Latest news with #squares
Malaysian Reserve
17-06-2025
- Health
- Malaysian Reserve
U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patien
ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacks Once-monthly dosing reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to placebo ANDEMBRY approval expands CSL's HAE franchise and underscores the company's legacy of delivering transformational innovations to the HAE community for over four decades KING OF PRUSSIA, Pa., June 16, 2025 /PRNewswire/ — Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) approved ANDEMBRY® (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. By targeting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, ANDEMBRY inhibits the top of the HAE cascade to prevent HAE attacks. ANDEMBRY, the only treatment to offer once-monthly dosing from the start for all patients, is a subcutaneous self-injection delivered in 15 seconds or less via an autoinjector with a citrate-free formula. HAE is a rare, chronic, and potentially life-threatening genetic disorder characterized by recurrent and unpredictable attacks of angioedema. Attacks of HAE are often painful and can affect multiple sites of the body, including the abdomen, larynx, face, and extremities. HAE occurs in about 1 in 50,000 people of any ethnic group. 'ANDEMBRY, the first monoclonal antibody discovered and developed entirely by CSL, offers people living with this life-threatening condition long-term control over their disease along with a convenient administration method,' said Bill Mezzanotte, MD, Executive Vice President, Head of R&D, CSL. 'ANDEMBRY underscores our long-standing and enduring commitment to better the lives of the patients we serve, including those suffering with HAE. I'd like to thank all the physicians, patients and my colleagues who contributed to this exciting milestone for HAE patients and CSL.' The approval is supported by data from the pivotal placebo-controlled Phase 3 VANGUARD trial evaluating the efficacy and safety of ANDEMBRY. The pivotal study (The Lancet, April 2023) demonstrated that treatment with ANDEMBRY: Led to 62 percent of ANDEMBRY-treated patients remaining attack-free throughout the treatment period. Reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to placebo. Achieved more than 99 percent median reduction and an 88 percent mean reduction in HAE attacks requiring on-demand therapy, compared to placebo. Attained more than 99 percent median reduction and a 90 percent mean reduction in moderate or severe attacks, compared to placebo. The most common adverse reactions in the pivotal trial (incidence ≥7%) are nasopharyngitis and abdominal pain. A published interim analysis (Allergy, Oct 2024) of the ongoing open-label extension study (median ANDEMBRY exposure of 13.8 months) showed that ANDEMBRY has a favorable long-term safety profile and provides sustained reductions in HAE attacks. In the pivotal trial and the open-label extension study, injection-site reactions (e.g., injection-site bruising, injection-site erythema, injection-site hematoma, injection-site pruritus, injection-site urticaria) were reported in 23 (14%) patients. 'We've made significant progress in treating hereditary angioedema, yet many patients still experience painful and sometimes life-threatening HAE attacks and require frequent injections to manage them,' said Dr. Tim Craig, Professor of Medicine, Pediatrics and Biomedical Sciences at Penn State University. 'We now have a new option to manage this condition through a new target, as it allows us for the first time to inhibit the top of the HAE cascade by targeting factor XIIa.' 'ANDEMBRY, a novel once-monthly subcutaneous treatment that inhibits factor XIIa, is a welcome addition to the HAE treatment landscape,' said Anthony J. Castaldo, CEO and Chairman of the Board, US HAE Association and HAE International. 'People with HAE now have another choice for lessening the burden associated with this lifelong condition and realizing the community's shared goal of experiencing life to the fullest.' This regulatory approval for ANDEMBRY is another crucial step in building toward the global availability of ANDEMBRY, which was recently approved in Australia, the United Kingdon (UK), the European Union (EU), Japan, Switzerland, and United Arab Emirates. CSL Behring will launch ANDEMBRY commercially immediately, with availability before the end of June. Healthcare professionals and patients interested in learning more about ANDEMBRY or accessing the therapy are encouraged to utilize ANDEMBRY ConnectSM, designed to offer comprehensive support and assistance through various programs. For more information, call 844-423-4273 or visit About HAE HAE is a rare and potentially life-threatening genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE is caused by deficient or dysfunctional C1INH, a protein in the blood that helps to control inflammation. Inadequate amounts of properly functioning C1INH can lead to the accumulation of fluid in body tissues, causing considerable swelling referred to as angioedema. HAE attacks can affect many parts of the body, including the face, abdomen, larynx, and extremities. Patients who have abdominal attacks of HAE can experience extreme pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if left untreated, death. About ANDEMBRYANDEMBRY is a novel monoclonal antibody inhibiting factor XIIa (anti-FXIIa mAb) that has completed the Phase 3 pivotal study as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. ANDEMBRY is CSL's first homegrown recombinant monoclonal antibody to gain FDA approval. It was discovered and optimized by scientists at CSL's Bio21-based research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. ANDEMBRY uniquely inhibits the plasma protein, FXIIa. FXII is the first protein activated in the HAE pathway, initiating the cascade of events leading to an HAE attack. By targeting activated FXII (FXIIa), ANDEMBRY inhibits this cascade at the top as compared to other HAE therapies that target downstream mediators. About the VANGUARD Trial The multicenter, randomized, double-blind, parallel-group VANGUARD trial evaluated the efficacy and safety of ANDEMBRY, an investigational first-in-class monoclonal antibody, as a prophylactic treatment for patients with hereditary angioedema. Patients aged 12 years and older with HAE type I or II underwent screening and a run-in study period to verify a baseline attack rate. Patients were randomized 3:2 to receive a loading dose of 400 mg followed by 200 mg of ANDEMBRY monthly (n=39) or volume matched placebo monthly (n=25) subcutaneously. After the six-month treatment period, patients were given the opportunity to continue into the open-label extension study, which is currently ongoing. The ongoing open-label extension of the Phase 3 VANGUARD study is evaluating the long-term safety and efficacy of ANDEMBRY (200 mg monthly) for the prophylactic treatment of hereditary angioedema attacks. IMPORTANT SAFETY INFORMATION What is ANDEMBRY?ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use, is a prescription medication used to prevent attacks of hereditary angioedema (HAE) in people 12 years and older. It is not known if ANDEMBRY is safe and effective in children under 12 years of age. What should I tell my healthcare provider before using ANDEMBRY?Before using ANDEMBRY, tell your healthcare provider about any medical condition you may have, especially if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if ANDEMBRY can harm your unborn baby or if ANDEMBRY passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while using ANDEMBRY. Tell your healthcare provider about all medications you take, including prescription medicines, over-the-counter treatments, vitamins, and herbal supplements. How should I use ANDEMBRY? Use ANDEMBRY exactly as instructed by your healthcare provider. Detailed instructions for use can be found in the patient information section of the full prescribing information. ANDEMBRY is given as an injection under your skin (subcutaneous) by you or a caregiver. Your healthcare provider should show you or your caregiver how to prepare and inject your dose of ANDEMBRY before you inject yourself for the first time. Do not try to inject ANDEMBRY unless you have been trained by your healthcare provider. What are the possible side effects of ANDEMBRY?The most common side effects of ANDEMBRY include: Redness, itchiness, and bruising (injection-site reactions) Stomach (abdominal) pain Runny or stuffy nose, sneezing, watery eyes (nasopharyngitis) Please see full prescribing information for ANDEMBRY, including patient information and instructions for use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958. About CSLCSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL, visit Media ContactsValerie BombergerCSLOffice: +1 610-291-5388 Mobile: +1 267-280-3829 Email: Etanjalie Ayala CSL Behring Mobile: +1 610 297 1069 Email: Greg HealyCSLMobile: +1 610-906-4564Email: In Australia: Kim O'DonohueCSLMobile: +61 449 884 603Email: Brett FoleyCSLMobile: +61 461 464 708 Email: Investors ContactChris CooperCSLMobile: +61 455 022 740Email:
Daily Record
16-06-2025
- Automotive
- Daily Record
Stopping on this road marking could land drivers a £130 fine
Failing to pay attention to road markings could result in a significant fine Motorists could face a penalty of up to £130 for stopping on a specific road marking common throughout the UK. Road markings serve as crucial guides, informing drivers about things they can and can't do. For instance, some markings indicate the appropriate lane to be in or no-parking zones. Ignoring these markings not only heightens the risk of accidents but could also lead to fines and potential legal complications. Yellow box junctions are another typical marking that frequently catch drivers out. These yellow squares, filled with a criss-cross pattern, instruct drivers not to stop, although there are a few exceptions. Not complying with this rule can result in a Fixed Penalty Notice (FPN) of up to £130 in London and £70 elsewhere, according to RAC. This fine is usually imposed when a vehicle obstructs traffic by stopping in the yellow box junction. However, there's often an opportunity to mitigate the full penalty by paying a reduced rate of 50% within the initial 14-day period. Exceptions to yellow box junction rules While vehicles are generally prohibited from remaining stationary within a yellow box junction, there exists a significant exception. As per Rule 174 of the Highway Code, drivers should refrain from entering the box until their exit road or lane is clear. The guidance states: "However, you may enter the box and wait when you want to turn right, and are only stopped from doing so by oncoming traffic, or by other vehicles waiting to turn right. At signalled roundabouts, you MUST NOT enter the box unless you can cross over it completely without stopping." Appealing a yellow box penalty Should you receive a fine for allegedly breaching a yellow box junction rule, you have the right to challenge it. Indeed, there's a variety of things that might help you dodge a fine. For example, one motorist who shared her experience of entering the yellow box on lane two with a clear exit ahead, only to find her path blocked by a car coming out from lane one, trapping her in the box. Her successful appeal was supported by CCTV footage. Similarly, another driver's defence was based on the fact that they entered the box with sufficient space to exit, assuming the traffic continued to flow; however, a vehicle from the adjacent lane cut in front, resulting in the driver needing to stop within the box – this appeal was also successful.
CBC
09-06-2025
- Entertainment
- CBC
Your horoscope for the week ahead: A series of challenging squares will keep us on our toes
In astrology, square alignments can often have us butting heads — and this week will be full of them. But these challenging aspects also offer us brilliant opportunities to reflect and rise above. The first of these squares will arrive on Monday morning, when communication-ruling Mercury aligns with domineering Saturn. We're usually wise to think carefully about what we want to say as these planets clash, so be sure to take a beat before speaking and consider the feelings of others. This will be particularly important when emotional Venus squares penetrating Pluto a few hours later, which will amp up the tension, and when Mercury squares delusional Neptune that night, which could cloud our minds with distorted perceptions. Luckily, things could become a lot clearer under the light of the full moon in intelligent Sagittarius early on Wednesday. You may even find yourself solving some mysteries you've been mulling over for a while. Hearing the call of adventure? This will also be a beautiful time to break free from any self-imposed limitations and really take the plunge. The strawberry moon reminds us that everything we need to succeed is already at our fingertips. Then, as hot-headed Mars squares unpredictable Uranus on Sunday, we'll need to keep our tempers in check. Taking extra time to respond and carefully evaluate your options is usually wise under this influence, but you may also find it helpful to channel this chaotic energy into an activity that allows you to show off your wild side in a safe setting. A creative project has the potential to really take off during this period. Finally, the week will wrap up with expansive Jupiter squaring strict Saturn, an alignment that could make us feel constrained and even a bit resentful. Finding a balance between expressing ourselves and respecting the rules will be key, especially when working with others, so open up the lines of communication and employ all the patience you can muster. Hard work and focus will ultimately help you accomplish your objectives — have faith in the process. Here is your horoscope for the week of Monday, June 9, 2025. Aries Are you feeling a bit depleted lately, Aries? Work matters can affect our overall well-being when we struggle to separate our professional and personal lives. So this week, focus on protecting your peace by clearly stating your needs in both realms — and try to avoid the temptation to overcommunicate. Meanwhile, you could find your mind drawn toward your domestic surroundings and how you can invest in them. This could be an excellent time to upgrade your home or even make a move to a larger one. Start writing down what your ideal space would look like to get the ball rolling in the right direction. Taurus You're known for your discerning mind, Taurus. And this week, you could be called to use it to process some important information and figure out your next steps. You'll be wise to do so in private, however, particularly if you find yourself mulling over your assets. You may inadvertently strike a sore spot if you start discussing finances with others. Meanwhile, you could feel called to take a step back and reflect on the endings of certain phases in your life. Take your time saying a proper goodbye to the things that no longer serve you — and tie up any loose ends you spot along the way. Gemini Prepare to get a significant confidence boost when it comes to your cash, Gemini. From now through the next 12 months, paying close attention to your income and spending could inspire you to take a more proactive approach to increasing your wealth. Enjoy speaking up about what you want to attain and cutting out any indulgences that put a kink in your grand plans. When it comes to your relationships, you could begin to notice that your bonds in love and business are entering a phase of reassessment, prompting you to clarify the path ahead. Now is the time to show up for the people who fill your life with meaning. Cancer Do you really need to explain yourself, Cancer? At the start of the week, an unexpected provocation from friends could crop up that tempts you to put up your barbs, but you'll be wise to ask yourself this question before responding. You might be better served by nestling into your safe space and reflecting on any fears of rejection or people-pleasing tendencies their comments might be bringing up. Then, toward the middle of the week, you could find yourself feeling more empowered and ready to take responsibility for your state of mind. Enjoy making changes to your day-to-day that will help you feel more comfortable in your own skin. Leo Save your breath, Leo. While your compassion for others is likely to grow from now through the next 12 months, some people in your life won't be ready to receive your advice this week — especially when it comes to financial matters. So if you face any pushback, do your best to keep your thoughts to yourself and let others learn their own lessons. If you can get into the habit of preserving your peace, you'll be happier for it. Meanwhile, you could begin to notice your dreams becoming more vivid, allowing you to take a peek behind the scenes of your mind. Enjoy discovering your hidden self as you look inward. Virgo Has it felt impossible to get a straight answer out of anyone lately, Virgo? Your nearest and dearest may seem a little unreliable right now, but that could be because they simply don't have the tools needed to help you navigate the tricky situations you've found yourself in. This week, try to redirect your focus inward as you search for clues to solve your conundrums. Meanwhile, on the domestic front, you may notice a home improvement project that requires your attention or feel compelled to go on a decluttering spree in your space. Enjoy making room for new memories to grow. Libra Try to resist the temptation to hand out reality checks, Libra. What you consider to be common sense could be a real bubble-burster to others at the beginning of the week. Instead, make an effort to direct your focus toward improving your own life. This is a particularly good time to start polishing up your image, as your career could start moving in a new direction over the next 12 months, propelling you into the professional spotlight. People in your network will likely be eager to hear what you have to say, too, so you may also want to spend some time developing and even rehearsing your talking points. Scorpio A difference of opinion can sometimes feel like a serious roadblock in our relationships, Scorpio. But you don't always have to agree with your loved ones' perspectives — you just have to be willing to hear them out. This week, give your companions a chance to say their piece, and if things get uncomfortable, put the conversation on hold and return to it once you've all cooled down. Meanwhile, if you feel driven to untether yourself from your usual routine, don't hesitate to explore exciting new travel destinations and educational pursuits. Who knows? They could help you reconnect with your greater purpose. Sagittarius No one likes to hear "I told you so," Sagittarius. And at the top of the week, your loved ones and colleagues may not be in the right state of mind to take in your constructive advice either. Keep this in mind as you interact with others, and try to practise supernatural kindness instead of attempting to solve everyone's problems. At the same time, you could start to feel a bit of a disconnect between your mind and your body, which could prevent you from finding your flow state. Do your best to reduce the distractions around you, and consider writing down your thoughts in a stream-of-consciousness style to realign yourself. Capricorn Timing really is everything, Capricorn. Keep this in mind this week if you've been planning to introduce new habits or ideas to your friends, family or romantic partner. People may be feeling overwhelmed by their personal responsibilities during this period, so if you face any resistance, consider scheduling another time to talk when the pressure is off. Toward the middle of the week, you may also find that indulging in downtime with your favourite people helps you recharge your emotional batteries. Don't be afraid to take things slow for a change, surrounded by your nearest and dearest. Aquarius Have you been biting off a bit more than you can chew lately, Aquarius? If so, a conflict between your professional and personal domains could have you feeling the pressure at the beginning of the week. But don't fear: you're sure to get through this tough spot if you can exercise some compassion for yourself in addition to all the people around you. Think carefully about what steps you need to take in order to bring back a sense of balance in your life. You'll be called to continue reflecting on this subject throughout the next 12 months as you establish which activities and practices are really best for your mind and body. Pisces Are you prepared to unleash your inner genius upon the world, Pisces? From now through the next 12 months, you could find that your creativity flows freely, infusing your life with extra whimsy, beauty and even romance. You'll be most successful when you speak from the heart and lean on your intuition, so be sure to stay true to yourself as your imagination unfolds and your mind fills up with inspired ideas. And if others start to take notice and want to team up on a creative endeavour, be sure to take a beat before committing to anything. People who don't truly understand your gifts may not be worth collaborating with.
Fox Sports
06-06-2025
- Sport
- Fox Sports
Bosnia vs. San Marino: How to watch, time, TV channel, streaming for World Cup Qualifier
Two 2026 World Cup hopefuls face off as Bosnia and Herzegovina squares off against San Marino in a qualifier matchup. Both teams will aim to make a statement, but Bosnia enters as the clear favorite on home soil. Here's everything you need to know to watch Bosnia vs. San Marino. When is Bosnia vs. San Marino? How to watch Date: Saturday, June 7, 2025 Time: 9:00 a.m. ET Location: Bilino Polje Stadium, Zenica, Bosnia TV: FS2 Streaming: FOX Sports app, Alexi Lalas and David Mosse broke down who they believe could break into the USMNT's starting XI before the 2026 World Cup. Check out which players they chose! Bosnia vs. San Marino Head to Head Bosnia is unbeaten (2-0) in its previous meetings with San Marino, both of which came during 2006 FIFA World Cup qualifying. Bosnia vs. San Marino Past Results 6/4/2005: Bosnia 3, San Marino 1 (FIFA World Cup) 10/8/2005: Bosnia 3, San Marino 0 (FIFA World Cup) Team Form Below are the last 5 matches for each team and the results: Bosnia 3/24: Bosnia 2-1 Cyprus (H) 3/21: Bosnia 1-0 Romania (A) 11/19: Bosnia 1-1 Netherlands (H) 11/16: Bosnia 0-7 Germany (A) 10/14: Bosnia 0-2 Hungary (H) San Marino 3/24: San Marino 1-5 Romania (H) 3/21: San Marino 0-2 Cyprus (A) 11/18: San Marino 3-1 Liechtenstein (A) 11/15: San Marino 1-1 Gibraltar (H) 10/13: San Marino 0-2 Andorra (A) Get more from WCQ - UEFA Follow your favorites to get information about games, news and more in this topic
Hindustan Times
04-05-2025
- Entertainment
- Hindustan Times
Dilli ‘O' Dilli visited by Punjab storytellers
Born and brought up in the fledgling city of Chandigarh, the greatest childhood joy was a five-hour drive in a bus flying on the old Ambala road to the wonderland called Dilli so different and buzzing from our city of squares and roundabouts designed so meticulously by Le Corbusier. To tell the truth that excitement never quite ended and continues even now in the senior citizen times. A trip vivid in my still was with my middle-aged parents when I was just about four and the youngest of eight siblings in those pre family planning times. The reason for the sojourn being that relationship between our parents was strained with building too large a house, to replicate the lost Lahore home post-retirement by commuting pension, taking loans and getting cheated by new-world contractors. My dashing captain brother, who was their only working child, suggested the old man and woman needed a holiday and I being the baby accompanied them. Well, Delhi held my four-year eyes in wonder in the year 1959 with a tonga ride, grandeur of the Red Fort, and staying in a hotel with a winding staircase and embossed tiles on the walls and pampering by my mother's younger brother who was the manager of this destination called 'The Royal Hotel' in old Delhi. Basti & Durbar Delhi was etched in the heart as a wonderous city as compared to the 'green hedges and white beards' of the early scantily populated city of ours largely of retired people. Delhi poet Devendra Satyarthy had defined it as 'Harian jharhian te chitian darhian' and added in another wise one on our city beautiful, 'Kal de jamme Chandigarh da ki itihas, Miss Das?' Well now this city of ours has its own character and history. But it was with the same excitement of a four-year old that I rushed early morning in a shared cab and a long metro ride from Dilli's Jahangirpuri to attend the launch of a collection of stories edited by Rakhshanda Jalil, a prolific creator of books and published by Ravi Singh of Speaking Tiger Books. Titled 'Basti & Durbar: Delhi-New Delhi' it is indeed a delightful collection of the city in across five languages, including English, Hindi, Urdu, Punjabi and Malyalam. Jalil says thus of the book: 'This book is a collaborative effort in every sense of the word. What eventually found place between its covers are my efforts combined with efforts of Ravi Singh and Nageez Mollah of Speaking Tiger Books.' She further quotes Delhi's pre-eminnent historian Percival Spear, who said, 'Full understanding is available to no one. For those who seek there are rewarding always Dilli dur ast, the Delhi of full knowledge is far off.' Builders, tongawala & whose story? What makes the anthology particularly interesting to the North Indian readers is the inclusion of vibrant tales from writers of Punjab. Partition of India in 1947 brought many of the Lahore writers to the Capital, like Amrita Pritam, Krishna Sobti, Bhisham Sahni, Ajeet Cour, Kartar Singh Duggal and others. But long before hailing back to the when the British crushed the first war of Independence in 1857, the city was reduced to ruin and marked only by graves of Hindu and Muslim revolutionaries and no one would touch them. Then came the enterprising Sikhs from west Punjab to build Lutyen's New Delhi. Khushwant Singh gives an inside view in the piece 'The Builders' including the role of his contractor father Sardar Sobha Singh. Known for his declaration of 'with malice to one and all' the writer says of his father: 'My father was a man of foresight with a knack of making money.' The rest of course is history. Other Punjabi fare is a touching tale by Kartar Singh Duggal in 'Majha Nahi Moya' (Majha is not dead) of the honour of a tongawala who would not compromise his values and honour, more so in case of a white skinned man, even if it meant him and his dear horse going hungry. 'Gango's Son', another touching tale comes from Bhisham Sahni, about a pregnant woman working at a construction site in the Capital, translated from Hindi with finesse by Jerry Pinto. Jalil herself translates a story by Gulzar 'Whose Story' set in the Sabzi Mandi area where the legendary poet grew up as a refugee boy. Indeed a collection that has much to offer! One cannot but add a parting couplet by Bashir Badr: 'Purani Dilli dil Ki basti hai, jo bhi guzra usi ne looti hai..' nirudutt@
