Press review

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EU will fight falsified drug imports, says Polish press

WARSAW, 19 June (APM) - According to the Fiscal Administration Chamber in Warsaw, rat poison, floor wax, cement and plaster and other poisonous and life-threatening substances can be found in falsified drugs which are being imported into Europe and then sold online, at bazaars and in markets, reported Dziennik Gazeta Prawna (pB6) on Tuesday.
The most commonly falsified drugs are steroids, psychotropics, antibiotics, analgesics, cardiology, antiepileptic and erectile dysfunction drugs.
During the 'Pangea' operation in March, Interpol intercepted 37,000 falsified medical products, such as protective masks, Covid-19 tests and disinfectants.
A total of 121 arrests were made, 37 crime organisations were disbanded, 4.4 million potentially harmful drugs of an aggregate value of €13 million were seized and 2,500 websites selling products advertised as helping with Covid-19 were closed. The European Anti-Fraud Office has announced it is working on imports of falsified products for combating Covid-19

Polish SMA patients need access to innovative gene drugs

Nusinersen is currently the only drug used for combating spinal muscular atrophy (SMA) which is reimbursed in Poland and patient societies and the Stop SMA foundation are urging the Ministry of Health (MoH) to add an innovative gene drug, Zolgensma (onasemnogene abeparvovec), to the reimbursement list and conduct SMA screening tests for every Polish infant, which would allow for the early detection and effective therapy of child patients before they experience the first symptoms, reports Gazeta Wyborcza (p20-21) on Friday.

Poland working on online direct import procedure

The Covid-19 pandemic has resulted in the MoH working on a Direct Drug Import Procedure Management System (SOID) which will enable direct drug imports, as well as drug registrations, which are currently only submitted and processed in writing, to be processed reported Rzeczpospolita (pA11) on Tuesday and Dziennik Gazeta Prawna (pB11) on Wednesday.

EU drug producers need to become independent of Asian API producers

The recent drug crisis caused by the global pandemic and temporary closures of Asian API producers proved that Poland and the whole of the European Union need to develop a new pharmaceutical strategy to ensure patient safety, reported Rzeczpospolita (pA14) on Monday.
According to experts, 90% of APIs used in European drugs are imported from Asia. Apart from the threat of breaking the supply chains, the quality of the imported APIs may not always be appropriate.
Therefore, the European Commission is preparing a pharmaceutical strategy to make the EU independent of imported drugs, to move drug production to the EU and manage drug prices so the costs of the proposed changes are not passed on to patients. This new strategy is expected by the end of the year.

Biomed cannot start Covid-19 immunoglobulin drug production

In late May, Biomed Lublin, a Polish tuberculosis (BCG) vaccine producer, announced the start of development of an anti-Sars-CoV-2 immunoglobulin drug based on the plasma of Covid-19 survivors but four weeks later, it cannot start production due to plasma collection procedure, reported Parkiet Gazeta Gieldy (p4) on Monday, (p1, p4) on Wednesday and (p4) on Friday.
The cooperation between Biomed Lublin and Independent Public Clinical Hospital No. 1 in Lublin financed by the Polish Medical Research Agency (ABM) gave hope of producing a first working Covid-19 drug in accordance with the guidelines of the World Health Organization (WHO).
Nevertheless, the collection procedure deactivates the plasma from Covid-19 survivors, so it cannot be used for Biomed's production. Despite the company's confusion, neither the MoH, which supervises the Regional Blood Centres (RCKiK) nor the ABM nor Independent Public Clinical Hospital No. 1 in Lublin are commenting on the situation and a possible change in the collection procedures.
According to unofficial information, a decision has been made to change the plasma collection procedure and Biomed should receive its first supply by the end of July, adds the newspaper on Friday.

EU countries placing their first orders for Covid-19 vaccines

Both Moderna and Johnson & Johnson have announced the start of the final phase of clinical trials for their Covid-19 vaccine-candidates for this July, while a vaccine researched by scientists from Oxford University and AstraZeneca will enter clinical trials this month..
In addition, the European Commission has announced a vaccine strategy which will help develop and distribute safe and working Covid-19 vaccines to EU member states within 12-18 months, reported Rzeczpospolita (pL2) from Bloomberg's news and (pA6) on Thursday and Gazeta Wyborcza (p11) on Tuesday.
Moderna will test its vaccine-candidate called mRNA-1273, which was tested in the previous phase on 600 patients, in cooperation with the U.S. National Institute of Allergy and Infectious Diseases, on 30,000 U.S. patients to study the prevention of the development of the disease and the prevention of severe complications caused by the virus. Meanwhile, in China, the employees of some of the large state-owned enterprises are being offered one of two vaccines which are still in the development stage, reported Rzeczpospolita.
AstraZeneca's vaccine candidate, which is being tested in 20,000 UK volunteers, is based on a model of a Sars-CoV-1 vaccine-candidate which was being researched during the 2002-2004 epidemic in Asia.
It has already been proved safe for patients. AstraZeneca has already started producing and forming supply chains for the vaccine, even before it has been proved effective against Sars-CoV-2.
It claims to be capable of producing two billion vaccine shots, which, if the trial results are negative, will go to waste. AstraZeneca says saving even one day from the pandemic is worth the financial risk.
At the weekend, Germany, the Netherlands, France and Italy signed an aggregate contract for 300 to 400 million doses. The European Commission is simultaneously working on another contract which would cover the needs of the whole of the EU population, reported Gazeta Wyborcza.
Some 135 different vaccine-candidates are currently being researched around the world. This Wednesday, the EU Commission announced its vaccine strategy to deliver safe and working Covid-19 vaccines to EU member states within 18 months from today. It will be financed by a dedicated budget of €2.7 billion in the form of an advance payment as an incentive for companies to research and develop vaccines for the virus within the EU, added Rzeczpospolita on Thursday.

Mabion to issue shares to accelerate development of its rituximab biosimilar

Mabion, the producer of MabionCD20, a rituximab biosimilar, will issue shares for up to 1.9 million zlotys (€420,000) to help accelerate the development and the central registration procedure for the commercial production of its drug, reported Parkiet Gazeta Gieldy (p4) on Wednesday.

Ryvu will invest in growth and R&D operations

Ryvu Therapeutics has announced its 2020-22 strategy, according to which the company will develop its SEL120 flagship project, have three other projects in clinical trials, two of which are planned to reach the Phase II, reported Parkiet Gazeta Gieldy (p4) on Wednesday.
The company's main focus will be SEL120, which is currently in Phase Ib at six U.S. clinics to test the molecule's safety profile, the recommended dosage for further phases of clinical trials and the preliminary levels of effectiveness against acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). Ryvu plans to publish the initial results of Phase I in the first half of 2021 and complete results in the second half of 2021, after which SEL120 is expected to enter phase 2.
The company will start Phase I in cases of solid cancers, such as breast cancer, in 2021. Ryvu plans to acquire 150 million zlotys (€34 million) for the project by issuing shares. The remainder of the financing will come from grants and $12 million from saved assets.
Furthermore, Ryvu will support its partner company, Menarini, with the development of the SEL24/MEN1703 molecule, which is planned to complete Phase II in 2022. It will also develop new molecules in pre-clinical stages. Ryvu will invest 220 million zlotys (€5 million) in cancer treatment research and development up to the end of 2021.

U.S. developing new drug for Covid-19 based on the antibodies of virus survivors

According to Science Magazine, the scientists from The Scripps Research Institute (TSRI) in California have discovered antibodies ensuring strong and long-term protection against Sars-CoV-2, and which can be used in a vaccine-type drug for Covid-19 patients in the early stages of infection or as a prevention antibody therapy for people with an increased risk of infection, such as elderly patients, patients suffering from autoimmune diseases and healthcare workers, reported Rzeczpospolita (pA8) on Wednesday.
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