Wed.Aug 24, 2022

article thumbnail

Study: Myocarditis Risk Is Significantly Higher After COVID-19 Infection Vs After Vaccine

Pharmacy Times

Analysis includes nearly 43 million individuals aged 13 year and older who received at least 1 dose in England between December 1, 2020, and December 15, 2021.

Vaccines 179
article thumbnail

Merck chases Bayer/Ionis with fast track for Factor XI drug

pharmaphorum

The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short over the bows of a rival programme in development at Ionis and Bayer. The anticoagulant – codenamed MK-2060 – is a monoclonal antibody designed to inhibit Factor XI and is currently in a phase 2b trial in ESRD patients on dialysis, who often need to be treated with anticoagulants to prevent blood clots.

FDA 115
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Mothers with Family History of Psychiatric Disorders Have Almost 2-Fold Risk of Developing Postpartum Depression

Pharmacy Times

A systematic review of literature found that family history of psychiatric disorders is a risk factor associated with postpartum depression, adding to a contradictory body of research.

123
123
article thumbnail

Using DBS (Deep Brain Stimulation) to Treat Parkinson’s

BuzzRx

Deep brain stimulation (DBS) is one of the surgical treatments performed to treat Parkinson's disease. It involves the placement of a deep brain stimulator (metal wires in the brain connected to a pulse generator in the chest). Abnormal electrical signals in the brain cause the motor complications seen in Parkinson’s disease. Deep brain stimulation works by regulating electrical stimulation in certain parts of the brain.

FDA 98
article thumbnail

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.

article thumbnail

Annual Incidence of COVID-19 Unexpectedly Lower Among People Experiencing Homelessness

Pharmacy Times

Survey data indicates that people experiencing homelessness had a lower annual incidence of COVID-19 despite having a higher burden of infectious diseases, suggesting opportunities for better integration of homelessness status in infectious disease reporting.

123
123
article thumbnail

Amgen’s Soliris biosimilar clears phase 3, but won’t launch until 2025

pharmaphorum

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The biotech has confirmed it will not launch the biosimilar until March 2025 however, honouring the terms of its 2020 agreement with Alexion that resolved litigation over the validity of patents covering Soliris (eculizumab) in the US.

More Trending

article thumbnail

With market success at stake, can tech help solve the diversity problem in clinical trials?

PharmaVoice

Diversity in clinical trials isn’t only important for the health of the overall patient population — it can save millions in lost profits.

105
105
article thumbnail

Timely Referral and Diagnosis of C. Difficile Infection (CDI)

Pharmacy Times

Drs. Abraham, Chopra and Feuerstadt discuss importance of timely referral and diagnostic methods to discern C. difficile infection (CDI).

132
132
article thumbnail

Reducing Anxiety in Children with ADHD Using Atomoxetine

Drug Topics

A recent review suggests that atomoxetine can reduce symptoms of anxiety in children and adolescents with ADHD.

98
article thumbnail

Daily Medication Pearl: Dextromethorphan and Bupropion (Auvelity)

Pharmacy Times

Auvelity is a combination of dextromethorphan and bupropion indicated for the treatment of major depressive disorder in adults.

132
132
article thumbnail

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.

article thumbnail

Environmental Monitoring In-Depth Focus 2022

European Pharmaceutical Review

A strategic approach to optimisations of testing bacterial endotoxins. Given industry’s recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise.

95
article thumbnail

Moderna Applies for EUA for Omicron-Targeting Bivalent COVID-19 Booster Candidate

Pharmacy Times

The mRNA-1273.222 vaccine candidate targets both the original SARS-CoV-2 strain in addition to the BA.4/BA.5 subvariants of the Omicron strain.

Vaccines 123
article thumbnail

European Pharmaceutical Review Issue 4 2022

European Pharmaceutical Review

Included in this issue: NITROSAMINES. Risks presented by active pharmaceutical ingredient nitrosamines. David Elder, David P Elder Consultancy. ENVIRONMENTAL MONITORING. Progress in the implementation of biofluorescent particle counters. Hannah Balfour with comment from Mike Russ at Genentech. REGULATORY INSIGHT. The EU HTA regulation: a new frontier for access to innovative technologies.

91
article thumbnail

Study: COVID-19 mRNA Vaccines Decrease Risk of Death for Those With Heart Failure

Pharmacy Times

Results also show that no association with an increased frequency of myocarditis, venous thromboembolism, or worsening HF in these individuals.

Vaccines 121
article thumbnail

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.

article thumbnail

Progress in the implementation of biofluorescent particle counters

European Pharmaceutical Review

With companies striving to produce cost-effective and high?quality therapeutics, utilising the most efficient methods possible has become a critical focus. Thus, the lengthy incubation periods needed with traditional culture?based microbiological monitoring techniques have long been a source of frustration. The introduction of alternative and rapid microbiological methods (ARMMs), without such extensive time requirements, is therefore helping companies overcome such limitations.

87
article thumbnail

National Institutes of Health Awards $23 Million to Establish Centers of Excellence to Study Telehealth for Cancer Care

Pharmacy Times

The 4 academic centers will evaluate the role of telehealth in areas such as prevention, screening, diagnosis, treatment, and survivorship.

123
123
article thumbnail

A strategic approach to optimisations of testing bacterial endotoxins

European Pharmaceutical Review

The topic of bacterial endotoxin testing (BET), while a unique requirement for the pharmaceutical industry, has far?reaching impact. In recent years, articles on the reliance on the horseshoe crab within the pharmaceutical industry 1-3 and considerations for alternative testing strategies have been widely discussed. 4-7 Here, the approach taken at AstraZeneca to optimise test methodology to provide assurance of patient safety, reduce the burden on a natural resource and continue to improve in th

84
article thumbnail

Medical Cannabis for Chronic Pain Shows Link to Small Risk of Heart Rhythm Disorders

Pharmacy Times

Danish analysis looks at the relationship between the therapy and cardiovascular adverse effects, particularly arrhythmias.

123
123
article thumbnail

Actualising the power of antibody-drug conjugates as cancer therapeutics

European Pharmaceutical Review

ANTIBODY-DRUG conjugates (ADCs) are therapeutic molecules designed as highly targeted medicines with the promise of changing the way we treat cancer and other diseases. An ADC combines the specificity of an antibody and the potent power of an anti?cancer agent or disease-relevant toxin. In total, there are 14 approved ADCs on the global market, all for oncology indications, and over 140 ADCs currently in clinical development. 1 While the first successes underscored the potential of this class of

article thumbnail

Preventative Measures for C. difficile Infection (CDI)

Pharmacy Times

Dr. Chopra shares multipronged approach to reducing C. difficile infection (CDI) and the role of antimicrobial stewardship.

123
123
article thumbnail

AI + Social Media: The Intersection of 2 Contemporary Inventions Takes Physician Engagement to the Next Level

PharmExec

The two technologies are helping HCPs spread information and collect data in new ways.

98
article thumbnail

Targeted Therapy Allows Patients to Live With CML

Pharmacy Times

Precise, more potent therapy can offer reduced toxicity.

123
123
article thumbnail

Togo becomes first country to eliminate four neglected tropical diseases

Pharmafile

WHO has announced that the Republic of Togo has been confirmed as the first country to eliminate four devastating neglected tropical diseases (NTDs). The West African nation has successfully eliminated dracunculiasis (Guinea worm disease), elephantiasis (lymphatic filariasis), human African trypanosomiasis (sleeping sickness) and trachoma, in an effort spanning between 2011 and 2022. read more.

52
article thumbnail

Venture Fund Looks to Invest in Opportunities Placing Pharmacy as a Hub in Health Care, in the Community

Pharmacy Times

George Rafferty and Jason Dinger of AmerisourceBergen discuss the investment interests of the venture capital fund AB Health Ventures within the retail pharmacy space.

65
article thumbnail

Paediatric Investigation Plan approved by MHRA

Pharmafile

Northwest Biotherapeutics has announced the approval from the MHRA of the company’s Paediatric Investigation Plan (PIP). The development, regulatory review, and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients. Northwest Biotherapeutics is a biotech company developing DCVax personalised immune therapies for solid cancers.

article thumbnail

Study Finds Men More Likely to Receive Care for Chronic Kidney Disease

Pharmacy Times

Early detection of chronic kidney disease is vital to preventing comorbid conditions.

132
132
article thumbnail

Oxford Uni scientists study Siga’s Tpoxx for protection against monkeypox

Pharmafile

The team at Oxford University, who conducted the landmark RECOVERY trial of COVID-19 therapies, is now studying if Siga Technologies’ smallpox drug Tpoxx can be used to fight the outbreak. The PLATINUM trial is now recruiting up to 500 patients across the UK to see if Tpoxx (tecovirimat), an antiviral drug that prevents the virus from leaving infected cells, can help people with monkeypox get better more quickly, and shorten the time that they are infectious to others. read more.

52
article thumbnail

Knowing Which OTC Drugs Patients Are Taking Is Vital

Pharmacy Times

Evaluating nonprescription medications, including dietary supplements, can prevent adverse effects.

73
article thumbnail

New study reveals the range of co-morbidities faced by patients with type 2 diabetes

Pharmafile

A new study has revealed the range and type of illnesses that people with type 2 diabetes are living with, highlighting the urgent need for a more personalised approach to care for these patients. The 1st and 5th most common comorbidities identified were hypertension and heart disease, conditions well known to have links with diabetes. For the first time, research has linked back pain, depression, and osteoarthritis as those included in the five most common conditions at diagnosis. read more.

52
article thumbnail

Generic Product News: August 2022

Pharmacy Times

This month's generic product new features vilazadone tablets, leuprolide acetate injection, and oxcarbazepine tablets.

65
article thumbnail

What Health Problems Are Related to Poor Oral Hygiene?

Compounding Pharmacy of America

Good oral hygiene doesn’t protect just your teeth. Your oral hygiene plays a critical role in your overall health and what happens in your mouth can affect almost every other part of your body. When health professionals look in your mouth, your oral health can show symptoms of serious conditions like heart disease, diabetes and […]. The post What Health Problems Are Related to Poor Oral Hygiene?

article thumbnail

Quality control for human cell lines and other human samples manipulated ex vivo

PharmExec

In this paper, learn about a variety of genetic analysis methods and how they’re valuable in ensuring that ex vivo human cells used for cell?based therapies are correctly identified, have the correct characteristics, and are free of contaminants. Download the white paper and read more about the importance of quality control (QC) for isolated human cells and tissues.

52
article thumbnail

Lacerta partners with Prevail to develop AAV capsids for CNS diseases

Pharmaceutical Technology

Lacerta Therapeutics has entered a new licensing and research partnership agreement with Eli Lilly and Company subsidiary, Prevail Therapeutics, to discover and develop adeno-associated virus (AAV) capsids for treating central nervous system (CNS) diseases. . Under the collaboration, Prevail will obtain rights to use one of the new AAV capsids of Lacerta for selected CNS targets that are currently undisclosed. .

52
article thumbnail

Prototype digital therapeutic shows value in tinnitus

pharmaphorum

An experimental digital therapy for tinnitus based on counselling and personalised passive and active game-based sound therapy has showed some encouraging results in a randomised clinical trial in New Zealand. The UpSilent prototype, developed by researchers at the University of Auckland, consisted of a smartphone app, Bluetooth bone conduction headphones and neck pillow speaker and a cloud-based dashboard that clinicians can use to enable messaging and personalise the digital treatment.

FDA 52