10 clinical trials to watch in the second half of 2023
BioPharma Dive
JUNE 27, 2023
A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.
Sat.Jun 24, 2023 - Fri.Jun 30, 2023
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How can real-world evidence support regulatory decision making?
European Pharmaceutical Review
JUNE 26, 2023
The European Medicines Agency (EMA) has published its report: Real-world evidence framework (RWE) to support EU regulatory decision-making. The review summarised what the organisation has learned from conducting real-world data (RWD) regulator-led studies from September 2021 to February 2023. There were 61 RWD research opportunities identified, 30 studies initiated and 27 completed in this period.
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Optimizing Patient Care Services with Rare Disease Limited Distribution Drugs
Orsini Pharmacy
JUNE 29, 2023
The complexities of managing the care of a rare disease patient are tremendous. Several models of care are efficient when optimizing patient care services with rare disease limited distribution drugs; however, the most promising is the concierge model. This model is where all communications would filter through the health plan. The health plan has a line of sight to precisely what that patient needs and where to get their drug.
Transgender patients are rarely included in clinical trials. Can pharma fix it?
PharmaVoice
JUNE 29, 2023
Transgender and nonbinary patients suffer more adverse health outcomes than the general population, yet are often underrepresented in clinical research. Now, there’s momentum to change the status quo.
Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape
Speaker: Jennifer Hill
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.
BioMarin finally secures FDA approval of hemophilia gene therapy
BioPharma Dive
JUNE 29, 2023
After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.
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Vertex and Lonza to establish T1D cell therapy manufacturing facility
Pharmaceutical Technology
JUNE 27, 2023
Vertex and Lonza have entered a partnership to establish a facility in Portsmouth, US, to manufacture cell therapies for type 1 diabetes.
US FDA grants fast track status for GSK’s gonorrhoea vaccine
Pharmaceutical Technology
JUNE 28, 2023
GSK has received a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine from the US Food and Drug Administration.
Microbiome therapies: a maturing movement
European Pharmaceutical Review
JUNE 27, 2023
Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.
STAT+: Grail faces uphill battle to get Medicare to cover its cancer screening test
STAT
JUNE 27, 2023
WASHINGTON — Grail is aggressively lobbying to get Medicare to pay for its cancer-screening test Galleri — but experts tell STAT that the company has a far more complicated path to that end than the makers of most medicines or medical devices. Grail’s controversial blood test Galleri screens for multiple cancers. The Food and Drug Administration has not yet approved it, so Medicare hasn’t had to make a decision on whether to cover it or not.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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 pharma summer — how leaders unwind and recharge their teams in the warmer months
PharmaVoice
JUNE 30, 2023
Vacation is calling, but so are patients. Here's how the industry adjusts in the summer.
Pursuing a Career in Pharmacy: Empowering LGBTQIA+ Students through Advocacy and Diversity
Pharmacy Is Right For Me
JUNE 30, 2023
Join us as we explore the inspiring journey of Cayden Miller, a passionate pharmacy graduate from Southern Illinois University at Edwardsville School of Pharmacy. Cayden’s experience as a member of the LGBTQIA+ community has shaped his path in pharmacy, driving him to become an advocate for diversity, equity, and inclusion (DEI) within the profession.
Genfit and Ipsen announce elafibranor results
Pharma Times
JUNE 30, 2023
ELATIVE, a randomised PBC trial involving 161 patients, has successfully met its primary endpoint - News - PharmaTimes
STAT+: Illumina to lay off 10% of research and development team in bid to cut costs by $100 million
STAT
JUNE 26, 2023
SAN DIEGO — Months after announcing plans to cut costs by $100 million, DNA sequencing giant Illumina has begun to lay off 10% of its research and development team, according to internal emails obtained and reviewed by STAT. The layoffs, which began last Wednesday, impact research teams across the company’s California sites in San Diego and Foster City, as well as locations in Madison, Wisconsin; Singapore; and the United Kingdom.
Why Every Small Business Needs an HCM Solution: A Comprehensive Guide
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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.
Major clinical trial trends transforming life sciences research
PharmaVoice
JUNE 29, 2023
From AI to diversity and decentralized trials, here’s how clinical trial operations are evolving.
NASH drugs race to cross the finish line
Pharmaceutical Technology
JUNE 26, 2023
After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.
Positive results for Evgen’s rhabdomyosarcoma therapy
Pharma Times
JUNE 27, 2023
Update on radiosensitising impact of SFX-01 when treating common soft tissue sarcoma condition - News - PharmaTimes
ADA says all diabetes patients should be screened for nonalcoholic fatty liver disease
STAT
JUNE 25, 2023
SAN DIEGO — The American Diabetes Association said Sunday that all adults with type 2 diabetes or prediabetes should be screened for nonalcoholic fatty liver disease, an increasingly prevalent condition that can lead to serious liver damage. There are no approved medications for the disease, but among available diabetes drugs, the ADA singled out GLP-1 treatments as an option doctors could consider, according to recommendations published during the annual ADA conference.
Position Your Pharmacy for Expansion
Speaker: Chris Antypas and Josh Halladay
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.
A unique study on COVID shows how machine learning can help personalize medicine
PharmaVoice
JUNE 26, 2023
Based on real-world data from patients in China, researchers were able to pinpoint factors that led to recurring infections — and which drug combos helped.
FDA approves first cell therapy for type 1 diabetes
pharmaphorum
JUNE 29, 2023
FDA approves first cell therapy for type 1 diabetes Phil.
MinervaX reveals completion of vaccine trial enrolment
Pharma Times
JUNE 27, 2023
The company is seeking to address the worldwide impact of group B streptococcus in older adults - News - PharmaTimes
Malaria cases in Florida and Texas: Here’s what you need to know
STAT
JUNE 30, 2023
The five cases of malaria diagnosed in Florida and Texas in recent weeks — the first cases of local transmission in the United States in 20 years — have worried some residents and led state and federal officials to issue public alerts about the cluster of infections. But scientists and public health officials, while advising people in the affected areas to take precautions, say there is little cause for alarm, for several reasons: The number of cases is very low; there are easy, lo
Best Practices to Streamline Compensation Management: A Foundation for Growth
Speaker: Joe Sharpe and James Carlson
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.
Pharma is still figuring out how to make DEI work. Here are some of the strategies companies are trying
PharmaVoice
JUNE 28, 2023
Although DEI efforts have ramped up, the industry is still searching for proven ways to get results.
Shionogi agrees $140m deal to buy antibiotic biotech Qpex
pharmaphorum
JUNE 26, 2023
Shionogi agrees $140m deal to buy antibiotic biotech Qpex Phil.
Momentum for Poolbeg and CytoReason’s AI collaboration
Pharma Times
JUNE 29, 2023
Partnership establishes several influenza therapy targets using artificial intelligence - News - PharmaTimes
Medical leaders decry Supreme Court decision on affirmative action
STAT
JUNE 29, 2023
Medical leaders on Thursday reacted swiftly to the Supreme Court’s decision to severely restrict the use of race in college admissions, saying the ruling could reverse decades of progress toward diversifying the nation’s physician workforce — something seen as key to helping end the country’s widespread and deeply entrenched health disparities.
Enhance Healthcare Efficiency With Top Payroll & HCM Services
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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.
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