IDStewardship

JULY 27, 2022

In this article antimicrobial stewardship in the United Kingdom is discussed. Interview with: Tariq Azamgarhi, MRPharmS, PGDip Clin Pharm, PG CEPIP. Interview by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP. Article posted 1 August 2022. Antibiotic use and resistance varies geographically, but across the world antimicrobial stewardship (AS) and antimicrobial stewardship programs (ASPs) can serve as critical towards supporting safe and appropriate antimicrobial drug use.

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Hospitals Clinic Management Labelling Vaccines 147

Pharmacy Times

JULY 29, 2022

The immune responses to the Omicron variant waned substantially with neutralizing antibody levels decreasing 2.4- to 5.3-fold by 3 months after the booster dose.

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Immunization 181

pharmaphorum

JULY 26, 2022

Newly diagnosed cancer patients across the UK will get free access to digital mental health therapies, thanks to a new partnership between Macmillan Cancer Support and Big Health. The alliance, billed as the first of its kind in the UK, means that cancer patients will be able to use Big Health apps like Sleepio and Daylight, which aim to treat insomnia and anxiety using cognitive behavioural therapy (CBT) techniques.

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Pharma Marketing Network

JULY 27, 2022

In the first two weeks after a cancer diagnosis, there are likely dozens of doctor’s visits, tests, consultations, and decision points. The patient care team supplies an abundance of information, although sifting through brochures and online resources can be daunting for the patient and their caregiver. Adhering to regulatory guidelines is an important step pharma takes to ensure that promotional medical materials contain balanced information that is accurate and relevant. 1 The marketer’s goal

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Communication Patient Care 130

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.

Pharmaceutical Technology

JULY 26, 2022

According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. The three major markets (3MM: the US, Germany and the UK) will increase in market size from $128.35m last year to $188.35m in 2031, at a compound annual growth rate (CAGR) of 3.9%.

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Compounding Labelling 122

Pharmacy Times

JULY 29, 2022

A majority of long-term care patients who received a fourth vaccination against COVID-19 were found to have increased protection against the omicron variant.

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Vaccines 162

Outsourcing Pharma

JULY 25, 2022

During the Decentralized Trial Technology event, experts from CVS Health, University of Chicago, and ACRP shared insight on what can increase DCT success.

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Pharmaceutical Technology

JULY 25, 2022

The COVID-19 pandemic triggered significant changes to the way healthcare operates. Digitalization is now in full swing as medical care integrates with ICT to take the patient experience to the next level. According to Tom Lenaerts, Head of Global Process Engineering at Datwyler, this transformation will reshape the entire healthcare ecosystem. “There are already opportunities for patients to track their health through smart medical devices sending reports directly to their healthcare provider.

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Health and Personal Care Stores Packaging Patient Care 114

Pharmacy Times

JULY 29, 2022

The pandemic saw reductions in the supply of methadone but no disruption to the supply of more easily accessible buprenorphine, though disparities in supply were observed across states.

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pharmaphorum

JULY 27, 2022

Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. The vaccine, codenamed BNT162b5, codes for “enhanced” prefusion spike proteins from the original wild-type strain of the virus and the Omicron variant that are designed to increase “the magnitude and breadth of the immune response.” The phase 2 trial will te

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Vaccines Immunization FDA 122

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.

FDA

PharmaVoice

JULY 27, 2022

So far, pharma has yet to provide an answer for long COVID. But award-winning lupus research by Yale professor Akiko Iwasaki help lead the way.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer has reported a 53% operational growth in revenues to $27.7bn in the second quarter (Q2) of 2022 compared to $18.9bn in the same quarter last year. The rise in revenues was chiefly driven by robust contributions from Covid-19 therapies Paxlovid and Comirnaty. On an operational basis, the revenues rose by $128m or 1%, excluding Paxlovid and Comirnaty’s contributions.

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Pharmacy Times

JULY 23, 2022

The most common way to detect bacteria and determine the right medication to use is with the gram stain test, which will show whether the bacteria is gram-positive or gram-negative.

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pharmaphorum

JULY 28, 2022

Supply chain shortages have dominated headlines for several months, and the pharma industry has been no exception. While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems.

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FDA Dosage Documentation Compounding 107

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European Pharmaceutical Review

JULY 25, 2022

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The Regulation will cover all SoHO (eg, blood, tissues, cells, breast milk and microbiota) except solid organs. A major aim of the proposal is to enhance the protection of recipients of SoHO therapies, as well as donors of SoHO and offspring from medically assisted reproduction.

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease. A decision from the regulatory agency on approval for the treatment is anticipated on 23 May next year.

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FDA Labelling Immunization Vaccines 105

Pharmacy Times

JULY 28, 2022

Researchers highlight how a lack of access to medications used to treat multiple sclerosis, migraines, and epilepsy, but not proven safe for pregnancy, threatens child-bearing aged women who live with these conditions.

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pharmaphorum

JULY 25, 2022

Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the US – and could soon start making inroads against its rival in Europe. Vabysmo (faricimab) has been recommended by the EMA’s human medicines committee as a treatment for neovascular or wet age-related macular degeneration (AMD) and diabetic macular oedema (DME), so could be fully approved and ready to roll out in the next few months, subject to pricin

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FDA Immunization 85

PharmaVoice

JULY 28, 2022

The digital medicine company’s chief strategy officer, John Varaklis, explains how its analytic predictive platform could lead to safer and quicker clinical trials.

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Pharmaceutical Technology

JULY 29, 2022

The rate at which children are being identified with autism spectrum disorder (ASD) has tripled in the past two decades. While the prevalence was 1 in 150 children in 2000, it reached the rate of 1 in 44 in 2018, in the US, according to the Centers for Disease Control and Prevention. Some people with ASD can experience acute agitation and crisis behaviours.

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Communication Labelling Hospitals FDA 105

Pharmacy Times

JULY 26, 2022

The bill allows pharmacists to dispense and administer drugs, order laboratory tests, and consult patients on HIV pre- and post-exposure drugs.

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pharmaphorum

JULY 27, 2022

Health innovation and technology specialist Healthware Group has added another element to its business with the launch of a dedicated medical communications and education division. The new unit – dubbed Healthware MedComms – promises to take a fresh approach to medical communications that meets “the always-on, audience-centric, evidence-driven demands of today’s modern clinical environment.” It adds to Healthware’s fast-growing presence in the healthcare communications se

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Communication 98

PharmaVoice

JULY 25, 2022

The latest trial failures in Alzheimer's have shown cracks in the foundation of ingrained theories like amyloid plaque clearance. What will it take to move forward?

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Pharmaceutical Technology

JULY 28, 2022

The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk. The review will facilitate the use of the therapy for emergency usage in countries in the European Union (EU). Under this process, the ETF will analyse all available data, including findings from a trial in moderate-to-severe Covid-19 patients admitted to hospital who are at incre

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Hospitals 104

Pharmacy Times

JULY 28, 2022

The FDA is evaluating the use of adagrasib (MRTX849) to treat patients with non-small cell lung cancer harboring a KRAS G12C mutation who have previously received at least 1 systemic therapy.

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FDA 132

pharmaphorum

JULY 27, 2022

Latest UK Life Sciences Competitive Indicators “ought to ring alarm bells across Government,” says ABPI. Despite the UK’s potential as an international life sciences leader, it lags many competitors in a number of key metrics, including access to new medicines and global share of clinical trial recruitment. Richard Torbett, chief executive at the Association of the British Pharmaceutical Industry (ABPI) said Life Sciences Competitive Indicators (LSCI) data published last week “ought to ring alar

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Documentation FDA 98

PharmaVoice

JULY 25, 2022

A combined venture with Roivant — called Priovant Therapeutics — is looking to be a forerunner in the burgeoning autoimmune disease market.

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Pharmaceutical Technology

JULY 28, 2022

Ulcerative colitis (UC), an inflammatory bowel disease, is characterised by inflammation and ulcers in the large intestine, often causing symptoms that impact a patient’s quality of life, including diarrhoea, abdominal pain and cramping, fatigue, weight loss and pain. While the exact cause of UC remains unknown, it is often associated with immune system malfunction.

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Immunization Documentation Labelling FDA 98

Pharmacy Times

JULY 27, 2022

With the vast number of drugs that can induce photosensitivity, patients taking any of these medications should receive safety counseling, especially during the summer months.

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European Pharmaceutical Review

JULY 29, 2022

Researchers have constructed biohybrid microrobots, by equipping Escherichia coli bacteria with artificial components, that could one day offer a highly targeted and effective cancer treatment option. The team of scientists from the Physical Intelligence Department at the Max Planck Institute for Intelligent Systems combined robotics with E. coli bacteria to construct their innovative drug delivery system.

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Immunization 94

Outsourcing Pharma

JULY 28, 2022

A joint study conducted by analysts from Medable and the Center for the Study of Drug Development points toward shorter cycle times, cost savings, and more.

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Pharmaceutical Technology

JULY 28, 2022

Bristol Myers Squibb (BMS) has reported a 2% rise in revenues to $11.9bn in the second quarter (Q2) of 2022 compared to $11.7bn in Q2 last year. The revenue growth was driven by in-line products, mainly Eliquis and Opdivo, as well as the company’s latest product portfolio comprising Abecma, Opdualag and Reblozyl. New LOE products, especially Revlimid and foreign exchange, impacts partially offset the increase in revenues.

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Pharmacy Times

JULY 28, 2022

People who performed 2 to 4 times above the recommended amount of moderate physical activity (300-600 minutes/week) saw an overall 26%-31% lower risk of mortality from all causes.

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European Pharmaceutical Review

JULY 26, 2022

Recommended for approval. Amvuttra * (vutrisiran) was recommended for marketing authorisation as a treatment for adults with hereditary transthyretin-mediated amyloidosis, a rare life-threatening disease that damages multiple nerves across the body. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Celdoxome pegylated liposomal (doxorubicin hydrochloride) for the treatment of metastatic breast cancer, advanced ovaria

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Vaccines Chemotherapy 88