Fri.Jul 01, 2022

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Colorectal Cancer: Screening Options and Potential Emerging Role for Pharmacists

Pharmacy Times

Nearly 63% of newly diagnosed patients have advanced colorectal cancer, which requires more aggressive treatment and reduces the associated 5-year survival rate.

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Magazine-How delays derailed Covid-19 vaccination in Africa

Pharmaceutical Technology

The latest issue of Pharma Technology Focus is out now. Read it for free on all devices. Some months after the first Covid-19 vaccines became available, the World Health Organization (WHO) set a target of vaccinating 70% of each country’s population by the end of June 2022. Global trends indicate that initially, a slow supply did not allow African countries, in particular, to stay on pace to meet this target, and now vaccination rates have even begun to slow down.

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Daily OTC Pearl: Anxiety & Stress Relief Ashwagandha KSM-66

Pharmacy Times

Ashwagandha KSM-66 (Anxiety & Stress Relief) from Nature’s Bounty is indicated to help manage occasional stress and anxiety.

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Pfizer seeks approval from US FDA for Covid-19 treatment

Pharmaceutical Technology

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally. Due to the oral form, the therapy can be prescribed in the early infection stage to avert severe illness.

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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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Hepcludex Shows Efficacy Treating Chronic Hepatitis Delta Virus

Pharmacy Times

Findings from a study highlight the efficacy and safety of bulevirtide for the treatment of chronic hepatitis delta virus.

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How should cleaning validation sampling locations be chosen?

European Pharmaceutical Review

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. The article, published in the Journal of Validation Technology ( JVT ), presents the case study of a company undergoing an investigation and developing a strategy for identifying worst-case sampling locations on equipment, after a regulatory auditor asked for such a rationale and no written documentation could be provided.

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Liver injuries prompt clinical hold on Sanofi BTK drug

pharmaphorum

One of the main assets of Sanofi’s $3.7 billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. The regulator is requiring Sanofi to stop dosing some patients in phase 3 trials of the BTK inhibitor tolebrutinib (SAR442168) in multiple sclerosis and myasthenia gravis, following reports of drug-induced liver damage in some subjects.

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The Role of the Microbiome in C. difficile Infection and Its Impact on Overall Health

Pharmacy Times

The first step to reducing recurrent C. difficile infections is prevention.

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Blueprint Medicines announces financing partnerships for $1.25bn

Pharmaceutical Technology

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. The company noted that the deal will bring substantial non-dilutive, low-cost capital to boost innovation and growth. The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects.

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Oncology Overview: Sonidegib (Odomzo) for Locally Advanced Basal Cell Carcinoma

Pharmacy Times

Sonidegib is a biphenyl carboxamide that blocks the signaling in the hedgehog pathway.

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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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Happy Independence Day Weekend!

OctariusRx

Let Freedom Ring! From all of us at OctariusRx, Happy Independence Day weekend! Thank you to all who serve or have served our Nation in pursuit of the freedom we enjoy today and every day! “Here is your country. Cherish these natural wonders, cherish the natural resources, cherish the history and romance as a sacred heritage, for your children and your children’s children.

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Helping Manage the Cost of Cancer with a Patient Lens: Opportunities for Pharmacists

Pharmacy Times

This webcast discusses opportunities for pharmacists to address the cost of cancer care and enable improved access and outcomes for patients. During the webcast, a panel of experts discusses how pharmacists can help minimize costs associated with cancer therapy, including treatment and clinical practice considerations, as well as more direct financial support that can help ensure access to effective therapies for patients.

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Uncover Your Hashimoto’s Root Cause with an Elimination Diet

The Thyroid Pharmacist

Through my years of experience working with people with thyroid disease, I’ve found that food sensitivities are often a huge trigger for people with Hashimoto’s. I too have had major sensitivities to dairy and gluten, and getting off of both of these foods helped me get rid of the acid reflux I had been battling for over three years. Changing my diet also helped me eliminate my bloating, symptoms of irritable bowel syndrome, anxiety, nasal congestion, and even carpal tunnel.

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Bringing Oncology Pharmacy Leaders, Payers Together to Address Unmet Educational Needs in the Field

Pharmacy Times

Bhavesh Shah, RPh, BCOP, steering committee co-chair of the 2022 ATOPP Summit, discusses the impact of the annual ATOPP summit on the oncology pharmacy field.

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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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Realizing That A True Blameless Culture Corrects The System and Increases Medication Error Reporting

The Happy PharmD

A while ago, there was a news story about a medication error. It seems a nurse gave a patient the wrong medication. The patient died. After a recent court battle, the nurse got three-years of probation. People make mistakes. Administrations and their hospitals know that they do. Yet, quite often, they make the people in the facility the scapegoat for medication errors.

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Daily Medication Pearl: Pitavastatin (Livalo)

Pharmacy Times

Livalo is an HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in adults with primary hyperlipidemia or mixed dyslipidemia.

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Medical Devices and IVD Conference

pharmaphorum

SAE Media Group’s Inaugural Conference…. Medical Devices and IVD 2022. 14 – 15 November 2022. London, UK. [link]. Navigating The MDR and IVDR and Best Strategies for Compliance. SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in London, UK. The MDR implementation last May has highlighted issues within the industry that need to be addressed and the upcoming IVDR updates will have a profound impact on the medical devi

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Novel Treatment Extends Time to Recurrence in Patients With C. Difficile

Pharmacy Times

Paul Feuerstadt, MD, FACG, AGAF, discussed the investigative C. difficile treatment RBX2660 and how it impacts time to recurrence.

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Blueprint cashes in on the past to build its future

pharmaphorum

Blueprint Medicines has taken an unusual route to raising cash for its R&D pipeline – selling off some of the royalties from its already-approved medicines in return for a cash injection of up to $1.25 billion. The targeted cancer drug specialist has sold its interest in tyrosine kinase inhibitor Ayvakit/Ayvakyt (avapritinib) and Roche-partnered RET inhibitor Gavreto (pralsetinib) in two separate transactions with Sixth Street and Royalty Pharma.

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Moving toward Supply Chain Solutions

Pharmaceutical Commerce

Logistics experts provide an outlook on what the industry must do to overcome potential bottlenecks.

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AZ takes aim at BMS’ lead in neoadjuvant NSCLC

pharmaphorum

Just weeks after Bristol-Myers Squibb claimed an FDA green light for Opdivo as a neoadjuvant therapy for non-small cell lung cancer, AstraZeneca is looking to encroach on its territory. Top-line results from the AEGEAN trial of AZ’s PD-L1 inhibitor Imfinzi (durvalumab) plus chemotherapy given pre-surgery for resectable NSCLC tumours have revealed a significant improvement in the pathologic complete response (pCR) rate compared to chemo alone.

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Charles River Debuts UK Manufacturing Site

Pharmaceutical Commerce

Cheshire facility will offer plasmid DNA production, CGT development.

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Novartis eyes earlier use of PD-1 drug in oesophageal cancer

pharmaphorum

Novartis is still waiting for FDA approval of its PD-1/PD-L1 inhibitor latecomer tislelizumab in relapsed oesophageal cancer, but is already planning a move the drug into the first-line setting. New phase 3 data from the RATIONALE 306 study have shown that previously-untreated patients with advanced oesophageal squamous cell carcinoma (ESCC) treated with tislelizumab plus chemotherapy had improved overall survival (OS) compared to those given chemo plus placebo.

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Sanofi’s Xenpozyme approved by European Commission

Pharma Times

Xenpozyme is a treatment for ASMD and the condition’s only current enzyme replacement therapy

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Bayer grabs Chinese okay for CKD therapy Kerendia

pharmaphorum

On the heels of approvals in the US, Europe and Japan, Bayer’s Kerendia for chronic kidney disease (CKD) associated with type 2 diabetes has been cleared for use in China, unlocking another big market for the drug. Kerendia (finerenone) – a non-steroidal, selective mineralocorticoid receptor (MR) antagonist – has been shown to reduce the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy in the FIDELIO-DKD study.

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Recommendation for Novartis’ chronic myeloid leukaemia STAMP inhibitor

Pharma Times

Chronic myeloid leukaemia therapy Scemblix receives NICE final draft recommendation in Britain

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A 3-step guide to addressing difficult issues and creating mutual solutions

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. This post, which includes references to Marshall B. Rosenberg’s psychological concept of Nonviolent Communication, shares a simple three-step method to solving conflicts without spoiling foundational human relationships – and sometimes even improving them.

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ESG considerations in Europe and Asia: social inclusion – the new diversity frontier in life sciences

European Pharmaceutical Review

The last several years have presented employers in the pharmaceutical industry with a challenging, rapidly changing landscape. With the advent of social movements such as #MeToo and Black Lives Matter, and the impact of the COVID-19 pandemic, the priorities and concerns of employers are shifting significantly. This evolving focus is clearly visible in the growing emphasis now placed by many global businesses on environmental, social and governance (ESG) issues – and especially the ‘social’ eleme

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Twist and Ildong to develop antibodies for immuno-oncology applications

Pharmaceutical Technology

Ildong Pharmaceutical will licence a suite of Twist Bioscience's VHH antibody libraries after the two companies entered a partnership agreement. Twist's VHH libraries, used for discovering and developing antibodies for use in immuno-oncology, will be licensed by Ildong for three years for research and development works. . Twist will be entitled to receive an upfront payment, annual maintenance fees, further payments on successfully meeting clinical and regulatory milestones and royalty payments

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A digital twin for the body: why patient data consent is vital

Pharmaceutical Technology

A digital twin of the human body presents immense potential for the future of diagnostics. Data gathered from a wide range of targeted areas builds a complete profile of the subject. When data is gathered over time, it can be used in tandem with artificial intelligence and machine learning to pinpoint any areas that may need attention, creating a specific treatment plan for that individual.

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Top tweets: CDC’s concern over UK’s Monkeypox outbreak and more

Pharmaceutical Technology

Pharmaceutical Technology lists five of the most popular tweets on infectious diseases in May 2022 based on data from GlobalData’ Pharma Influencer Platform. The top tweets are based on total engagements (likes and retweets) received on tweets from more than 191 infectious diseases experts tracked by GlobalData’s Pharma Influencer platform during May 2022.