Jordan's Economic Outlook For 2024"Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum." Section 1.10.32 of "de Finibus Bonorum et Malorum", written by Cicero in 45 BC "Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Neque porro quisquam est, qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit, sed quia non numquam eius modi tempora incidunt ut labore et dolore magnam aliquam quaerat voluptatem. Ut enim ad minima veniam, quis nostrum exercitationem ullam corporis suscipit laboriosam, nisi ut aliquid ex ea commodi consequatur? Quis autem vel eum iure reprehenderit qui in ea voluptate velit esse quam nihil molestiae consequatur, vel illum qui dolorem eum fugiat quo voluptas nulla pariatur?" 1914 translation by H. Rackham "But I must explain to you how all this mistaken idea of denouncing pleasure and praising pain was born and I will give you a complete account of the system, and expound the actual teachings of the great explorer of the truth, the master-builder of human happiness. No one rejects, dislikes, or avoids pleasure itself, because it is pleasure, but because those who do not know how to pursue pleasure rationally encounter consequences that are extremely painful. Nor again is there anyone who loves or pursues or desires to obtain pain of itself, because it is pain, but because occasionally circumstances occur in which toil and pain can procure him some great pleasure. To take a trivial example, which of us ever undertakes laborious physical exercise, except to obtain some advantage from it? But who has any right to find fault with a man who chooses to enjoy a pleasure that has no annoying consequences, or one who avoids a pain that produces no resultant pleasure?" 1914 translation by H. Rackham "But I must explain to you how all this mistaken idea of denouncing pleasure and praising pain was born and I will give you a complete account of the system, and expound the actual teachings of the great explorer of the truth, the master-builder of human happiness. No one rejects, dislikes, or avoids pleasure itself, because it is pleasure, but because those who do not know how to pursue pleasure rationally encounter consequences that are extremely painful. Nor again is there anyone who loves or pursues or desires to obtain pain of itself, because it is pain, but because occasionally circumstances occur in which toil and pain can procure him some great pleasure. To take a trivial example, which of us ever undertakes laborious physical exercise, except to obtain some advantage from it? But who has any right to find fault with a man who chooses to enjoy a pleasure that has no annoying consequences, or one who avoids a pain that produces no resultant pleasure?" Thanks for your interest in Kalkine Media's content! To continue reading, please log in to your account or create your free account with us.
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The Two Faces Of Violence:Column: How veterans can lead America’s fight for unityOverall Outlook in 2025 Libra, 2025 promises to be a year of growth and transformation for you. Saturn’s influence will bring employment opportunities and success in competitions, while Jupiter will help you rise in social status and expand your contacts. This year, you may experience some delays and challenges, but these will pave the way for long-term achievements. Stay focused and patient as the stars guide you towards personal and professional advancement. Love & Relationships in 2025 This year, your relationships may go through a mix of highs and lows. While Saturn's influence may bring some delays or challenges in romantic matters, Jupiter’s placement after May will bring opportunities to connect with influential people, enriching your social circle. If you’re in a relationship, focus on communication and understanding. Career & Finances in 2025 Saturn’s placement will push you to work hard and excel in your career. Expect success in competitive ventures, especially in the first half of the year. Jupiter will play a pivotal role in boosting your reputation and bringing recognition for your efforts. Financially, you may face minor challenges, but these will be outweighed by gains from strategic decisions. Avoid impulsive investments and focus on long-term financial stability. Health in 2025 Health might need extra attention, especially in the first half of the year. Saturn’s transit could bring minor health issues or fatigue due to overwork. However, as Jupiter moves into a favorable position, you’ll notice improvements in energy and overall wellness. Maintain a balanced lifestyle, prioritize rest, and adopt a healthy diet to keep any health concerns at bay. Best Months of 2025 The most favorable months for you will be June, July, and August. These months will bring positivity in both personal and professional life, helping you make significant progress. Bad Months of 2025 Be cautious during January, February, and April. These months may bring delays in your plans and minor challenges in relationships and finances. Handle situations with patience and care. Key Mantra for 2025 "Patience and persistence pave the path to success." Stay focused on your goals, and trust that your hard work will lead to remarkable outcomes. Libra Sign Attributes Strength: Idealist, socially presentable, Aesthetic, Charming, Artsy, Generous Weakness: Uncertain, Lazy, Non-interventionist Symbol: Scales Element: Air Body Part: Kidneys & Bladder Sign Ruler: Venus Lucky Day: Friday Lucky Color: Brown Lucky Number: 3 Lucky Stone: Diamond Libra Sign Compatibility Chart Natural affinity: Gemini, Leo, Sagittarius, Aquarius Good compatibility: Aries, Libra Fair compatibility: Taurus, Virgo, Scorpio, Pisces Less compatibility: Cancer, Capricorn By: Dr. J. N. Pandey Vedic Astrology & Vastu Expert Website: www.astrologerjnpandey.com E-mail: djnpandey@gmail.com Phone: 91-9811107060 (WhatsApp Only)
Delray Beach (US), Dec 29 (AP) A high-speed passenger train collided with a fire truck at a crossing Saturday morning in Florida, injuring three firefighters and at least a dozen train passengers, authorities said. The crash happened at 10:45 am in crowded downtown Delray Beach, multiple news outlets reported. The Brightline train was stopped on the tracks, its front destroyed, about a block away from the Delray Beach Fire Rescue truck, its ladder ripped off and strewn in the grass several yards away, The Sun-Sentinel reported. The Delray Beach Fire Rescue said in a social media post that three Delray Beach firefighters were in stable condition at a hospital. Palm Beach County Fire Rescue took 12 people from the train to the hospital with minor injuries. Emmanuel Amaral rushed to the scene on his golf cart after hearing a loud crash and screeching train brakes from where he was having breakfast a couple of blocks away. He saw firefighters climbing out of the window of their damaged truck and pulling injured colleagues away from the tracks. One of their helmets came to rest several hundred feet away from the crash. “The front of that train is completely smashed, and there was even some of the parts to the fire truck stuck in the front of the train, but it split the car right in half. It split the fire truck right in half, and the debris was everywhere,” Amaral said. Brightline officials did not immediately comment on the crash. A spokesperson for the National Transportation Safety Board said it was still gathering information about the crash and had not decided yet whether it will investigate. The NTSB is already investigating two crashes involving Brightline's high-speed trains that killed three people early this year at the same crossing along the railroad's route between Miami and Orlando. More than 100 people have died after being hit by trains since Brightline began operations in July 2017 — giving the railroad the worst death rate in the nation. But most of those deaths have been either suicides, pedestrians who tried to run across the tracks ahead of a train or drivers who went around crossing gates instead of waiting for a train to pass. Brightline has not been found to be at fault in those previous deaths. Railroad safety has been a concern since a Norfolk Southern train derailed in East Palestine, Ohio, in February 2023, spilling toxic chemicals that caught fire. Regulators urged the industry to improve safety and members of Congress proposed a package of reforms, but railroads have not made many major changes to their operations and the bill has stalled. Earlier this month the two operators of a Union Pacific train were killed after it collided with a semitrailer truck that was blocking a crossing in the small West Texas town of Pecos. Three other people were injured, and the local Chamber of Commerce building was damaged. (AP) SCY SCY (This story has not been edited by THE WEEK and is auto-generated from PTI)
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec 8, 2024-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from a five-year follow-up of the pivotal Phase III POLARIX study evaluating Polivy ® (polatuzumab vedotin-piiq) in combination with Rituxan ® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (DLBCL). Data were presented in an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, December 7-10, 2024 in San Diego, California. This latest analysis conducted after a median follow-up of 60.9 months, includes descriptive data on primary and secondary endpoints, as well as safety results. “POLARIX was the first trial to elevate treatment standards for frontline diffuse large B-cell lymphoma in 20 years and we are additionally encouraged by the five-year follow-up results,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “More than 38,000 people worldwide have been treated with Polivy in combination with R-CHP and these data continue to underscore its potential to improve outcomes for people diagnosed with this aggressive lymphoma.” Follow-up exploratory analysis after five-years indicated a positive trend in overall survival (OS) in the intent-to-treat (ITT) population in favor of Polivy in combination with R-CHP compared to Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). Results showed a trend in reduction in the risk of death (HR 0.85; 95% CI: 0.63–1.15) for people with previously untreated DLBCL with the Polivy combination, an improvement on the three-year follow-up data (HR 0.94; 95% CI: 0.67–1.33). The five-year analysis of POLARIX indicates that the full difference in OS between treatment arms has yet to be observed and an additional two years of follow-up will continue. “Diffuse large B-cell lymphoma is a notoriously challenging cancer to treat, however, Polivy in combination with R-CHP has shown to be a critical advance for patients by helping to reduce relapse and disease progression,” said Gilles Salles, M.D., Ph.D., chief of Lymphoma Service, Division of Hematological Malignancies, Memorial Sloan Kettering Cancer Center, New York. “The survival trend seen in this follow-up analysis reinforces the potential impact of frontline treatment with Polivy in combination with R-CHP and its role as a standard of care therapy.” In addition to the positive trend in OS, an observational analysis suggested nearly 25% fewer follow-up treatments such as radiation, systemic chemotherapy and CAR-T cell therapy were needed in patients receiving Polivy in combination with R-CHP compared to those treated with R-CHOP (38.3% versus 61.7%). At five years of follow-up, benefits in progression-free survival and disease-free survival with Polivy in combination with R-CHP were maintained, consistent with the three-year follow-up data, reinforcing the potential of Polivy in combination with R-CHP to provide durable and lasting remissions. The latest follow-up data also showed a numerical reduction in death related to patients’ lymphoma in those treated with Polivy in combination with R-CHP compared to those treated with R-CHOP (9.0% versus 11.4%). The safety profile remains consistent with the known profiles of the individual study medicines with no new safety signals observed, reinforcing the positive benefit-risk profile of this Polivy combination. Results from an expanded cohort of 1,000 patients including global and Chinese patients demonstrated comparability to the global ITT population. Polivy in combination with R-CHP is currently approved for the treatment of first-line (1L) DLBCL in more than 90 countries worldwide including the U.S., countries throughout the EU, the U.K., Japan, Canada and China. Genentech continues to work with health authorities around the world to bring this treatment regimen to even more patients. Genentech aims to offer various treatment options for DLBCL that meet the diverse needs of patients and healthcare systems. In an effort to elevate treatment standards even further, Genentech is exploring Polivy in combination with other molecules, including its bispecific antibodies. Studies include the Phase III SUNMO trial evaluating the efficacy and safety of subcutaneously administered Lunsumio ® (mosunetuzumab-axgb) in combination with intravenous (IV) Polivy versus IV Rituxan plus gemcitabine and oxaliplatin (R-GemOx) in second-line or later DLBCL, and the Phase III SKYGLO trial investigating the efficacy of Polivy in combination with R-CHP and Columvi ® (glofitamab-gxbm) versus Polivy in combination with R-CHP in 1L DLBCL. About the POLARIX Study POLARIX [ NCT03274492 ] is an international Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy ® (polatuzumab vedotin-piiq) plus Rituxan ® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) versus Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Eight-hundred and seventy-nine patients were randomized 1:1 to receive either Polivy plus R-CHP plus a vincristine placebo for six cycles, followed by Rituxan for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of Rituxan. The primary outcome measure is progression-free survival as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma. POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). About Diffuse Large B-Cell Lymphoma Diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and is the most common form of non-Hodgkin’s lymphoma (NHL) in the U.S. While many people with DLBCL are responsive to treatment, the majority of those who relapse or are refractory to subsequent treatments have poor outcomes. DLBCL not otherwise specified is the most common category of large B-cell lymphoma (LBCL) and accounts for about 80% or more of cases. It applies to cases that do not fall into any specific disease subgroups of LBCL. About Polivy ® (polatuzumab vedotin-piiq) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL. Polivy U.S. Indication Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL). Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies. Important Safety Information Possible serious side effects Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects. Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication Side effects seen most often The most common side effects during treatment were Nerve problems in arms and legs Nausea Tiredness or lack of energy Diarrhea Constipation Hair loss Redness and sores of the lining of the mouth, lips, throat, and digestive tract Polivy may lower your red or white blood cell counts and increase uric acid levels. Polivy may not be for everyone. Talk to your doctor if you are Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment. You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . You may also report side effects to Genentech at (888) 835-2555. Please see the full Prescribing Information and visit https://www.Polivy.com for additional Important Safety Information. About Lunsumio ® (mosunetuzumab-axgb) Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin’s lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers. Lunsumio U.S. Indication Lunsumio (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer. It is not known if Lunsumio is safe and effective in children. The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the drug works. What is the most important information I should know about Lunsumio? Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including: fever of 100.4°F (38°C) or higher chills low blood pressure fast or irregular heartbeat tiredness or weakness difficulty breathing headache confusion feeling anxious dizziness or light-headedness nausea vomiting Due to the risk of CRS, you will receive Lunsumio on a “step-up dosing schedule.” The step-up dosing schedule is when you receive smaller “step-up” doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment You will receive a higher dose of Lunsumio on Day 15 of your first cycle of treatment If your dose of Lunsumio is delayed for any reason, you may need to repeat the step-up dosing schedule Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS Your healthcare provider will check you for CRS during treatment with Lunsumio and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio, if you have severe side effects. What are the possible side effects of Lunsumio? Lunsumio may cause serious side effects, including: neurologic problems. Lunsumio can cause serious and life-threatening neurological problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio, including: headache numbness and tingling of the arms, legs, hands, or feet dizziness confusion and disorientation difficulty paying attention or understanding things forgetting things or forgetting who or where you are trouble speaking, reading, or writing sleepiness or trouble sleeping tremors loss of consciousness seizures muscle problems or muscle weakness loss of balance or trouble walking tiredness serious infections. Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Lunsumio, including: fever of 100.4° F (38° C) or higher chest pain tiredness shortness of breath painful rash sore throat pain during urination feeling weak or generally unwell hemophagocytic lymphohistiocytosis (HLH) . Lunsumio can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with Lunsumio. Your health care provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include: fever enlarged spleen easy bruising low blood cell counts liver problems low blood cell counts. Low blood cell counts are common during treatment with Lunsumio and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio. Lunsumio can cause the following low blood cell counts: low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems growth in your tumor or worsening of tumor related problems (tumor flare). Lunsumio can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with Lunsumio: chest pain cough trouble breathing tender or swollen lymph nodes pain or swelling at the site of the tumor Your healthcare provider may temporarily stop or permanently stop treatment with Lunsumio if you develop severe side effects. The most common side effects of Lunsumio include: tiredness, rash, fever, and headache. The most common severe abnormal blood test results with Lunsumio include: decreased phosphate, increased glucose, and increased uric acid levels. Before receiving Lunsumio, tell your healthcare provider about all of your medical conditions, including if you: have ever had an infusion reaction after receiving Lunsumio have an infection, or have had an infection in the past which lasted a long time or keeps coming back have or have had Epstein-Barr Virus are pregnant or plan to become pregnant. Lunsumio may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio Females who are able to become pregnant: your healthcare provider should do a pregnancy test before you start treatment with Lunsumio you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of Lunsumio are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while receiving Lunsumio? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems. These are not all the possible side effects of Lunsumio. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio. You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . You may also report side effects to Genentech at (888) 835-2555. Please see Important Safety Information, including Serious Side Effects, as well as the Lunsumio full Prescribing Information and Medication Guide or visit https://www.Lunsumio.com . About Columvi ® (glofitamab-gxbm) Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Genentech’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development program that also includes Lunsumio ® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Genentech is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma. Columvi U.S. Indication Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer. It is not known if Columvi is safe and effective in children. The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works. What is the most important information I should know about Columvi? Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death. Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher chills or shaking fast or irregular heartbeat dizziness or light-headedness trouble breathing shortness of breath Due to the risk of CRS, you will receive Columvi on a “step-up dosing schedule”. A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1). You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller “step-up” doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose. You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2). If your dose of Columvi is delayed for any reason, you may need to repeat the “step-up dosing schedule”. If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi. Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions. Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects. Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away. What are the possible side effects of Columvi? Columvi may cause serious side effects, including: Cytokine Release Syndrome. Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: headache confusion and disorientation difficulty paying attention or understanding things trouble speaking sleepiness memory problems numbness, tingling, or weakness of the hands or feet dizziness shaking (tremors) Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat. Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare: tender or swollen lymph nodes pain or swelling at the site of the tumor chest pain cough trouble breathing The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness. The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting). Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects. Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you: have an infection have kidney problems are pregnant or plan to become pregnant. Columvi may harm your unborn baby Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Columvi. You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi. are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while receiving Columvi? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems. These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi. You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . You may also report side effects to Genentech at (888) 835-2555. Please see Important Safety Information, including Serious Side Effects , as well as the Columvi full Prescribing Information and Medication Guide or visit https://www.Columvi.com About Genentech in Hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology . About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com . Dr. Salles has financial interests related to Roche and Genentech. View source version on businesswire.com : https://www.businesswire.com/news/home/20241208818007/en/ CONTACT: Media Contact: Kristen Ingram, (650) 467-6800Advocacy Contact: Catherine Creme Henry, (202) 258-8228Investor Contacts: Loren Kalm, (650) 225-3217 Bruno Eschli, 011 41 61 687 5284 KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY SOURCE: Genentech Copyright Business Wire 2024. PUB: 12/08/2024 12:30 PM/DISC: 12/08/2024 12:30 PM http://www.businesswire.com/news/home/20241208818007/enFrench President Emmanuel Macron assembled a new government under Francois Bayrou, his fourth prime minister of the year, on Monday evening. He appointed a cabinet to drag the second-largest EU economy out of a political crisis over budget proposals. Eric Lombard, a finance professional, was appointed finance minister. He is tasked with delivering the country's next budget after the previous government collapsed over contentious budget proposals of €60 billion ($62.9 billion) worth of tax increases and spending cuts. The country has been running without passing a formal budget since. Lombard will aim to quickly pass the 2025 budget and survive the test of a no-confidence motion by the opposition. Finding support for the new budget is expected to be difficult as Macron's party lawmakers are in the minority in the National Assembly. Former prime minister Elisabeth Borne, 63, was appointed the education minister in the new cabinet. Manuel Valls (62), also a former prime minister, returned as overseas territories minister, while former interior minister Gerald Darmanin was appointed justice minister. Macron decided to retain Defence Minister Sebastien Lecornu and Foreign Minister Jean-Noel Barrot for their current assignment. Interior Minister Bruno Retailleau, a conservative who has promised to crack down on illegal immigration, and right-wing Culture Minister Rachida Dati also retained their ministries. Bayrou expressed confidence in delivering the budget by mid-February after consulting various groups and stakeholders. The first meeting of the cabinet will be on January 3, and the prime minister will lay out a policy agenda to the National Assembly on January 14. "I believe the path exists — maybe it’s mad optimism — but I can tell you with certainty that if we don’t succeed in this attempt, it’s the last stop before the cliff edge,” Bayrou said in an interview with France 2 television on Thursday. (With inputs from AFP)