NOVAX PHARMA’s Post

The Ukrainian government has removed cannabis from the list of particularly dangerous drugs and instead included it in the list of substances with restricted circulation. The Cabinet of Ministers of Ukraine adopted a resolution on changes to the list of narcotics, psychotropic substances, and precursors. This was reported by the press service of the Ministry of Health of Ukraine on Friday, April 26. The circulation of cannabis in Ukraine will be controlled. The ministry's message does not specify the changes made by the government. However, the draft resolution published on March 27, 2024, states that cannabis, as well as its resin, extracts, and tinctures, have been removed from the list of particularly dangerous drugs. Additionally, some variants of tetrahydrocannabinol (THC), the psychoactive substance in hemp plants, have been removed from the list of substances whose circulation is prohibited in Ukraine. These changes were made to allow the use of cannabis for medical purposes. At the same time, cannabis and its products, as well as THC, have been added to the list of substances whose circulation is restricted within Ukraine. Hemp can only be cultivated for educational, scientific, and technical-scientific purposes, as well as for the production of medicines. Simultaneously, the THC concentration in the dry plants intended for use in medicine manufacturing cannot exceed 0.3%. "As a result of the ongoing aggression of the Russian Federation against Ukraine, the number of patients with chronic pain, military and civilians suffering from PTSD with concomitant anxiety disorders, chronic pain, including central and/or peripheral neuropathic pain, has increased. Therefore, cannabinoid-based medications are of particular relevance to Ukraine for therapeutic purposes, especially when non-pharmacological treatment methods are ineffective," states the explanatory note of the draft resolution. It is recalled that the Verkhovna Rada adopted the law on the legalization of medicinal cannabis in the first reading in July 2023. The law was finally approved in December 2023, but on the same day, the "Homeland" faction blocked its signing. Only on February 15, 2024, did the President of Ukraine, Volodymyr Zelenskyi, sign the law on the legalization of medicinal cannabis. It is set to come into effect in July 2024. https://lnkd.in/dYgafdgW

Early stages of pharmacovigilance in drug development: 1. Preclinical Research and Early Safety Assessment Based on non-human data, pharmacovigilance experts assess potential safety concerns in this initial phase . The following elements are integral to this phase: Pharmacokinetics (PK): Understanding how the drug is absorbed, distributed, metabolised, and excreted (ADME) in preclinical models is key to predicting potential toxicities. Pharmacodynamics (PD): Investigating the drug's effects on the body helps identify therapeutic targets and predict side effects. Key Activities in Preclinical Pharmacovigilance: Safety Pharmacology: Evaluating the drug's effects on vital organ systems (e.g., cardiovascular and respiratory) to detect early signs of toxicity. Toxicology Studies involve animal acute and chronic toxicity tests to determine safe dose ranges and highlight potential risks. Early Signal Detection: Pharmacovigilance experts use predictive models and biomarkers to assess early safety signals that could guide dosing strategies and safety measures in clinical trials. #drugsafety #drugdevelopment #pharmacovigilance #safetypharmacology https://lnkd.in/eSrWjdPw

I have summarized the Daewoong Bio bioplant press article as follows. https://naver.me/xk13jzJw 🏢 Daewoong Bio Expands into Biopharmaceutical CMO Business 🧬 Daewoong Bio is making a significant leap into the biopharmaceutical contract manufacturing (CMO) sector by establishing a cGMP-standard bio plant focused on microbial-based biopharmaceuticals. This strategic move expands their operations from active pharmaceutical ingredients (API) to biopharmaceutical production. 🔬 Key Points: The new bio plant aims to enhance capabilities in microbial-based recombinant biologics. The plant features single-direction flow to prevent cross-contamination and incorporates automated systems for cost efficiency. It includes independent production lines for various formulations, such as liquid vials and sprays. Scheduled for completion in August, the plant seeks major GMP approvals by 2027 and FDA approval by 2028. 🌐 Daewoong Bio plans to transfer existing biopharmaceutical production to the new facility, aiming for KRW 100 billion in global sales of BMP-2 by 2030. With this expansion, they target KRW 1 trillion in sales by 2030. 🚀 “Our efforts to grow from an API manufacturer to a biopharmaceutical company will drive us into the global CMO market,” said Hojin Lee, Head of Bio Plant. #Daewoongbio #Bioplant #MicrobialCMO #Biologics

I was a guest on the "Aravot Luso" program 📺 on Public Television,  together with the director of ArPharMa NGO, where we discussed: 💊 The implementation of the Pharmaceutical Industry Development Program and its related measures. 🧪 The program’s primary goal is the continuous advancement of the pharmaceutical industry and enhancing Armenia’s medicinal self-sufficiency. ✅ The program introduces tools aimed at increasing local pharmaceutical production volumes, expanding and diversifying export markets, raising the share of locally produced medicines in the domestic market, improving the sector’s visibility, and promoting deeper research in the pharmaceutical field. More: https://lnkd.in/eynHTX7P #armenia #pharma #ministryOfEconomy

🧪"Despite the war, Ukraine remains a country with great potential for clinical trials and is confidently restoring its position." ✔What is happening in the field of clinical trials in the third year of the war, how much the full-scale invasion of Russia has affected the clinical trials sector and how the Ukrainian pharmaceutical industry is overcoming these challenges - in the material of Mind. UA 👇. https://lnkd.in/exYkJmPk EBA Clinical Trials Subcommittee, Darnytsia Pharmaceutical Company , Andrii Doroshenko #EBACTS #EBA #clinicaltrials

With the #drug #serialization deadline approaching, it is encouraging to see that the regulator is listening to some of the business proposals. On the regulatory legal acts portal, the document "On amendments to the Decree of the Government of the Republic of #Kazakhstan dated September 10, 2020 No. 568 "On determining the list of goods subject to #labeling" has been posted for discussion. The third paragraph of the note is revised as follows: A mandatory labeling requirement will apply to medicines MANUFACTURED since July 1, 2024, whether they are packaged in dosage form (including transdermal systems) or in retail packaging, with the exception of #medicine and vaccines used for veterinary purposes. Before this change, manufacturers were unclear whether they could import medicines produced before July 1 without marking codes. This resolution will take effect sixty days after it is published, which seems confusing. But business comments will likely prompt the regulator to reduce the timeline for implementing this change. #marketaccess; #serializationofdrugs https://lnkd.in/dzpmMrZ3

MEDICAL CANNABIS: A GROWING INTEREST Medical cannabis has become the No.1 topic of inquiries from Archimed's clients over the past few months. Companies are actively exploring the potential of this new niche and the ways to implement projects for producing medicines based on medical cannabis. The law legalizing medical cannabis is set to take effect by mid-July this year. Yet, there are still more questions than answers. The market is awaiting government regulations on the practical aspects of governing medical cannabis-based drug production. It's already clear that there will be numerous challenges—regulatory, procedural, and cultural. Nick Romanok, CEO, briefly outlines the issues in an article for Forbes. Read more here: https://lnkd.in/dduXt_yx

On the occasion of World Health Day I highlighted the multiple benefits of pharmaceutical innovation. Enjoy the reading of the full article. https://lnkd.in/dzjvzNtN

We were honored to host H.E. Yossi Levi Sfari, the Ambassador of the State of Israel to Bulgaria, and Mr. Parvan Dangov, the Mayor of Dupnitsa, at our Teva plant in Dupnitsa, which proudly celebrates its 70th anniversary this year. During the visit, the Ambassador and Mayor were introduced to the significant economic impact Teva has on Bulgaria, our innovative production practices, and our strong commitment to environmental sustainability. The discussions also touched on the challenges faced by the pharmaceutical industry. Together with Mr. Robert Kuzela, Director of the Dupnitsa plant, and Mr. Nikolay Hadzhidonchev, Executive Director of Teva's sales divisions in Bulgaria and Greece, the visitors explored our new production facility, which represents a USD 42 million investment. This expansion will increase our production capacity and create new jobs, further supporting the local community in Dupnitsa and the surrounding region. It was emphasized the significant contribution of Teva's investments in Dupnitsa, Troyan, and Sofia to Bulgaria's economic development, providing stable employment for nearly 2,000 people. The Dupnitsa plant, equipped with state-of-the-art technology, produces high-quality medicines for over 70 markets worldwide. Teva is positioning Bulgaria as an important part of its corporate production network. We are proud to be at the forefront of these developments, driving innovation, and contributing to Bulgaria's growth and prosperity. #TevaBulgaria #70YearsOfExcellence #IsraelBulgariaRelations #Pharmaceuticals #Innovation #EconomicImpact #CorporateSocialResponsibility #Healthcare

👉 Arterium among the largest taxpayers in the Ukrainian pharmaceutical industry   📎 The ranking of top taxpayers was compiled by the Ukrainian business publication Delo.ua.   📊 The pharmaceutical sector remains an important source of revenue for the state budget. According to the article, in 2023, pharmaceutical companies of Ukraine paid 5 billion UAH in taxes. Arterium contributed 525.7 million UAH in taxes for 2023, and for the first seven months of 2024, it paid 451.7 million UAH, already exceeding the amount of taxes and fees paid during the same period last year.   📌 More details about the ranking and the prospects of Ukrainian drug manufacturers can be found via the link: https://lnkd.in/eFFZa9wN