as well as a position on the board of directors of a British company.

Orchard has already raised about $ 200 million in the C Series financing round and now expects to receive $ 173 million in the IPO process, which will make its financial situation quite stable. The company plans to conduct reference studies of three gene-therapeutic drugs, and then – filing registration applications in the USA and Europe. The only source of revenue for the company is Strimvelis sales.

Link: pharmvestnik.ru

A Cancer Patient’s Guide to Clinical Trials

Clinical trials are a crucial step in getting new treatments to market. Before a drug can be approved by the U.S. Food and Drug Administration and released widely, manufacturers are required to carry out studies in humans to document that it is effective and to discover any side effects.

Fewer than 5 percent of adult cancer patients enroll in clinical trials. ProPublica has found that the vast majority of participants in these studies are white, even when minorities have a similar or higher risk of getting the cancer that the drug treats.

Most trials are run at academic medical centers and conducted by researchers there. Patients outside those centers often aren’t aware that clinical trials are an option, or they may wonder what joining a study entails. For patients who might consider a clinical trial, here are answers to some common questions.

Why should I join a clinical trial?

Drugs being tested in a trial often reflect the most cutting-edge technology and most current understanding of the disease. In the past decade, the cancer field has seen rapid advances in treatments, dramatically changing outcomes for some patients. Participating in a trial gives you early access to a drug that may relieve your symptoms or extend your life.

By participating in a trial, you’re also helping scientists find a treatment for your disease. It may take researchers months or even years to recruit the hundreds or thousands of patients needed for a large study. The faster the trial is fully enrolled, the sooner scientists can learn how well the drug works.

Are clinical trials a last resort?

Patients may be eligible to join a trial at any stage of their illness. Some trials seek patients who are newly diagnosed, and others are for people who have already tried other therapies.

Typically, treatments that haven’t been approved are tested first in patients who have exhausted all other options. Once approved, those drugs may then go into another round of trials for patients who are newly diagnosed.

Not all trials involve new drugs. Some test approved drugs in new combinations. Those trials may also limit eligibility based on the disease’s progression.

What are the risks of joining a clinical trial?

All trials come with risks. If a drug has not been approved, researchers may not fully understand its side effects. It’s possible that the treatment could worsen your condition or, in very rare cases, prove fatal.

Testing is usually done in three phases. The first trial is usually the smallest, and its main goal is to make sure the drug is safe. Risks of unexpected side effects may be higher in phase one trials than in phases two or three.

You should ask your doctor to discuss the possible benefits and risks of the study with you to help you decide whether to enroll.

How do I join a clinical trial?

Not every trial may be right for you. Studies have enrollment criteria, which may include your age, what stage your cancer is at and whether you are newly diagnosed or have already taken other treatments.

You don’t have to wait for your doctor to recruit you for a trial. You can ask your oncologist what studies you may be eligible for. If you are being treated at a community hospital, your doctor may need to refer you to an academic hospital that can help you enroll in a trial.

Some foundations that support the fight against certain diseases, like the Leukemia and Lymphoma Society, have specially trained staff to connect patients with an appropriate trial. You can also use online search tools, such as this one from the National Cancer Institute or clinicaltrials.gov.

Will I be given a placebo?

A placebo is a “dummy” treatment that has no effect. It’s unethical to give patients a placebo if they could benefit from further treatment, so placebos are rarely used in cancer trials. If they are, the researcher who is running the study is supposed to explain that to you.

Studies that use placebos typically are comparing a new drug to what’s known as “standard of care,” which is the typical treatment that the patient would get outside of a study. One group of patients receives the standard of care plus a placebo, and another gets the standard of care plus the experimental drug.

If there are no available treatments for a disease or patients have exhausted all options, a study may compare an experimental drug to a placebo to see if it is better than no treatment at all.

Will I be paid to join a trial?

Many trials reimburse patients for expenses like travel and parking. Most do not cover lost earnings or family expenses such as day care. Each trial is different, so talk to the trial coordinator to find out what will be covered. Some foundations may provide financial support to cover costs associated with trials.

The manufacturer always provides the experimental drug for free. You have to pay for any already-approved treatments you may take as part of the study, as well as any related care such as hospital stays, but your health insurance may cover part or all of that cost.

How much time does it take to participate in a trial?

Every trial is different. Some can run for just a few weeks, others can last for years, especially if they are measuring a drug’s impact on survival.

The impact on the patient’s daily life also varies. Some studies may require you to make extra trips to the doctor or undergo additional medical tests, such as a new biopsy.

Some trials are reducing patients’ travel by sending nurses to their homes for checkups and measurements.

What is informed consent?

Informed consent is a process that gives you information about the study you are about to participate in. Before the trial starts, researchers should explain to you what the purpose of the study is, what procedures will take place, the possible benefits and risks, and the number of visits or medical tests required. They should also answer any questions you have about the study.

After you understand what the trial will entail, you’ll be asked to sign an informed consent form before taking part in the study.

Will my privacy be maintained?

As part of the informed consent process, the study coordinators should explain to you what type of information will be gathered about you, who will be able to view it, how it will be shared and how long it will be kept. When the results of the study are published, no personally identifying information, like your name, will be printed.

What if I cannot find a trial that will accept me?

It’s possible that there won’t be a trial with enrollment criteria that match your profile. In that case, keep checking with your doctor, as new trials may start in the months ahead. Also, as your circumstances change, new opportunities may arise. For example, you may not be eligible for a trial when you are first diagnosed, but you may become eligible if your cancer relapses.

Can I quit a clinical trial?

Yes, you can end your participation any time, for any reason.

What happens if the FDA doesn’t approve the drug?

If the FDA rejects the treatment, that means the manufacturer didn’t provide sufficient evidence that the drug is safe and effective. In that case, the manufacturer may stop making the drug, unless it’s approved to treat another condition. Sometimes the FDA requests more information, and the drugmaker may extend the trial or start a new one.

Link: www.propublica.org