Thu.Aug 05, 2021

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Gilead's Kite bets on early-stage biotech to advance allogeneic cell therapies

Bio Pharma Dive

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.

Research 294
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Artificial intelligence stands to ‘revolutionize’ research: Bioclinica

Outsourcing Pharma

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.

Research 145
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Moderna says vaccine protective through six months, but warns boosters needed this fall

Bio Pharma Dive

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.

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Evaluating methods targeting Protein-Protein Interactions

pharmaphorum

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.

Protein 126
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Regeneron drug extends survival in lung cancer trial, lifting company's hopes in field

Bio Pharma Dive

The biotech also reported second quarter earnings on Thursday that widely surpassed Wall Street expectations.

Trials 286
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With US Covered, Novavax Moves COVID-19 Vaccine Focus to Rest of World

BioSpace

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.

More Trending

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Oyster Point Pharma Inks Deal with Ji Xing for Dry Eye Disease Therapies

BioSpace

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.

Licensing 103
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Polysaccharide an effective adjuvant to support vaccine efficacy

BioPharma Reporter

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.

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Inconsistent Results in Subtype Trip Up Dicerna with Rare Disease Drug

BioSpace

?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.

Drugs 98
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Understanding Adherence: 5 Questions Patients Want to Be Asked

pharmaphorum

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.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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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NICE pens two-year collaboration with the Academic Health Science Network

Pharma Times

Agreement will support use of the 'best evidence-based healthcare' in the NHS

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Sierra Signs Exclusive Deal with AstraZeneca for Potent BRD4 BET Inhibitor

BioSpace

?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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Positive Phase III results for Valneva’s chikungunya vaccine

Pharma Times

Neutralising antibody titers were observed in 98.

Antibody 139
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Research Roundup: Getting the Inner Ear to Regenerate and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

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The New Age of Decentralized Clinical Trials

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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16- and 17-year-olds should receive first COVID-19 vaccine, advises JCVI

Pharma Times

Vaccine side effects rare and outweighed by the benefits

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Genetown's EQRx Joins SPAC Parade, Debuts on Nasdaq

BioSpace

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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Report finds reducing primary care antibiotic use 'not enough' to halt antimicrobial resistance

Pharma Times

Drug resistant E.

Drugs 123
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Aprea's “Cancer Guardian” Protein Activator Drug Forced to Press Pause

BioSpace

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.

Protein 76
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Accelerating Clinical Supply Through Integrated Drug Development

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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New patent for Vertex Pharms drug ORKAMBI

Drug Patent Watch

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.

Drugs 52
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Turn Around Low Patient Enrollment: Four Must-Know Tactics

Imperical Blog

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.

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New patent for Adamas Pharma drug GOCOVRI

Drug Patent Watch

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.

Drugs 52
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Nurse Practitioner Interview: Why Clinical Research?

Clinical Trial Gurus

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.

Nurses 52
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How Machine Learning Drives Clinical Trial Efficiency

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.

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WTO lists critical inputs for COVID-19 vaccines to address gaps in global supply

BioPharma Reporter

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.

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People on the Move: August 2021

Outsourcing Pharma

This monthâs news on hires, promotions, acquisitions, expansions, and funding includes items about Syneos Health, ProSciento, Phastar, CPhI, Immunai, and other key industry players.

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Medicines Discovery Catapult relaunches Wolfson Radiochemistry facility in Manchester

pharmaphorum

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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New database could accelerate drug repurposing for various diseases

The Pharma Data

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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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

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American Conference Institute’s Premiere Conference on Life Sciences Antitrust

pharmaphorum

* Pay-for-Delay Lawsuits *. * Price Fixing Investigations *. * M&A Scrutiny in the U.S. and Abroad *. * New Antitrust Enforcement Policies *. Now more than ever, life sciences companies must remain abreast of the emerging enforcement trends as well as the government’s antitrust analysis for evaluating anticompetitive behavior. As we proceed through 2021, the spotlight on antitrust activity in the life sciences industry shines brighter than ever.

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Coffee protects against liver cancer while alcohol is linked with numerous cancers

The Pharma Data

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.

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Pfizer, Flynn in the firing line again over UK epilepsy drug pricing

pharmaphorum

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.

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RINVOQ® (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) for Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis

The Pharma Data

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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.