Fri.Dec 23, 2022

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Study: Travel Times Are Still a Major Obstacle for Women Seeking Breast Cancer Screening

Pharmacy Times

In 10 states, the data showed more than 26% of women had limited accessibility to mammography, primarily in the Rocky Mountains and the South.

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Flu activity in the U.S. continues to decline after early surge

STAT

Flu activity across the United States continues to decline, though it remains at high levels in most parts of the country, the Centers for Disease Control and Prevention reported Friday in its weekly influenza update for the week ending Dec. 17. The percentage of people seeking medical care for influenza-like illness dropped for the third straight week, and hospitalizations due to flu declined for the second week in a row.

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NIH Awards $7.8 Million for Antibiotic Study of Patients With Emphysema, HIV

Pharmacy Times

The National Institute of Health’s grant funds a phase 2 clinical trial of doxycycline in a large group of individuals with the 2 conditions who are smokers or used to smoke.

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Lilly and ProQR to expand genetic medicine development agreement

Pharmaceutical Technology

Eli Lilly and Company has expanded a licencing and partnership agreement with ProQR Therapeutics to discover, develop and market new genetic medicines. The companies entered the initial agreement in September last year. This alliance is utilising the Axiomer ribonucleic acid (RNA) editing platform of ProQR to address ailments affecting the liver and nervous system.

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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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Top 5 Most Read Zoster Articles in 2022

Pharmacy Times

From newsworthy moments to groundbreaking research, these are the most popular articles in the zoster space, published on Pharmacy Times® during 2022.

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STAT+: ‘Apples to apples’: How new health data rules could hold providers accountable

STAT

Last year, medical records opened up to patients. This year, they’re opening up to the nation. Before the ball drops on New Year’s Eve, electronic health care record vendors will have to provide tools to easily pull big batches of patient data from their systems. Just as information blocking rules gave individual patients the ability to access their medical records, this next round of federal rules gives a framework for sharing insights — within a health system, or with trus

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California medical school apologizes for unethical prisoner experiments

STAT

SAN FRANCISCO — A prominent California medical school has apologized for conducting dozens of unethical medical experiments on at least 2,600 incarcerated men in the 1960s and 1970s, including putting pesticides and herbicides on the men’s skin and injecting it into their veins. Two dermatologists at the University of California, San Francisco — one of whom remains at the university — conducted the experiments on men at the California Medical Facility, a prison hospit

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Innovator Liability Theory Applies to Pharmaceuticals

Pharmacy Times

Can a brand name manufacturer be held liable for damages caused by a drug product manufactured by another firm?

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Opinion: Allowing pharmacies to dispense methadone is dangerous for patients and communities

STAT

Congress is expected to pass a massive $1.7 trillion omnibus spending package that includes numerous provisions aimed at addressing the opioid epidemic. I have been advocating for greater access to opioid addiction treatment for more than two decades. While the spending package contains many positive opioid treatment reforms, I am deeply concerned that Congress and others without on-the-ground experience will continue pushing dangerous policies to solve the opioid epidemic in the next Congress.

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COVID-19 Vaccine-Associated Myopericarditis

Drug Topics

A recent analysis showed that vaccine-associated myopericarditis was rare in adolescents and young adults, and that outcomes were favorable.

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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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7 commercial, sales, and marketing predictions for 2023

pharmaphorum

In 2022, life sciences companies have been hard at work breaking down silos to better serve patients and healthcare professionals (HCPs). They’ve laid the necessary groundwork for cross-functional visibility, collaboration, and connectivity. And in 2023, these investments will hopefully pay off. Here are seven commercial predictions from Veeva’s industry experts for the year ahead.

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New FDA guidance explains that Plan B is not an abortion pill

STAT

The Food and Drug Administration on Friday altered the language attached to emergency contraceptive pills to clarify that they are not abortion drugs. The agency’s update eliminates previous language that had suggested that the over-the-counter products, commonly described as morning-after pills or Plan B, could prevent a fertilized egg from implanting in the uterus.

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Collaboration promotes sustainable pharmaceutical packaging

European Pharmaceutical Review

Astellas Pharma, Eisai, Daiichi Sankyo and Takeda have agreed to collaborate to reduce the environmental burden in the field of pharmaceutical packaging. As part of the collaboration, the four pharma companies plan to share knowledge on packaging technologies to reduce environmental burden. . Areas covered will include blister packs made of biomass-based plastic instead of petroleum-derived plastic, compact packaging, recycled packaging materials, and recyclable packaging materials.

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STAT+: Parker Institute extends ‘crazy idea’ funding to two more cancer centers

STAT

With his Parker Institute for Cancer Immunotherapy, Sean Parker has been building a dream team of cancer researchers. Since 2016, the Parker Institute — known as PICI for short — has poured hundreds of millions of dollars into six research centers that it’s created at some of the top academic institutions in the country and folded luminaries like the CAR-T pioneer Carl June and Nobel Prize winner Jim Allison into its network.

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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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While 'Certainly' Still in a Pandemic, COVID-19 Cases are Less Harsh

Drug Topics

Dr. Syra Madad of the NYC hospital system and an Infectious Disease Epidemiologist at Harvard's Belfer Center for Science and International Affairs responded to Dr. Anthony Fauci's, director of NIAID, statement made in late November that the U.S. is “certainly” still in the middle of a Covid-19 pandemic.

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STAT+: Pharmalittle: FDA approves a Genentech blood-cancer drug; Sean Parker expands his immunotherapy research empire

STAT

Good morning, Pharmalittle family! Your loyal scribe Ed Silverman is taking today off, so he bestowed upon me, Adam Feuerstein, the great honor of delivering today’s roundup of pharma news. But first, my coffee: Intelligentsia House Blend, brewed in a Chemex. Old school. Hints of apple, citrus, and milk chocolate. Or, so they say. To me, it just tastes like a really good cup of joe on a stormy Friday morning.

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Study: Survivors of Hodgkin Lymphoma Show Signs of Dementia in Early Adulthood

Pharmacy Times

Participants who survived Hodgkin lymphoma as children showed signs of being biologically older than their peers, with a heightened risk of cognitive problems.

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Simplify, standardise, digitalise to transform manufacturing

European Pharmaceutical Review

With over 90,000 employees across the globe, Sanofi supplies over 5 billion doses of medicines and vaccines every year, supporting the health needs of millions of patients in more than 170 countries. This responsibility has increased significantly in recent years, due to the COVID-19 pandemic ; the war in Ukraine; rising energy costs and inflation and the increase in geopolitical tensions globally – all of which are creating unprecedented upheaval and disruptions to global supply chains.

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BioNTech begins phase 1 trial for malaria vaccine

Pharmafile

BioNTech has announced the start of its new first-in-human phase 1 trial for BNT165b1, a candidate from its programme which aims to develop a multi-antigen malaria vaccine. The study will assess a set of mRNA-encoded antigens of the malaria-causing parasite, plasmodium falciparum, in order to select the best candidate to progress to further stages of the trials.

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FDA approves first capsid inhibitor for HIV

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Gilead’s Sunlenca (lenacapavir), a capsid inhibitor for adults living with human immunodeficiency virus type 1 (HIV-1), who cannot be successfully treated with other available treatments. Sunlenca is the first of a new class of drugs called capsid inhibitors to be approved by the FDA for treating HIV-1.

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Merry Christmas!

OctariusRx

Merry Christmas! The holidays are a good time to reflect and give thanks. Our entire team is always grateful and giving thanks for all our blessings. We are thankful for our clients who have been with us for many years, as well as the new partners who joined us in 2022. A successful year would be impossible without our hardworking team. We are thankful for all they do throughout the year to support our clients.

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Best of Conference Coverage in 2022

Drug Topics

Take a look back at our most popular conference coverage for 2022.

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Expert Discusses How Pharmacists Can Treat PONV With Medication, Other Therapies

Pharmacy Times

Jawad Saleh, PharmD, BSPharm, BCCCP, BCPS, clinical manager of Pharmacy Services at the Hospital for Special Surgery, discusses how pharmacists can treat postoperative nausea and vomiting.

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News Roundup: December 19 to December 23

Drug Topics

Your weekly roundup of the latest news from Drug Topics®.

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Expert: Immune System Acts as a Perfect Analogy of Appropriate, Inappropriate Discrimination, Showing Disorder Discrimination Can Cause When It Runs Awry

Pharmacy Times

Steve Simske, PhD, discusses his research investigating how the occurrence of discrimination in biology can act as an agnostic analogy for discrimination in humans’ social environments.

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Celltrion submits application for CT-P13 SC to FDA

Pharmafile

Celltrion has announced that it has finalised its submission of a biologics license application for the subcutaneous version of a biosimilar to anti-inflammatory medicine Remicade, to be submitted to the FDA. CT-P13 SC, also known as Remsima SC, is the company’s subcutaneous (SC) formulation of the infliximab biosimilar for Johnson & Johnson’s Remicade, which treats rheumatoid arthritis.

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Study: Imbruvica for CLL Is Less Likely to Lead to Next-Line Treatment Than Acalabrutinib

Pharmacy Times

Results show possible impact of using Janssen Pharmaceuticals’ ibrutinib in the front-line setting, providing additional data on chronic lymphocytic leukemia therapies.

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Moderna signs ten-year deal with UK Government for vaccine production

Pharmafile

US biotech company Moderna has finalised a partnership with the UK government to produce vaccines, the main element of which is the construction of a new manufacturing centre in the UK. The aim of the partnership is to generate a ready supply of UK-produced mRNA vaccines for COVID-19 and other infectious diseases like flu and respiratory syncytial virus (RSV).

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FDA grants approval for Gilead’s multi-drug resistant HIV-1 treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection. The treatment is indicated for adult patients who are heavily treatment-experienced (HTE) with multi-drug resistant (MDR) HIV-1 infection. This approval is backed by findings from the multicentre, double-blinded, placebo-controlled, international Phase II/III CAPELLA clinical trial of lenacap

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COVID-19 antiviral treatment shown to speed up recovery in trial

Pharmafile

Molnupiravir, made by Merck, Sharp and Dohme (MSD), has been found to reduce the recovery time of COVID-19 patients, however it did not decrease mortality rates or hospital admissions. The trial was conducted to see whether it followed previous studies of molnupiravir, which had looked at its effectiveness at reducing hospital admissions among patients with mild-to-moderate COVID-19.

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After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

pharmaphorum

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Here, Richard Staines reports on phase I/II data unveiled at the American Society of Hematology conference that supports further clinical development of inobrodib in multiple myeloma and other blood cancers.

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Merck and Kelun-Biotech enter ADC development deal

Pharmaceutical Technology

Merck (MSD outside North America) has signed an exclusive licence and partnership agreement with Kelun-Biotech for developing seven investigational preclinical antibody-drug conjugates (ADC) to treat cancer. As per the deal, Merck will receive exclusive international licences from Kelun-Biotech for carrying out the research, development, production and marketing of these ADC therapies.

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Exploring the importance we play in our own health maintenance – a pharmaphorum podcast extra

pharmaphorum

While at Anthropy 2022, pharmaphorum’s web editor Nicole Raleigh briefly spoke with Karyn Johnston, chief executive of East Cheshire Hospice, who had taken part in the Adelphi Group’s panel, ‘Later life care and dementia’. Discussing provocative statements, the new Fourth Age, the hundreds of different forms of dementia, and the complexity of patients at end of life – longevity, it was clear, is a gift, but one that comes with its own challenges.

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EC approves Zynlonta® for large B-cell lymphoma

European Pharmaceutical Review

The European Commission (EC) has granted conditional marketing authorisation for Zynlonta ® (loncastuximab tesirine), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Zynlonta is being developed by Sobi and ADC Therapeutics. The approval follows a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use in September.

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