Hera Cuku

Today is the International Day for the Elimination of Violence against Women, an essential occasion to shed light on the burden of gender violence. As part of Angelini Industries and on a journey to raise awareness around brain and mental health with Angelini Pharma, I've decided to focus on a critical yet invisible impact of gender violence: its toll on mental health. Violence against women, in fact, deeply impacts mental health, doubling the risk of depression and increasing PTSD and suicide risk among survivors.  You can read the full article here: https://lnkd.in/diYgWtMT #NoExcuse #AngeliniPharma #EveryStepCloser #WithYouInMind

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Readiness for the journey….

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Managed entry agreements (MEAs) notionally saved the Italian healthcare system €220mn in 2022—an increase of 3.3% relative to 2022—according to new data from the Italian Medicines Agency (AIFA). However, it is important to bear in mind that savings are calculated relative to theoretical spending without MEAs, whereas prices would likely have been lower without MEAs. Several types of outcomes agreements are possible in Italy: 𝗥𝗶𝘀𝗸 𝘀𝗵𝗮𝗿𝗶𝗻𝗴 requires pharmaceutical companies to refund part of the treatment cost for non-responders. 𝗣𝗮𝘆𝗺𝗲𝗻𝘁 𝗯𝘆 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 (𝗣𝗯𝗥) requires manufacturers to repay in full the treatment cost for non-responders. PbR is used to manage a high degree of uncertainty for drugs that are perceived to have an unfavourable benefit/risk ratio at launch. Virtually all of the active outcomes agreements are PbR schemes. 𝗦𝘂𝗰𝗰𝗲𝘀𝘀 𝗳𝗲𝗲 deals involve payments only if outcomes targets are met. 𝗣𝗮𝘆𝗺𝗲𝗻𝘁 𝗮𝘁 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 (𝗣𝗮𝗥) is a variation on the success fee model, with staggered payments made if outcomes are met at specified timepoints. AIFA also operates two types of financial agreements: 𝗖𝗼𝘀𝘁 𝘀𝗵𝗮𝗿𝗶𝗻𝗴 provides for a discount on the cost of the first cycle of treatment, or the entire course of therapy, for all eligible patients. This type of deal is generally used in cases of uncertainty regarding the potential financial impact of a new medicine (as opposed to uncertainty regarding its effectiveness). 𝗖𝗮𝗽𝗽𝗶𝗻𝗴 sets a ceiling on expenditure on a drug per patient, beyond which the manufacturer covers all remaining costs. In addition to the patient-level MEAs managed through AIFA’s registries, Italy makes use of two population-level approaches to managed entry: 𝗣𝗿𝗼𝗱𝘂𝗰𝘁-𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝗲𝘅𝗽𝗲𝗻𝗱𝗶𝘁𝘂𝗿𝗲 𝗰𝗲𝗶𝗹𝗶𝗻𝗴𝘀: AIFA negotiates a national limit for spending on a given drug in its first 12 or 24 months on the market. If this limit is exceeded, the manufacturer must refund excess costs to regional administrations. 𝗣𝗿𝗶𝗰𝗲-𝘃𝗼𝗹𝘂𝗺𝗲 𝗮𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁𝘀 provide for incremental discounts on list prices in response to growing prescription volume. The discounts may be in the form of a price reduction or a refund to the regions. In 2023, AIFA had 5 PbR schemes (down from 10 in 2022), 3 PaR agreements (same as in 2022), 5 cost-sharing deals (down from 6 in 2022) and 7 capping arrangements in operation (same as in 2022). Expenditure ceilings were in place for 16 drugs (up from 12 in 2022), while 6 products were subject to price-volume agreements (up from 4 in 2022). The accompanying figure shows that notional savings from expenditure ceilings grew dramatically, whereas refunds from price-volume agreements, cost sharing, PbR, capping and risk sharing declined. PaR agreements are not included in the savings calculations because they provide for deferred billings over time rather than refunds. #Italy #managedentry #MEA #AIFA

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🤳 𝐂𝐃𝐌𝐎 𝐌𝐚𝐫𝐤𝐞𝐭 𝐔𝐩𝐝𝐚𝐭𝐞𝐬 𝐓𝐡𝐢𝐬 𝐖𝐞𝐞𝐤 🔄 Alfasigma has rebranded its CDMO Business Unit as Morpho, underscoring its growth and leadership in the pharmaceutical industry. Established in 2017, Alfasigma’s CDMO arm has built a strong reputation in third-party pharmaceutical development and manufacturing. The rebrand as Morpho reflects the company's evolution and future ambitions to expand its capabilities in the sector. 🤝 Matica Biotechnology, Inc. and CytoImmune Therapeutics have entered a strategic partnership to advance cell therapy targeting cancer. Matica will produce viral vectors at its Texas GMP facility, while CytoImmune will manufacture the cell therapies in Puerto Rico. The collaboration aims to accelerate clinical trials and the development of new cancer therapies. ⚙️ Evonik is refocusing its Health Care division on high-growth sectors like complex APIs, drug delivery systems, and biosolutions such as lipids for mRNA and gene therapies. As part of this shift, the company will discontinue keto acid production at its Hanau facility by the end of 2025, affecting 260 employees, who will receive support for job transitions. 💉 Kindeva Drug Delivery has completed its first registration batch at its high-volume injectable manufacturing site in Bridgeton, marking a major milestone. The facility, designed to expand injectable production, will install three additional production lines over the next 18 months to meet increasing demand for pharmaceutical products. 📊 Cellipont Bioservices has named Darren Head as CEO, further strengthening its leadership as the company embarks on an expansion phase. The appointment coincides with a minority growth equity investment from HealthQuest Capital, which, alongside continued backing from GPP, will fuel Cellipont’s growth in cell and gene therapy manufacturing. 🌍 MilliporeSigma has opened a €290 million biosafety testing and cell banking facility in Rockville, Maryland. This state-of-the-art 23,000-square-meter complex consolidates operations into one building, enhancing efficiency, collaboration, and automation to meet rising global demand for biosafety and analytical testing services. 🏭 Ardena has acquired Catalent Pharma Solutions's state-of-the-art facility in Somerset, NJ, enhancing its late-stage and small-scale commercial manufacturing capabilities for oral drug products. This acquisition supports Ardena’s goal to offer end-to-end pharmaceutical development solutions across its global network of GMP facilities. 🚀 Thermo Fisher Scientific has launched Accelerator Drug Development, expanding its CDMO and CRO services. This follows significant upgrades to its Middleton, WI, GMP facility and expansions in Cincinnati, OH, and Bend, OR, which will boost manufacturing and testing capabilities for oral solid dose drugs, addressing issues like solubility and bioavailability in pharma and biotech development. Stay tuned for more industry highlights! #CDMO #News

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Menarini Group signs licensing deal with Insilico for promising cancer treatment The asset is a highly selective and potentially best-in-class small molecule inhibitor targeting a broad range of solid tumor cancers, developed with the help of Chemistry42, Insilico's generative chemistry engine, and Insilico's drug discovery team. The asset has successfully completed preclinical development and has demonstrated broad anti-tumor activity in selected cancers. Source:

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🌍✨ Today marks World Asthma Day 2024! ✨🌍 On this day, let's celebrate the remarkable resilience of individuals living with asthma. They defy the constraints of their condition, surpassing limits, and embracing life to the fullest. At Chiesi we are honored to share compelling stories of patients who have defied the limitations imposed by their condition. Today, we shine a spotlight on their inspirational journeys, highlighting their resilience and determination in overcoming the challenges of living with asthma. Behind these inspiring individuals lie stark statistics: Asthma is one of the most common chronic non-communicable diseases that affects over 260 million worldwide, leading to 450,000 annual deaths, many of which could have been prevented. Join us in honoring our patients and raising awareness about this respiratory disease. Happy World Asthma Day! 🌍 #Limitless #Sustainability #RespiratoryHealth

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Faster access in Italy and prioritisation of innovative drugs that address unmet need—these are the ambitions of AIFA Agenzia Italiana del farmaco following its recent reorganisation. Roberto Nisticò, the Agency’s new President, made these commitments in his first meeting with Marcello Cattani, the President of Farmindustria (tinyurl.com/y5xrudu4).   In a press release, Nisticò said: “We are working to reduce the time of access procedures with a reduction of bureaucracy and with administrative simplification, ensuring that citizens may quickly use truly innovative medicines.” To that end, a technical working group has been established to identify simplification tools that will prioritise the approval of drugs that can improve the quality of care and expand the therapeutic options available. In addition, the Scientific and Economic Committee (CSE) will be relieved of certain (unspecified) procedures that could be carried out automatically. The CSE will hold more frequent meetings in the short term to clear the backlog of applications that has built up “because our goal is to prioritise drugs that fill a therapeutic gap,” according to Nisticò.   A new online platform for access authorisation procedures will be established. Pierluigi Russo, AIFA’s Technical and Scientific Director, says the objective is “to make communication between companies and the Agency more effective and transparent concerning the CSE process, in addition to updating the guideline on the dossiers for requesting the price and reimbursement of medicines.”   Addressing problems associated with antimicrobial resistance will also be high on AIFA’s agenda. There is a need for incentives and rapid approval pathways for novel antibiotics. Nisticò believes “an effective model is the legislation that has allowed to incentivise the research for orphan drugs for rare diseases, which can be duplicated for new antibiotics not resistant to bacterial infections. But this will require legislative action, also at a European level, and we will commit to raising awareness among decision-makers at various levels.”   AIFA has confirmed that it will apply the EU Regulation on Health Technology Assessment and make use of joint clinical assessment reports. They will help to support “a multidimensional evaluation of the drug on the healthcare system, economic aspects and protection of citizens' health.” #Italy #AIFA #HTA #marketaccess #innovation

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In this very important day #COPDDay I think we must play more attention to SMOKING CESSATION: please read this Surgeon General’s Report on tobacco-related health disparities in the United States. This report recognizes that while we’ve made remarkable progress reducing tobacco use in the past 60 years, that progress has not been even. Smoking remains the leading preventable cause of disease and death in the United States. Cigarette smoking and exposure to secondhand tobacco smoke cause nearly half a million deaths in the United States each year—nearly one in five of all deaths. https://lnkd.in/deq6Q7JE from Dr. Vivek Murthy Surgeon General's Report Società Italiana di Pneumologia Corsi e Congressi AIPO Ricerche Centers for Disease Control and Prevention

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What does it mean to be MSL in Angelini Pharma❓ Thogether with our strong partner #MoreLaboratoriodiOrganizzazione and some of our most advanced MSLs we will reshape the MSL role in Angelini Pharma in the upcoming weeks, to be ready for the future. 💪 I am grateful to lead this wonderful project. 🌱🚀🩷🙌 In the dynamic landscape of pharmaceuticals, the role of Medical Science Liaisons (MSLs) is evolving every day to meet the ever-changing demands of healthcare. In Angelini we know that our MSLs are pivotal in bridging scientific knowledge and clinical practice, ensuring that healthcare professionals have access to the latest research and insights. This evolution is driven by our commitment to enhancing patient care through innovation and collaboration. By leveraging cutting-edge technologies and fostering strong relationships with key opinion leaders, our MSLs are not just adapting to change but leading it, embodying our mission to make a meaningful impact on global health. #MSL #MSLS #medicalscienceliaison

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Ottimo spunto anche per le Società Scientifiche Italiane: British Journal of Pain 2024, Vol. 0(0) 1–26 https://lnkd.in/dd2QzutA "The British Pain Society updated their recommendations on intrathecal drug delivery (ITDD) for the management of pain and spasticity in adults. The recommendations are primarily evidence based but where necessary comprise the consensus opinion of the working group. The recommendations are accompanied by information for patients and their carers, intended to inform and support patients in their decision making. The updated guidance includes recent evidence base of ITDD use in pain and spasticity, address the issues of drug pump compatibility following the latest manufacturer and Medicines and Healthcare products Regulatory Agency (MHRA) recommendations as well as provide an update on the indications and complication management particularly endocrine complications and intrathecal granuloma formation." AISD Staff dell'Associazione Italiana Studio Dolore SIAARTI federDolore-SICD AIOM | Associazione Italiana di Oncologia Medica Federazione Cure Palliative Società Italiana Cure Palliative

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Sharing a great post on key takeaways from #CPhIMilan and the evolving CDMO and pharmaceutical market from our Daniele Giavini

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Teva - Italy We are proud to share that Teva Italy obtained the Gender Equality Certification, recognized and supported by the State as part of the National Recovery and Resilience Plan. As part of the ESG strategy, we are fully committed in implementing a D&I culture across the organization; in line with this several initiatives have been put in place in the Italian affiliate in the recent past, in order to have an organization based on #equality #inclusion #diversity principles. As a result, 53% of employees are women and managerial roles are covered 65% by women, far above country average. This certification marks a key milestone in this journey which we are still on, with a mindset of continuous improvement. In Italy only few companies obtained the Gender Equality Certification, and we are amongst the first pharma companies. It is a privilege to be driving such a cultural change in the industry and in the society! #tevaitalia #teva #genderequality #InclusionAndDiversity

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The MENARINI Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, will present updated results from phase 1b/2 ELECTRA and ELEVATE clinical studies evaluating elacestrant (ORSERDU®) in combination with other treatments. Both the ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms observed in estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC) and improve patient outcomes through novel oral-oral combination treatment options. Data will be presented at the 2024 American Society of Clinical Oncology (ASCO), on June 2 from 9 a.m. to 12 p.m. CT. “It is encouraging to see that, even in the early stages of the trial, the combination of elacestrant plus abemaciclib indicates a tolerable and manageable safety profile for the patients in the clinical trial,” said Erika Hamilton, MD, Director of Breast Cancer Research and Executive Chair of the Breast Cancer Research Executive Committee for Sarah Cannon Research Institute. “The study continues to demonstrate elacestrant’s potential in combination with other therapies and we look forward to analyzing more data from this combination for this patient population in need of new options.” “As we evaluate the various combinations of elacestrant plus CDK4/6 and PI3K/AKT/mTOR inhibitors, we continue to see consistent and manageable safety findings across all arms of the trial, and so far, elacestrant does not appear to add any incremental toxicity to the combination regimens in which it is being studied,” Hope S. Rugo, MD, Professor of Medicine and Winterhof Family Endowed Professor in Breast Cancer, Director, Breast Oncology and Clinical Trials Education, University of California San Francisco. “These data build on our understanding of elacestrant’s role in metastatic breast cancer and reinforce its potential as an endocrine therapy backbone in combination regimens.” “Since its approval in 2023, ORSERDU has had a meaningful impact as an endocrine therapy for people who are living with ER+, HER2- metastatic breast cancer harboring ESR1 mutations,” said Elcin Barker Ergun, CEO of the Menarini Group. “The data we are presenting at ASCO highlight elacestrant’s potential to further enhance patient outcomes when combined with other compounds.” #BreastOncology #MetastaticBreastCancer #mBC #elacestrant #ORSERDU #Menarini #Stemline 👉 https://lnkd.in/dcKf7uEr

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How can access to ATMPs in Italy be improved? A range of experts offered their perspectives at a recent meeting hosted by the Higher Institute of Health and Assobiotec.   Robert Nisticò, the new President of AIFA, spoke of the need to “ensure that these increasingly expensive therapies can actually reach the patient. If they don't, it's a failure in the primary objective. We must work so that the sustainability of advanced therapies and accessibility go hand in hand.” He added: “We cannot rely on old patterns of thinking, because complex problems require complex solutions. Flexible solutions must be structured.” Therefore, “we are also studying new access models, so that the effectiveness of the most innovative treatments can be concrete and real for those who need them.”   Domenico Mantoan, the Director General of the National Agency for Regional Health Services (Agenas), sees a “need to create a network of hospitals and national hubs where resources can be concentrated for the use, research and study of these therapies.” He noted that “there are places in Italy where these treatments are used more , others less. We have to find a way for there to be balanced use across the country.”   Giovanna Scroccaro, Director of the Pharmaceutical, Prosthetics and Medical Devices Directorate of the Veneto Region and a member of AIFA’s new Scientific and Economic Commission, offered some fascinating insights on the challenges at regional level: “As a region, we have to solve two problems when an advanced therapy drug arrives: quickly identifying the centres and making a budget expenditure forecast. For the first, it must be said that it is not the regions that set the limits, but rather the criteria for defining the centres, which are set at the national level. For the second, on the other hand, we have understood that the current rule does not allow the expenditure to be paid in instalments in the first year of application. This, however, presents difficulties for some regions that are unable to spend.”   Scroccaro continued: “We need to move faster. The regions would like to start six months before the publication of the approval of the drug in the Official Journal and make these assessments. My region, for example, has started to evaluate the EMA data. But these are of no help because we don’t know whether AIFA will impose restrictions, and then we don’t know the price. The exercise undertaken in Veneto therefore is of little help. Instead, I would like to make a proposal: out of 17 advanced therapies evaluated by AIFA, the average time until yesterday was 470 days. With the new AIFA, the prospect is lower, but in all this time there must be interaction with the regions to ensure that they know the evaluation and the price before it is published in the Official Journal. If they could already do this three months in advance, for example, the regions could gear up in time and be ready a week afterwards.” #Italy #AIFA #marketaccess #reimbursement #ATMPs

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Sandoz, the global leader in generic and biosimilar medicines, today announced that the European Commission (EC) has granted marketing authorization for Afqlir® (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference medicine Eylea®. Afqlir® is indicated to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD), aiming to prevent disease-related blindness. Afqlir® is one of several biosimilar value drivers for Sandoz and this approval represents a major step in advancing the company’s growth strategy. Launch is expected as of Q4 2025. Claire D'Abreu-Hayling, Chief Scientific Officer, Sandoz, said: "Vision loss significantly affects daily activities, from work to social interactions. Early and expanded access to effective treatments is essential for patients to maintain and improve their visual acuity. The approval of Afqlir® is a pivotal moment in delivering an affordable and effective treatment option to patients in Europe who are affected by conditions such as nAMD. This milestone underscores our commitment to improving patient outcomes through accessible, high-quality biosimilars." nAMD is a subtype of AMD, characterized by a vision loss in the central zone, and is a leading cause of vision impairment in patients over 65 years of age. nAMD accounts for approximately 10 to 20% of all AMD cases, but is responsible for 90% of the severe vision loss due to AMD. A study found that the prevalence of nAMD in France, Germany, Italy, Spain, the UK, the US and Japan is around 3.6 million patients, of which 2.5 million are diagnosed and only 1.7 million receive treatment. #retinaldiseases #nAMD #visionloss #generics #biosimilars #aflibercept #Afqlir #Sandoz #pioneeringaccessforpatients

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Yesterday, I had the opportunity to represent Sanofi at 𝗠𝗼𝗺𝗸𝗲𝘁𝗶𝗻𝗴 𝟮𝟬𝟮𝟰. 𝗠𝗼𝗺𝗸𝗲𝘁𝗶𝗻𝗴 is the Italian conference, organized by FattoreMamma, 𝗱𝗲𝗱𝗶𝗰𝗮𝘁𝗲𝗱 𝘁𝗼 𝗺𝗮𝗿𝗸𝗲𝘁𝗶𝗻𝗴 𝘄𝗶𝘁𝗵 𝗮 𝗳𝗼𝗰𝘂𝘀 𝗼𝗻 𝗺𝗼𝗺𝘀 𝗮𝗻𝗱 𝗳𝗮𝗺𝗶𝗹𝗶𝗲𝘀. The opportunity to meet and share trends and best practices. I had the chance to present our journey of the last 3 years with our #𝗧𝗼𝗴𝗲𝘁𝗵𝗲𝗿𝗔𝗴𝗮𝗶𝗻𝘀𝘁𝗥𝗦𝗩 𝗰𝗮𝗺𝗽𝗮𝗶𝗴𝗻 𝘁𝗼 𝗿𝗮𝗶𝘀𝗲 𝗽𝗮𝗿𝗲𝗻𝘁𝘀 𝗮𝗻𝗱 𝗳𝗮𝗺𝗶𝗹𝘆 𝗮𝘄𝗮𝗿𝗲𝗻𝗲𝘀𝘀 𝗼𝗻 𝗥𝗲𝘀𝗽𝗶𝗿𝗮𝘁𝗼𝗿𝘆𝗦𝘆𝗻𝗰𝘆𝘁𝗶𝗮𝗹𝗩𝗶𝗿𝘂𝘀 (#RSV). Based on our experience, I think there are some key elements that companies approaching this type of initiative need to consider and adapt to their context/industry. 👂 𝗟𝗶𝘀𝘁𝗲𝗻𝗶𝗻𝗴: companies must have the ability to actively listen their target audience, understand their needs and their evolution over time. 🔄 𝗖𝗼-𝗖𝗿𝗲𝗮𝘁𝗶𝗼𝗻: Companies should directly engage their communities in co-creation projects and activities. This helps build trust and can lead the community to support and disseminate the initiatives carried out by the company, in a kind of widespread activism. 📳 👨‍👩‍👧‍👦 𝗖𝗿𝗲𝗮𝘁𝗲 𝗘𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲𝘀...𝘆𝗲𝘀 𝗯𝘂𝘁 𝗵𝘆𝗯𝗿𝗶𝗱: The company's ability to intercept what is relevant to its target audience is essential. The importance of awareness campaigns is to connect with communities not only in a mediated relationship on screens but also directly, in person. ✅ 𝗧𝗿𝘂𝘀𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆: The importance of having reliable and scientifically correct information, that is at the same time communicatively effective. 📢 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻: importance for companies to be able to tailor communication, authentically, to the right tool, with the right tone by leveraging the strengths that each tool provides. ⬇️ In the video below what we built on our journey.. #TogetherAgainstRSV #prevention #sanofistories

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🚀 With Heppeler Institute joining the ever-growing Normec family, our healthcare division became stronger! This exciting partnership combines Normec’s vast resources with Heppelers expertise in the field of pharmaceutical analysis 🌟 By joining the Normec Group, Heppeler is further expanding and enhancing its expertise and services. A great example is the new possibility of nitrosamine testing.  #nitrosamine #GMP #pharmaceutical

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🎉So proud of my Italian colleagues who pave the way! 🏆Teva Italy obtained the Gender Equality Certification, recognized and supported by the State as part of the National Recovery and Resilience Plan. 🌟As part of the ESG strategy, we are fully committed in implementing a D&I culture across the organization; in line with this several initiatives have been put in place in the Italian affiliate in the recent past, in order to have an organization based on #equality #inclusion #diversity principles. 🔥As a result, 53% of employees are women and managerial roles are covered 65% by women, far above country average. 🙌This certification marks a key milestone in this journey which we are still on, with a mindset of continuous improvement. 🇮🇹In Italy only few companies obtained the Gender Equality Certification, and we are amongst the first pharma companies. It is a privilege to be driving such a cultural change in the industry and in the society! Giordana Cortinovis Umberto Comberiati Serena Corazzina #tevaitalia #teva #genderequality #InclusionAndDiversity #tevalife

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Happy to share our comprehensive review on less known #CDKs #PCTAIREs, their structure, function and alterations in different types of #cancer

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