Citryll gains Series B funds to develop NET-targeting antibody
Pharmaceutical Technology
DECEMBER 9, 2024
Citryll has secured an oversubscribed Series B funding round, raising 85m ($89.8m) to advance the clinical development of CIT-013.
Sat.Dec 07, 2024 - Fri.Dec 13, 2024
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Imfinzi receives NICE recommendation for lung cancer treatment
Pharma Times
DECEMBER 9, 2024
Trial results lead to new treatment option for lung cancer
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MASH Clinical Trials: New Approaches and Methodologies
XTalks
DECEMBER 10, 2024
Metabolic dysfunction-associated steatohepatitis (MASH), previously known as non-alcoholic steatohepatitis (NASH), is a growing health concern. In the US, MASH affects an estimated three to six percent of the population. This chronic liver disease results from fat accumulation that leads to liver cell damage and inflammation. It is often associated with obesity, type 2 diabetes and cardiovascular risks.
FDA Refines Accelerated Approval Pathway with New Draft Guidance
XTalks
DECEMBER 9, 2024
The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.
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
Reprieve for Chinese biotechs as BIOSECURE Act left out of key bill
Pharmaceutical Technology
DECEMBER 9, 2024
Shares in WuXi AppTec, one of those implicated in the Chinese biotech blacklisting legislation, surged following the omission.
December 11, 2024: Home Blood Pressure Telemonitoring in Black and Hispanic Patients With Stroke, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
DECEMBER 11, 2024
Dr. Gbenga Ogedegbe In this Friday’s PCT Grand Rounds, Gbenga Ogedegbe of the NYU Grossman School of Medicine will present “Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, December 13, 2024, at 1:00 pm eastern.
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AI-powered blood test can spot earliest sign of breast cancer
Medical Xpress
DECEMBER 13, 2024
A new screening method that combines laser analysis with a type of AI is the first of its kind to identify patients in the earliest stage of breast cancer, a study suggests.
Nobel laureates ‘strongly urge’ Senate to oppose confirmation of RFK Jr
Pharmaceutical Technology
DECEMBER 12, 2024
In the letter, 77 Nobel Prize winners argue that appointing RFK as Secretary of HHS would put the US publics health in jeopardy.
December 12, 2024: Another Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
Rethinking Clinical Trials
DECEMBER 12, 2024
In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups , and results from the NIH Collaboratory Trials.
Leriglitazone meets endpoint in trial for cerebral adrenoleukodystrophy
Pharma Times
DECEMBER 11, 2024
Promising results set stage for European marketing authorization
Japanese researchers test pioneering drug to regrow teeth
Medical Xpress
DECEMBER 13, 2024
People with missing teeth may be able to grow new ones, say Japanese dentists testing a pioneering drug they hope will offer an alternative to dentures and implants.
UK indefinitely bans puberty blockers for teenagers due to “unacceptable risk”
Pharmaceutical Technology
DECEMBER 12, 2024
Puberty blockers for people aged under 18 with gender dysphoria will be indefinitely banned by the UK Government.
After Moderna's pediatric RSV vaccine trial hold, expert panel says more testing is needed
Fierce Pharma
DECEMBER 13, 2024
Two days after the FDA revealed that it had halted enrollment in trials of respiratory syncytial virus (RSV) vaccines that involve young children, experts from an FDA advisory panel expressed their | An FDA advisory committeeexamining the halt of a trial of two Moderna respiratory syncytial virus (RSV) vaccines because of severe lower respiratory tract infections (LRTIs)echoed frustration in knowledge gaps about the disease and said that more testing is needed.
iOnctura achieves new clinical milestones in uveal melanoma therapy
Pharma Times
DECEMBER 11, 2024
Successful phase 1 study highlights potential of roginolisib
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
Overcoming challenges in biosimilar analytical characterization
Drug Patent Watch
DECEMBER 9, 2024
Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.
Sanofi’s combo vaccines gain FDA fast track designation
Pharmaceutical Technology
DECEMBER 12, 2024
Sanofi has announced that its two combination vaccine candidates have received fast track status from the US FDA.
Light-induced gene therapy disables cancer cells' mitochondria
Medical Xpress
DECEMBER 13, 2024
Researchers are shining a light on cancer cells' energy centersliterallyto damage these power sources and trigger widespread cancer cell death. In a new study, scientists combined strategies to deliver energy-disrupting gene therapy using nanoparticles manufactured to zero in only on cancer cells. Experiments showed the targeted therapy is effective at shrinking glioblastoma brain tumors and aggressive breast cancer tumors in mice.
CatalYm shows potential of visugromab for treating cachexia
Pharma Times
DECEMBER 10, 2024
New findings presented at international SCWD conference
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.
Addressing Generic Drug Market Challenges: Strategies for Stability and Affordability
Drug Patent Watch
DECEMBER 12, 2024
The generic drug market in the United States faces significant challenges, including price volatility, supply chain disruptions, and strategies employed by brand-name manufacturers to delay market entry. These challenges can lead to drug shortages, price spikes, and reduced affordability for patients and payers. To address these issues, several market-based proposals and regulatory reforms have been suggested.
ASH 2024 discussions shine spotlight on advances in haemophilia treatments
Pharmaceutical Technology
DECEMBER 11, 2024
When a room of physicians at ASH 2024 was asked whether they had prescribed a gene therapy in a commercial context, only a handful said yes.
An unexpected side effect: Intermittent fasting may slow hair regrowth
Medical Xpress
DECEMBER 13, 2024
Intermittent fasting has proven benefits for metabolic health, but a new study shows that it could slow hair growthat least in mice. Researchers report December 13 in the journal Cell that mice subjected to intermittent fasting regimes showed improved metabolic health but slower hair regeneration compared to mice with 24/7 access to food.
Poolbeg Pharma presents positive results for POLB 001
Pharma Times
DECEMBER 9, 2024
promising pre-clinical data on preventing cytokine release syndrome
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.
How to Evaluate CDMO Performance: Key Considerations and Best Practices
Drug Patent Watch
DECEMBER 12, 2024
The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial. Evaluating CDMO performance is a critical step in this process, ensuring that the chosen partner can meet the required standards and deliver high-quality products.
Priority FDA review given to AstraZeneca’s Imfinzi sBLA for MIBC
Pharmaceutical Technology
DECEMBER 9, 2024
The US FDA has granted priority review to AstraZeneca's sBLA for Imfinzi (durvalumab) for muscle-invasive bladder cancer (MIBC) treatment.
Who Will Pay for Prescription Drugs in 2032: Four Takeaways from the New Government Forecasts (rerun)
Drug Channels
DECEMBER 13, 2024
This week, Im rerunning some popular posts while I prepare for todays Drug Channels Outlook 2025 live video webinar. (If you sign up before 12 p.m. ET, you can attend the live event.) Click here to see the original post. The econowonks at the Centers for Medicare & Medicaid Services (CMS) recently released the latest projections for U.S. spending on healthcare.
Leriglitazone meets primary endpoint in pivotal cALD trial
Pharma Times
DECEMBER 12, 2024
Promising trial results support marketing authorisation application
The Role of Scientific Expertise in Generic Drug Development
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts. This article will delve into the importance of scientific expertise in generic drug development, highlighting the key areas where scientific knowledge is essential.
AIM ImmunoTech gains Netherlands patent for post-Covid fatigue therapy
Pharmaceutical Technology
DECEMBER 13, 2024
AIM ImmunoTech has secured a patent from the Netherlands Patent Office for Ampligen, targeting the treatment of post-Covid fatigue.
Novo Nordisk’s chief scientific officer looks to the future of GLP-1s
Fierce Pharma
DECEMBER 12, 2024
GLP-1 agonists have taken the pharma world by storm, and Novo Nordisk has been at the forefront of it all thanks to blockbuster drug semaglutide, which it sells as Ozempic, Wegovy and Rybelsus. | This week on The Top Line, we hear from Novo Nordisk CSO Marcus Schindler about his role at the Danish pharma and whats next for the GLP-1 drug class.
From Yemen to France, research reveals spread of highly drug-resistant cholera strain
Medical Xpress
DECEMBER 13, 2024
Scientists from the National Reference Center for Vibrios and Cholera at the Institut Pasteur, in collaboration with the Center hospitalier de Mayotte, have revealed the spread of a highly drug-resistant cholera strain. The study was published on December 11, 2024 in the New England Journal of Medicine.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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