Latest news with #GLP
Fashion Value Chain
15 hours ago
- Business
- Fashion Value Chain
Pharmacy Council of India Gives Nod to Chandigarh University, Uttar Pradesh to Launch Courses at School of Pharmacy
Chandigarh University, Uttar Pradesh, continues to break new ground in AI-augmented multidisciplinary education with a major milestone-its School of Pharmacy has received formal approval from the Pharmacy Council of India (PCI) for its Bachelor of Pharmacy (B. Pharma) programme. This development marks a significant step in establishing Uttar Pradesh as a forward-looking destination for pharmacy education. Chandigarh University Uttar Pradesh Officials After Receiving the Approval Letter from Pharmacy Council of India for Kick Starting Programs in Pharmacy at CU UP Campus The School of Pharmacy at CU Uttar Pradesh has been conceptualized with a future-ready educational model aligned with industry demands and driven by cutting-edge technology. The curriculum is designed to balance theoretical foundations with hands-on training, ensuring that students graduate as competent and industry-ready healthcare professionals. The Pharmacy Council of India has granted formal approval to Chandigarh University, Lucknow Campus to begin offering 60 seats in the Pharmacy course from the academic session 2025. State-of-the-Art Infrastructure for Research-Driven Learning The School of Pharmacy offers an infrastructure tailored for advanced research. Students actively participate in projects related to pharmacokinetics, clinical pharmacy, medicinal chemistry, and toxicology. The curriculum has been crafted in collaboration with international industry experts and academicians, enabling students to grasp both traditional and emerging subjects with clarity while sharpening their skills in line with global standards. The availability of AI-powered tools and modern laboratories encourages experiential learning. Students also engage in internships, research assignments, and community-driven projects, making education at CU not only theoretical but deeply practical and immersive. A Booming Sector with Expanding Opportunities With the global pharmaceutical industry projected to grow at an estimated rate of 4.7% from 2024 to 2029-reaching a market size of approximately USD 1,454 billion-career prospects in pharmacy remain robust. Recognizing this trend, Chandigarh University has developed an ecosystem equipped with high-tech labs, experienced industry professionals, and collaborative learning environments to prepare a skilled and adaptable workforce. Industry-Collaborated Education for Future-Ready Professionals Students at the School of Pharmacy can pursue careers in diverse fields such as Clinical Research, Intellectual Property Management, Regulatory Affairs, Quality Control, and Medical Writing. The university also imparts regulatory training in Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), ensuring graduates are prepared to work in highly regulated environments. Chandigarh University, Uttar Pradesh, stands as a model of integrated education where learning, technology, and industry interface seamlessly. Students not only receive rigorous academic instruction but also benefit from industry training, internships, and research exposure, preparing them for a balanced and successful career. The universitys AI-supported, modern campus in Unnao-backed by industry-aligned curriculum, advanced labs, and seasoned faculty-provides a solid academic foundation. Strategic partnerships with leading companies and government bodies further enhance student opportunities by offering essential skill training and diverse career pathways. Academic Leadership at the Helm The school is led by Prof. (Dr.) Amit Verma. Prof. Verma is accompanied by rich international, industry, and academic experience. Having more than 20 years of pharmaceutical education, research, and industrial experience, Prof. Verma has made notable contributions towards international collaborations, drug development plans, regulatory documentation, and innovation in pharmaceutical sciences. He has collaborated with Indias and the worlds premier institutions and pharmaceutical industries, providing his services in drug discovery, formulation science, regulatory affairs, clinical research and academic leadership. His passion for pharmacy education is evident in his strong desire for interactive learning, digital integration, research mentorship, and international academic collaborations. Being the Indias first AI-enabled campus Chandigarh University Uttar Pradesh is committed to revolutionize education through modern technology. This smart campus offers AI-powered learning platforms, real-time simulation, virtual labs, that foster an environment of incubation, innovation and critical thinking. The university believe in quality professional education where the eminent faculty on roll are equipped with advanced pedagogy to produce pharmacy professionals to not only adept in their field but also competent in leveraging technology to enhance patient care and drug development. This initiative and commitment ensure our dedication to shape future-ready pharmacy leaders to meet healthcare industry requirement. Backed with the legacy of Chandigarh University Mohali, students will get an opportunity for the international exposure through the collaborations with over 150 foreign universities, enriching their academic and cultural perspectives. Chandigarh University Uttar Pradesh is committed to nurturing competent and compassionate pharmacy professionals who can contribute meaningfully to the global healthcare ecosystem'. About Chandigarh University Uttar Pradesh (Lucknow) Envisioned to foster a culture of sustainability and empower future global leaders, Chandigarh University, Uttar Pradesh, immerses 21st-century learners in a personalised and experiential learning experience, integrating an AI-powered academic model and a multidimensional, futuristic perspective on education. Our Uttar Pradesh campus carries forward the venerable legacy of more than a decade of Chandigarh University, Punjab, which has established itself as Indias No. 1 Private University and a torchbearer of groundbreaking pedagogy and research-driven innovation. The AI-augmented new campus offers a broad spectrum of industry-driven futuristic academic programs encompassing data-driven insights, virtual reality experiences, real-world simulations, corporate mentorship, international perspective, interdisciplinary research, cultivation of entrepreneurial spirit, and professional competencies. Website:
Yahoo
2 days ago
- Business
- Yahoo
Recludix Pharma Announces Development Candidate Nomination of First-in-Class Oral STAT6 Inhibitor for Inflammatory Diseases and Achievement of Significant Milestone Under Collaboration with Sanofi
--Completion of GLP toxicology studies associated with a $50 million payment to Recludix under the collaboration with Sanofi -- REX-8756 is a potent and selective oral STAT6 inhibitor that demonstrates complete pathway inhibition and is well tolerated in preclinical studies --Investigational New Drug (IND)-enabling activities ongoing to support IND submission later this year SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for inflammatory disease, today announced that the company has nominated a lead development candidate REX-8756, an oral, selective and reversible small molecule inhibitor of STAT6, and completed the GLP toxicology studies for the compound. Many allergic and inflammatory diseases -- such as asthma, COPD, and atopic dermatitis -- are caused by Type 2 inflammation, driven by the production of the cytokines Interleukin-4 (IL-4) and Interleukin-13 (IL-13). STAT6 is required for IL-4 and IL-13 signaling but is downstream in the disease pathway from other drug targets, and therefore, its inhibition has been shown in preclinical studies to be a more selective approach than Janus Kinase (JAK) family inhibitors, with potential for fewer side effects. 'There is significant opportunity to develop oral medicines with biologic-like activity and favorable safety profiles to provide alternatives to current therapies, such as JAK inhibitors which can impact viral immunity and hematopoiesis,' said Nancy Whiting, Pharm.D., president and chief executive officer of Recludix. 'At Recludix, we are driven to discover and develop best-in-class drug candidates that have the potential to become transformative medicines. We and our partner Sanofi are pleased to have reached this significant milestone in this important program and look forward to advancing REX-8756 to the clinic in the near term.' In preclinical studies, REX-8756 achieved complete and durable STAT6 inhibition, without degradation of the protein. STAT6 inhibition disrupted the production of IL-4/13 stimulated inflammatory biomarkers and has demonstrated potent efficacy in models of asthma, acute lung inflammation and dermatitis. REX-8756 inhibits STAT6 through its SH2 domain, which plays a key role in mediating protein-protein interactions and had been previously deemed undruggable. Through Recludix's proprietary platform that integrates new chemical approaches and technologies, the company has created massive custom SH2 domain-focused DNA-encoded libraries and proprietary selection assays, enabling the development of precision small molecule medicines against the SH2 domain of high-interest targets. 'We have discovered a number of oral STAT6 SH2 domain inhibitors that performed impressively in preclinical studies, speaking to the power of our platform,' said Ajay Nirula, M.D., Ph.D., executive vice president and head of research and development of Recludix. 'Following our recently presented preclinical data at the May 2025 American Thoracic Society Conference that further demonstrated the robust efficacy and differentiated safety profile of our STAT6 inhibitors, we are excited to advance REX-8756 as a potential first-in-class oral therapy for patients with immune-related inflammatory disease.' About Sanofi CollaborationRecludix is advancing STAT6 inhibitors from preclinical research and development until the start of Phase 2 clinical trials. Sanofi will assume worldwide clinical development and commercialization responsibilities thereafter. Sanofi has global rights to small molecule STAT6 inhibitors developed under the partnership. Recludix has the option to participate in U.S. profit/loss share, which includes the ability to share equally in the costs, profits and losses, and to certain co-promotion activities for the partnered product in the U.S. Recludix has now received $125 million in near-term payments. Additionally, Recludix may receive more than $1.2 billion in potential development, regulatory and sales milestones, as well as up to double-digit royalties on possible future product sales. About STAT6Signal transducer and activator of transcription (STAT) proteins are both signaling proteins and transcription factors that play a role in cell growth, differentiation and function. STAT6 is a key nodal transcription factor that selectively mediates downstream signaling of IL-4 and IL-13, dominant and central cytokines in the pathophysiology of Type 2 inflammatory diseases. A STAT6 inhibitor offers the potential for a novel first-in-class targeted oral therapy for patients in the treatment of Type 2 inflammatory diseases. About RecludixRecludix is a leader in developing platform approaches to discover potent and selective inhibitors of challenging protein targets. The company's management team includes industry veterans with a track record of success, including former leaders of Seagen, Blueprint Medicines, and Lilly. Recludix has developed a unique drug discovery platform that integrates custom generated DNA-encoded libraries, massively parallel determination of structure activity relationships, and a proprietary screening tool to ensure selectivity. The company is employing this approach first in the development of SH2 domain inhibitors. Recludix's most advanced program is focused on STAT6 (signal transducer and activator of transcription 6) where abnormal activation is found in inflammatory diseases, such as atopic dermatitis, asthma, rheumatoid arthritis and chronic spontaneous urticaria. The company has a strategic collaboration with Sanofi for the development and commercialization of a STAT6 inhibitor. Recludix is also advancing a potential first-in-class BTK SH2 domain inhibitor for B cell or mast cell-driven I&I diseases, as well as additional programs. Recludix was named a 2024 Fierce 15 biotech company. For more information, please visit the company's website at Recludix ContactsMatt Caldemeyer Chief Business Officermcaldemeyer@ Alexandra Santos asantos@ Aljanae Reynoldsareynolds@ in to access your portfolio
Business Wire
27-05-2025
- Business
- Business Wire
Inter Scientific Achieves UK GLP Monitoring Authority Status to Support Regulatory Studies for Medicines, Devices and Novel Products
LIVERPOOL, England--(BUSINESS WIRE)--Inter Scientific Ltd is proud to announce its acceptance onto the UK Good Laboratory Practice (GLP) Monitoring Authority, granting the company official GLP status. This accreditation enables Inter Scientific to conduct fully compliant non-clinical safety studies in accordance with OECD guidelines and GLP standards, supporting the authorisation of regulated products such as pharmaceuticals, medical devices, cosmetics, and products requiring Premarket Tobacco Product Applications (PMTAs). The GLP status is a major milestone for Inter Scientific and reflects the company's commitment to delivering the highest standards of scientific and regulatory excellence. It enhances the company's ability to provide accurate, defensible data for regulatory submissions in the UK and internationally. 'This is a significant step forward for Inter Scientific,' said David Lawson, CEO of Inter Scientific. 'Achieving GLP status recognises the quality of our people, systems, and scientific capabilities. It allows us to support clients more comprehensively in bringing safe, effective, and compliant products to market.' The GLP framework ensures the reliability, integrity, and traceability of data submitted to regulatory bodies. Inter Scientific's accreditation confirms its laboratories meet the rigorous requirements set out by the UK GLP Monitoring Authority. Ben Green, Global Technical Specialist for Nicotine-Containing Products at Inter Scientific, added: 'Our focus has always been on delivering accurate, impartial regulatory studies that ultimately support public health. GLP accreditation underlines our readiness to contribute to the responsible regulation of a wide range of consumer and healthcare products.' Inter Scientific's inclusion on the official UK GLP Compliance Monitoring Programme can be found here: About Inter Scientific Ltd Inter Scientific is a regulatory science company specialising in global regulatory compliance and providing laboratory testing and consultancy for medicines, medical devices, cosmetics, and novel nicotine products. With a multidisciplinary team of experts, the company supports clients globally through all stages of product development and regulatory submission.
Yahoo
19-05-2025
- Entertainment
- Yahoo
'Dancing With the Stars' Cheryl Burke Is Unrecognizable in Video Sparking Fan Concern
Dancing With the Stars pro was practically unrecognizable in a new video as she marked a special occasion—and some fans expressed serious concern. On May 4, the DWTS alum took to Instagram in honor of her birthday with a fresh-faced clip before doing her makeup for the day. 🎬 SIGN UP for Parade's Daily newsletter to get the latest pop culture news & celebrity interviews delivered right to your inbox 🎬 "Definitely went less smoky and more clean girl for my birthday glam…💜🎂," Burke, now 41, captioned her update. In the video, a makeup-free Burke—with her freckles on full display—lip-synced to AntonioVivald's "Done With Yuh Ex" before the clip suddenly transitioned to her all dressed up with a full glam. She then continued to sing while dancing sassily in a lilac dress. Although Burke left DWTS as a professional dancer after Season 31, fans of the show flooded her comments with well-wishes for her birthday. And many couldn't believe how amazing and youthful she looked without makeup—even if they didn't recognize her at first. One Instagram user wrote, "Happy birthday!!! You look stunning ❤️," as a different fan echoed, "Happy Birthday beautiful 🎉🎉." Another shared, "Luv the freckles." Someone else declared, "Happy birthday Cheryl it's giving 25💅." Still, others were concerned by her appearance. "Omg! What happened to her?" one follower wondered. "She lost way too much weight," a different Instagram user pointed out. Yet another worried fan shared, "This is very sad. What kind of message are you sending to women and our young girls!!! Get off of the GLP. Start showing us healthy eating and working out and not this ridiculously thin anorexic look. Shameful!!!!!" Meanwhile, someone else wrote, "You don't even look like you anymore. I'm all for feeling great in your own skin and your work is impeccable but, I wonder how parents or family feel about you not looking like the person they raised and created." Parade reached out to Burke's rep but did not immediately hear back. Next:
Western Telegraph
16-05-2025
- Politics
- Western Telegraph
Campaigners take step in legal action over toilet guidance after gender ruling
Good Law Project (GLP) said on Friday that it had sent a pre-action letter to the Equality and Human Rights Commission (EHRC) over the guidance, which it said 'authorises and approves unlawful discrimination'. GLP and the individuals – two of whom are trans and one of whom is intersex – have also sent the letter to the women and equalities minister, Bridget Phillipson, and said that they had asked for a response within seven days. It follows the Supreme Court ruling in April that said the words 'woman' and 'sex' in the Equality Act 2010 refer to a biological woman and biological sex, following a challenge against the Scottish Government by campaign group For Women Scotland. It is deeply unkind, far removed from the national mood of mutual respect and live and let live, and is unlawful to boot. Jolyom Maugham KC, Good Law Project The EHRC issued interim guidance following the judgment that said trans women 'should not be permitted to use the women's facilities' in workplaces or public-facing services like shops and hospitals, with the same applying for trans men using men's toilets. But GLP said on Friday that the guidance is 'wrong in law' and the definition of gender in the Equality Act 2010 'does not read across' to legislation governing use of toilets, to which 'the normal legal meaning of those words, which include lived gender, continues to apply'. Jolyon Maugham KC, the founder and executive director of GLP, said: 'The stark and needlessly cruel position adopted by the Government and the EHRC humiliates trans people by forcing them to use the wrong toilets and obliges them to reveal deeply personal information about their gender to complete strangers just to take a wee. 'It is deeply unkind, far removed from the national mood of mutual respect and live and let live, and is unlawful to boot.' The Supreme Court challenge was brought by campaign group For Women Scotland against the Scottish government (Lucy North/PA) GLP also said that if the EHRC guidance is correct in law, it breaches the UK's obligations under the Human Rights Act 1998. The commission said it issued its interim guidance last month as 'many people have questions about the judgment and what it means for them'. But it also said that trans people 'should not be put in a position where there are no facilities for them to use'. It added that it would undertake a public consultation on how the judgment should be reflected in a more detailed code of conduct, which it aimed to finalise for ministerial approval by June. In the pre-action letter, GLP said that the claim related to the guidance 'purporting to set out, inter alia, that employers and providers of services which are open to the public are legally required to prohibit trans people from using the toilets in their acquired gender'. The notion that the judgment puts beyond debate that trans women must be excluded from women's toilets in workplaces and services open to the public and trans men must be excluded from men's toilets is an extraordinary – and legally erroneous – position to have taken. Good Law Project's Pre-Action Letter It continued that it believed that the guidance 'evidently represents what the commission regards as the indisputable legal consequences' of the judgment, and that the impact of the guidance 'should not be underestimated'. It said: 'This proposed challenge is not to an 'interim' position, but guidance on an interpretation of the law which the commission has made clear is not up for discussion in the forthcoming consultation. 'The notion that the judgment puts beyond debate that trans women must be excluded from women's toilets in workplaces and services open to the public and trans men must be excluded from men's toilets is an extraordinary – and legally erroneous – position to have taken. 'The claimants will be challenging that guidance on the basis that it is irrational and/or wrong in law.' A Government spokesperson said: 'We do not comment on ongoing legal proceedings. 'The UK Supreme Court has ruled on the For Women for Scotland case with a unanimous opinion. 'We will consider the updated draft code of practice from the EHRC once it has been submitted and, importantly, engage with them to ensure it provides the certainty and clarity service providers and businesses need, in line with the Supreme Court ruling.' A spokesperson for the EHRC said: 'We are unable to comment on any threat of legal action at this stage.'
