Bio Pharma Dive
AUGUST 5, 2021
Appia Bio, which launched with over $50 million in Series A funding earlier this year, will provide preclinical research for two CAR-iNKT candidates, which Kite will pick up should they advance past early clinical testing.
Camargo
AUGUST 5, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. In July, Astellas Pharma US received FDA approval for the use of Prograf (tacrolimus) capsules, injection, and oral suspension for the prevention of lung transplant rejection.
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Bio Pharma Dive
AUGUST 5, 2021
Final results from the Phase 3 trial that led to the shot's authorization showed efficacy remained high, at 93%, although that data was collected before the delta variant had spread widely.
Outsourcing Pharma
AUGUST 5, 2021
A leader from the clinical research tech specialist explains how the use of AI is increasing in the field and outlines the many ways it could SOMETHING.
Bio Pharma Dive
AUGUST 5, 2021
The biotech also reported second quarter earnings on Thursday that widely surpassed Wall Street expectations.
pharmaphorum
AUGUST 5, 2021
Protein-protein interactions (PPIs) are becoming increasingly relevant in the pathology of many diseases, including cancer. The issue, however, is developing an effective way of targeting them. . The latest advancements in methods targeting PPIs are designed to overcome the challenges limiting the conventional methods. Targeting PPIs offers another potential therapeutic target for diseases with complex biological profiles.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
AUGUST 5, 2021
U.S. authorization is likely not a priority for Novavax since half the population is already vaccinated. But with other parts of the world, there’s still plenty of room for a Novavax vaccine.
BioPharma Reporter
AUGUST 5, 2021
The non-digestible polysaccharide Arabinoxylan may be an effective oral adjuvant to support vaccine efficacy, according to a new pilot study involving 231 elderly participants.
BioSpace
AUGUST 5, 2021
Oyster Point Pharma inked a license and collaboration deal with Ji Xing Pharmaceuticals to develop and market OC-01 (varenicline) and OC-02 (simpinicline) nasal sprays for dry eye disease in Great China.
Delveinsight
AUGUST 5, 2021
Sanofi bets USD 3.2 Billion on mRNA with a deal to acquire Translate Bio. Sanofi is betting the genetic technology behind the fast development of two highly effective coronavirus shots last year will result in vaccines for other viruses as well as drugs for diseases of the lung and liver, announcing a deal to acquire a research partner Translate Bio for USD 3.2 billion.
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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 5, 2021
Healthcare professionals and individuals with chronic health conditions understand that various factors can impact the level of adherence to a treatment plan, from lifestyle to side effects. Additionally, it’s clear that HCP relationships can affect a patient’s health journey, which may also impact adherence. Health Union’s white paper, Beyond the Treatment, Making the HCP-Patient Relationship Work: A Study Uncovering the Patient Perspective , explores those relationships in detail.
BioSpace
AUGUST 5, 2021
?While the study hit its primary efficacy endpoints, investors are likely concerned about reports of “inconsistent results” regarding reducing Uox excretion in a subtype of patients with the rare disease.
Pharma Times
AUGUST 5, 2021
Agreement will support use of the 'best evidence-based healthcare' in the NHS
BioSpace
AUGUST 5, 2021
?Sierra will have access to AZD5153, a potent and selective BRD4 BET inhibitor, to initiate a study that combines the said component with momelotinib for treating patients with myelofibrosis.
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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
Pharma Times
AUGUST 5, 2021
Neutralising antibody titers were observed in 98.
BioSpace
AUGUST 5, 2021
The deal will give EQRx a pre-transaction enterprise value of $3.65 billion and an immediate $1.8 billion in cash that will be used to advance the development of the company’s pipeline.
Pharma Times
AUGUST 5, 2021
Vaccine side effects rare and outweighed by the benefits
BioSpace
AUGUST 5, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
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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.
Pharma Times
AUGUST 5, 2021
Drug resistant E.
BioSpace
AUGUST 5, 2021
The co-head of a Phase III trial reported Johnson & Johnson’s single-shot COVID-19 vaccine was highly effective at preventing severe disease, including among patients infected with the circulating Delta coronavirus variant.
Drug Patent Watch
AUGUST 5, 2021
Annual Drug Patent Expirations for ORKAMBI Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are nineteen…. The post New patent for Vertex Pharms drug ORKAMBI appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
AUGUST 5, 2021
Aprea faces another disappointment this week in the clinic. The FDA held up a yellow card, and the Boston-based biotech has placed a partial clinical hold on its myeloid malignancy program.
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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.
Drug Patent Watch
AUGUST 5, 2021
Annual Drug Patent Expirations for GOCOVRI Gocovri is a drug marketed by Adamas Pharma and is included in one NDA. It is available from one supplier. There are fifteen patents…. The post New patent for Adamas Pharma drug GOCOVRI appeared first on DrugPatentWatch - Make Better Decisions.
Intouch Solutions
AUGUST 5, 2021
Download the PDF. “I will … benefit my patients according to my greatest ability and judgment, and I will do no harm or injustice to them.” This is a line from the Hippocratic Oath. It, like the Nightingale Pledge for nurses, is a list of tenets that physicians abide by to uphold certain morals and to ensure healthcare professionals (HCPs) provide top-quality care to all who seek it.
Imperical Blog
AUGUST 5, 2021
If you’ve ever had to manage a trial with underperforming enrollment levels (chances are, you have!), you know firsthand the headaches this can cause. Teams often feel overwhelmed and helpless. I first blogged about this subject in 2015. In general, clinical trial sponsors are much more proactive when it comes to planning their study enrollment strategies and tactics than they were back then.
Clinical Trial Gurus
AUGUST 5, 2021
In my opinion, nurse practitioners are the most underutilized and under appreciated personnel in clinical research. In this particular episode, I interview one of my business partners, fellow site owner, and practicing nurse practitioner.
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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.
BioPharma Reporter
AUGUST 5, 2021
The World Trade Organization (WTO) Secretariat has published a list of critical inputs for COVID-19 vaccines as part of an effort to address gaps in global production and distribution of the products.
Outsourcing Pharma
AUGUST 5, 2021
This monthâs news on hires, promotions, acquisitions, expansions, and funding includes items about Syneos Health, ProSciento, Phastar, CPhI, Immunai, and other key industry players.
BioPharma Reporter
AUGUST 5, 2021
Vaccine company Valneva has announced positive Phase 3 pivotal results for its single-shot chikungunya vaccine. âWe are a step closer to addressing this major, growing and unmet public health threat,â says the company.
pharmaphorum
AUGUST 5, 2021
Medicines Discovery Catapult (MDC) today announces the relaunch of radiochemistry at the Wolfson Molecular Imaging Centre (WMIC) in Manchester. The facility, which was closed in 2020, includes the multi-million pound cyclotron, one of only a handful in the UK. It will supply hard-to-make radiochemicals to drug discovery biotechs and academic innovators – increasing the UK’s potential to discover new and better therapies for patients, faster.
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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.
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