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Chiesi Farmaceutici acquires Amryt Pharma - 0 views

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    Chiesi Farmaceutici, the international, research-focused biopharmaceuticals and healthcare group has acquired Amryt Pharma, a global biopharmaceutical company dedicated to developing novel treatments for rare diseases. More than 300 million people worldwide are affected by rare diseases, including those who are living with ultra-rare metabolic and dermatologic conditions who still have no approved treatment. The acquisition reinforces Chiesi's commitment to deliver innovative treatments to patients with highly unmet medical needs. As a benefit corporation and a B Corp, Chiesi strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. Chiesi's Head of Chiesi Global Rare diseases Giacomo Chiesi commented: "We are excited to add the Amryt family to our company in this acquisition that demonstrates our commitment to rare diseases and aligns with our growth strategy through partnerships beyond internal research and development." Chiesi's new CEO Giuseppe Accogli said: "By joining forces and expertise we will be able to grow our capabilities and further strengthen our position to provide a positive impact on patients living with rare diseases." With regard to the financing of the deal, cash consideration has been partially financed through a EUR 700m syndicated loan led by BNP Paribas and Crédit Agricole as Global Coordinators and ESG Structuring Banks, acting alongside BPER and Deutsche Bank as Mandated Lead Arrangers. Crédit Agricole is Loan Agent too. Lenders have been advised by Clifford Chance, while Baker and McKenzie has assisted Chiesi Farmaceutici.
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Alliance Pharma founder donates £5m to create University of Sunderland's new ... - 0 views

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    John Dawson, the founder and former CEO of Alliance Pharma, has donated £5million to the University of Sunderland towards the creation of a new drug research centre. The donation - the biggest in the university's history - will create the John Dawson Drug Discovery and Development Research Institute to improve health and wellbeing of millions of people worldwide. The new centre has been named after the pharmaceutical entrepreneur and Sunderland graduate who, alongside wife Sam, has provided the funding. He and Sam were on Thursday (April 20) joined by specially invited guests from across the region's health, education, and business communities, to launch the Institute housed in the University's Sciences Complex. Unveiling a plaque inside the building, John said: "It's an absolute honour and privilege to be able to launch the new Drug Discovery and Development Research Institute at the University of Sunderland today. "It's been wonderful to be back on the campus and see the incredible developments that have taken place since I studied pharmacy here more than 50 years ago. "I was immediately impressed at what has been achieved in that intervening half-century and I've been delighted to assist the University continue its development, particularly in the health arena. "I hope the launch of this institute will mark the next phase in the University's evolution and I'm very much looking forward to working with the team as they bring their projects to fruition."
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JAS Healthcare Unit Granted WDA(H) License for Pharma Excellence - 0 views

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    Global logistics company, JAS has received the Wholesale Distribution Authorisation (WDA(H)) license from the UK's Medicine and Healthcare Products Regulatory Agency (MHRA) for its Pharma and Healthcare Division. In a press release issued on Thursday (22 February), the company said that securing the license empowers its UK healthcare division to "seamlessly connect" with its more than 40 GDP (Good Distribution Practice) certified overseas stations, strengthening its capabilities for handling pharmaceutical shipments. Headquartered in Atlanta, Georgia, USA, the company boasts a team of over 7,000 professionals, with operations spanning over 100 countries. Adrian Frodsham, Regional Director for JAS, said that they were granted the WDA(H) license after a "stringent audit process." "JAS UK's pharma and healthcare division prides itself of offering innovative solutions for the international delivery of pharmaceutical products, further enhancing the growth of our pre-established healthcare division," he added.
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Elsevier PharmaPendium : Empowering Pharma Excellence - 0 views

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    The global company in information and data analytics, Elsevier launched a platform, PharmaPendium for drug candidates. It is an effective tool that provides data including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages for drug development. The platform is supported by the FDA, the Medical Devices Agency (PMDA) and the top 20 global pharma companies. Olivier Barberan, Director of Translational Medicine Solutions spoke about how "improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies." "Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the new PharmaPendium to solve this," he added.
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Paroxetine 40mg tab: Crescent Pharma recalls specific batch - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to stop supplying a specific batch of Paroxetine 40mg Film Coated Tablets immediately. Crescent Pharma Limited is recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure due to out of specification results for dissolution during routine stability testing. "Quarantine all remaining stock of the said batch and return it to your supplier, using your supplier's approved process," said MHRA. The agency alerted the patients that this is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.
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Zealand Pharma and Boehringer Ingelheim's weight-loss drug - 0 views

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    Denmark's Zealand Pharma and Boehringer Ingelheim said their experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial, lining up a potential contestant in the booming obesity drug market. In a statement on Wednesday (May 10), the partners said that the Phase II dose-finding trial met its primary endpoint of weight loss after 46 weeks. Paola Casarosa, head of therapeutic areas at Germany's Boehringer Ingelheim told Reuters the partners are in discussion with regulators about the design of a planned follow-up trial in the third and last phase of testing. The enormous demand for weight-loss treatments such as Novo Nordisk's Wegovy, or potentially Eli Lilly's Mounjaro, could support as many as 10 competing products with annual sales reaching up to $100 billion within a decade, mostly in the United States, industry executives and analysts said. Lilly said about a year ago that Mounjaro was shown to reduce up to 22.5% in weight after 72 weeks of treatment in a much larger late-stage trial.
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Special Achievement Award:HRA Pharma Hana pill wins award - 0 views

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    HRA Pharma's progestogen-only contraceptive pill, Hana, has won the 'Special Achievement Award' at the Nicolas Hall awards. The awards took place on May 5, 2022 in Athens. HRA's Marketing Director for the UK, Ireland and the Nordics, Kate Evans, was in attendance to represent the Hana team and accept the award. The Hana pill became available in July 2021 for women in the UK to purchase without a prescription following a pharmacy consultation. The launch has made it easier for women to access effective daily contraception. This reclassification made HRA Pharma one of the leaders in this new healthcare category. The switch followed the authorisation of reclassification of desogestrel by UK regulator MHRA. Hana was one of the first products to enter this new market.
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Impact of Pharma Recalls on the Industry and Consumers - 0 views

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    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.
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Buy Innoveda Arthrella Online - Supplement for Joint Pain & Osteoarthritis - 0 views

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    Arthrella is a rich combination of joint support phytochemicals. Arthrella combines the extracts of 4 herbs which offer support to the bones and the joints and help regulate healthy active joints and muscles. Arthrella helps in promoting normal structure and functioning of musculoskeletal system Social Media Site https://www.youtube.com/user/CharakPharma https://www.facebook.com/CharakPharma https://twitter.com/charak_pharma https://plus.google.com/+charakpharma https://www.linkedin.com/company/charak-pharma-pvt.-ltd. https://www.pinterest.com/OTCSupermarket/charak-pharma/ https://plus.google.com/u/0/communities/112690639266834894016 CONTACT US Charak Pharma (USA) inc 303-5th Avenue, Suite # 1007 New York, NY 10016 United States Website- http://www.charakusa.com/ Email : enquiry@charakusa.com info@charakusa.com 91 22 33016734 Google My Business Location- http://listings.findthecompany.com/l/474216049/Charak-Pharma-Usa-Inc-in-New-York-NY Buy Innoveda Arthrella Online - Shop, Cart & checkout Page Url Shop - http://www.charakusa.com/shop/ Add to Card - http://www.charakusa.com/cart/ Proceed to Checkout- http://www.charakusa.com/checkout/
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Pharma Companies Face Suspension Amid Contamination Concerns - 0 views

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    The Indian government has suspended manufacturing in over 40 pharmaceutical companies based on a risk-based assessment conducted earlier in the year across 162 firms, according to the data provided by Union Health Minister Mansukh Mandaviya in Parliament on Thursday (Aug. 10). "Overall, a sum of 143 show-cause notices has been issued," Mandaviya said. There have been numerous recent incidents involving accusations from foreign countries regarding the contamination of syrups, eye drops, and ointments manufactured in India. Countries such as the Gambia, Uzbekistan, and Cameroon have linked the deaths of 70, 18, and six children, respectively, to cough syrups contaminated in India. Licenses for specific products have been either temporarily suspended or fully revoked for an additional 66 companies. In one case, an FIR has been registered, and in 21 cases, warning letters have been issued following inspections by both the Central Drugs Standard Control Organization and State authorities, the Minister added. Meanwhile, the Indian government has mandated rigorous testing for cough syrups before export. Starting June 1, any cough syrup must possess a government laboratory-issued certificate of analysis before being exported, the government said in a notice dated May 22.
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Ravindra Limaye:OBE honour for contribution to health sector - 0 views

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    Wockhardt UK managing director Ravindra Limaye has been chosen for honorary British awards given to foreign nationals. Limaye gets the Order of the British Empire (OBE) honour for his contribution to health, particularly during the Covid-19 pandemic. The honours were announced on Thursday (13). Limaye has been the chief executive of the UK arm of the Mumbai-based pharma and biotech company Wockhardt since 2019. He previously worked for another Indian pharma company Biocon, overseeing its global commercial operations. He led the company's entry into global biosimilar markets and spearheaded its operations in the US.
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MHRA Class 3 Recall: Sildenafil 100mg Tablets - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for Sildenafil 100mg Film-coated Tablets (Strandhaven Limited T/A Somex Pharma). Manufacturer of drug, Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch state 8 tablets instead of 4 tablets. This is an error due to cartons being mixed at the printers. All cartons with batch number ET22028 contain one blister strip of 4 tablets regardless of whether it states 8 tablets or 4 tablets on the pack. Only the batch number ET22028 is affected. Due to the low number of complaints received, only the packs labelled as containing 8 tablets are being recalled at this time. The batch is comprised of 60340 packs, to date 195 packs have been found to be mislabelled.
pharmacybiz

Windsor Framework UK : A new way forward - 0 views

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    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.
pharmacybiz

Drug shortage: Fixing the medicines shortage crisis - 0 views

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    From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among patients, the government, and the wider pharma industry. Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine, and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February. The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like amoxicillin and Adderall, an ADHD medication. To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic. The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping containers. Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution in times of additional need.
pharmacybiz

Aspire Pharma Oncology Leap: Leuprorelin Acetate's Game-Changing Addition - 0 views

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    Aspire Pharma Limited has solidified its position as a leading specialty generics enterprise by adding leuprorelin acetate as a branded generic to its oncology portfolio. Leuprorelin acetate is hormone therapy recommended for patients with high-risk localised, locally advanced, and metastatic prostate cancer, serving as an alternative to surgical castration for locally advanced cases. Used as an alternative to surgical castration for locally advanced prostate cancer, a pre-filled syringe containing 11.25mg of leuprorelin acetate (equivalent to 10.72 mg leuprorelin) is injected subcutaneously into the abdomen. The British pharmaceutical company noted that one of its primary objectives is to seek "new investment opportunities" that brings products and companies into its portfolio, aligning closely with Aspire values and therapeutic focus areas. Prostate cancer is the most common cancer among men in the UK, with an average of over 52,000 men receiving a diagnosis of prostate cancer annually, as per Prostate Cancer UK.
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PI-Gen Pharma Acquires Medipharmacy for £7.1M - 0 views

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    Medipharmacy has been bought out by PI-Gen Pharma Limited, an arm of the independent pharmacy group Enimed, for a total of £7.1 million, after the business entered into administration. In a report published on Companies House on January 30, administrators at FRP confirmed that the transaction was completed on 18 January, with PI-Gen beating five other bidders to acquire the insolvent NHS pharmacy chain. The report added that PI-Gen submitted a cash offer of non-refundable £500k for Medipharmacy's goodwill, £2.1m for its freehold properties, and a further amount for its fixtures and fittings, motor vehicles and stock. An FRP spokesperson told The Standard that Medipharmacy, which operated a chain of 25 NHS community pharmacies across London, Kent, Surrey and West Sussex, had faced increasing cashflow challenges in recent months. According to the administrators' report, Medipharmacy's revenues had grown exponentially from £27.9m in 2022 to £69m in 2023 but didn't deliver corresponding improvements in profitability.
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Vani Manja:Boehringer Ingelheim Country MD - 0 views

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    Boehringer Ingelheim UK & Ireland has appointed Vani Manja as its new Country Managing Director and Head of Human Pharma. Manja has been associated with Boehringer Ingelheim for over 11 years, in successful leadership roles in Germany, the United States and most recently as General Manager, India. Her career started as a commissioned officer in the Indian Army Ordnance Corps which preceded leadership roles at Becton Dickinson and McKinsey. She brings extensive experience of strategy, marketing, sales, business development, people management, and cultural transformation and is passionate about tackling healthcare inequalities and advancing sustainable healthcare. Commenting on her new role, Manja said: "It is with great heart that I bring the spirit of conscious leadership to my new role. I look forward to being fully present and partnering with key stakeholders in the healthcare ecosystem in our collective quest to improve health for humans and animals in the UK and Ireland."
pharmacybiz

Sodium Chloride Eye Drops : Stockport Pharma recalls - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine) Stockport Pharmaceuticals. Stockport Pharmaceuticals said that the above batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (Jan 2022). The authority said, "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers, and the manufacturer has full traceability of the product's distribution." "Remaining stock of the above batch should be quarantined and returned to Stockport Pharmaceuticals directly."
pharmacybiz

Community pharmacy:What does the collapse mean? - 0 views

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    The collapse of the three trading entities in the Converse Pharma Group (Testerworld Limited, Doncaster Pharmaceuticals Group Limited and Eclipse Generics Limited) (the Group) in May 2022 undoubtedly caused ripples throughout the pharmacy industry. The Group, a major supplier of pharmaceuticals, had a combined turnover over £300m, employed 1,000 staff members and supplied over 4,000 pharmacies throughout the country. The Group is licensed and regulated by the MHRA. At the beginning of 2021, a breach of the MHRA licensing regulations caused a temporary (but prolonged) cessation of trading. The Group was able to secure the ongoing support of its secured creditors during this time, however, when the licenses were subsequently reinstated, they came with restrictions. Unfortunately for the Group, the period of the suspension and the subsequent restrictions over the licences caused a significant reduction in revenue, from which the Group was unable to recover. Ultimately, by May this year, the companies in the Group had exhausted their working capital and had no prospect of raising the funding they required to continue to trade.
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Technology and big data in the pharmaceutical industry 2023 - 0 views

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    As we take look back over the past year and reflect on what we have achieved, it's also important that we look ahead to new challenges and opportunities that may arise in 2023. We have seen remarkable innovation across the industry in 2022, from big break throughs in treatment and improvements to patient outcomes, to how the industry is working with big data and technology. But it's fair to say that these achievements came paired with just as many challenges including a continued talent shortage, hangovers from the pandemic, increasing pressures to innovate and ongoing macroeconomic challenges. As we head into 2023, I expect these existing challenges to continue alongside new ones, but I also anticipate more opportunities to present themselves. At Pharamanovia, we predict that the key trends set to catalyse the pharmaceutical and healthcare industries in 2023 include break through innovations, technology, big data, sustainability, ongoing policy changes and a shift in investment due to inflation. Utilising big data and tech Technology has been recognised as one of the industry's biggest tools for many years, and I don't expect to see the pace of how we use technology in healthcare and pharma to slow down any time soon. In 2023, I expect that we will see further automation in the way we work, with an increase in digital engagement and healthcare providers leveraging remote access further.
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