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The California Institute for Regenerative Medicine has for a decade owned a human stem cell biobank that was once the largest of its kind in the world. But the agency and its partners are now racing to sell off thousands of precious samples in a massive fire sale before many of them are discarded. Created by state voters to fund stem cell research, the institute amassed a vast array of precursor cells called induced pluripotent stem cells, or iPSCs.
The main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make good on the deal, other secondary patents will need to hold up.
The Food and Drug Administration rejected a marketing application from Capricor Therapeutics for a cell therapy to treat Duchenne muscular dystrophy, the company said Friday. In its letter to Capricor, the FDA said the company’s application “does not meet the statutory requirement for substantial evidence of effectiveness” and requested additional clinical data, the company said.
HHS Secretary Robert F. Kennedy Jr. wants every American using a wearable health device within four years. But is that goal worthwhile — and attainable? Health system leaders told Becker’s that it’s a deserving outcome that won’t be easy to accomplish. “Wearables hold tremendous promise — especially when used to empower patients, enrich remote care and enable early intervention, although the value depends heavily on context, accuracy and integration,” said Sunil Dad
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.
As technology reshapes healthcare, pharmacists are stepping into expanded, patient-focused roles – leveraging automation, telehealth, and digital tools to transform how care is delivered.
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of complete response letters. FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy From my colleague Adam Feuerstein: The Food and Drug Administration rejected a marketing application from Capricor Therape
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has expressed urgent concerns over the recent circular issued by the Central Drugs Standard Control Organization (CDSCO), which mandates exclusive online submission of Certificate of Pharmaceutical Product (COPP) applications via the ONDLS portal. While the Council supports digital integration and modernization of regulatory frameworks, it foresees a major disruption to India’s pharmaceutical exports – particularly to Rest
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has expressed urgent concerns over the recent circular issued by the Central Drugs Standard Control Organization (CDSCO), which mandates exclusive online submission of Certificate of Pharmaceutical Product (COPP) applications via the ONDLS portal. While the Council supports digital integration and modernization of regulatory frameworks, it foresees a major disruption to India’s pharmaceutical exports – particularly to Rest
Diclofenac (Voltarol Ophtha) 0.1% eye drops 0.3ml unit dose preservative free are out of stock until early October 2025, according to a medicine supply notification issued by the Department of Health and Social Care (DHSC). Ketorolac 0.5% eye drops, bromfenac 0.9mg/ml eye drops, and nepafenac 1mg/ml and 3mg/ml eye drops remain available to support increased […] The post Diclofenac eye drops hit by stock shortage appeared first on The Pharmacist.
In the third part of this roundtable discussion, a panel of thought leaders explore the value of serialization, data sharing, and predictive analytics in identifying potential quality issues before they arise.
‘How are you coping with the heat?’ It’s a staple phrase in the lexicon of British small talk during the kind of scorching hot summer the UK is currently experiencing. But for pharmacists, the question represents more than just casual conversation; it hits upon the practical and operational considerations that the hot weather demands. According […] The post Keeping medicines safe in hot weather – a dual challenge for pharmacists appeared first on The Pharmacist.
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the agency during deramiocel’s review.
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
A new approach to approving and adopting medicines will be introduced in England, the government’s recently published 10-year NHS plan has suggested – with the aim of getting innovative treatments to patients more quickly. According to the 168-page document, the Medicines and Healthcare products Regulatory Agency (MHRA) will adopt 'a more pro-innovation approach to regulation, […] The post MHRA and NICE to join forces to speed up medicines approval appeared first on The Pharmacist.
New research finds that nearly half of the racial and ethnic disparities in outpatient COVID-19 antiviral prescriptions stem from encounter-level care barriers, such as limited access to rapid tests and telehealth, which emphasizes the need for systemic and practice-level reforms.
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.
This partnership will combine the OligoCreator technology of Secarna with Vect-Horus’ VECTrans system. The alliance uses Vect-Horus’ expertise in delivering compounds across biological barriers using its VECTrans platform. The system employs engineered peptides and single-domain antibodies to transport therapeutic payloads into the CNS. Secarna’s OligoCreator platform utilises artificial intelligence (AI) to quickly identify and optimise oligonucleotide therapies that are both effect
Today’s guest post comes from Lindsay Reel, VP of Pharmacy Practice & Specialty Solutions at EVERSANA. In this article, Lindsay shares a pharmacist’s firsthand perspective on the growing complexity of patient access and the limitations of traditional pharmacy models. She argues that emerging Direct-to-Patient (DTP) strategies can reshape the care experience by addressing longstanding inefficiencies, enhancing transparency, and simplifying therapy initiation for both patients and providers.
A report by Fact.MR has predicted that worldwide, the lab automation market will value $4,936 million by 2035. Between 2025 and 2035, the industry is expected to grow at a CAGR of 7.3 percent, “driven by rising technological advancements that have transformed laboratory functions”. Major factors driving growth of the global lab automation market According to the report, a key driver of the market is the “ever-changing pace of technology, which includes advanced robotics, specifically designed fo
After 50 years of LAL testing, the pharmaceutical industry is transitioning to recombinant Factor C (rFC) methods. USP Chapter <86> (November 2024) eliminates the biggest barrier—method validation—making adoption faster and easier than ever. It is now important to switch to recombinant methods than ever before! Why ? Sustainability : Eliminate dependence on horseshoe crab blood while protecting coastal ecosystems and ensuring ethical manufacturing practices.
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 main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make good on the deal, other secondary patents will need to hold up.
BioMed X and Servier have announced the launch of Europe’s first XSeed Labs research project, located at the Spartners incubator in Paris-Saclay, France. The initiative, hosted within Servier’s research site and operated by BioLabs, will develop an AI-enabled platform for sterically-guided bispecific antibody design. The XSeed Labs model, pioneered by BioMed X, brings together scientists […] The post BioMed X and Servier launch Europe’s first XSeed Labs to advance AI-powered antibody desig
Union workers at Minneapolis-based Hennepin County Medical Center have asked county commissioners to launch an outside investigation into management’s alleged treatment of workers, The Minneapolis Star Tribune reported July 10. Unionized medical assistants, physical therapists and mental health workers held a news conference outside the hospital asking for commissioners to initiate an investigation into the hospital’s “internal culture, management practices and personnel decisi
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.
Hospitals headed into the summer on slightly weaker financial footing, as operating margins narrowed, outpatient revenues declined and expenses continued to rise — most notably for prescription drugs, according to Kaufman Hall’s “ National Hospital Flash Report ,” published July 10. The May data, drawn from more than 1,300 hospitals, points to softening patient volumes and growing cost pressures that could pose significant challenges for hospital performances in the second half of the year
German-based Cube Biotech announced the appointment of Joachim Kreuzburg to its board of directors. This will support the development of the company’s automation technology for membrane protein production. Kreuzberg brings over two decades of executive leadership experience in the life sciences industry. As former CEO and chairman of the executive board of Sartorius, global pharma […] The post Cube Biotech appoints Joachim Kreuzburg to its board of directors appeared first on Pharmafile.
A research team led by Prof. LIU Qingsong and Prof. LIU Jing from the Hefei Institutes of Physical Science, Chinese Academy of Sciences, has recently developed a new class of compounds that effectively inhibit both wild-type CDK9 and its drug-resistant mutant form, offering a promising strategy for treating hematological malignancies.
Eli Lilly (Lilly) has announced that the National Institute for Health and Care Excellence (NICE) has recommended mirikizumab (omvoh) for use on the NHS in England and Wales to treat moderately to severely active Crohn’s disease. This provides patients who responded inadequately to other therapies a new treatment option. Specifically, the therapy is recommended for […] The post NICE recommends NHS use of mirikizumab for Crohn’s disease appeared first on Pharmafile.
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.
In the final part of his Pharma Commerce video interview, Marschall Runge, MD, PhD, dean of the University of Michigan Medical School and author of The Great Healthcare Disruption, details the role that academic medical centers play in shaping Medicaid policy.
In a recent webinar, industry experts explain how real-world data and patient-centric support can shape regulatory success and sustainable reimbursement.
Don’t get me wrong – I’m crazy about protein. It keeps me fuller for longer, helps support my muscles and metabolism and so much more. But you’d probably all agree that it has been given more than enough of a spotlight when it comes to women’s health and perimenopause. It may have even accidentally taken the focus off some other key nutrients that are vital in this life stage.
Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.
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