MangoRx hits back at Eli Lilly’s weight loss drug copycat claims
Pharmaceutical Technology
OCTOBER 22, 2024
Eli Lilly sued three online vendors and medical spas earlier this week over improper copying of tirzepatide.
Sat.Oct 19, 2024 - Fri.Oct 25, 2024
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RNA editing: emerging from CRISPR’s shadow
Bio Pharma Dive
OCTOBER 22, 2024
Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.
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Roche trial confirms Vabysmo efficacy in minorities
pharmaphorum
OCTOBER 21, 2024
A study has shown that Roche's diabetic macular oedema (DME) therapy Vabysmo is effective in patients who identify as African American, Black, Hispanic and Latino, plugging a gap in the data for the drug.Vabysmo (faricimab) has been approved by the FDA for treating DME since 2022, quickly becoming one of the Swiss pharma group's fastest-growing products with sales of $1.1 billion in the first half of the year.
October 21, 2024: BEST-ICU and Chat 4 Heart Health Have Updated Study Snapshots, Ethics and Regulatory Documentation
Rethinking Clinical Trials
OCTOBER 21, 2024
Updated study snapshots and ethics and regulatory documentation are now available for the BEST-ICU and Chat 4 Heart Health trials. Both of these NIH Collaboratory Trials are supported by awards from the National Heart, Lung, and Blood Institute. BEST-ICU transitioned from the planning phase to the implementation phase during the summer. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.
Bridging Innovation & Patient Care: The Growing Role of AI
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Sanofi in 'exclusive negotiations' to sell 50% stake in €16B consumer health unit Opella
Fierce Pharma
OCTOBER 21, 2024
Sanofi is now in “exclusive negotiations” with U.S. | Sanofi is now in “exclusive negotiations" with U.S. private equity firm Clayton, Dubilier & Rice to sell a 50% controlling stake in its consumer health business Opella, the company said. The deal values the consumer group at 16 billion euros.
Intellia data spark debate about CRISPR drug’s potential
Bio Pharma Dive
OCTOBER 24, 2024
Newly published data show the therapy reduced the rate of swelling attacks in people with hereditary angioedema, but didn't silence questions about its commercial outlook.
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Pharma companies must adapt to keep pace with AI developments, say experts
Pharmaceutical Technology
OCTOBER 25, 2024
At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.
Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide
Fierce Pharma
OCTOBER 23, 2024
The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and Wegovy, claiming the drugs are too complex to safely replicate.
Editas, changing course again, looks to partner lead CRISPR therapy
Bio Pharma Dive
OCTOBER 22, 2024
The gene editing company will focus on “in vivo” medicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.
New ‘Mechanical’ Weight Loss Pill from Oxford Medical Products Shows Positive Safety Data
XTalks
OCTOBER 23, 2024
Oxford Medical Products has shared promising safety data from a first-in-human study for its ‘mechanical’ weight loss pill. The pill, called Sirona, is actually a device that presents a new, non-pharmacological approach to managing weight. Sirona is designed as a non-invasive solution for individuals struggling with obesity, offering a safer alternative to traditional weight-loss medications and surgeries.
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 slow start for self-amplifying mRNA vaccines
Pharmaceutical Technology
OCTOBER 23, 2024
A year after the first samRNA vaccine approval, experts say others are likely to face scientific and regulatory hurdles.
Discover the Top Site Challenges of 2024 – Data and Insights on Site Barriers and Trial Efficiency
ACRP blog
OCTOBER 22, 2024
This is a sponsored message. The clinical research industry plays a vital role in advancing medical knowledge and improving healthcare; however, the increasing complexity of clinical trials has created a perfect storm of challenges for clinical research sites, posing significant risks to the efficiency, effectiveness, and sustainability of clinical trials at large.
Pharmaceutical research on mRNA and CAR T-cell therapy in cancer: Pioneering the future of oncology
Bio Pharma Dive
OCTOBER 21, 2024
Immunotherapy and precision medicine show promise in better fighting cancer. What else does the research tell us?
Syneos Health Welcomes Costa Panagos as New CEO
XTalks
OCTOBER 24, 2024
Biopharmaceutical solutions organization Syneos Health has announced the appointment of Costa Panagos as its new Chief Executive Officer (CEO). Panagos, an industry veteran with extensive experience in the healthcare and life sciences sector, takes over from Colin Shannon, who served as CEO for one year following the company’s acquisition by a consortium of private equity firms.
GSK pumps up to $800m for US manufacturing site upgrade
Pharmaceutical Technology
OCTOBER 25, 2024
A new vaccines drug substance facility and R&D pilot plant, completed by the end of 2028, will create over 200 new jobs.
How to Manage Regulatory Challenges in Generic Drugs
Drug Patent Watch
OCTOBER 24, 2024
The generic drug industry faces significant regulatory challenges that can impact the quality and safety of these life-saving medications. With the majority of generic drugs manufactured overseas, ensuring compliance with regulatory standards is crucial. This article delves into the complexities of generic drug regulation, highlighting the challenges faced by the U.S.
Harnessing the power of upstream platform integration to accelerate biopharma innovation
Bio Pharma Dive
OCTOBER 21, 2024
Learn how Syngene’s integrated strategy can enhance your mAb production capabilities.
Shields Health Solutions’ New Collaboration to Boost Specialty Pharmacy Access in Chronic Care
XTalks
OCTOBER 25, 2024
Shields Health Solutions, a specialty pharmacy owned by Walgreens, has partnered with Sutter Health to expand access to specialty medications across the US. This collaboration aims to support patients with chronic and complex conditions, particularly in oncology, rheumatology and dermatology. Nearly 3,000 healthcare providers will benefit, as Shields’ broad payer network and access to limited distribution drugs will offer patients more treatment options and cost-saving support.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
AAO 2024: Nanoscope Therapeutics’ MCO-010 RESTOREs vision in RP patients
Pharmaceutical Technology
OCTOBER 21, 2024
This trial investigated the potential of Nanoscope Therapeutics' MCO-010 to restore vision in patients with retinitis pigmentosa (RP).
NICE recommendation for new Alexion PNH treatment
Pharma Times
OCTOBER 24, 2024
danicopan shown to improve haemoglobin levels and reduce anaemia
Starboard makes case for change at Pfizer, citing research, M&A missteps
Bio Pharma Dive
OCTOBER 22, 2024
The activist investor claims Pfizer failed to capitalize on the windfall earned from its COVID-19 vaccine and, in the process, destroyed tens of billions of dollars in market value.
Mira’s New Menopause Transitions Kit Allows for At-Home Hormone Monitoring
XTalks
OCTOBER 23, 2024
Mira, a California-based women’s health technology company, has introduced its Menopause Transitions Kit, a new hormone monitoring kit designed for menopausal women. The at-home device enables women to track key hormone levels, offering real-time insights into the complex hormonal fluctuations associated with perimenopause and menopause. The product is an AI-powered hormone monitoring device designed for women aged 35 to 60.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
J&J’s Darzalex combination gains expanded label for multiple myeloma in Europe
Pharmaceutical Technology
OCTOBER 23, 2024
Darzalex will now be available to patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant.
Calluna Pharma completes successful phase 1 trial of new fibrotic disease drug
Pharma Times
OCTOBER 23, 2024
CAL101 shows promising results and is set to enter phase 2 development
Brain drug developer Seaport raises another $225M
Bio Pharma Dive
OCTOBER 21, 2024
Launched by PureTech and backed by well-known venture capital firms, the startup has raised $325 million since its debut this spring.
Transforming Clinical Research: A Conversation with Morgan Hanger, Executive Director of CTTI
XTalks
OCTOBER 23, 2024
In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, with an ambitious “Transforming Trials 2030” vision. Hanger shares her career journey, from her roles at PatientsLikeMe and Memorial Sloan Kettering Cancer Center, to leading CTTI.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Editas and Genevant team up to develop gene editing therapies
Pharmaceutical Technology
OCTOBER 22, 2024
Editas is partnering its CRISPR platform with Genevant’s LNP technology to develop novel gene editing medicines in a deal worth $283m.
Learna and University of Wolverhampton launch flexible healthcare courses
Pharma Times
OCTOBER 21, 2024
The five new programmes are designed to fit alongside full-time work and clinical practice
PureTech thinks the ‘hub-and-spoke’ startup model is still a good bet. If only investors agreed.
Bio Pharma Dive
OCTOBER 21, 2024
Shares in the Boston-based biotech creator, which had a standout success in forming Karuna Therapeutics, trade around cash levels — a "huge value disconnect" its leaders are trying to bridge.
VISION Technology Contributes to over 7,000 Randomizations Across the U.S. and Europe
Velocity Clinical Research
OCTOBER 24, 2024
As of today, VISION technology has now contributed to over 7,000 randomizations across the U.S. and Europe. At just a year since its launch, VISION is already making clinical trials more accessible to all on a global scale. We’re proud of the impact our team and technology are making in advancing clinical research. Here’s to the next 7,000 and beyond!
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