News Digest 11.08.2023 - 14.08.2023
Market news
The Ministry of Industry and Trade is going to present a plan for the implementation of the Pharma-2030 strategy at Biotechmed in October, follows from the conference program.
The strategy itself, we recall, was approved by the government in June (it took five years to coordinate and adjust it). The document contains key targets, main directions, threats and challenges for the industry. And what is proposed to be done to achieve these indicators should be contained precisely in the plan for implementing the strategy. The Ministry of Industry and Trade must submit it to the government by December.
The session was called "Strategy of our tomorrow". The Ministry of Industry and Trade has already presented the strategy itself at Biotechmed in 2021. It was never agreed upon, and after February 2022, it was reworked for another year.
Source: https://biotechmedconf.ru/wp-content/uploads/pdf/2023/btm-2023-schedule.pdf
DPR will present prostheses of its production
The DPR will present its capabilities for the production of prostheses at the Army forum, Inga Yapparova, chairman of the board of the Donbass Development Corporation, told RIA Novosti.
"The Development Corporation is engaged not only in attracting investors, but also in promoting the products of the DPR outside its borders. So we will help our colleagues in the sale of their products, therefore, at the Army ... we plan to present the products of our large plant, which will open - the Center for Prosthetics, which is under construction in Donetsk," Yapparova said.
According to her, the center is already operating, but this year there are plans to launch a whole plant on its basis. Accordingly, now the DPR is interested in finding customers for its products.
“We are presenting real samples that will be produced there. They are already being produced, we are just reaching the volume. We will show what we are already doing, what we can do. production facilities - ed.) Production is aimed at a fairly large volume of output, so these products will be used not only by our rehabilitation center, but also by other centers on the territory and beyond," Yapparova explained.
Source: https://ria.ru/20230810/protezy-1889188693.html
PacBio announces acquisition of Apton Biosystems
Biotechnology company Pacific Biosciences of California, Inc. (PacBio) announced that it has entered into a transaction to acquire Apton Biosystems, Inc. is a company that develops a high-performance sequencer using the latest advances in chemistry, optics and image processing. PacBio intends to integrate its Sequencing by Binding (SBB) technology into this tool to jointly create a dedicated, high-throughput, short-read sequencer. (PacBio representatives spoke about their plans related to SBB technology in January 2023 at the 41st J.P. Morgan Healthcare conference. See also Vladimir Zubov's speech at DNA Day 2022).
The agreement provides for an upfront payment of approximately $85 million in an all-share deal involving approximately 6.3 million PacBio shares, plus an additional $25 million to be paid upon reaching a certain level of revenue from sales of the new sequencer.
Source: https://pcr.news/korotko/pacbio-obyavila-o-zaklyuchenii-sdelki-po-priobreteniyu-apton-biosystems/
Other
Supplier of medical equipment accused of bribing the head of the Ulyanovsk Ministry of Health
The prosecutor's office of the Ulyanovsk region sent to court a criminal case on the case of giving a bribe to the head of the Ulyanovsk Ministry of Health. We are talking about the amount of 2 million rubles, which a local entrepreneur tried to give the minister to buy expensive medical equipment. The entrepreneur faces up to 15 years in prison.
According to the prosecutor's office, the entrepreneur is a co-founder of several commercial organizations. He intended to pay a bribe of 2 million rubles. head of the regional ministry of health. In response, the ministry had to purchase expensive medical equipment from a company controlled by the supplier.
However, the head of the Ministry of Health informed law enforcement officers about this. On July 1, 2022, he handed over the money received from the entrepreneur to law enforcement agencies. Now the supplier faces imprisonment for a term of 8 to 15 years. The name of the accused and the head of the Ministry of Health are not known. At that time, the department was headed by Alexander Gashkov.
News of monitoring the effectiveness and safety of medical devices, carried out by specialists of the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor
Monitoring of foreign regulatory authorities
An adverse event regarding an intravascular stent was reported on the official FDA website. The device may be manufactured with the wrong length of the inner stent and may not be suitable for its intended use. The manufacturer makes a voluntary recall from the circulation of a medical product.
FDA - US Food and Drug Administration
Olympus has discovered that their medical device may fail and result in the loss of functionality of a product component. There is no health check for this component that users can perform, so there is a risk to patient health (eg transmission of infection). A request has been sent to the manufacturer Health Canada - Canadian government department responsible for national health policy.
Monitoring of adverse events on the territory of the Russian Federation
The automated information system of Roszdravnadzor received a message about an adverse event that reported a fatal outcome when using a medical device - heart valve prostheses. The manufacturer is conducting an internal investigation.
Specialists of the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor, on their own initiative, prepared an expert opinion with a recommendation to Roszdravnadzor to suspend the use of a medical device - an intravenous cannula, during which a threat of harm to the life and health of the patient was revealed.
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