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The pharmaceutical industry is one of the most important and valuable industries in the world. It is responsible for developing and producing medicines that improve and save lives. However, there are some things you may not know about this fascinating industry. In this blog post, we will discuss six interesting facts about the pharmaceutical industry! 1. THE MANUFACTURING PROCESS OF PHARMACEUTICALS IS HIGHLY REGULATED All pharmaceutical products must go through a rigorous manufacturing process before they can be made available to patients. This process is heavily regulated by various government agencies to ensure that the medicines are safe and effective. The pharmaceutical manufacturing process usually involves multiple steps, including the preparation of raw materials, the manufacturing of active pharmaceutical ingredients (APIs), and the packaging and labeling of finished products. To ensure patient safety, all pharmaceutical companies must adhere to strict regulations set by government agencies such as the Food and Drug Administration (FDA). These regulations are designed to protect patients by ensuring that medicines are safe and effective.

The UK must act swiftly to fend off competition if it wants to build the world's leading life sciences sciences hub, a new report suggests. A year on from the launch of the government's life science vision, the report commissioned by the the Association of the British Pharmaceutical Industry said although achieving the ambition remained feasible, the UK would need an attractive business environment because its competitor countries were becoming more adept at attracting investment. To achieve the ambition of the vision, the PwC-produced report suggested raising pharmaceutical R&D investment in the UK to build a 'stronger manufacturing and research infrastructure', alongside better investment in, access to and uptake of innovative medicines. It said the UK would also need to adopt a renewed approach to the priority healthcare challenges identified in the government's 'Life Science Vision', which would mean cutting the overall burden on health of dementia, cancer, cardiovascular and respiratory disease and mental health. The report quantified the size of the prize if the vision was implemented in full and the UK could emulate the successes of leading EU countries, which included: £68 billion in additional GDP over 30 years, owing to increased R&D investment £16.3 billion additional annual GDP from increased pharmaceutical exports Supporting 85,000 additional jobs Up to 40 per cent decrease in disease burden across the whole UK - for areas like cardiovascular disease, mental health conditions and Cancer. Reduced variation in speed of access to new medicines within three months of licensing for all NHS patients.

Moderna has joined one of the UK's leading pharmaceutical industry body, Association of the British Pharmaceutical Industry (ABPI) to expand its footprint and investment in the UK. The biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines will strengthen its footprint with the new state-of-the-art vaccine research, development and manufacturing facility in the UK. It will create valuable new jobs and build on the strength of the UK's life sciences ecosystem. The company is best known for their work during the COVID-19 pandemic and are now developing a range of mRNA-based vaccines for a number of conditions. The ABPI represents companies of all sizes who invest in discovering the medicines of the future, including some of the world's largest, most innovative, and most successful pharmaceutical firms. Darius Hughes, UK General Manager, Moderna, said: "We are delighted to join the ABPI - this alliance is an important part of our long-term commitment to the UK and supports the wider significant investments in manufacturing, research and development we are making in this country.

Pharmaceutical Press, the Royal Pharmaceutical Society publishing arm, has announced its partnership with Datapharm Ltd. Under the new partnership, Electronic Medicines Compendium (emc) the latest product to be added to MedicinesComplete, the online medicines information platform from Pharmaceutical Press. MedicinesComplete users can easily search emc information, with direct links to the trusted, clinical guidance from the British National Formulary (BNF). "emc through MedicinesComplete will include printable, ready-to-use patient information leaflets written by manufacturers to use at the point of care, and users will have access to an unlimited number of searches. In addition, emc will also include the full Summary of Product Characteristics (SmPC) document, which accompanies all regulator approved medicines in the UK," said the RPS. Available to all countries outside the UK, emc will be launched early next year on subscription through MedicinesComplete. UK access is available on request.

The Royal Pharmaceutical Society (RPS) has confirmed that the recall of blood pressure drugs amlodipine and olmesartan by the Food and Drug Administration is only for the US market and will not have any impact in the UK. MHRA also clarified that the manufacturer of these drugs, Macleod Pharmaceuticals, does not supply amlodipine medicines in the UK. It was published online in both the Daily Record and Daily Express on the morning of Monday, March 21, that the drugs had been recalled in the US by the FDA due to deviations from standard manufacturing protocols by the manufacturer. RPS intervened to ensure the articles were edited to make clear that this is not an issue in the UK after confirmation from the MHRA. Amlodipine tablets from Macleod Pharmaceuticals aren't available for wholesale distribution in the UK.

British Pharma giant, GSK is planning to invest more than £200 million (about $253 million) into the United Kingdom over the next two years to strengthen its manufacturing network. The money will be used to improve the pharmaceutical group's UK sites, including construction of new facilities and assembly lines, The Daily Mail first reported on Sunday. GSK has already earmarked £67 million to upgrade its manufacturing site in Montrose, Scotland, where a new production facility is being constructed. The upgrade is expected to help boost its production of active pharmaceutical ingredients (API) for the future supply of medicines. Regis Simard, head of global supply chain, told the publication that their six UK manufacturing sites, including Montrose, are an important part of their global manufacturing network.

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.

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.

An Indian court has sentenced two pharmaceutical company executives to two-and-half years in jail for exporting substandard drugs to Vietnam a decade ago, months after the WHO linked their cough syrups to the deaths of children in Gambia. India suspended production at Maiden Pharmaceuticals in October last year for violations of manufacturing standards after the World Health Organization said four of its cough syrups may have killed dozens of children in Gambia. The company has denied its drugs were at fault for the deaths in Gambia and tests by an Indian government laboratory found there were no toxins in them. The company had been facing legal difficulties for years over suspected shoddy products. A court in Sonipat, near New Delhi, where Maiden has its main production facility, ordered jail for company founder Naresh Kumar Goel and technical director M.K. Sharma for exporting heartburn medicine "not of standard quality" to Vietnam.

Well Pharmacy has announced the acquisition of Lexon UK Holdings and Asurex Limited, a family-owned pharmaceutical wholesaler with five depots in Redditch, Leeds, Durham, East Kilbride and Dublin and a network of community pharmacies across the Midlands, Northwest, and Northeast of England. Lexon, is a family-owned business which has been in operation for over 25 years, running primarily as a pharmaceutical wholesaler for 3,000 retail pharmacy customers across the UK and Ireland. The business also operates 42 community pharmacies - currently trading as Knights Pharmacy - and is also a specialist developer and manufacturer of generic pharmaceuticals and is a data and solutions provider to pharmacy. The acquisition will be notified to the Competition and Markets Authority (CMA). Both parties have proactively engaged with the CMA in pre-notification discussions and look forward to continuing to do so productively during the CMA review period. Haider Choudrey, CFO of Bestway Group which own Well Pharmacy, said: "Through this acquisition we seek to augment our growth momentum and bring in even greater benefits to both community pharmacies and patients. Well Pharmacy had been searching for a target to expand its footprint and complement its growth trajectory and we are confident that Lexon fits this criterion."

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.

AmerisourceBergen, a leading pharmaceutical solutions organisation announced its intent to change its name to 'Cencora' to better reflect its bold vision and purpose-driven approach to creating healthier futures. Steven H. Collis, Chairman, President & Chief Executive Officer of AmerisourceBergen said: "Over time, we have established ourselves as a trusted industry partner that prioritizes innovation, advocates for patient access and advances strategic partnerships across the global pharmaceutical supply chain. To further bolster our position, we must continue to adapt and evolve within our dynamic industry as we pursue the goal of enhancing health outcomes. Building a unified brand is fundamental to our identity as a global healthcare company. We believe our new name better reflects who we are today and our impact across pharmaceutical care." AmerisourceBergen intends to begin operating as Cencora in the second half of calendar year 2023. The change to Cencora is aligned with the organisation's growth strategy and continued emphasis on innovation. AmerisourceBergen has focused on supporting pharmaceutical advancement and access for patients, manufacturers, and providers across the global healthcare supply chain.

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.

An alliance of companies has pledged to ensure equitable access to vaccines and treatments for pandemics, as the friction around intellectual property rights for Covid-19 interventions between the pharmaceutical industry and developing nations endures. At the heart of the plan is a commitment to set aside part of the production of vaccines and treatments upfront for vulnerable populations in low-income countries when the next pandemic arises, given how fragmented access to Covid tools has left many populations unprotected. In order to do better next time - and without knowing which companies will develop the first drugs and vaccines for the next pandemic - having the industry collectively make this commitment is potentially transformative, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The pledge, called the Berlin Declaration, was made on July 19 by members of the global pharmaceutical industry group that include many of the companies involved in developing Covid interventions, such as AstraZeneca, GSK, Moderna, Pfizer and Merck. The declaration is not legally binding. However, if a company that signed on reneges on its vow, it would face grave consequences in the court of public opinion, said Cueni.

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.

AAH Pharmaceuticals on Tuesday (November 15) announced the promotion of its commercial director David Bound to chief executive officer of the company. In his 10 years in the company, Mr Bound has helped to drive growth across the AAH business, implementing new digital channels for customers, and developing strategic partnerships with pharmaceutical manufacturers - drawing on from his vast experience in the healthcare industry, as well as in supply chain, operations, and trading. Commenting on his promotion, he said: "I'm delighted to be taking on this role at such a critical time for healthcare. There are many challenges affecting the industry right now - from inflationary pressures to workforce issues - and I'm looking forward to tackling them head-on alongside my excellent team."

Pharmaceutical companies AbbVie and Eli Lilly have withdrawn from Britain's voluntary medicines pricing agreement, an industry body said on Monday. Companies are increasingly arguing that it is no longer possible to justify the UK's "voluntary scheme" to global boardrooms and investors as repayment rates in 2023 have surged to 26.5 per cent of revenue, the Association of the British Pharmaceutical Industry (ABPI) said in a statement. "The current scheme has harmed innovation, with costs spiralling out of control, and the UK falling behind other major countries to be left as a global outlier," said Laura Steele, president and general manager for Eli Lilly's Northern Europe division. ABPI said it was seeking early talks with the government to set out a new future settlement. In December, the industry body had said the government raised the amount manufacturers of branded medicines within the voluntary scheme will be required to return to almost £3.3 billion in sales revenue from an earlier amount of £1.8 billion.

The British Generic Manufacturers Association (BGMA) has elected Diane DiGangi Trench to be its new vice-chair. DiGangi Trench takes up the position replacing Xiromed's Peter Ballard and in 12-months' time will assume the association's chair role from Accord's Peter Kelly. With over 25 years of pharmaceutical industry experience, DiGangi Trench has held a number of senior commercial roles including stints with Takeda and Astra Zeneca. She joined Sandoz in 2018 in the US, where she served as Vice-President, Market Access and Patient Services. In 2021, she became the head of Sandoz' UK business and in her two years in role, she has led the organisation through a post-COVID recovery and growth phase to prepare for the proposed spin out of the company from its parent, Novartis, expected later this year. She said: "It's a great honor to take on the role of Vice Chair of the BGMA. The success of the generics and biosimilar industry is essential to the functioning of the NHS. Generic medicines fill four out of five UK prescriptions and biosimilars enable the NHS to expand access to more patients. I am passionate about increasing the sustainability of our industry so we can continue to play our vital part in the health of the nation." Mark Samuels, BGMA chief executive, said: "We are extremely fortunate to be able to call upon the expertise of Diane who has already added significant value through her role on the BGMA board and leadership of a key strategic committee.

The Competition Appeal Tribunal (CAT) has upheld the Competition and Markets Authority's (CMA) findings against two pharmaceutical manufacturers who consistently overcharged hydrocortisone tablets for over a decade. Auden/Actavis UK's pricing for the critical medicine 'hydrocortisone' from 2008 to 2018 constituted an abuse of their dominant market position, leading to fines nearing £130 million, CMA said in a statement. "These companies increased the price of this crucial medicine by over 10,000 per cent, soaring from 70p to £72 within that period. These are the highest ever CMA penalties upheld by the Tribunal," the CMA said. In July 2021, the CMA imposed fines exceeding £265 million on hydrocortisone manufacturers Auden Mckenzie and Actavis UK, which acquired Auden's business in 2015 and subsequently became Accord-UK. The fines were imposed for abuse of dominance and collusion by both the parent companies and potential competitors. The recent verdict, announced on September 18, comes five weeks after the Tribunal supported the CMA's decision in a separate case regarding the pricing of medicines supplied to the NHS. In that prior case, fines amounted to £84 million.

The British Generic Manufacturers Association (BGMA) has sought a judicial review of the Department of Health and Social Care's (DHSC) decision to negotiate a new Voluntary Scheme for branded medicines with the Association of the British Pharmaceutical Industry (ABPI). Mark Samuels, Chief Executive of BGMA said: "The Government has decided not to involve the trade body representing these medicine suppliers in its negotiations on the voluntary scheme for branded medicine pricing (VPAS). "We are deeply concerned by this decision. It has left us no choice but to take legal action." "While not all generic drugs fall within VPAS, four out of ten products in the current scheme are branded generics or biosimilars. As the representative trade body for both generic and biosimilar UK manufacturers, we must play a full part in the VPAS negotiations for the next period of the scheme from 2024 to 2028." "The VPAS tax has risen five-fold in under two years, an unprecedented tax increase. Yet our sector currently has no input into the negotiations on future schemes or rates; this is untenable as any decisions made on VPAS could significantly define the future of our sector in the UK and its ability to supply the NHS. The association had raised its full participation in the negotiations with the Government last November.