Bio Pharma Dive
APRIL 8, 2024
Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.
Pharmaceutical Technology
APRIL 8, 2024
The FDA has approved the NDA for SH-201, an oral liquid drug that slows or stops the growth of certain types of leukaemia.
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Bio Pharma Dive
APRIL 8, 2024
Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.
Pharmaceutical Technology
APRIL 8, 2024
Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma have received FDA approval for relapsed or refractory multiple myeloma (RRMM).
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
APRIL 8, 2024
The results were the second time Novo has shown its weight loss treatment can help with the condition, and may help it secure broader use of the drug.
Pharmaceutical Technology
APRIL 8, 2024
J&J and Legend’s CAR-T cell therapy has been approved as a second-line therapy for patients with multiple myeloma (MM).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Worldwide Clinical Trials
APRIL 8, 2024
By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success. Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research.
Bio Pharma Dive
APRIL 8, 2024
Twenty-six drugmakers closed private fundraising rounds worth more than $100 million, according to HSBC data shared with BioPharma Dive.
Pharmaceutical Technology
APRIL 8, 2024
In the second part of this series, F. Randy Vogenberg talks about how planning early can positively impact insurance coverage for new therapies, especially in the case of orphan drugs.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 8, 2024
The Drugs Technical Advisory Board (DTAB) has suggested to the ministry of health and family welfare (MoHFW) to write to the ministry of corporate affairs to mandate the pharma companies to spend almost one per cent of their net profit for providing free medicines in medicine banks as part of the Corporate Social Responsibility (CSR).
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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
Pharmaceutical Technology
APRIL 8, 2024
The US FDA has approved Daiichi Sankyo and AstraZeneca’s Enhertu for adults with HER2-positive solid tumours.
BioSpace
APRIL 8, 2024
As the antibody-drug conjugate space continues to heat up, Merck has acquired preclinical startup Abceutics—spun out of the University at Buffalo—and its novel platform that aims to make ADC therapeutics safer.
Pharmaceutical Technology
APRIL 8, 2024
In an interview with Pharmaceutical Technology, Pluri’s CEO discussed its recent launch as a CDMO as well as its cell therapy pipeline.
Fierce Pharma
APRIL 8, 2024
With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s (ADC's) reach in the U.S.< | With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s reach in the United States.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Technology
APRIL 8, 2024
Medicxi has partnered with Starpharma for the formation of Petalion Therapeutics to develop dendrimer-based oncology treatments.
Drug Discovery World
APRIL 8, 2024
The latest sponsored DDW Sitting Down With vodcast features Dr Adriano Flora, Director of Business Development at The Jackson Laboratory (JAX). He discusses alternatives to non-human primates, the key benefits of this, and what impact will they have on the future of drug development. Moreover, he answers questions on the key breakthroughs in recent years in this field and how have these impacted future success, as well as challenges in the clinic that must be overcome to ensure this success is a
Pharmaceutical Technology
APRIL 8, 2024
AdAlta has signed an MOU with SYNthesis to explore the creation of a jointly owned special purpose entity, AdCella.
pharmaphorum
APRIL 8, 2024
SGLT2 inhibitors have transformed the treatment of heart failure in the last few years, but an attempt to extend their use into the setting of post-heart attack patients has suffered a setback.
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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.
Pharmaceutical Technology
APRIL 8, 2024
Sensorion expects results from a Phase I/II trial of its lead candidate SENS-501 in the second half of 2025.
pharmaphorum
APRIL 8, 2024
Empower women's health with digital tools and technology. Learn about the latest advancements and resources to promote wellness and empowerment in women's health.
BioSpace
APRIL 8, 2024
Fresh off of its $14 billion acquisition of Karuna Therapeutics, Bristol Myers Squibb on Saturday reported promising late-stage data for Karuna’s antipsychotic KarXT, which elicited significant symptomatic improvement in schizophrenia symptoms.
Fierce Pharma
APRIL 8, 2024
One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. | Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
pharmaphorum
APRIL 8, 2024
Creating a winning playbook for consistent digital product success involves strategic planning, execution, and continuous improvement. Discover key strategies and practices to ensure your digital products achieve lasting success.
Fierce Pharma
APRIL 8, 2024
The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The following year, the agency doled out a complete response letter, dashing Supernus' second try.
pharmaphorum
APRIL 8, 2024
Drugs from Ionis and Arrowhead Pharma that block apolipoprotein C-III (apoC-III) have shown their value in treating diseases associated with elevated triglyceride levels in two studies presented at the American College of Cardiology annual congress. The two companies are racing to bring their apoC-III inhibitors to market for severe hypertriglyceridaemia (HTG) and ultra-rare disorder familial chylomicronaemia syndrome (FCS).
Fierce Pharma
APRIL 8, 2024
Merely hours after Bristol Myers Squibb’s Abecma secured the FDA’s blessing to break into earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti received a simil | Merely hours after Bristol Myers Squibb’s Abecma secured the FDA’s blessing to break into earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti received a similar go-ahead—but in an even earlier setting and with expanded manufacturing specifications.
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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.
pharmaphorum
APRIL 8, 2024
Less than half of the cancer therapies given accelerated approval by the FDA in 2013 to 2017 showed a clinical benefit in a confirmatory trial within the next five years
Pharmaceutical Commerce
APRIL 8, 2024
In an interview with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value & Access Advisor, Schoonveld Advisory, offers his thoughts on lower drug prices in the US and provides a sneak peak into future PC features.
Intouch Solutions
APRIL 8, 2024
In the dynamic realm where technology meets humanity, digital humans emerge as catalysts for a healthier future. With endless opportunities for innovation and advancement, these AI-driven entities are reshaping education, research and training in the life sciences industry. What are digital humans? Also known as digital twins or synthetic clones, digital humans blend cutting-edge innovation with human-like charm, surpassing traditional avatars or chatbots by emulating human behavior, expressions
Pharma Times
APRIL 8, 2024
The project aims to advance therapeutics for tuberculosis, malaria and hepatitis C in LMICs
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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