Latest news with #Novartis
Yahoo
10 hours ago
- Entertainment
- Yahoo
Amy Dowden opens up about the ‘guilt' of feeling ‘angry and bitter' after ringing bell to end cancer treatment
Amy Dowden has opened up about the 'guilt' of feeling 'angry and bitter' after ringing the bell which signalled the end of her cancer treatment, during a speech at an awareness launch. Instead of feeling 'happy and celebrating' like she'd presumed she would, Amy said that 'deep inside I felt angry and bitter.' The Strictly star was speaking at an event to launch the Keep Ahead disease awareness campaign. It 'aims to raise awareness of the life after breast cancer' or 'beyond the bell', according to a release from Novartis, who are behind the initiative. 'I was a bit naïve and in denial as, once I rang the bell, I honestly thought that that's it,' Amy explained. 'I had my life back, but I didn't really anticipate or understand that I had a very long journey of recovery, both physically and mentally to get back to where I was before.' While Amy was going through her treatment, she said she felt like she was working towards a solution, a purpose which, when it ended, she no longer had: 'You're actively doing something. Then all of a sudden, you face a reality of trying to rebuild a new version of you.' Instead, when her treatment finished, Amy said she found herself at an 'all time low' and 'was very emotional. I was scared, petrified and thought 'what if I haven't done enough.' She admitted she experienced 'guilt' for feeling that way. The physical consequences of Amy's treatment and cancer journey meant a long road to recovery. 'I'd had blood clots. I'd had sepsis. I'd broken a bone during chemo," Amy revealed. 'My stamina levels were the lowest they've ever been in my life [and] having to start again - that journey to the dance floor - felt like a million miles away.' However, where Amy is today is a far cry from those first few weeks, following a UK dance tour this year with fellow Strictly star Carlos Gu and filming as a contestant on Celebrity Hunted. 'I took time to really work on myself and to process everything to really get as fit as I possibly could for the gym, physio and dancing,' Amy said. 'I feel like Amy's back, but actually a newer, stronger version of me and I'm really grateful to be in this position. It's been a long road of recovery.' You Might Also Like The anti-ageing wonder ingredient you're missing in your skincare routine 15 dresses perfect for a summer wedding 6 items our fashion team always take on a beach holiday
The Star
17 hours ago
- Health
- The Star
First malaria drug for infants receives Swiss approval
A mother and her child sitting on a bed covered with a mosquito net to protect against malaria-carrying mosquitoes near the town of Bagamoyo in Tanzania. The African nation is one of eight that is expediting approval of the first malaria drug for infants weighing less than 4.5kg. — AFP filepic The first malaria treatment for newborns and young infants has received approval from Swiss health regulators, with eight African countries poised to roll the drug out rapidly, Swiss pharmaceutical giant Novartis announced on July 8 (2025). Malaria is a major killer in Africa, with the continent accounting for 95% of the 597,000 deaths from the disease worldwide in 2023, according to the World Health Organization (WHO). Of those deaths, about 76% – more than 432,000 – were children under five years old, according to the WHO. The infant version of the combined drugs artemether and lumefantrine was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Geneva-based organisation specialising in research and development of medicines against the disease. 'Until now, there has been no approved malaria treatment for infants weighing less than 4.5kg,' Novartis said in a statement. The approval from Switzerland's health authority is for a dose designed for babies weighing two to five kilogrammes. Eight of the countries hit hardest by malaria – Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda – participated in the Swiss approval process. The countries are now expected to approve the treatment quickly themselves, under a programme to facilitate access to medicines for low- and middle-income countries, Novartis said. The pharmaceutical company said it would introduce the treatment 'on a largely not-for-profit basis' to increase access in places where the mosquito-borne disease is endemic. An estimated 263 million people worldwide had malaria in 2023, according to the WHO. Funding to fight the disease is under threat after US President Donald Trump's moves to cut foreign aid. The US government previously provided around 40% of annual funding globally for control and research into malaria. – AFP
Globe and Mail
17 hours ago
- Business
- Globe and Mail
KISQALI Achieves Significant Market Growth, Strengthening Its Position in Breast Cancer and CDK4/6 Inhibitors Segment
KISQALI is a promising CDK4/6 inhibitor used in combination with aromatase inhibitors for the treatment of HR-positive, HER2-negative breast cancer. Its market potential remains strong, driven by its efficacy in prolonging progression-free survival in early and metastatic stages of the disease. With a growing demand for targeted therapies and increasing patient awareness, KISQALI's market is expected to expand further. DelveInsight's ' KISQALI Market Size, Forecast, and Market Insight Report ' highlights the details around KISQALI, a cyclin-dependent kinase (CDK4/6 inhibitor). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of KISQALI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Novartis' KISQALI (ribociclib) Overview KISQALI (ribociclib) is a targeted cyclin-dependent kinase inhibitor, a type of drug that helps slow cancer progression by blocking two proteins, cyclin-dependent kinase 4 and 6 (CDK4/6). When these proteins are overactive, they can cause cancer cells to grow and divide too quickly. By specifically targeting CDK4/6, KISQALI aims to prevent cancer cells from replicating uncontrollably. KISQALI was developed by Novartis in collaboration with Astex Pharmaceuticals. In addition to its FDA approval for early breast cancer (EBC) patients in the US, KISQALI is undergoing regulatory reviews in other regions, including the EU and China. KISQALI has received approval for treating metastatic breast cancer (MBC) in 99 countries, including the US and EU. In the US, it is approved for adults with HR+/HER2- advanced or MBC in combination with an aromatase inhibitor (AI) as initial endocrine therapy (ET) or fulvestrant as initial ET or after disease progression. In the EU, it is approved for women with HR+/HER2- advanced or MBC in combination with an AI or fulvestrant as initial ET or after disease progression. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist. In the context of MBC, KISQALI has consistently shown significant overall survival benefits in three Phase III trials. The NCCN Guidelines for breast cancer recommend KISQALI (ribociclib) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment in HR+/HER2- patients when combined with an AI, making KISQALI the preferred first-line treatment in the US for this patient group. Additionally, KISQALI received the highest score among CDK4/6 inhibitors on the ESMO Magnitude of Clinical Benefit Scale, scoring five out of five for first-line treatment of pre-menopausal patients with HR+/HER2- advanced breast cancer. KISQALI, when combined with either letrozole or fulvestrant, earned a four out of five rating for post-menopausal patients with HR+/HER2- advanced breast cancer in the first-line setting. KISQALI Dosage and Administration The suggested KISQALI dosage is 600 mg (equivalent to three 200 mg film-coated tablets) taken orally once a day for 21 consecutive days, followed by a 7-day break from treatment, making a full cycle of 28 days. KISQALI can be taken with or without food. When used in combination with KISQALI, the recommended dose of fulvestrant is 500 mg, administered on Days 1, 15, 29, and then once a month thereafter. KISAQALI at a Glance Drug Name: KISQALI (ribociclib) Molecule type: Small molecule Developer: Novartis Primary Indication: HR+/HER2− breast cancer Mechanism of action: Cyclin-dependent kinases 4 and 6 inhibitor Route of administration: Oral CDK4/6 inhibitors are a type of targeted cancer therapy that work by blocking the function of cyclin-dependent kinases 4 and 6—enzymes crucial for regulating the cell cycle, particularly the progression from the G1 to S phase, where cells begin DNA replication. By inhibiting these kinases, the drugs effectively stop cancer cell proliferation, leading to growth arrest and potentially cell death. This precise mechanism makes them especially effective in treating hormone receptor-positive, HER2-negative breast cancers, among other types. The introduction and approval of CDK4/6 inhibitors have significantly reshaped the treatment approach for HR+/HER2− metastatic breast cancer. Currently, three main selective CDK4/6 inhibitors, IBRANCE (palbociclib), KISQALI (ribociclib), and VERZENIO (abemaciclib), are commonly used in combination with endocrine therapy as the first-line treatment. Notably, the NCCN now recommends KISQALI as the preferred first-line option for metastatic cases. Once endocrine and targeted therapies no longer work, chemotherapy and antibody-drug conjugates (ADCs) are typically used. IBRANCE remains the market leader among CDK4/6 inhibitors, with around 70% of U.S. patients receiving it when prescribed a drug in this class. Looking ahead, there is strong potential to extend the use of CDK4/6 inhibitors beyond HR+/HER2− advanced breast cancer. According to DelveInsight, market growth in the 7MM is expected to be fueled by rising cancer incidence, greater awareness and access to treatment, and an active pipeline of new indications. Emerging Competitors of KISQALI Some of the CDK4/6 inhibitors in the pipeline include Lerociclib (G1 Therapeutics and Pepper Bio), Atirmociclib (Pfizer), PRT3645 (Prelude Therapeutics), Trilaciclib (G1 Therapeutics), SPH4336 (Shanghai Pharma Biotherapeutics), Dalpiciclib (Jiangsu Hengrui Pharmaceuticals), BGB-43395 (BeiGene), BTX-9341 (Biotheryx), and Euthare-155008 (Shengke Pharmaceuticals), among others. In May 2024, G1 Therapeutics and Pepper Bio announced a global licensing agreement (excluding Asia-Pacific) for lerociclib, a selective CDK4/6 inhibitor. Using their COMPASS platform, Pepper Bio identified CDK4/6 as key targets for Hepatocellular carcinoma, with preclinical models showing superior efficacy. Lerociclib is now advancing to Phase II trials. Key Milestones of KISQALI In December 2024, Novartis shared updated findings from the pivotal Phase III NATALEE trial of KISQALI, highlighting its prolonged effectiveness even after treatment ends when used alongside endocrine therapy (ET). The results demonstrated a 28.5% sustained reduction in the risk of distant recurrence (HR=0.715; 95% CI 0.604–0.847; nominal P<0.0001) compared to ET alone in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC). In November 2024, Novartis announced that the European Commission (EC) had approved KISQALI, in combination with an aromatase inhibitor (AI), for use as adjuvant treatment in patients with HR-positive HER2-negative early breast cancer who are at high risk of recurrence. In September 2024, Novartis announced that the FDA has approved KISQALI, in combination with an aromatase inhibitor (AI), for adjuvant treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) who are at high risk of recurrence — including individuals with node-negative (N0) disease. In September 2020, Novartis proudly shared that KISQALI received the highest possible score—five out of five—on the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale (ESMO-MCBS) for use as a first-line treatment in premenopausal patients with hormone receptor-positive, HER2-negative (HR+/HER2-) advanced or metastatic breast cancer. In July 2018, Novartis received a new approval from the FDA for KISQALI (ribociclib) to treat women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced or metastatic breast cancer. In March 2017, the FDA approved KISQALI, in combination with an aromatase inhibitor, as a first-line endocrine-based treatment for postmenopausal women with hormone receptor-positive, HER2-negative (HR+/HER2−) advanced or metastatic breast cancer. Discover how KISQALI CDK4/6 inhibitor is shaping the breast cancer treatment landscape @ KISQALI Cost KISQALI Market Dynamics KISQALI (ribociclib) is a CDK4/6 inhibitor used primarily in the treatment of HR-positive, HER2-negative breast cancer. Since its approval in 2017 by the FDA, it has become a key player in the competitive oncology market. The drug works by inhibiting cyclin-dependent kinases 4 and 6, which are responsible for the progression of many cancers, including breast cancer. KISQALI is typically used in combination with aromatase inhibitors or letrozole, offering a therapeutic advantage by enhancing anti-tumor efficacy while also maintaining manageable safety profiles. The market dynamics for KISQALI are heavily influenced by the broader competitive landscape of CDK4/6 inhibitors, with notable competitors including IBRANCE (palbociclib) and VERZENIO (abemaciclib). These drugs are all vying for market share in a segment that is expected to grow significantly due to increasing breast cancer diagnoses and the demand for targeted therapies. KISQALI has carved a niche for itself with favorable clinical trial data, including its ability to deliver improved progression-free survival rates, which is appealing to oncologists and healthcare providers. However, pricing pressures, especially in markets with significant healthcare budget constraints, and the rising popularity of combination therapies will influence KISQALI's market position in the coming years. Additionally, ongoing research and the potential for new indications could further shape KISQALI's growth trajectory. Table of Contents 1. Report Introduction 2. KISQALI: Novartis 2.1. Product Overview 2.2. Other Development Activities 2.3. Clinical Development 2.4. Clinical Trials Information 2.5. Safety and Efficacy 2.6. Product Profile 2.7. Market Assessment 2.7.1. The 7MM Analysis 2.7.1.1. Cost Assumptions and Rebate 2.7.1.2. Pricing Trends 2.7.1.3. Analogue Assessment 2.7.1.4. Launch Year and Therapy Uptake 2.7.2. The United States Market Analysis 2.7.3. EU4 and the United Kingdom Market Analysis 2.7.3.1. Germany 2.7.3.2. France 2.7.3.3. Italy 2.7.3.4. Spain 2.7.3.5. UK 2.7.4. Japan Market Analysis 2.8. Market Drivers 2.9. Market Barriers 2.10. SWOT Analysis 3. Key Cross of Marketed Competitors of KISQALI 4. Key Cross of Emerging Competitors of KISQALI Related Reports CDK4/6 Inhibitor Market CDK4/6 Inhibitor Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CDK4/6 inhibitor companies, including Pfizer, Prelude Therapeutics, G1 Therapeutics, Pepper Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Media Contact Company Name: DelveInsight Contact Person: Sandeep Joshi Email: Send Email Phone: +14699457679 Address: 304 S. 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Yahoo
a day ago
- Health
- Yahoo
Analysis Group Co-Authors Examine the Advancements in and Application of Health Economics and Outcomes Research to the Evaluation of Cell and Gene Therapies for Rare Diseases
BOSTON, July 22, 2025 /PRNewswire/ -- In a new article published in Value in Health, researchers from Analysis Group, a global leader in health economics and outcomes research (HEOR), collaborated with Novartis to examine how HEOR is transforming the evaluation and access pathways for cell and gene therapies (CGTs) for rare diseases. As CGTs move from experimental to increasingly approved treatments for rare diseases, health systems face urgent questions about how to evaluate, reimburse, and scale their access equitably. In their article, the authors spotlight five key HEOR innovation areas that are enhancing the generation of real-world evidence (RWE), supporting novel endpoints, and shaping future models of affordability and access. Because of small patient populations, heterogeneous disease presentations, a lack of effective alternative treatments, and hence, ethical concerns, gold standard randomized double-blind controlled clinical trials are often not suitable for establishing efficacy and safety for CGT treatments. Consequently, traditional economic models are not able to capture the holistic value of CGTs, given that the true benefits associated with such treatments are subject to a much longer time outside of the trial periods. For example, for patients with rare hereditary genetic disorders, timely access to CGTs can yield real differences in meaningful gains in life years. To address these challenges, researchers are increasingly relying on innovations in HEOR to inform proper clinical and economic evaluation of CGTs. An Analysis Group team led by Managing Principal Min Yang, Manager Su Zhang, and affiliate Lou Garrison collaborated with researchers from Novartis, led by Dr. Walter Toro, to examine the advancements in the evaluation of CGTs made possible by HEOR innovations, including the design and collection of long-term real-world data (RWD) for CGT efficacy extrapolation, justification for use of novel endpoints, integration of patient voices and preferences, and application of sophisticated statistical methodology, sometimes augmented with artificial intelligence (AI) or natural language processors. These advances are reflected in regulators' and health technology assessment (HTA) agencies' growing openness to the acceptance of RWE and patient-centered endpoints in their evaluations, marking a shift from traditional standards that may not suit CGTs. The authors note that emerging value assessment frameworks and novel reimbursement models offer solutions and adaptability to decision makers with enhanced ability to manage health equity and affordability.
Int'l Business Times
2 days ago
- Business
- Int'l Business Times
AstraZeneca To Invest $50 Bn In The US As Tariff Threat Looms
British pharmaceutical giant AstraZeneca said Tuesday it would invest $50 billion in the United States by 2030 amid Donald Trump's threats to impose tariffs on the sector. The funds will boost its manufacturing and research operations in the US, including the construction of a multi-billion-dollar factory in Virginia, the company said in a statement. "Today's announcement underpins our belief in America's innovation in biopharmaceuticals," chief executive Pascal Soriot said in a statement. US President Donald Trump has opened the door to potential tariffs targeting pharmaceuticals, which had up to now benefited from exemptions to his sweeping levies on imports from trading partners. He ordered an investigation into pharmaceutical imports, suggesting that levies could reach up to 200 percent. The United States is a key market for the pharmaceutical industry, and AstraZeneca said it expects 50 percent of its revenue to come from the US by 2030. AstraZeneca has already begun transferring part of its European production to the United States, it announced in April. While the drugmaker could become exposed to US levies on its European-made products, Soriot has said that the impact would be limited due to the ongoing shift in production. Other major pharmaceutical companies, which had been exempt from tariffs for 30 years, have in recent months begun shifting investment and production to the United States. Swiss pharmaceutical giants Roche and Novartis and France's Sanofi have all announced multi-billion-dollar investments in the US. "For decades, Americans have been reliant on foreign supply of key pharmaceutical products," US Commerce Secretary Howard Lutnick said in a statement. He added that the new tariffs are focused on "ending this structural weakness". Tuesday's announcement included a new factory in Virginia, which will be the company's "largest single manufacturing investment". It adds to AstraZeneca's previously announced $3.5 billion investment in the US by 2026. "Soriot implied... that AstraZeneca wasn't wedded to a particular country and that it would invest wherever it made financial sense," said AJ Bell investment director Russ Mould. However, he noted that "the more business it does in the country, the greater the likelihood that investors might push for AstraZeneca to switch its main stock listing to the US." The pharmaceutical company abandoned plans earlier in the year to build a GBP450 million ($606 million) vaccine plant in the UK city of Liverpool, citing timing issues and a reduction in subsidies offered by the government. The move "was the big clue that it was losing patience with the UK government," said Mould. AstraZeneca reported a first-quarter profit rise of over 30 percent in April, noting that 40 percent of its revenue was generated in the US.
