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.
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.
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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.
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.
Bio Pharma Dive
AUGUST 5, 2021
The biotech also reported second quarter earnings on Thursday that widely surpassed Wall Street expectations.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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.
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.
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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
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.
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.
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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
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.
Pharma Times
AUGUST 5, 2021
Drug resistant E.
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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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.
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.
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.
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.
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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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.
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.
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.
The Pharma Data
AUGUST 5, 2021
Researchers have created a new open-access database of information on drug candidates and how they are metabolised by the body, which could help speed up the repurposing of old drugs as new treatments. There is an urgent need for more effective treatments for many conditions, including COVID-19, cancer and malaria. But the process of developing new drugs is costly, can take decades, and often leads to failed treatments.
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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
AUGUST 5, 2021
The UK’s Competition and Markets Authority (CMA) has resurrected a complaint against Pfizer and Flynn Pharma, claiming the two companies charged the NHS excessive prices for a widely-used epilepsy therapy. In a provisional judgment, the CMA has concluded that Pfizer and Flynn abused a dominant position to overcharge the NHS for phenytoin sodium capsules, causing NHS spending on the drug to balloon from around £2 million a year in 2012 to £50 million the following year.
The Pharma Data
AUGUST 5, 2021
Alcohol consumption is a major risk factor for several cancers including head & neck (mouth, pharynx, larynx), oesophageal and bowel cancer – as well as the more widely known links to breast and liver cancer – according to a new study funded by World Cancer Research Fund (WCRF)(1), and published this week in Nature Communications. The study also found increased coffee consumption was associated with a lower risk of developing liver cancer and basal cell carcinoma of the skin.
pharmaphorum
AUGUST 5, 2021
Bayer headlined its second-quarter results this morning by unveiling a deal to buy Vividion Therapeutics, saying it will boost its ability to develop medicines against targets once considered “undruggable.” Bayer is paying $1.5 billion upfront to claim ownership of Vividion ‘s drug discovery platform, which uses chemoproteomics to identify new binding sites on proteins and find small-molecule compounds that interact with them, with another $500 million on the table if pipeline
The Pharma Data
AUGUST 5, 2021
Upadacitinib (30 mg, once daily) monotherapy demonstrated significantly greater rates of skin clearance improvement and itch reduction compared to dupilumab (300 mg, every other week) monotherapy at 16 weeks[1] – Early, significant results were seen in upadacitinib-treated patients — including skin clearance improvements (EASI 75) at two weeks and itch reduction at one week — compared to dupilumab[1] – The safety profile of upadacitinib was consistent with previous atopi
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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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