The most expensive drugs in the US
Pharmaceutical Technology
AUGUST 29, 2024
From Orchard’s Lenmeldy to Vertex and CRISPR Therapeutics’s Casgevy, Pharmaceutical Technology lists the top ten priciest therapies in the US.
Thu.Aug 29, 2024
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Cell and gene therapy investment, once booming, is now in a slump
Bio Pharma Dive
AUGUST 29, 2024
Far fewer venture funding rounds were closed by cell and gene therapy developers over the first six months of 2024 than in prior years. Experts say there are several factors.
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August 29, 2024: HDRN Canada Pragmatic Trials Training Program Offers Open-Access Learning Modules
Rethinking Clinical Trials
AUGUST 29, 2024
A virtual, asynchronous learning program that offers open-access modules to anyone interested in learning about the complex art of pragmatic clinical trial design and implementation is now available. Every week, a new open-access module features essential resources and leading Canadian trialists discussing a key component of clinical trials. The 2-year, pan-Canadian program—HDRN Canada Pragmatic Trials Training Program—follows a structured curriculum that covers 12 key components of clinical tri
PBM executives threatened with fines for alleged perjury in House hearing
Bio Pharma Dive
AUGUST 29, 2024
Testimony from the heads of Express Scripts, Optum Rx and Caremark in July defending pharmacy benefit managers’ business practices could be coming back to bite them.
Eating Seaweed May Help Prevent Parkinson’s, Study Finds
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 29, 2024
(Douglas Klug/Getty Images) Eating the seaweed Ecklonia cava may be able to slow down or prevent Parkinson’s disease, according to a 2024 study. Researchers found that antioxidants in the seaweed – which is often used in soups and salads in Asian cuisine – may protect our neurons from free radicals to prevent this debilitating disease.
Keytruda fails lung and skin cancer trials, limiting further expansion
Bio Pharma Dive
AUGUST 29, 2024
The trial setbacks for Merck’s best-selling drug, which faces patent expiration in 2028, are a blow to the company’s plans for further indication expansion.
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BioMarin to lay off over 200 employees
Bio Pharma Dive
AUGUST 29, 2024
The company has reshuffled its executive team, cut back spending and trimmed its drug pipeline this year, changes aimed at refocusing its resources.
Steroid 17 Alpha Hydroxylase/17,20 Lyase drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the Steroid 17 Alpha Hydroxylase/17,20 Lyase pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Optimizing Patient-Driven Site Engagement in Rare Disease Clinical Trials
Worldwide Clinical Trials
AUGUST 29, 2024
By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around. This departure from traditional recruitment methods, where sites would typically initiate contact with patients, presents both opportunities and challenges, marking a pivotal moment in how we ap
T Lymphocyte Activation Antigen CD80 drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the T Lymphocyte Activation Antigen CD80 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
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
J&J submits touted autoimmune disease drug for FDA approval
Bio Pharma Dive
AUGUST 29, 2024
Nipocalimab is one of several drugs J&J has forecast for multi-billion dollar sales. The company’s initial application is for its use in myasthenia gravis.
E3 Ubiquitin Protein Ligase CBL B drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the E3 Ubiquitin Protein Ligase CBL B pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
CDSCO declares 70 drugs tested in July as NSQs
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 29, 2024
The Central Drugs Standard Control Organisation (CDSCO) has released a list of 70 drug samples declared as Not of Standard Quality (NSQ), with samples of drugs labelled as manufactured by some of the major companies failing the quality test.
Myotonin Protein Kinase drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the Myotonin Protein Kinase pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Merck’s Keytruda flunks pivotal studies in early-stage lung and skin cancers
Fierce Pharma
AUGUST 29, 2024
A Merck & Co. effort to move its PD-1 behemoth Keytruda into early treatment of lung cancer has reached a dead end, along with another bid to expand into a type of early-stage skin cancer. | A Merck & Co. effort to move its PD-1 behemoth Keytruda into early treatment of lung cancer has reached a dead end, along with another bid to expand into a type of early-stage skin cancer.
Growth/Differentiation Factor 15 drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the Growth/Differentiation Factor 15 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
AbbVie's Ubrelvy wards off migraines when used in reaction to early warning signs: study
Fierce Pharma
AUGUST 29, 2024
Despite competing against several drugs that have been approved to fend off migraine headaches, AbbVie’s Ubrelvy (ubrogepant) —which is approved only to treat them—has carved out a significant nich | Recent trial results indicate that AbbVie's migraine treatment Ubrelvy works as a preventative. In a study published this week in the journal Neurology, Ubrelvy was 73% more effective in preventing a migraine attack than placebo.
Transmembrane Protein PVRIG drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the Transmembrane Protein PVRIG pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
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.
How to Ensure Your Generic Drug Meets FDA Standards
Drug Patent Watch
AUGUST 29, 2024
Ensuring that a generic drug meets FDA standards is crucial for maintaining the high quality and efficacy of medications. The FDA’s Office of Generic Drugs (OGD) plays a vital role in this process by following a rigorous review process to ensure that generic medications meet the same standards as their brand-name counterparts. The FDA’s review process for generic drugs involves several key steps.
Son Of Sevenless Homolog 1 drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the Son Of Sevenless Homolog 1 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Neurocrine slides as schizophrenia data disappoints
pharmaphorum
AUGUST 29, 2024
Shares in Neurocrine Biosciences took a tumble after it reported mid-stage data for a key pipeline drug for schizophrenia that failed to impress investors
Connective Tissue Growth Factor drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the Connective Tissue Growth Factor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
GSK gets EU okay for RSV shot in younger age group
pharmaphorum
AUGUST 29, 2024
GSK gets EU approval for its RSV vaccine Arexvy in a younger age group, a potential leg-up in a market tussle with Pfizer and Moderna
5-Hydroxytryptamine Receptor 4 drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the 5-Hydroxytryptamine Receptor 4 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Fierce Pharma Asia—Sanofi's flu shot setback; DualityBio's IPO plan; UCB's China asset sale
Fierce Pharma
AUGUST 29, 2024
Sanofi has suspended distribution of its two flu vaccines in China out of concern of waning potency. BioNTech's antibody-drug conjugate partner, DualityBio, has filed for a Hong Kong IPO. | Sanofi has suspended distribution of its two flu vaccines in China. BioNTech's ADC partner, DualityBio, has filed for a Hong Kong IPO. UCB will offload some Chinese assets for $680 million.
Mu Type Opioid Receptor drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the Mu Type Opioid Receptor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
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.
Push for self-injected drugs prompts Novartis/Lindy alliance
pharmaphorum
AUGUST 29, 2024
Novartis partners with startup Lindy in a near-$1bn deal to develop subcutaneous formulations of biologic drugs
Putative Fidgetin Like Protein 2 drugs in development, 2024
Pharmaceutical Technology
AUGUST 29, 2024
The Putative Fidgetin Like Protein 2 pipeline drugs market research report outlays comprehensive information on the Putative Fidgetin Like Protein…
HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA
Pharmaceutical Commerce
AUGUST 29, 2024
Panel offers suggestions on how compliance teams should be considering handling SOPs, stabilization, and much more.
Biocon Biologics signs agreement with Janssen to market Bmab 1200
Pharmaceutical Technology
AUGUST 29, 2024
Biocon has reached a settlement and license agreement with Janssen for the commercialisation of Bmab 1200, a proposed biosimilar to Stelara.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
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