Latest news with #EU-approved
Daily Record
a day ago
- General
- Daily Record
Massive turnout as Navy's last Falklands warship departs dock for the final time
The Type 82 destroyer was launched in 1969 and was the only one of its kind to be built - and now it is being towed to an EU-approved scrapyard in Turkey after being decommissioned A massive crowd flocked to Portsmouth Harbour this week to bid an emotional farewell to the last Royal Navy ship from the Falklands War. Veterans and the public gathered to see off HMS Bristol as it was towed away on Wednesday, nearly five years after being decommissioned. The Type 82 destroyer is headed for an EU-approved scrapyard in Turkey, where its parts will be recycled by the Defence Recycling & Disposals Team. Chris Howe, from the South Atlantic Medal Association 1982, said: "As HMS Bristol embarks on its final voyage to the scrapyard in Turkey, we pause to reflect on its remarkable and unique legacy". "For many veterans, Bristol was more than a vessel - it was a home, a place of camaraderie, and a symbol of resilience. Its departure marks the end of an era, but its contributions to our history and the memories of those who served aboard will endure. "We honour all who sailed in her and bid HMS Bristol a respectful farewell." First commissioned in March 1973, HMS Bristol initially was designed to escort an aircraft carrier that was never built, making it the only warship of its class to enter service. During the Falklands conflict, it led a group of ships to provide reinforcements before joining the carrier battle task group as an air defence destroyer, reports the Express. Following the conflict, the Bristol briefly served as the flagship of the Royal Naval fleet in the region. In 1987, it was converted into a training ship, but an explosion in its boiler led to its repurposing as a harbour training vessel. The ship was eventually decommissioned in October 2020 after 48 years of service. Alistair Hughes, the head of DRDT, outlined the process to Force News: "Recycling of ships at the end of their hull life is routine business for the Royal Navy. "Our aim is to achieve maximum value for money for defence in an environmentally compliant manner - HMS Bristol is a fitting example of this after her many dedicated years of service."
Associated Press
20-03-2025
- Business
- Associated Press
Aspire Biopharma Holdings, Inc., Contract Manufacturer, Glatt Air Techniques, Inc., has Completed Its First Good Manufacturing Practice ('GMP') Clinical Batch of Pharmaceutical Grade Oral Mucosal Fast Acting Formulation of Aspirin
Subsequent phase involves completion of chemistry, manufacturing, and controls (CMC) testing for data to support FDA submission Company expects to commence bioavailability study in April 2025 Aspire intends to request 'fast track' approval on FDA application for its high dose aspirin product HUMACAO, PR AND NEW YORK, NY / ACCESS Newswire / March 20, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ('Aspire' or the 'Company'), a developer of a multi-faceted patent pending drug delivery technology, today announced that it its contract manufacturer, Glatt Air Techniques, Inc., part of Glatt Group, a vertically integrated pharmaceutical services company with FDA- and EU-approved sites, has completed its first Good Manufacturing Practice ('GMP') Clinical Batch of its pharmaceutical-grade oral mucosal formulation of aspirin that utilizes Aspire's fast-acting formulation. Aspire's GMP extracts are set to be administered in a bioavailability study in healthy human volunteers in April 2025. Aspire's lead product candidate, high-dose sublingual aspirin, is a granular or powder formulation of a soluble, Ph neutral, fast-acting aspirin designed to address cardiology emergencies and pain management. Aspire believes the benefits of 'rapid absorption' aspirin include the potential to quickly address cardiac incidents; allow high dose absorption for pain management including fast headache relief, post-surgery, cancer pain management, and general pain relief. The benefits of 'rapid absorption' are to provide nearly instant treatment impact and high dose absorption. The Company's patent pending delivery system includes components specifically formulated to allow rapid sublingual absorption of drugs into the blood stream, thus by-passing the gastrointestinal tract, and potentially provide an improved treatment outcome. 'This marks another important milestone for Aspire,' commented Kraig Higginson, Chief Executive Officer of Aspire. 'We have been collaborating with Glatt Air Techniques since 2021 with the ultimate goal of building a high-quality, cost-effective manufacturing solution for our lead product candidate, high-dose sublingual aspirin. This cooperation enables Aspire to advance our key programs, centered around our patent pending technology, so that we can facilitate delivery of high-quality, safe, and effective therapeutics to individuals seeking relief from pain or when the need arises in cardiology emergencies.' Glatt Air Techniques has conducted testing and manufacturing of Aspire's GMP Clinical Batch of its oral mucosal fast acting formulation of aspirin under both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ('PIC/S GMP') and the United States Food and Drug Administration's Current Good Manufacturing Practice regulations. Following release of the GMP Clinical Batch by Glatt Air Techniques, Aspire intends to initiate the preparation of Chemistry, Manufacturing, and Controls ('CMC') information and conduct clinical trials supporting its planned FDA submission. Aspirin Product Development and Clinical Trials Key Potential Features of the Aspire Platform About Aspire Biopharma, Inc. Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology through a Novel Soluble Formulation which addresses emergencies, drug efficacy, dosage management, and response time. For more information, please visit Safe Harbor Statement Certain statements made in this communication are 'forward-looking statements' within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of words such as 'estimate,' 'projects,' 'expects,' 'anticipates,' 'forecasts,' 'plans,' 'intends,' 'believes,' 'seeks,' 'may,' 'will,' 'would,' 'should,' 'future,' 'propose,' 'potential,' 'target,' 'goal,' 'objective,' 'outlook' and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the financial position, business strategy and the plans and objectives of management for future operations. These statements are based on various assumptions, whether or not identified in this communication, and on the current expectations of Aspire's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the parties, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. Aspire Biopharma Holdings, Inc. Contact TraDigital IR
Euronews
12-03-2025
- Health
- Euronews
Which critical medicines are in short supply in the European Union?
The drug shortages are the result of manufacturing problems, increased demand, and other issues. ADVERTISEMENT The European Union is in short supply of 16 medicines that are considered 'critical' for people's health. A drug can be put on the EU's shortages list because of production issues, a surge in demand, or a drugmaker deciding to pull it off the market – anything that limits the bloc's supply on either a temporary or permanent basis. There are ongoing shortages of 34 medicines, according to the European Medicines Agency (EMA). Sixteen of those are on the EU's list of essential drugs that the European Commission aims to bolster through its new Critical Medicines Act. Here are the critical medicines in short supply in the EU, according to the latest available information from the EMA and member states. Cyanide poisoning antidote Cyanokit is the only EU-approved medicine to treat cyanide poisoning. It contains the active ingredient hydroxocobalamin or vitamin B12a, which is on the EU's critical medicines list. In December 2024, health authorities said Cyanokit manufacturing was being suspended after the drugmaker discovered that some batches may have been contaminated. However, because the risk of contamination is low and there is no alternative antidote, they are still in circulation, according to the EMA. The shortage is expected to be resolved by May 2025. Amoxicillin Amoxicillin is an antibiotic for bacterial infections. Shortages began in October 2022 after an uptick in respiratory illnesses led to higher demand for antibiotics. Related Big pharma urges Commission to slow down on new critical medicines rules Manufacturers also lacked enough staff to make the medicine, the EMA said. These issues have since eased in most countries, but some intermittent supply problems persist across Europe. Some inhalers People with asthma, chronic obstructive pulmonary disease (COPD), and other breathing issues take salbutamol, typically using an inhaler or a nebuliser. Manufacturers are struggling to meet the growing demand for inhalers, leading to intermittent shortages of salbutamol across most of the EU. Alternatives are available, but the scarcity is expected to last until at least mid-2025. A few types of insulin Patients with type 1 or 2 diabetes take insulin to control their blood sugar. Manufacturing problems for certain types of insulin – Insuman Rapid, Basal and Comb 25 – in early 2023, caused delays across the supply chain. The drugmaker also decided to stop producing these types of insulin, prompting the EMA to urge doctors to transition their patients to other brands. Seven cancer drugs The EU does not have enough of seven drugs used to treat various types of cancers, including hycamtin, methotrexate, fludarabine, fluorouracil, cisplatin, fasturtec, and paclitaxel. The shortages are mainly due to manufacturing problems, though unexpected demand for methotrexate injections – which can also help treat inflammatory conditions like rheumatoid arthritis, psoriasis, and Crohn's disease – has exacerbated their scarcity in some European countries. Shortages are beginning to be resolved for several of these medications, and in the meantime, alternative options are available for some of them. ADVERTISEMENT Vaccine for mosquito-borne virus Ixiaro is a vaccine for Japanese encephalitis, which is related to the dengue, yellow fever, and West Nile viruses and causes brain inflammation. Increased demand and manufacturing problems caused a shortage of the vaccine, though supply levels have since improved. The EMA expected the shortage, which has affected Ireland, Italy, Poland, Portugal, and Spain, to be resolved by late January, but Irish authorities now say it should be back in stock there by the end of April 2025. Blood disease medicine Peginterferon alfa-2a, sold as Pegasys, is used to treat chronic hepatitis B and C as well as other blood diseases. Unexpectedly high demand for the medicine has led to shortages that the EMA said should be resolved later in 2025. ADVERTISEMENT Schizophrenia treatment Zypadhera, also known as olanzapine, helps treat schizophrenia. Patients who have taken the drug by mouth can then start taking it via injection – but the needles are in short supply due to manufacturing issues, leading to intermittent shortages of Zypadhera in some European countries. Limited quantities are now available in places like Belgium. Heart attack prevention drug Integrilin can help prevent heart attacks for adults with severe chest pain and those who have already had a certain type of heart attack. Supply issues with the active ingredient, eptifibatide, prompted drugmaker GlaxoSmithKline to stop manufacturing the medicine and pull it off the EU market. However, alternatives are available. ADVERTISEMENT Eye problems medicine Verteporfin, sold as Visudyne, is a treatment for people with certain eye problems, for example a type of age-related macular degeneration. Manufacturing has been limited since May 2020, leaving the medicine in short supply, though other treatments are available. Limited quantities are now available in places like Austria, with a restock there expected by the end of 2025.
Euronews
11-03-2025
- Health
- Euronews
More than 200 influencers illegally promoted nicotine products in France, report finds
The drug shortages are the result of manufacturing problems, increased demand, and other issues. ADVERTISEMENT The European Union is in short supply of 16 medicines that are considered 'critical' for people's health. A drug can be put on the EU's shortages list because of production issues, a surge in demand, or a drugmaker deciding to pull it off the market – anything that limits the bloc's supply on either a temporary or permanent basis. There are ongoing shortages of 34 medicines, according to the European Medicines Agency (EMA). Sixteen of those are on the EU's list of essential drugs that the European Commission aims to bolster through its new Critical Medicines Act. Here are the critical medicines in short supply in the EU, according to the latest available information from the EMA and member states. Cyanide poisoning antidote Cyanokit is the only EU-approved medicine to treat cyanide poisoning. It contains the active ingredient hydroxocobalamin or vitamin B12a, which is on the EU's critical medicines list. In December 2024, health authorities said Cyanokit manufacturing was being suspended after the drugmaker discovered that some batches may have been contaminated. However, because the risk of contamination is low and there is no alternative antidote, they are still in circulation, according to the EMA. The shortage is expected to be resolved by May 2025. Amoxicillin Amoxicillin is an antibiotic for bacterial infections. Shortages began in October 2022 after an uptick in respiratory illnesses led to higher demand for antibiotics. Related Big pharma urges Commission to slow down on new critical medicines rules Manufacturers also lacked enough staff to make the medicine, the EMA said. These issues have since eased in most countries, but some intermittent supply problems persist across Europe. Some inhalers People with asthma, chronic obstructive pulmonary disease (COPD), and other breathing issues take salbutamol, typically using an inhaler or a nebuliser. Manufacturers are struggling to meet the growing demand for inhalers, leading to intermittent shortages of salbutamol across most of the EU. Alternatives are available, but the scarcity is expected to last until at least mid-2025. A few types of insulin Patients with type 1 or 2 diabetes take insulin to control their blood sugar. Manufacturing problems for certain types of insulin – Insuman Rapid, Basal and Comb 25 – in early 2023, caused delays across the supply chain. The drugmaker also decided to stop producing these types of insulin, prompting the EMA to urge doctors to transition their patients to other brands. Seven cancer drugs The EU does not have enough of seven drugs used to treat various types of cancers, including hycamtin, methotrexate, fludarabine, fluorouracil, cisplatin, fasturtec, and paclitaxel. The shortages are mainly due to manufacturing problems, though unexpected demand for methotrexate injections – which can also help treat inflammatory conditions like rheumatoid arthritis, psoriasis, and Crohn's disease – has exacerbated their scarcity in some European countries. Shortages are beginning to be resolved for several of these medications, and in the meantime, alternative options are available for some of them. ADVERTISEMENT Vaccine for mosquito-borne virus Ixiaro is a vaccine for Japanese encephalitis, which is related to the dengue, yellow fever, and West Nile viruses and causes brain inflammation. Increased demand and manufacturing problems caused a shortage of the vaccine, though supply levels have since improved. The EMA expected the shortage, which has affected Ireland, Italy, Poland, Portugal, and Spain, to be resolved by late January, but Irish authorities now say it should be back in stock there by the end of April 2025. Blood disease medicine Peginterferon alfa-2a, sold as Pegasys, is used to treat chronic hepatitis B and C as well as other blood diseases. Unexpectedly high demand for the medicine has led to shortages that the EMA said should be resolved later in 2025. ADVERTISEMENT Schizophrenia treatment Zypadhera, also known as olanzapine, helps treat schizophrenia. Patients who have taken the drug by mouth can then start taking it via injection – but the needles are in short supply due to manufacturing issues, leading to intermittent shortages of Zypadhera in some European countries. Limited quantities are now available in places like Belgium. Heart attack prevention drug Integrilin can help prevent heart attacks for adults with severe chest pain and those who have already had a certain type of heart attack. Supply issues with the active ingredient, eptifibatide, prompted drugmaker GlaxoSmithKline to stop manufacturing the medicine and pull it off the EU market. However, alternatives are available. ADVERTISEMENT Eye problems medicine Verteporfin, sold as Visudyne, is a treatment for people with certain eye problems, for example a type of age-related macular degeneration. Manufacturing has been limited since May 2020, leaving the medicine in short supply, though other treatments are available. Limited quantities are now available in places like Austria, with a restock there expected by the end of 2025.
Euronews
11-03-2025
- Health
- Euronews
Which critical medicines are in short supply in the EU?
The drug shortages are the result of manufacturing problems, increased demand, and other issues. ADVERTISEMENT The European Union is in short supply of 16 medicines that are considered 'critical' for people's health. A drug can be put on the EU's shortages list because of production issues, a surge in demand, or a drugmaker deciding to pull it off the market – anything that limits the bloc's supply on either a temporary or permanent basis. There are ongoing shortages of 34 medicines, according to the European Medicines Agency (EMA). Sixteen of those are on the EU's list of essential drugs that the European Commission aims to bolster through its new Critical Medicines Act. Here are the critical medicines in short supply in the EU, according to the latest available information from the EMA and member states. Cyanide poisoning antidote Cyanokit is the only EU-approved medicine to treat cyanide poisoning. It contains the active ingredient hydroxocobalamin or vitamin B12a, which is on the EU's critical medicines list. In December 2024, health authorities said Cyanokit manufacturing was being suspended after the drugmaker discovered that some batches may have been contaminated. However, because the risk of contamination is low and there is no alternative antidote, they are still in circulation, according to the EMA. The shortage is expected to be resolved by May 2025. Amoxicillin Amoxicillin is an antibiotic for bacterial infections. Shortages began in October 2022 after an uptick in respiratory illnesses led to higher demand for antibiotics. Related Big pharma urges Commission to slow down on new critical medicines rules Manufacturers also lacked enough staff to make the medicine, the EMA said. These issues have since eased in most countries, but some intermittent supply problems persist across Europe. Some inhalers People with asthma, chronic obstructive pulmonary disease (COPD), and other breathing issues take salbutamol, typically using an inhaler or a nebuliser. Manufacturers are struggling to meet the growing demand for inhalers, leading to intermittent shortages of salbutamol across most of the EU. Alternatives are available, but the scarcity is expected to last until at least mid-2025. A few types of insulin Patients with type 1 or 2 diabetes take insulin to control their blood sugar. Manufacturing problems for certain types of insulin – Insuman Rapid, Basal and Comb 25 – in early 2023, caused delays across the supply chain. The drugmaker also decided to stop producing these types of insulin, prompting the EMA to urge doctors to transition their patients to other brands. Seven cancer drugs The EU does not have enough of seven drugs used to treat various types of cancers, including hycamtin, methotrexate, fludarabine, fluorouracil, cisplatin, fasturtec, and paclitaxel. The shortages are mainly due to manufacturing problems, though unexpected demand for methotrexate injections – which can also help treat inflammatory conditions like rheumatoid arthritis, psoriasis, and Crohn's disease – has exacerbated their scarcity in some European countries. Shortages are beginning to be resolved for several of these medications, and in the meantime, alternative options are available for some of them. ADVERTISEMENT Vaccine for mosquito-borne virus Ixiaro is a vaccine for Japanese encephalitis, which is related to the dengue, yellow fever, and West Nile viruses and causes brain inflammation. Increased demand and manufacturing problems caused a shortage of the vaccine, though supply levels have since improved. The EMA expected the shortage, which has affected Ireland, Italy, Poland, Portugal, and Spain, to be resolved by late January, but Irish authorities now say it should be back in stock there by the end of April 2025. Blood disease medicine Peginterferon alfa-2a, sold as Pegasys, is used to treat chronic hepatitis B and C as well as other blood diseases. Unexpectedly high demand for the medicine has led to shortages that the EMA said should be resolved later in 2025. ADVERTISEMENT Schizophrenia treatment Zypadhera, also known as olanzapine, helps treat schizophrenia. Patients who have taken the drug by mouth can then start taking it via injection – but the needles are in short supply due to manufacturing issues, leading to intermittent shortages of Zypadhera in some European countries. Limited quantities are now available in places like Belgium. Heart attack prevention drug Integrilin can help prevent heart attacks for adults with severe chest pain and those who have already had a certain type of heart attack. Supply issues with the active ingredient, eptifibatide, prompted drugmaker GlaxoSmithKline to stop manufacturing the medicine and pull it off the EU market. However, alternatives are available. ADVERTISEMENT Eye problems medicine Verteporfin, sold as Visudyne, is a treatment for people with certain eye problems, for example a type of age-related macular degeneration. Manufacturing has been limited since May 2020, leaving the medicine in short supply, though other treatments are available. Limited quantities are now available in places like Austria, with a restock there expected by the end of 2025.
