What made Mount Etna's latest eruption so rare
MILAN — Mount Etna, the volcano that towers over eastern Sicily, has again captivated the world with a spectacular show , spewing smoke and high into the sky.
But the defining event of Monday's eruption was the more rare pyroclastic flow from the southwestern crater not visible from a distance.
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Final Data from Teva's PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY® (fremanezumab) for the Prevention of Chronic and Episodic Migraine
Final analysis of PEARL real world migraine prevention study presented at 11th Congress of the European Academy of Neurology (EAN 2025) Congress in Helsinki1,2 Fremanezumab demonstrated sustained effectiveness and a favourable safety and tolerability profile over the two-year study period1,2 Injection adherence remained high throughout the study (~90%), while over 75% of patients completed the study duration1 TEL AVIV, Israel, June 23, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the final analysis of the pan-European PEARL Phase 4 migraine prevention study showed that AJOVY (fremanezumab), an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, delivered sustained effectiveness over a two-year period in reducing frequency, duration and severity of migraine attacks in patients with chronic and episodic migraine.1 The final data was presented at the Congress of the European Academy of Neurology (EAN 2025) congress in Helsinki confirming that primary and secondary endpoints had been met.1 Investigators concluded that the findings underscore the sustained effectiveness and the robust injection adherence rates to long-term fremanezumab treatment in migraine prevention.1 'Over the last two years, we have observed the benefit of fremanezumab for sustained migraine prevention and its positive impact on patient outcomes,' says Messoud Ashina, Professor and Director of the Human Migraine Research Unit, the Danish Headache Center and Department of Neurology. 'The PEARL study has provided valuable insight, not only into the pivotal role that fremanezumab can play in migraine prevention, but also in the importance of real-world studies in helping build our knowledge and shape clinical practice.' PEARL, a 24-month real-world observational study assessed the impact of fremanezumab for migraine prevention in 1,140 patients, predominantly female (87.25%) with 33.1% living with episodic migraine (EM), and 66.9% with chronic migraine (CM). The final study showed that over 66% of patients with EM and 51.6% with CM who had achieved the primary endpoint of a ≥50% reduction in Monthly Migraine Days (MMD) during the first 6 months of treatment benefitted from sustained migraine prevention for over 24 months. Injection adherence rates remained high throughout (~90%) the study, with over 75% (854/1129) of participants completing the study duration.1 The investigators also noted the favourable long-term safety and tolerability of fremanezumab that was consistent with its known safety profile from previous PEARL interim analyses and randomised controlled trials, supporting its continued clinical use for migraine prevention.2 'The final analysis of the PEARL real-world study reaffirms the long-term effectiveness and safety profile of fremanezumab in the preventive treatment of chronic and episodic migraine,' said Pinar Kokturk, M.D., Vice President and Head of Medical Affairs Europe at Teva. 'These data provide valuable real-world evidence supporting fremanezumab's sustained clinical benefit, particularly in a population burdened by high disease impact and a need for preventive therapy. With migraine being the second leading cause of disability worldwide,3 the recognition of CGRP-pathway therapies by health authorities is critical for improving patient outcomes.' Editors' Notes PEARL (Pan-European Real-World study), a two-year prospective, observational Phase IV study is investigating the effectiveness of AJOVY® (fremanezumab) in 1140 patients with chronic or episodic migraine. Fremanezumab is a humanised monoclonal antibody (mAb) that selectively targets the calcitonin gene-related peptide (CGRP) pathway. Of the 1140 participants enrolled, 1129 were included in the effectiveness analysis (EM, 33.1%; CM, 66.9%; 87.2% female). Eligible participants were adults with EM or CM receiving fremanezumab for migraine prevention, who maintained a daily headache diary prior to and throughout the study period. The primary endpoint was the proportion of participants with >=50% reduction in monthly migraine days (MMD) during the 6-month period after fremanezumab initiation. Secondary endpoints across Months 1–24 included mean change from baseline in MMD, and treatment adherence (participants who took their prescribed dose within ±5 days of the scheduled monthly/quarterly dosing regimen, per injection) and persistence. About AJOVY® (fremanezumab-vfrm) injection AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a health care professional or at home by a patient or caregiver. No starting dose is required to begin treatment. Information for Europe about AJOVY can be found here. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit Cautionary Note Regarding Forward-Looking Statements This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AJOVY (fremanezumab) for the prevention of chronic or episodic migraine; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned 'Risk Factors.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Teva Media Inquiries:TevaCommunicationsNorthAmerica@ Teva Investor Relations Inquires:TevaIR@ References 1. Ashina M. et al, Real-World Effectiveness of Fremanezumab in Migraine Prevention: Final Outcomes of the Pan-European PEARL Study (EPR-039), poster presented at the European Academy of Neurology (EAN) Congress; 21 – 24 June, 2025; Helsinki, Finland.2. Ashina M et al, Real-World Safety and Tolerability of Fremanezumab in Migraine Prevention: Final Outcomes of the PEARL Study (EPO-063), poster presented at the European Academy of Neurology (EAN) Congress; 21 – 24 June, 2025; Helsinki, Finland.3. Steiner, T.J., Stovner, L.J., Jensen, R. et al. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21, 137 (2020).Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Bloomberg
an hour ago
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Greece Evacuates Parts of Xios After Fires Hit Aegean Sea Island
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Yahoo
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AB Science - New peer-reviewed data provide strong evidence supporting masitinib potential for the treatment of Alzheimer's disease
PRESS RELEASE NEW PEER-REVIEWED DATA PROVIDE STRONG EVIDENCE SUPPORTING MASITINIB'S POTENTIAL FOR THE TREATMENT OF ALZHEIMER'S DISEASE THROUGH A DUAL MECHANISM OF COGNITIVE ENHANCEMENT AND NEUROPROTECTION THIS PUBLICATION CORROBORATES NEW ANALYSIS FROM THE CLINICAL PHASE 2B/3 STUDY SHOWING COGNITIVE IMPROVEMENT UNDER MASITINIB TREATMENT PHASE 3 CLINICAL STUDY WITH MASITINIB AS A DISEASE-MODIFYING THERAPY FOR ALZHEIMER'S DISEASE HAS BEEN AUTHORIZED BY THE FDA AND KEY EU COUNTRIES Paris, June 23, 2025, 8am CET AB Science SA (Euronext - FR0010557264 - AB) today announced that a new peer-reviewed study from an independent research team based in China (Guangdong Pharmaceutical University and Sun Yat-sen University) presents new evidence showing that masitinib offers a promising new approach to treating Alzheimer's disease, specifically the most common form, sporadic Alzheimer's disease (sAD), which accounts for over 95% of all cases. Masitinib is a highly innovative drug for Alzheimer's disease because unlike the majority of drug development research in this indication, masitinib targets the brain's innate immune system, including mast cells and microglia. The positioning of masitinib as a treatment of Alzheimer's disease is also different from other drugs. New evidence from peer-reviewed study This new publication is accessible online from the Neuroscience Letters journal website at: [1] In the study, researchers used a well-established mouse model that mimics the cognitive and behavioral symptoms of human sAD. When treated with masitinib, the mice showed marked improvements in memory, learning, sense of smell, and anxiety-like behaviors, all of which are early indicators of Alzheimer's progression. The research also revealed that masitinib: • Reduced toxic brain proteins such as hyperphosphorylated Tau. • Alleviated synaptic dysfunction and morphological damage, i.e., it protected synapses, which are essential for brain cell communication. • Suppressed microglial activation, which in turn inhibited the NF-κB/NLRP3/caspase-1 signaling axis, a key inflammatory signaling cascade linked to Alzheimer's disease, thereby suppressing inflammation in the brain of sAD mice. The authors emphasized that this is the first study to demonstrate that masitinib attenuates sporadic Alzheimer's disease pathology through dual mechanisms of cognitive enhancement and neuroprotection. Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France said, 'These new, independent findings provide strong evidence supporting masitinib as a promising disease-modifying therapy for sporadic Alzheimer's disease and perfectly compliment previously published clinical and preclinical data for masitinib in this indication.' New data from phase 2B/3 study in patients with mild Alzheimer's disease It has previously been shown that masitinib enhances cognitive function and synaptic integrity in a familial Alzheimer's disease mouse model [2]. Moreover, randomized, placebo-controlled, phase 2 and phase 2B/3 studies demonstrated that masitinib (4.5 mg/kg/day) can effectively delay or mitigate the progression of dementia [3,4]. Clinical and preclinical study findings have also been summarized in a review article [5], with the authors concluding that 'all research studies revealed positive effects concerning the cognitive functions in Alzheimer's disease and generally with good safety and tolerability'. New analysis from the completed phase 2B/3 study (AB09004), shows that masitinib treatment may not only slow down worsening of cognition in patients with mild Alzheimer's disease, but actually improves it over the treatment period of 24 weeks. Indeed, study AB09004 included patient with both mild and moderate AD (MMSE [12 - 25]). In the overall study population, which included patient with both mild and moderate AD (MMSE [12 - 25]), masitinib 4.5 mg/kg/day plus standard of care (memantine and anticholinesterase) demonstrated a significant reduction in cognitive impairment (ADAS-Cog LS Mean Diff = -2.15; p=0.0003) compared with standard of care alone. However, the clinical benefit on ADAS-Cog was greater in patients with mild impairment (LS Mean Diff = -2.89 ; p=0.0008) than in patients with moderate impairment (LS Mean Diff = -1.74; p=0.0284). Notably, there was a meaningful improvement in cognitive function between baseline and week 24 in the mild AD subgroup under masitinib treatment (LS Mean = -2.47), while it remained stable in the control arm (LS Mean = -0.42), as presented in the table below. ADAS-COG Change from Baseline to Week 24 N LS Mean LS Mean Diff.(97.51% CI) p-value Mild and moderate AD patients Masitinib 4.5 mg/kg/day + SoC 182 -1.45 -2.15(-3.48, -0.81) 0.0003 Placebo + SoC 176 0.69 ADAS-COG Change from Baseline to Week 24 N LS Mean LS Mean Diff.(97.51% CI) p-value Mild patients [MMSE (21-25)] Masitinib 4.5 mg/kg/day + SoC 63 -2.47 -2.89(-4.80, -0.99) 0.0008 Placebo + SoC 61 0.42 Moderate patients [MMSE (12-20)] Masitinib 4.5 mg/kg/day + SoC 119 -1.04 -1.74(-3.52, 0.04) 0.0284 Placebo + SoC 115 0.70 SoC = Standard of care = memantine and anticholinesteraseNote : Negative change in LS Mean of ADAS-COG means an improvement of cognition. Positive change in LS Mean of ADAS-COG means a worsening of cognition. Authorized phase 3 to support New Drug Application in case of success AB Science previously received an Investigational New Drug (IND) approval letter from the FDA and similar authorizations from several European countries to initiate Phase III study (AB21004) in patients with Alzheimer's disease. Study AB21004 is a randomized, double-blind phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild Alzheimer's disease, as an add-on therapy to standard of care, cholinesterase inhibitors and/or memantine. The study will enroll 600 patients. The objective of study AB21004 is to confirm results from the first phase 2B/3 study, AB09004, which showed that masitinib administered at 4.5 mg/kg/day significantly slowed cognitive deterioration relative to placebo and also reduced loss of functional ability in activities of daily living in the targeted AD population. Study AB21004 will evaluate the effect of masitinib on absolute change from baseline in cognition (ADAS-Cog-11) as primary endpoint and integrated AD rating scale (iADRS) and daily living (ADCS-ADL) as secondary endpoints. Expected patent protection until 2041 Based on the results from AB09004 study, AB Science filed a patent application relating to methods of treating Alzheimer's disease (i.e. a medical use patent) with its lead compound masitinib (WO2022129410A1). If granted, this patent will provide intellectual property protection for masitinib in this indication until 2041. A similar strategy was successfully applied in Amyotrophic Lateral Sclerosis, with medical use patent for masitinib in ALS being granted worldwide (press release dated June 1st 2023). References : Jia K, Shen Q, Zhang Z, et al. Masitinib attenuates neuropathological changes in acrolein-induced sAD mouse model via NF-κB/NLRP3/Caspase-1 signaling pathway. Neurosci Lett. Volume 862, 27 July 2025, 138300. Published online June 10, 2025. Li T, Martin E, Abada YS, et al. Effects of Chronic Masitinib Treatment in APPswe/PSEN1dE9 Transgenic Mice Modeling Alzheimer's Disease. J Alzheimers Dis. 2020;76(4):1339-1345. doi:10.3233/JAD-200466 Dubois B, López-Arrieta J, Lipschitz S, et al. Masitinib for mild-to-moderate Alzheimer's disease: results from a randomized, placebo-controlled, phase 3, clinical trial [published correction appears in Alzheimers Res Ther. 2023 Apr 22;15(1):85. doi: 10.1186/s13195-023-01230-9.]. Alzheimers Res Ther. 2023;15(1):39. Piette F, Belmin J, Vincent H, et al. Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial. Alzheimers Res Ther. 2011;3(2):16. Published 2011 Apr 19. doi:10.1186/alzrt75 Ettcheto M, Cano A, Sanchez-López E, et al. Masitinib for the treatment of Alzheimer's disease. Neurodegener Dis Manag. 2021;11(4):263-276. doi:10.2217/nmt-2021-0019 About AB ScienceFounded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment. AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB). Further information is available on AB Science's website: Forward-looking Statements - AB ScienceThis press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance. These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB ScienceFinancial Communication & Media Relations investors@ Attachment Alz sAD Model PreClin vENG VFError while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
