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Achieving operational excellence in a Contract Development and Manufacturing Organization (CDMO) is crucial to ensure the quality and consistency of products and services. This can be achieved by implementing robust controls, optimizing workflows, and fostering a culture of continuous improvement. Here are some key strategies to achieve operational excellence in a CDMO: Implementing Robust Controls Compliance with Regulatory Guidelines : Ensure compliance with strict regulatory standards set by
During 2023, drugmakers substantially raised prices on five widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $815 million last year, according to a new report. The drug for which spending increased the most due to a price increase was Biktarvy, which is prescribed to treat HIV and is a franchise product for Gilead Sciences.
Non-clinical pharmacy managers in England could come under the scope of regulation proposals launched by the Department of Health and Social Care (DHSC). Itspublic consultation sets out measures that aim to increase accountability of NHS managers and leaders, and set clear and consistent professional standards, including a potential regulatory system.
Dr. Reddy’s Laboratories has recently become the first Indian company to launch checkpoint inhibitor Zytorvi (toripalimab) in collaboration with Shanghai Junshi Biosciences. Zytorvi is an immuno-oncology therapy for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). This marks a transformative moment, bringing a next-generation PD-1 inhibitor to India and addressing significant unmet medical needs.
Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.
Generic drugs play a crucial role in providing affordable healthcare options to millions of patients worldwide. One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product qua
A proposed Senate bill that would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies rattled investors on Wednesday, but some Wall Street analysts believe the legislation is unlikely to gain much traction, at least for now. The bipartisan bill , which would require divestiture within three years, is aimed at what the lawmakers call an “inherent conflict of interest” that has forced Americans to pay more for medicines and hastened the
A proposed Senate bill that would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies rattled investors on Wednesday, but some Wall Street analysts believe the legislation is unlikely to gain much traction, at least for now. The bipartisan bill , which would require divestiture within three years, is aimed at what the lawmakers call an “inherent conflict of interest” that has forced Americans to pay more for medicines and hastened the
A new, confidential, 24/7 text support service has been launched to support healthcare workers 'who may have had a tough day, are feeling worried or overwhelmed, or have a lot on their mind and need to talk it through'. The NHS England (NHSE) support offer will extend to all staff, including community pharmacists and their […] The post New helpline to support pharmacists 'feeling worried or overwhelmed' appeared first on The Pharmacist.
The respiratory syncytial virus (RSV) prophylaxis market across the eight major markets (8MM*) is forecast to grow at a compound annual growth rate (CAGR) of 26.7 per cent from $582 million in 2020 to $6.2 billion in 2030, with the pediatric and adult segments accounting for $2.2 billion and $4.0 billion, respectively, according to GlobalData. GlobalDatas latest report, Respiratory Syncytial Virus Prophylaxis: Eight-Market Drug Forecast and Market Analysis Update, reveals that market growth wil
India has long been recognized as a significant player in the global pharmaceutical industry, particularly in the production of generic drugs. The country’s pharmaceutical sector has experienced substantial growth over the years, driven by both domestic and international demand for affordable and high-quality medicines. This article delves into India’s growing importance in generic drug API manufacturing, highlighting the key factors contributing to its success and the challenges it
WASHINGTON — Legislation to restrict U.S. drugmakers from using key Chinese contract manufacturers was dealt a major blow when senators left it out of a must-pass defense budget bill this weekend. The BIOSECURE Act would prohibit pharmaceutical and biotechnology companies from using services or equipment from Chinese “companies of concern,” including WuXi AppTec and WuXi Biologics, in work that is contracted or funded by the U.S. federal government.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
The government has committed to a 'refreshed' workforce plan with a 'laser-focus on shifting care from hospitals and into the community', to be published in the summer. This comes as the Department of Health and Social Care (DHSC) has told The Pharmacistthat community pharmacies 'will play a vital role helping to shift the focus of […] The post Government commits to new workforce plan with 'laser-focus' on community appeared first on The Pharmacist.
In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents?
Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.
Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.
NHS England has 'no primary care strategy or expansion plan' and pockets of short-term investment in the sector have 'failed', the government has been warned. Primary care representatives including those within community pharmacy, GP, dentist, optometry and audiology have issued a damning response to the government's 10-Year Health Plan consultation.
Press Release ARLINGTON, Va., December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaini
The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles. Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy.
SAN DIEGO — Pfizer’s abrupt withdrawal of its sickle cell drug Oxybryta over safety concerns was called “tone deaf” during a panel discussion among sickle cell experts Saturday at STAT@ASH , which took place during the American Society of Hematology’s annual meeting. They said patients were despondent over how suddenly the drug was pulled from the market in September because there had been no clear indication of problems in advance of the announcement.
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
The government has planned for a pay rise of 2.8% for pharmacists working in general practice and the NHS for 2025/26, it has been announced. In written evidence to the pay review bodies for general practice staff and NHS staff, the Department of Health and Social Care (DHSC) said it had set aside 2.8% for […] The post Government recommends 2.8% pay uplift for GP and PCN pharmacists appeared first on The Pharmacist.
Power Gummies has raised Rs 10 crore in the bridge round. Led by the Jaipuria Family Office and Quadrant, the funding round was also joined by previous investors 100unicorn, DSGCP, Wipro Consumer, Venture Catalysts, Agility, Sharrp Ventures, Dhianu Das and NB Ventures. The fresh capital would be instrumental in enabling the brand to become completely sugar-free in its products, followed by expansion into no-added sugar products and an upgraded composition in the existing range.
The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drug developers.
Top of the morning to you, and a fine one it is. Clear blue skies and chilly breezes are wafting across the Pharmalot campus, where the official mascots are snoozing after foraging for their breakfast. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation. Our choice today is maple cinnamon French toast.
Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.
The UK ban on private prescribing of puberty blockers in under-18s with gender dysphoria has been extended indefinitely, the government has announced. It follows a consultation on the measures and independent advice from the Commission on Human Medicines (CHM) which found an unacceptable safety risk in the continued prescription of puberty blockers to children.
In November 2024, the pharma and healthcare industry reported 95 deals worth $14.8 billion, compared to the last 12-month (November 2023 to October 2024) average of 102 deals worth $16.8 billion. Hoffmann-La Roche, to acquire Poseida Therapeutics, a clinical-stage allogeneic cell therapy and genetic medicine company for an equity value of $1.5 billion; Ampersand Capital Partners and GHO Capital Partners, to acquire Avid Bioservices, a biologics contract development and manufacturing organisation
The pharmaceutical industry is heavily reliant on patents to protect intellectual property and maintain market exclusivity. However, with the increasing competition from generic and biosimilar manufacturers, patent invalidity claims have become a significant challenge for pharmaceutical companies.
Like many Americans, Holden Karau said she was fed up with health insurance. The software engineer’s disillusionment began in 2019, when her insurer, UnitedHealthcare, balked at covering physical therapy after she was hit by a car and could not walk. She said the hassles piled on stress, forced her to pay more out of pocket, and delayed access to care she needed to recover from multiple broken bones.
Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.
Funding, commissioning and regulation must change to enable a digital-first future for community pharmacy, sector bodies have said. The National Pharmacy Association (NPA), the Independent Pharmacies Association (IPA) and the Company Chemists' Association (CCA) set out a vision for an artificial intelligence (AI) and automation-enabled future for community pharmacy in their responses to the government's […] The post Pharmacy bodies hint at 'AI dispensing' future - but funding, co
Biocon has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (US FDA). The company received the EIR for their API facility (Site 2), located at SEZ Plot no. 2,3,4 and 5 Bommasandra-Jigani Link Road, Bengaluru, Karnataka. This is based on a surveillance inspection conducted by the agency between September 23-27, 2024.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
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