Russian scientists are working to create a vaccine for hepatitis C

About 3 million Russians suffer from a disease that is considered incurable – hepatitis C.

Despite the fact that over the past few years, the incidence in the country has decreased, about 15 thousand people die from the effects of chronic hepatitis C every year.

The main danger of the disease is in its asymptomatic course.  According to the WHO, only 20% of those infected will find out in time about the diagnosis.

The rest do it until the moment when it is too late to go to the doctor.  A mass vaccination could be the solution to the problem, but there is currently no vaccination.

Therefore, scientists from different countries, including Russia, are working to solve this problem.

Since 2015, a synthetic peptide vaccine against hepatitis C has been developed at the VN Orekhovich Research Institute of Biomedical Chemistry. It is based on artificially created peptide constructs that contain parts of the E2 protein of the hepatitis C virus. This protein is unique in that its antibodies are not detected in  all patients, that is, the immune system for some reason does not recognize it.

In experiments on laboratory animals, these peptide fragments worked perfectly.

They forced the body of mice and rats to produce antibodies capable of binding viral envelope proteins.  That is, the rodent immune system is activated.

Moreover, the scientists thus obtained antibodies were tested on the hepatitis C virus, extracted from the blood plasma of five sick people.  They were also effective against “human” viral particles.

The authors say that if they succeed in choosing the right adjuvant — a complex of substances that boosts the immune response, the antigen dose, route and route of administration — then the resulting drug will be effective precisely against those types of hepatitis C that are common in Russia.

Link: gmpnews.ru

The second stage of clinical trials of a drug for the treatment of systemic lupus erythematosus has begun in China

Chinese scientists have begun the second phase of clinical trials of the drug for the treatment of an autoimmune disease – systemic lupus erythematous.

The new patent-protected drug SM934, which is a water-soluble artemisinin derivative, was developed by researchers at the Shanghai Institute of Pharmacology at the Academy of Sciences of China ANC.

The first stage of clinical trials of a new drug has already been completed, and the second stage began in one of the Shanghai hospitals.

Systemic lupus erythematous, one of the most common types of lupus erythematous, is an autoimmune disease in which the human immune system mistakenly attacks healthy tissues of the body, causing damage to the joints, skin, kidneys, blood cells, brain, heart and lungs.

One of the hallmarks of lupus is a rash on the face, resembling butterfly wings in outline.
In China, nearly one million people are reported to have lupus erythematous.

Since the causes of the origin and development of the disease remain unclear, the development of new drugs for this disease causes difficulties.

According to the ANC, the drug SM934 is an oral drug with a low dosage and a pronounced effect.  It can modulate autoimmune reactions and restore the body’s immune balance.

Link: gmpnews.ru

Sanofi gets rights to Tamiflu in the US market

The French group Sanofi has signed an agreement with Roche on the transfer of rights to the antiviral drug Tamiflu (oseltamivir) in the United States.

Sanofi will receive exclusive rights to Tamiflu over-the-counter in the United States.  This drug is intended for the prevention and treatment of influenza.

Alan Main, executive vice president of consumer healthcare at Sanofi, said that this is a strategic and important deal for the company, as the company seeks to bring innovations to the market on an ongoing basis.

Link: gmpnews.ru

Trastuzumab and bevacizumab biosimilars enter the US market

For a long time, Roche’s three drugs, Rituxan, Herceptin and Avastin, dominated the global market.

However, on July 18, their competitors appeared – Amgen and Allergan introduced the biosimilars of Herceptin preparations for the treatment of HER2-positive breast cancer and Avastin for the treatment of colorectal cancer to the USA, which threatened the total sales volume of two originators produced in 2018.

Mvasi, Avastin’s biosimilar from Amgen, became the first biosimilar of the drug, which was approved by the FDA at the end of 2017. The American regulator approved Kanjinti, Herceptin’s biosimilar, in June of this year.

These biosimilars will enter the market at a wholesale price that is 15% lower than the price of
reference biotech drugs.

For Amgen and Allergan, the departure from Roche’s “settlement” will help get more dividends in terms of sales, while for other competitors the outlook may be bleak.

Rituxan, whose sales in the US in 2018 amounted to $4.24 billion, could be hit by the following biosimilars.

Link: pharmvestnik.ru

FDA Approved Bayer Gadavist Contrast Agent Contrast Agent

Bayer Gadavist (gadobutrol) is the first and only contrast agent for use in cardiac magnetic resonance imaging (CMRT) in adult patients with diagnosed or suspected coronary heart disease (CHD) and has been approved by the FDA.

This decision is based on the data of two prospective multicenter open phase non-randomized blind clinical trials of the third phase, where diagnostic results of MRTT were studied using gadobutrol to assess significant coronary artery disease.

CMRT is a medical imaging technology for non-invasive evaluation of the function and structure of the cardiovascular system.  Daniel Berman, Head of the Cardiac Imaging and Nuclear Cardiology Department of the Heart Institute of the Cedars-Sinai Medical Center, said that approval of the Gadavist contrast agent is an important step in creating a validated non-invasive method for assessing the condition of patients with the most common form of heart disease in the world.

This method is derived from MRI and uses the same basic principles as MRI, but is optimized for use in the diagnosis of diseases of the cardiovascular system.

A historic mutual recognition agreement between FDA and EMA was signed

The FDA and EMA have confirmed the inclusion of Slovakia in the mutual recognition agreement. The activities of this country’s GMP inspectorate received a positive assessment.

The authorities announced this on Friday, July 12, before the deadline (July 15), which was set aside for all parties to sign the contract.

Now, the FDA has recognized the results of GMP inspections conducted by the inspectorates of all 28 EU member states.

The EMA, in turn, agreed with the FDA that the results of inspections carried out by inspectors from the United States would not require repeated inspections from the European regulator.

The process of mutual recognition of the results of GMP inspections has been developing since 1998, after the EU and the USA signed the mutual recognition agreement, which included a “pharmaceutical application”, according to which it was possible to rely, to a limited extent, on the results of inspections conducted by EU and US regulators, respectively.

Link: pharmvestnik.ru

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