Mon.Jun 27, 2022

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FDA Approves Lisocabtagene Maraleucel for Second-Line Large B-cell Lymphoma

Pharmacy Times

Lisocabtagene maraleucel (liso-cel, Breyanzi; Bristol Myers Squibb) approved for the second-line treatment of patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B.

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GSK hepatitis B hope bepirovirsen heads for phase 3 test

pharmaphorum

An antisense drug in development at GSK has shown further activity against hepatitis B virus (HBV) in a mid-stage trial, setting up a phase 3 assessment next year to see if it could offer a “functional cure” for the widespread disease. Interim results from the phase 2b B-Clear showed that bepirovirsen reduced levels of hepatitis B surface antigen (HBsAg) and HBV DNA after 24 weeks’ treatment to below the lower limit of detection in people with chronic hepatitis B, raising hopes

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Pharmacists Can Help Create a Safe, Tolerant Workplace for LGBTQ+ Employees

Pharmacy Times

As we mark the second anniversary of Bostock v. Clayton County this month, let’s remember to treat each other with dignity, empathy, and respect, while we work together for a safer and more tolerant workplace.

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Study exposes lack of diversity in US cancer trials

pharmaphorum

Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. The analysis – from a dataset that spans more than half a million patients – reveals once again the lack of inclusivity in clinical research, which undermines the ability of clinical trials to generate results that reflect the real-world situation in US cancer treatmen

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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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AbbVie Submits sNDA to FDA for Qulipta for Preventive Treatment of Chronic Migraine

Pharmacy Times

Submission is based on phase 2 study results evaluating atogepant in adults who met the primary endpoint of a statistically significant reduction from the baseline compared with a placebo.

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Ipsen beefs up in oncology, buying US biopharma Epizyme

pharmaphorum

The revamp of French drugmaker Ipsen has continued with a takeover agreement for US counterpart Epizyme and its cancer therapy Tazverik, in a deal valued at a little under $250 million. Ipsen is offering $1.45 per share for Cambridge, Massachusetts-based Epizyme – valuing the US company at around $247 million – and is also promising a further contingent value right (CVR) payment of up to $1 per share if Tazverik (tazemetostat) achieves certain development and sales targets.

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WHO’s new hepatitis C guidelines a step forward in reaching those in need

Pharmaceutical Technology

Last Friday, the World Health Organization (WHO) launched updated guidelines for the treatment of hepatitis C , calling for testing and treatment to be delivered in peripheral and community-based facilities and integrating these with available care services. While some countries are making progress in eliminating hepatitis C, many remain challenged in reaching those affected, Dr Philippa Easterbrook, Senior Scientist at WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infection

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Study Break: The Importance of Fellowship Opportunities and the Community Pharmacy Fellowship from NCPA, CPESN

Pharmacy Times

We spoke with Carlie Traylor, PharmD, of the National Community Pharmacy Association to learn about a fellowship program offered by NCPA and CPESN.

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BMS receives US FDA approval for CAR T cell therapy to treat B-cell lymphoma

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for its CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory large B-cell lymphoma (LBCL) in adult patients. Breyanzi is given as a defined composition for reducing the variability of the CD8 and CD4 component dose.

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Research Shows Improved Treatment Options for Heart Defect Prevention Before Birth

Pharmacy Times

The researchers noted that new therapies have faced challenges because of this knowledge gap in CHD.

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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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Global Blood Therapeutics: driving innovation in sickle cell disease

European Pharmaceutical Review

Sickle cell disease – a rare, yet prevalent, genetic disease in Europe. Sickle cell disease (SCD) is a devastating, lifelong blood disorder that occurs when someone inherits sickle cell genes from both parents. 1 It affects haemoglobin, a protein carried by red blood cells that delivers oxygen throughout the body. 2 SCD predominantly affects those whose ancestors are from sub-Saharan Africa but is also common in people of Hispanic, South Asian, Southern European and Middle Eastern ancestry. 3 Wh

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From vineyards to antivirals, Gilly Regev brings creative thinking to science

PharmaVoice

The CEO of SaNOtize is tapping into outside-the-box innovation to develop a nitric oxide-delivery platform to treat and prevent COVID-19.

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Pursuing new paths in targeted protein degradation drug development

European Pharmaceutical Review

DRUG DEVELOPMENT based on targeted protein degradation (TPD) has progressed rapidly since the publication in 2015 of three landmark papers 1-3 that highlighted important early-stage breakthroughs with drug-like molecules in this area of research. Since that time, the field has advanced to the point where there are now more than two dozen companies dedicated to working on the development of TPD drugs, some of which have advanced to later-stage clinical development.

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Sanofi pushes to accelerate medical writing, reporting processes

Outsourcing Pharma

The pharmaceutical company has enlisted the help of the AI and NLP tech specialist to streamline clinical study report generation and submission processes.

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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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How the US’s pending PIE Act will improve patient access to medication

pharmaphorum

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. . The AMCP backed bill (H.R. 7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Admini

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Dengue Vaccine: What Pharmacists Need to Know

Pharmacy Times

The FDA approved the first vaccine for dengue disease in May 2019.

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Healthier Together and philanthropic ventures in tropical disease

European Pharmaceutical Review

Europe’s Healthier Together initiative. The European Commission (EC) has launched the Healthier Together: EU Non-communicable diseases (NCDs) initiative to support EU Member States in reducing the burden of NCDs by addressing the leading causes of avoidable premature death in Europe and improving citizens’ health and well-being. The €156 million initiative identifies effective actions and the available legal and financial supporting tools across five main areas: cardiovascular diseases, di

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Current Standards of Care in Platinum-Resistant Ovarian Cancer

Pharmacy Times

Folate receptor ? may be an important treatment target for ovarian tumors.

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Drug Development In-Depth Focus 2022

European Pharmaceutical Review

Pursuing new paths in targeted protein degradation drug development. Targeted protein degradation (TPD) therapy has grown rapidly as a field, with transformational potential. TPD is poised to be successful in delivering marketed products, but limitations are now starting to emerge, including tumour resistance, a lack of mechanisms for oral dosing, and the inability to penetrate tissues such as the CNS.

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Daily Medication Pearl: Venlafaxine Extended-Release (Effexor XR)

Pharmacy Times

Venlafaxine Extended-Release (Effexor XR) is indicated for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder.

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Rapid method development to overcome challenges of bi-specific antibody purification

European Pharmaceutical Review

With expanding biologics pipelines encompassing an increasingly diverse range of new molecular formats, the therapeutic potential of bi-specific antibodies (bsAbs) continues to receive widespread interest. 1 The majority of bsAbs consist of three or more light chain (LC) and heavy chain (HC) combinations and have the advantage of simultaneously binding two antigens via different epitopes on each antigen-binding fragment (Fab) arm ( Figure 1 ).

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June 27 is National HIV Testing Day

Pharmacy Times

June 27 is National HIV Testing Day, so Pharmacy Times® sat down with Brad McElya, PharmD, director of Specialty Health Solutions at Walgreens, to discuss the importance of HIV testing.

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Alexion to expand biologics manufacturing with €65m investment

European Pharmaceutical Review

Alexion , AstraZeneca’s Rare Disease group, will invest €65 million to enhance its production capabilities in Ireland. The investment will help the company scale up its biologics manufacturing capacity and expand R&D efforts over the next 18 months. The money will go towards the installation of new drug substance production equipment and warehousing facilities to support ambient and cold storage at two sites: College Park in Blanchardstown and Monksland Industrial Park in Athlone.

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New Recommendations Show How to Use Genetic Testing to Prevent Sudden Cardiac

Pharmacy Times

Clinical evaluation dictates the need for preventive therapy and advice on exercising and participation in competitive sports, according to the European Society of Cardiology.

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Janssen invests $5m in Stand Up To Cancer’s health equity effort

Outsourcing Pharma

The sponsorship from Janssen Pharmaceutical Companies will be used by the cancer support network to boost diversity in Phase I and Phase 2 clinical trials.

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Oncology Overview: Lenvatinib (Lenvima) for Multiple Cancer Types

Pharmacy Times

Lenvima (lenvatinib) is approved for the treatment of thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma.

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Cybersecurity hiring levels in the pharmaceutical industry rose in May 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for cybersecurity related positions rose in May 2022 compared with the equivalent month last year, with 46.8% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 39.4% of companies who were hiring for cybersecurity related jobs a year ago and an increase compared to the figure of 43.6% in April 2022.

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Daily OTC Pearl: All Natural Acid Indigestion Relief

Pharmacy Times

Maty's All Natural Acid and Indigestion Relief is an alternative to traditional antacid tablets to relieve indigestion and heartburn.

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Ipsen to buy biopharmaceutical company Epizyme for $247m

Pharmaceutical Technology

Ipsen has signed a definitive merger agreement to acquire all the outstanding shares of commercial-stage biopharmaceutical company Epizyme, for an initial total consideration of $247m. The company will begin an all-cash tender offer through its subsidiary to buy Epizyme’s all outstanding shares for $1.45 per share in cash along with a contingent value right (CVR) of $1.00 for each share.

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The Method rolls out experience for living as a Type 2 diabetes patient for a day

Outsourcing Pharma

The company has added Type 2 diabetes to the list of conditions it simulates in itĂ¢s A Life in a Day program, enabling people to spend a day living as if they have the disease.

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Turning Point Therapeutics and MD Anderson collaborate to advance cancer therapies

Pharmaceutical Technology

Turning Point Therapeutics has entered a strategic research and development alliance with the University of Texas MD Anderson Cancer Center (MD Anderson) to advance the evaluation of two of its investigational small molecules for precision cancer treatments. The focus of this strategic alliance will be on drug candidates, repotrectinib and elzovantinib (TPX-0022).

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Top Resources for the Sleep Medicine Board Exam

Board Vitals - Pharmacist

The ABIM Sleep Medicine board exam is a notoriously difficult test, with a pass rate of just 88% in 2021. As you study for the Sleep Medicine boards, you are likely wondering which preparation books and courses are worth your time, energy and money. We’ve compiled the best time-tested Sleep Medicine resources to help you get ready for test day. The BoardVitals Sleep Medicine Question Bank is a great resource for board review questions.

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The Ultimate Guide for Paying Off Medical School Loans

The Physician Pharmacist

As a pharmacist considering medical school, I often recommend you make sure your finances are in order before moving forward with this massive decision. One of the most frequent questions I receive often involves handling medical school tuition along with my pharmacy school loans. I am no stranger to pharmacy loans as I have personally accrued $150,000 in student loan burden prior to my medical school expenses.

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Well-Being Survey Discussion: Alex Barker and Mike Koelzer

The Happy PharmD

Well Being Report: Are Pharmacists going crazy? Listen to the full episode at the link below: [link] . . Pharmacist well-being: Changes Post-COVID-19. 78% of Pharmacists say they are not happy at work Post COVID-19 Pandemic. Many surveys conducted before COVID among pharmacists showed that many pharmacists were not happy with their jobs. In one of such studies by Drug Topics® in 2020, 7 out of 10 pharmacists revealed they were not happy with their jobs.