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Aspire Pharma Limited, a leading UK provider of niche generic and branded medicines, on Monday, announced that it has successfully acquired Cenoté Pharma as part of the company's ongoing strategy to supplement its organic growth through acquisitions and strategic partnerships. Cenoté Pharma is a UK-based pharmaceutical company that specialises in addressing carnitine deficiencies. Carnitine is an amino acid derivative whose insufficiency can impair the metabolism of essential tissues, such as those of the liver, heart and muscles. While the exact prevalence of systemic primary carnitine deficiency (SPCD) remains uncertain and varies depending on ethnicity, the estimated prevalence is 1 in 20,000 to 1 in 70,000 newborns in Europe and the USA, as stated by Aspire Pharma in its press release. Aspire CEO Richard Condon expressed enthusiasm about the addition of a new therapy area into the company's portfolio. "This acquisition underscores our commitment to advancing the science and treatment options for vulnerable patient groups," he said.

An international specialty pharmaceutical group, Essential Pharma has announced the completion of two transactions with fellow UK-based Rosemont Pharmaceuticals. The company completed the divestment of its oral liquid portfolio to Rosemont, and acquired a series of attractive, niche products with "geographic expansion potential." Commenting on the announcement, Essential Pharma chief executive Steen Vangsgaard said: "The Rosemont products bring additional niche products into our portfolio with international expansion potential. "The divestiture of our UK oral liquid products streamlines our portfolio, allowing us to focus and accelerate our strategic growth ambition of building a leading international specialty pharma platform." Under the divestment deal, Rosemont Pharmaceuticals will acquire the product portfolio of licences, registrations and trademarks, as well as related commercial rights, to a number of oral generic products which are used to treat a range of conditions in various therapeutic areas.

Essential Pharma, an international speciality pharma group, has procured an establishment and manufacturing licences in Switzerland and Malta. Following a successful inspection by Swissmedic, the company has been granted an establishment licence in Switzerland, which will allow the company to significantly enhance its supply chain efficiency for a wide range of important medicinal products. It will apply to transactions for both finished and unfinished pharmaceuticals, allowing importing, exporting, wholesaling and trading abroad. Essential Pharma has also received a manufacturing and importation authorisation (MIA) in Malta, following a successful Good Manufacturing Practice (GMP) inspection by the Malta Medicines Authority. The MIA will allow the company to import medicinal products into the European Union where manufacturing has taken place in a third country. This will allow greater flexibility in how the business manages the flow of medicines across its territories. These approvals strengthen the company's geographical expansion, improve its operational efficiencies, and enhance its offering as a global business partner. They will also provide new strategic opportunities for the company and will play a fundamental role in driving value creation through functional improvements to scale and productivity.

Pharmaceutical recalls are complicated and expensive, just like in any other business. Pharmaceutical recalls, however, pose a further risk because they might change both short- and long-term health effects. To ensure smooth recalls with few negative effects on public health, it is crucial to understand the pharmaceutical product recall procedure and the roles of each key player. Throughout the recall procedure, patient safety is crucially ensured by the FDA, pharmaceutical companies, pharmacy technicians, and other healthcare professionals. Learning about pharma recalls, procedures, and responsibilities is essential for guaranteeing patient safety for key actors like the Food and Drug Administration (FDA), manufacturers, and other medical specialists. RECALL CLASSIFICATIONS Recalls can fall into one of three categories-class I, II, or III-with class I being the most serious and lethal. Products that have the potential to result in serious, permanent complications or death are subject to Class I recalls. Class II recalls are recommended for product flaws that have a low likelihood of harmful events or that can result in reversible side effects. Last but not least, class III recalls typically arise from problems with packaging that do not pose a risk. Since they are frequently issued out of an abundance of prudence rather than due to any negative impacts, many people may even describe this kind of recall as benign.

Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said last week (January 17). Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March. "Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said. Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says. The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said. Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.