Bio Pharma Dive
AUGUST 7, 2020
Development of EDIT-101, the first CRISPR-based therapy to be used in a company-led trial to alter genes within a person's body, will now move forward under Editas' sole ownership.
World of DTC Marketing
AUGUST 2, 2020
QUICK READ : Obesity is associated with a higher risk of developing severe symptoms and complications of coronavirus disease, independent of other illnesses, such as cardiovascular disease. So why haven’t we acted? Data seems to suggest that people with obesity are more likely to become severely ill due to COVID-19, the disease caused by the novel coronavirus.
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Camargo
AUGUST 5, 2020
Whether you plan to out-license or commercialize your product, getting the label right matters. When. The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo.
BioSpace
AUGUST 4, 2020
According to BioSpace research, 69% of biotech professionals feel they are on the verge of job burnout. Do you fall into that 69%? Is it time for a new job? Check out the top companies who are looking for candidates like you right now!
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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
Bio Pharma Dive
AUGUST 4, 2020
Early-stage results appear to show that Novavax's shot passed its first meaningful test, helping the Maryland biotech keep pace with larger competitors.
World of DTC Marketing
AUGUST 5, 2020
QUICK READ: There are a lot of patient-centered, hard-working people within the pharma industry. The problem is that there are way too many senior managers whose only goal is to remain relevant within the organization even if it means patients suffer. Trade magazine awards don’t mean anything if one company makes a bad decision that stains our industry.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
AUGUST 4, 2020
According to a study published in the journal Science Advances on July 24, an international team of researchers led by neuroscientists at Harvard Medical School has uncovered which olfactory cell types are most vulnerable to infection by SARS-CoV-2, which causes COVID-19.
Bio Pharma Dive
AUGUST 3, 2020
Seeking fast answers in a pandemic, Lilly will use mobile RVs to set up infusion clinics at assisted living facilities, which have become COVID-19 hot spots.
World of DTC Marketing
AUGUST 3, 2020
QUICK READ: As COVID-19 vaccines enter Phase III trials one has to wonder just how transparent pharma companies will be with the data. Personally I would want to know as much as I can before I ask for the vaccine but I also know that greed can make people do stupid things and there is a lot of money at stake here. The rush to develop a COVID-19 vaccine is well underway because there are billions of dollars in profits at stake.
JAMA Internal Medicine
AUGUST 6, 2020
This cohort study quantitatively describes molecular viral shedding in asymptomatic and symptomatic patients with SARS-CoV-2 infection.
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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
BioSpace
AUGUST 6, 2020
Investors in Bristol Myers Squibb and Pfizer are singing a happy song this morning after a federal court upheld patent claims regarding Eliquis, which blocks generic rivals from carving out a share of the market for at least six years.
Bio Pharma Dive
AUGUST 7, 2020
Approval of Evrysdi, from Roche and PTC Therapeutics, adds a third option for treating the neuromuscular disease, joining Spinraza and Zolgensma.
pharmaphorum
AUGUST 4, 2020
New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. Several factors make it difficult for HTA bodies often to assess orphan drugs, including a lack of robust trial data due to difficulties in finding patients, the absence of randomised controlled tri
XTalks
AUGUST 5, 2020
Single cell sequencing has revolutionized the study of biological tissues and systems at the cellular and molecular level. Recent advances in the technology have allowed for the interrogation of distinct subsets of cell populations within tissues, and associated molecular markers that may function as important disease drivers. The use of single cell sequencing in profiling bulk, heterogeneous tissues at the single cell level can help in the identification of dominant, unique and rare cell subtyp
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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.
BioSpace
AUGUST 7, 2020
Intravenous immunoglobulin (IVIG) could be a key to combating seriously ill COVID-19 patients who have been hospitalized due to complications from the disease, and Octapharma AG aims to find out as it assesses the plasma-based treatment in a Phase III study.
Bio Pharma Dive
AUGUST 5, 2020
Early preorders for small quantities of Moderna's shot set a price per dose of $32 to $37, although the biotech plans to charge less in larger agreements.
pharmaphorum
AUGUST 7, 2020
Pfizer has signed a multi-year agreement with Gilead to manufacture and supply the COVID-19 antiviral remdesivir, which is also being tested in combination with other drugs in an effort to fight the pandemic. Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease.
NY Times
AUGUST 6, 2020
A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel when reviewing data on coronavirus trials.
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.
BioSpace
AUGUST 7, 2020
Aerovate Therapeutics secured $72.6 million in Series A funding to advance trials of AV-101, an inhaled, dry powder aerosol version of Novartis’ cancer drug Gleevec (imatinib) in a repurposed effort to treat pulmonary arterial hypertension (PAH).
Bio Pharma Dive
AUGUST 7, 2020
The agency's decision kicks off a historic and dramatic regulatory review, as significant lingering questions surround aducanumab's approval chances.
pharmaphorum
AUGUST 5, 2020
The UK government has asked pharma companies to build a six-week stockpile of drugs and find alternative shipping routes to the congested Dover-Calais crossing as the country heads for Brexit at the end of the year. In a letter , Steve Oldfield, chief commercial officer at the Department of Health and Social Care, said the government is focused on preventing potential disruption to any categories of medical supplies.
Outsourcing Pharma
AUGUST 5, 2020
The firms are working to create a platform that gives the ability to monitor temperature-sensitive treatments, vaccines and other products.
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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.
BioSpace
AUGUST 6, 2020
A small biotech company is aiming to recharge tired cells, giving mitochondrial disease patients new hope of a disease-specific treatment.
Bio Pharma Dive
AUGUST 3, 2020
The trial is testing whether drugs from Amgen, Takeda and AbbVie can combat the life-threatening immune overreaction some COVID-19 patients experience.
pharmaphorum
AUGUST 7, 2020
Pharma’s reputation has soared due to the COVID-19 pandemic – but coronavirus is starting to bite companies’ sales. Find out more in our roundup of the biggest R&D, market access and digital stories from the past week. The perception of pharma and medical companies has surged upward since the start of the COVID-19 pandemic, but they still lie mostly outside the top-rated firms in the FutureBrand Index.
Pharma Times
AUGUST 4, 2020
New deal with Wockhardt boosts capacity at the crucial 'fill and finish' stage
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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.
BioSpace
AUGUST 4, 2020
In June, it dosed its first two patients using a novel therapeutic, AMT-130, delivered directly to the brain. Initial readouts are expected in a year’s time.
Bio Pharma Dive
AUGUST 4, 2020
Early results from a trial testing Kymriah in follicular lymphoma were reportedly positive, supporting the pharma's plans to ask for another approval.
pharmaphorum
AUGUST 4, 2020
Sanofi has been placed under formal investigation in France for possible charges including manslaughter relating to the epilepsy drug Depakine, following the deaths of four babies whose mothers took the drug. Depakine was found to carry a high risk of birth defects if taken by pregnant women. Sanofi , which denies wrongdoing and says it warned of the risks long ago, is already being prosecuted in France following allegations it provided misleading information about the drug.
Pharma Times
AUGUST 3, 2020
Collaboration will explore experimental treatment IMM-101 in combination with other therapies in advanced cancers
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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.
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