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.
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
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AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 27, 2024
(Thirdman/Pexels) The proverbial “sugar high” that follows the ingestion of a sweet treat is a familiar example of the potentially positive effects of food on mood.
Pharmaceutical Technology
AUGUST 27, 2024
Unlike its close neighbour Thailand, Singapore has not yet confirmed an mpox clade Ib case.
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
Bio Pharma Dive
AUGUST 28, 2024
Under a collaboration with NextRNA Therapeutics, Bayer will access the biotech’s platform to target long, non-coding RNA interactions with small molecule drugs.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 25, 2024
(Jordi Salas/Moment/Getty Images) A new mouse study challenges conventional wisdom that cutting down on calories can lead to a drop in exercise performance. Even when dieting, it seems mammalian bodies are able and willing to keep up previous activity levels.
Pharmaceutical Technology
AUGUST 30, 2024
GlobalData’s report assesses the drugs in the CD44 Antigen pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
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.
Bio Pharma Dive
AUGUST 28, 2024
Despite “positive” results, shares of the biotech slid by 20%. Analysts cautioned that Neurocrine shouldn’t get “the benefit of the doubt” with its data.
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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
pharmaphorum
AUGUST 28, 2024
The £400m pledged by industry as part of the new VPAG voluntary scheme of pharma rebates will be used mainly to support the UK clinical research sector
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 28, 2024
Federation of Asian Biotech Associations’ (FABA) Life Sciences Innovation Cluster is now working to strengthen the global partnerships to propel an ecosystem for novel biologics and diagnostics.
Pharmaceutical Technology
AUGUST 29, 2024
GlobalData’s report assesses the drugs in the Claudin 18 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Fierce Pharma
AUGUST 27, 2024
For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of federal agencies. | In June, when the Supreme Court voted 6-3 to overturn the Chevron doctrine, it brought significant impact for the healthcare industry and federal regulators like the FDA and the Centers for Medicare & Medicaid Services.
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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.
Bio Pharma Dive
AUGUST 27, 2024
The platform is similar in concept to a service launched this year by Eli Lilly, and aims to give consumers easier access to Pfizer’s migraine, COVID-19 and flu treatments.
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.
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.
Pharmaceutical Technology
AUGUST 30, 2024
GlobalData’s report assesses the drugs in the Aromatase pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
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.
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.
Bio Pharma Dive
AUGUST 26, 2024
The buzzy startup, which had raised over $200 million in venture funding, is letting go of much of its workforce, according to a state regulatory notice.
pharmaphorum
AUGUST 26, 2024
A US government agency has hit back at a plan by Johnson & Johnson to change the way it pays discounts on drugs to hospitals in the controversial 340B programme
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 26, 2024
(iprogressman/Getty Images) Consuming too much caffeine is definitely bad for your health, and there may be good reasons why some people want to quit it altogether. But if you despair at the idea of giving up your morning coffee, fear not.
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A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Pharmaceutical Technology
AUGUST 30, 2024
GlobalData tracks 39 drugs in development for Eosinophilic Esophagitis by 36 companies/universities/institutes. The top development phase for Eosinophilic Esophagitis is preclinical, with 14 drugs in that stage.
Fierce Pharma
AUGUST 28, 2024
The rightsizing at BioMarin continues to take its toll as CEO Alexander Hardy devises a new corporate strategy for the rare disease biotech. | The rightsizing at BioMarin continues to take its toll as CEO Alexander Hardy devises a new corporate strategy for the rare disease biotech.
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.
FDA Law Blog
AUGUST 26, 2024
By Larry K. Houck — Who says nothing happens in Washington, D.C., in August? The Drug Enforcement Administration (“DEA”) will announce Thursday in the Federal Register that it will hold a hearing on the proposed rescheduling of marijuana to schedule III at DEA Headquarters in Arlington, Virginia on December 2, 2024. DEA received over 43,500 public comments in response to the agency’s Notice of Proposed Rulemaking in the Federal Register on May 21, 2024.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 27, 2024
In the ever-evolving pharmaceutical landscape, modified release (MR) dosage forms have emerged as a groundbreaking innovation, providing solutions that significantly improve patient compliance by simplifying complex drug regimens.
Pharmaceutical Technology
AUGUST 30, 2024
GlobalData tracks 85 drugs in development for Esophagitis by 74 companies/universities/institutes. The top development phase for Esophagitis is phase i, with 26 drugs in that stage.
Fierce Pharma
AUGUST 30, 2024
After a regulatory hiccup earlier this month, Novo Nordisk’s heart failure ambitions for its obesity star Wegovy (semaglutide) are starting to get back on track. | Novo’s semaglutide cut the risk of combined cardiovascular death or worsening heart failure events by 31%, based on an incident rate of 5.4% in semaglutide patients versus 7.5% in those on placebo, the company said Friday.
Bio Pharma Dive
AUGUST 30, 2024
Detailed results from the Helios-B study support summary findings disclosed in June. But they may not make vutrisiran the standard of care as easily as Alnylam hopes.
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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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