Pharmaceutical Technology

OCTOBER 31, 2022

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

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Bio Pharma Dive

OCTOBER 31, 2022

Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

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Clinical Trials Clinical Trials Drug Trials Trials 317

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 31, 2022

Rheumatoid arthritis affects 1 in 100 people worldwide. It causes inflamed, painful and swollen joints, often in the hands and wrists, and can lead to loss of joint function as well as chronic pain and joint deformities and damage. What causes this condition has been unknown. [link] In our recently published study, my colleagues and […].

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Clinical Trials Clinical Trials Clinical Research Trials 202

Bio Pharma Dive

OCTOBER 31, 2022

For the second time this year, the agency has put off a decision on Amicus' therapy for Pompe disease. European regulators are also reviewing the treatment and could soon issue an opinion.

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Regulation Drugs 298

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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

Clinical Research

Pharmaceutical Technology

OCTOBER 31, 2022

The osteoarthritis (OA) market was valued at $2.5 billion in the 7MM (seven major markets) in 2021, and is expected to increase to $3.8 billion in 2031, at a compound annual growth rate (CAGR) of 4.4%. Major drivers of growth in the OA market over the forecast period include the launch of new biologic therapies as well as the launch of drugs with novel mechanisms of action (MOAs) and disease-modifying effects.

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Marketing Sales Clinical Trials Clinical Trials 147

Bio Pharma Dive

OCTOBER 31, 2022

The Inflation Reduction Act helps support American families by lowering prescription drug prices and reducing overall healthcare costs.

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Drugs 246

Bio Pharma Dive

OCTOBER 31, 2022

How flexible API access to integrated 'omics data helps boost agility and speed in drug research.

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Research Drugs Development 246

Pharmaceutical Technology

OCTOBER 31, 2022

The European Medicines Agency (EMA) has validated AbbVie ’s marketing authorization application (MAA) for epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients following two or more lines of systemic therapy. Simultaneously, Genmab has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the investigational subcutaneous IgG1-bispecific antibody to treat R/R large B-cell lymphoma (LBCL)

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Antibody Licensing Licensing Trials 130

Bio Pharma Dive

OCTOBER 31, 2022

The public debut of Eudora comes three months after Replay emerged with $55 million and gene delivery technology it claims can outperform AAV viral vectors.

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Gene Gene Therapy 177

pharmaphorum

OCTOBER 31, 2022

Verge Genomics has joined a select group of biotechs who have taken a drug discovered and developed using artificial intelligence into human testing. The small-molecule PIKfyve inhibitor – called VRG50635 – has been administered to the first subject in the phase 1 trial involving healthy volunteers, according to the San Francisco-based biotech, which was founded in 2015 by Alice Zhang and Jason Chen.

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Genome Genomics Drugs RNA 133

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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

Clinical Trials

Bio Pharma Dive

OCTOBER 31, 2022

Reblozyl, one of the drugmaker’s key assets, outperformed an older anemia drug in early-stage myelodysplastic syndrome, which could double the number of potentially eligible patients.

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Drugs Trials 141

NPR Health - Shots

OCTOBER 31, 2022

In a recent small study, the antidepressant effects of ketamine lasted longer when an intravenous dose was followed with computer games featuring smiling faces or words aimed at boosting self-esteem.

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Drugs 131

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 31, 2022

The Department of Pharmaceuticals (DoP) has rejected the review application of Ind-Swift Limited in connection to the National Pharmaceutical Pricing Authority (NPPA) fixing the retail prices of its vitamin formulation Neurovit/Provita capsules. The Reviewing Authority under the DoP also decided that the issue related to overcharging amount imposed by the NPPA on the product does […].

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Production Clinical Trials Clinical Trials Clinical Research 100

NPR Health - Shots

OCTOBER 31, 2022

There's finally been a fix to the "family glitch" that made marketplace health plans sometimes unaffordable. And although premiums are rising, subsidies are too, and more people are eligible.

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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.

Clinical Supply

STAT News

OCTOBER 31, 2022

It would be anathema for a health care facility in the U.S. to have a main entrance that’s not physically accessible to all people. Yet many of their digital front doors block people with disabilities. They need to change that. More than 30 years after the Americans with Disabilities Act was signed into law with the aim of removing obstacles to people who are blind, deaf, or have other physical or mental disabilities, the digital landscape continues to erect barriers to access.

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Vaccination Vaccine 119

NPR Health - Shots

OCTOBER 31, 2022

Experts say misinformation about candy laced with drugs happens every Halloween. But public alarm from a DEA warning about bright-colored fentanyl pills remains.

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Drugs 118

STAT News

OCTOBER 31, 2022

Before the allegations of neglect, before the lawsuits, before the government investigations, the health care nonprofit InnovAge had a simple mission: Help the sickest and poorest seniors live comfortably in their communities, beyond the confines of nursing homes and hospitals. It accomplished this by coordinating care for older Americans in a handful of states under a little-known, taxpayer-funded program.

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Nurses 105

BioSpace

OCTOBER 31, 2022

A new municipal law took effect Tuesday in New York City, requiring companies with four or more employees to include a specific pay range in every job posting.

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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.

Clinical Trials

STAT News

OCTOBER 31, 2022

Physicians who treat children who develop a strange polio-like syndrome known as acute flaccid myelitis had been steeling themselves this fall for an onslaught of cases of the irreversible condition, which appears to be triggered by infection with an enterovirus known as EV-D68. Like many respiratory viruses, circulation of EV-D68 appeared to be suppressed by Covid-19 control measures earlier in the pandemic.

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pharmaphorum

OCTOBER 31, 2022

Between the 2nd and 4th November, a veritable who’s who of British industry will gather at the Eden Project in Boldeva, Cornwall for Anthropy 2022, the event’s second year. Over three days and across 12 stages within multiple biomes, over 130 sessions will take place, including 300 speakers. The singular purpose of them all? ‘A Vision for Britain.’.

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Production 91

STAT News

OCTOBER 31, 2022

The promise of personalized medicine — safer and more effective treatments tailored to each individual’s body and needs — isn’t being fully met because of challenges associated with its implementation in clinical practice. In a special report published today in JCO Precision Oncology, we and our colleagues from Diaceutics, the Personalized Medicine Coalition, and Reservoir Communications provide the first in-depth look at the efforts of United States health systems to

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BioSpace

OCTOBER 31, 2022

With $120 million in backing, HI-Bio launched two assets licensed from MorphoSys AG, including the anti-CD38 antibody felzartamab and HIB210 aimed at severe immune-mediated diseases.

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Licensing Licensing Antibody 98

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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.

Clinical Supply

STAT News

OCTOBER 31, 2022

Good morning, and welcome to a spooky edition of Pharmalittle. It’s Jason Mast here, filling in for Ed. Nothing too scary on the docket — unless you consider broken partnerships and spurned FDA applications scary — but I have dropped a Reese’s cup in my coffee this morning, which, for bean purists, is probably a little frightful.

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Drugs 98

BioSpace

OCTOBER 31, 2022

Unity announced advances in diabetic macular edema via Phase II study results, potentially allowing its recipients to return to tasks of daily living, like driving.

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STAT News

OCTOBER 31, 2022

A slightly larger share of nurse practitioners, physician assistants, and other advanced practice clinicians accept payments from drug and device makers compared with physicians, a first-of-its-kind study found. Of all the advanced practice clinicians working in the U.S. in 2021, 36% accepted payments from industry, compared with 35% of physicians, according to new findings released Monday in the Journal of the American Medical Association.

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BioSpace

OCTOBER 31, 2022

Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio's SBT-272 was granted Orphan Drug designation by the FDA.

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Genome Genomics Trials Drugs 98

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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.

Clinical Trials

Pharma Times

OCTOBER 31, 2022

Information from 17 existing studies was reviewed, involving 91 million people

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NPR Health - Shots

OCTOBER 31, 2022

Trick-or-treaters with allergies have to be extra careful on Halloween — the Teal Pumpkin Project is making the day a little less scary for them.

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Allergies 90

Outsourcing Pharma

OCTOBER 31, 2022

The company states that its platform combines quantum-inspired physics and machine learning to accelerate drug discovery.

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Drugs Clinical Development Development 98

FDA Law Blog

OCTOBER 31, 2022

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here.

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Compliance Regulation Manufacturing Marketing 72

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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.

Clinical Trials