First oral drug for spinal muscular atrophy approved by FDA
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.
Sat.Aug 01, 2020 - Fri.Aug 07, 2020
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COVID-19 and obesity is a lethal mix
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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Developing Drug Products with the Label’s Commercial Value in Mind
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.
Researchers says hydroxychloroquine could still prevent COVID-19
Pharma Times
AUGUST 7, 2020
Scientists from the University of Oxford say the drug is being ‘discarded prematurely’
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
With first results, Novavax takes step forward in coronavirus vaccine race
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.
On the pharma ecosystem
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.
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UK increases COVID-19 vaccine manufacturing capacity
Pharma Times
AUGUST 4, 2020
New deal with Wockhardt boosts capacity at the crucial 'fill and finish' stage
Lilly to test COVID-19 antibody drug in unorthodox nursing home study
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.
Will people line up for a COVID-19 vaccine?
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.
Top 12 Biotech Companies Hiring Now
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!
AstraZeneca forges licensing agreement with Redx Pharma
Pharma Times
AUGUST 5, 2020
AZ will pay $17m in early milestone payments for the UK biotech’s fibrotic asset
Big pharma alliance recruits first patients for unusual COVID-19 study
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.
Health Experts to F.D.A.: Make Your Vaccine Deliberations Public
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.
Restoring Cellular Power Outages: A New Drug to Treat Mitochondrial Diseases
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.
The New Age of Decentralized Clinical Trials
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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’s reputation has climbed during COVID-19 pandemic, study finds
Pharma Times
AUGUST 5, 2020
Roche, AstraZeneca, Novo Nordisk and Sanofi all climbed index rankings
Editas, AbbVie rework gene editing deal as pioneering CRISPR trial resumes
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.
How does HTA for orphan drugs differ across Europe?
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
With Court Win, BMS and Pfizer Stave Off Generic Challengers to Eliquis – For Now
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.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Cosentyx wins EU approval for first-line paediatric psoriasis
Pharma Times
AUGUST 3, 2020
Low-dose and high-dose Cosentyx is effective in rapidly improving skin symptoms and quality of life
Moderna sets high price in early coronavirus vaccine supply deals
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.
CSafe, Cloudleaf partner on cold-chain tracking tech
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.
uniQure Begins First-in-Human Gene Therapy Trials for Huntington’s Disease
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.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Oxford Biomedica and Beam Therapeutics sign CAR-T deal
Pharma Times
AUGUST 4, 2020
Agreement will utilise Oxford Biomedica's LentiVector platform
FDA agrees to review Biogen's Alzheimer's drug
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.
Pfizer signs deal with Gilead to manufacture COVID-19 antiviral remdesivir
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.
Octapharma Uses IVIG as Potential Treatment for COVID-19
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.
Roche’s tumour-agnostic therapy Rozlytrek approved in EU
Pharma Times
AUGUST 4, 2020
Therapy has been approved to treat advanced NTRK fusion-positive solid tumours
Novartis says CAR-T cancer therapy works in second lymphoma type
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.
Combining the Powers of Single Cell Sequencing and AI in Understanding Disease Biology and Drug Development
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
Fearing Brexit chaos, UK asks pharma to build six-week drug stockpile
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.
The New Age of Decentralized Clinical Trials
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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.
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