Sat.Jun 26, 2021 - Fri.Jul 02, 2021

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Blockchain: Ready to revolutionise medicinal cannabis research?

pharmaphorum

Robert Galarza outlines how blockchain technology can be utilised to verify, validate and standardise the efficacy of medical cannabis and other plant based therapies in clinical trials. . The Chinese surgeon Huo Tuo first mixed powdered cannabis with wine to make an anesthetic sometime between 140 and 208 CE. Indeed, the Chinese term for “anesthesia” (mázui ??

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Formedix launches cloud-based clinical metadata repository

Outsourcing Pharma

The companyâs Ryze technology combines a clinical MDR and study automation platform, designed to accelerate and optimize design and execution of trials.

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BioMarin resubmits haemophilia A gene therapy to the EMA

Pharma Times

Company initially withdrew a marketing authorisation application for the gene therapy last year

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Ciprofloxacin for UTI Prophylaxis – Case Study

Med Ed 101

An 89-year-old female has a history of frequent UTIs. She has been taking ciprofloxacin for UTI prophylaxis at 250 mg once daily for about 1 year. She has not had a UTI since starting on the ciprofloxacin. She takes it in the morning with her breakfast. She has a history of diabetes, CKD, osteoarthritis, neuropathy, […]. The post Ciprofloxacin for UTI Prophylaxis – Case Study appeared first on Med Ed 101.

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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

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Intellia, Regeneron ace first trial with ‘in vivo’ CRISPR drug

pharmaphorum

The first ever clinical data with a CRISPR/Cas9 drug used to edit the genomes of cells within the body has yielded impressive results in patients with ATTR amyloidosis, a life-threatening rare disease. . Preliminary results from a phase 1 trial run by Regeneron and CRISPR specialist Intellia Therapeutics – co-founded by Nobel Prize winner Jennifer Doudna – showed steep reductions in a biomarker of ATTR amyloidosis disease activity with a single dose of the NTLA-2001 drug.

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Signify Health partners on decentralized trials for children’s cancer

Outsourcing Pharma

The trial solutions firm is working with Childrenâs Oncology Group to expand in-home research and care options for investigational immune-oncology therapy.

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Comparing Alpha-2-Adrenergic Agonists

Med Ed 101

In this article, we take a look at the Alpha-2 Adrenergic Agonists. In comparing Alpha-2 Adrenergic Agonists, we will primarily look at dosing, adverse effects, and notable indications. Clonidine is FDA-approved for attention deficit hyperactivity disorder (ADHD), cancer pain, and hypertension. It is also used off-label for a variety of reasons, such as hot sweats, […].

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COVID-19 vaccine development: Safety monitoring continues revolution in RWD

pharmaphorum

From cancer to COVID, real-world data is changing the way we research therapeutics, monitor safety, and collaborate on the development of treatments designed to improve outcomes for patients in need. In today’s feature, Dr. Miruna Sasu lays out how real-world data is evolving in the post COVID-19 vaccine reality. . Only a year after the emergence of COVID-19, a handful of life science companies started publishing data on the encouragingly high efficacy of their vaccine candidates.

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Experts to talk rare and orphan diseases, patient experience at webinar

Outsourcing Pharma

On July 7, a group of seasoned industry leaders will offer insights at Rare/orphan diseases, special patient population, a focused, free online event.

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‘Mix and match’ COVID-19 vaccine study yields promising results

Pharma Times

Mixing different vaccines produces a strong immune response against virus, according to researchers

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Feeling Hot Hot Hot

Dr. Jamie Hardy: The Lifestyle Pharmacist

Heat stroke and heat exhaustion are serious, life-threatening conditions. More than 600 people in the United States are killed by the extreme heat every year, according to the Centers for Disease Control and Prevention. How to protect yourself from heat exhaustion and heat stroke. Protecting yourself from the dangers of heat exhaustion and heat stroke is a must.

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AZ starts phase 2/3 trial of new-variant COVID-19 vaccine

pharmaphorum

AstraZeneca and Oxford University have started dosing patients in a trial of a new version of their COVID-19 vaccine that is designed to target the beta or South African variant of the SARS-CoV-2 virus. The beta variant – also known as B.1.351 – is estimated to be around 50% more transmissible than earlier strains of SARS-CoV-2, but seems to be able to evade the antibodies generated by current COVID-19 vaccines including AZ’s current Vaxzevria (AZD1222) shot.

Vaccines 101
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Mobile optometry service expands clinical trial support

Outsourcing Pharma

Thanks in part to the recent completion of an $8m investment, 2020 On-site plans to expand its services, including the mobile support of vision research.

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Sanofi plans €400m investment in mRNA vaccines ‘centre of excellence’

Pharma Times

Sanofi is currently collaborating with Translate Bio on a mRNA-based COVID-19 vaccine candidate

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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.

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AZ drug for hard-to-treat heart failure has mixed results in trial

pharmaphorum

AstraZeneca has reported the first phase 2 results with a drug for heart failure with preserved ejection fraction (HFpEF), showing it worked as expected but wasn’t able to provide any clinical benefit to patients. . Daily doses of AZD4831 were able to reduce the activity of myeloperoxidase (MPO), an enzyme linked to tissue and blood vessel damage due to inflammation and scar tissues formation (fibrosis) in models of cardiovascular disease, by 69% after 30 days in the phase 2a SATELLITE stu

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MHRA grants bluebird ‘innovation passport’ for sickle cell therapy

pharmaphorum

bluebird bio’s sickle cell disease (CD) gene therapy LentiGlobin is the latest recipient of an ‘innovation passport’ introduced in the UK earlier this year to speed up NHS access to promising new medicines. The designation means that LentiGlobin will be reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new innovative licensing and access pathway (ILAP) introduced last December.

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Altimmune ditches nasal COVID vaccine on weak trial data

pharmaphorum

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . It’s a big disappointment for Altimmune, which said back in February that it was hoping to find a more convenient alternative to injected COVID-19 vaccines – and one which would be stable at room temperature, making distribution and delivery easier.

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Climate change: The elephant in the waiting room of health

pharmaphorum

Pharma has both an opportunity and a responsibility to do its part in tackling climate change – and the time to act is now, according to speakers at a recent event. Amanda Barrell reports. The pharma industry has clearly stated its commitment to a net zero future, but where are we on that journey, what else can be done, and could organisations achieve more if they worked together?

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Zydus Cadila nears world-first human plasmid DNA vaccine approval

pharmaphorum

Zydus Cadila has filed for emergency use approval (EUA) in India of its plasmid DNA-based vaccine for COVID-19, which if given a green light could become the first shot of its type to be cleared for widespread use in humans. . Leaving aside the possible technological milestone, the ZyCOV-D vaccine has a few characteristics that could stand in the way of its rollout, including a need for three doses, whereas all India’s current vaccines only need two.

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Merck partners neuroloop on bioelectronic device for inflammation

pharmaphorum

Merck KGaA has joined forces with a unit of medtech firm B Braun – neuroloop – on a way to treat inflammatory diseases using neurostimulator devices. The German drugmaker will work with startup neuroloop on bioelectronics , put simply the harnessing of electrical stimulation to treat human disease, with a focus on chronic conditions like arthritis and inflammatory bowel disease. neuroloop – a spinout of Freiburg University in Germany formed in 2016 – has been working to date on using its device

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Manchester joint venture will trial Morningside’s digital health portfolio

pharmaphorum

The University of Manchester has formed a joint venture with Morningside to carry out clinical trials of various digital health technologies developed by the investment group’s portfolio companies. . Health Innovation Manchester and its Academic Health Science Centre are also participating in the JV, which will focus on digital diagnostics and interventions that could play a role in prevention and early detection of disease and helping more patients to receive treatment outside the hospita

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How do CDISC standards fit into the drug development process?

pharmaphorum

Introduction. The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential. And so are data standards! The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to receive, process, review and archive submissions efficiently.

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WHO cautions against overestimating AI’s impact on health

pharmaphorum

Artificial intelligence (AI) has the potential to improve the delivery of healthcare, but only if ethics and human rights are put at its heart of its design and use, according to the World Health Organisation (WHO). Digital technologies and AI are already being deployed to improve the speed and accuracy of diagnosis and screening for diseases, assist with clinical care, support R&D, and guide public health policy, according to a just-published WHO document called Ethics and governance of art

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ICER revises its view of Aduhelm’s price – but not by much

pharmaphorum

The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range for Aduhelm (aducanumab) upwards, but only by a small amount.

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Cerevel soars on first data for muscarinic schizophrenia drug

pharmaphorum

Shares in Pfizer spinout Cerevel Therapeutics have more than doubled after it reported positive early-stage results with CVL-231, a drug for schizophrenia that it thinks could have a clear side-effect profile than current therapies. The drug – a selective muscarinic M4 receptor positive allosteric modulator (PAM) – is designed to have limited effect on dopamine neurotransmission, a mechanism thought to contribute to tolerability issues with the current generation of antipsychotic drugs.

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Scleroderma Foundation increases research funding by more than 100%

Outsourcing Pharma

The organization, focused on building awareness and finding therapies for the rare disease, is boosting its annual research funding to more than $2.7m USD.

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ABPI launches updated Code of Practice

Pharma Times

The new Code has been updated to reflect changes in the pharma environment

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AZ says MPO inhibitor AZD4831 shows promise in heart failure study

Pharma Times

AZD4831 is being investigated in patients with heart failure with preserved ejection fraction (HFpEF)

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ABPI launches 2021 Code of Practice

pharmaphorum

The Association of the British Pharmaceutical Industry (ABPI) has launched its 2021 Code of Practice to help companies operate to high ethical standards. . The ABPI Code of Practice is the industry’s commitment to operate in a professional, ethical, and transparent manner, for the benefit of patients and the public. It is independently administered by the Prescription Medicines Code of Practice Authority (PMCPA).

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GSK backs CEO Walmsley, rejecting Elliott’s call to change board

pharmaphorum

GlaxoSmithKline’s board had responded to the broadside attack delivered by activist investor Elliott Management yesterday, saying it stands firmly behind the leadership of chief executive Emma Walmsley. The drugmaker rejected calls by Elliott to change its board and accelerate the complete divestment of its consumer health unit which is due to be split from the ‘new GSK’ pharma business next year, and said it had “widespread and strong support” among shareholders fo

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Merck pulls Keytruda’s FDA nod for third-line stomach cancer

pharmaphorum

Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy in this setting were a bust. . The decision comes after FDA advisors voted six to two in April that Keytruda (pembrolizumab) should not stay on the market as a treatment option for patients with PD-L1-expressing gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have received two or more earlier lin

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Health Innovators: Eliot Forster, F-Star

pharmaphorum

In this episode of Health Innovators , pharmaphorum founder Paul Tunnah interviews Eliot Forster, CEO of F-Star – a clinical-stage, NASDAQ-listed biopharmaceutical company focused on transforming the lives of patients with cancer. About the author. Dr Paul Tunnah is chief content officer and UK managing director for Healthware Group , a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a uni

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Brace yourselves for clinical trial guideline update: Remarque

Outsourcing Pharma

A leader from the trial management specialist says sites and sponsors prepare for International Council for Harmonization guideline changes on the horizon.

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