Thu.Aug 04, 2022

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An open letter to Congress: Stand with patients and future cures

PhRMA

I recently joined PhRMA board members in penning the letter below to Congress, urging them to abandon their latest drug pricing proposal.

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Notable Revisions in Diabetes Treatment According to ADA Guidelines

Pharmacy Times

American Diabetes Association updates recommendations regarding SGLT-2 inhibitors, GLP-1 RA, and finerenone for cardiovascular and renal comorbidities.

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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.

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Overdose Deaths Increased in Wave 4 of the Opioid Crisis, Coinciding with the COVID-19 Pandemic

Pharmacy Times

The suggested wave 4 of the opioid crisis saw high opioid-involved overdose death rates in urban counties and high acceleration of overdose deaths in rural counties, indicating that the opioid crisis worsened during the COVID-19 pandemic.

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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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North America is seeing a hiring boom in pharmaceutical industry machine learning roles

Pharmaceutical Technology

North America extended its dominance for machine learning hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 63.9% of total machine learning jobs - up from 62.6% in the same quarter last year. That was followed by Europe, which saw a 0.6 year-on-year percentage point change in machine learning roles.

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Johns Hopkins University Releases Academic Proposal to Improve Access to PrEP

Pharmacy Times

The effective preventive treatment could reduce HIV rates but needs greater access and affordability, especially among Black and Latino populations, investigators contend.

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More Trending

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Patient-Reported Outcome Measures Useful in Clinical Treatment of Pediatric Patients with Cancer

Pharmacy Times

Electronic symptom self-measuring provided early detection of toxic effects and helped anticipate necessary medical interventions for pediatric patients with cancer.

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Generic subscription services like Mark Cuban’s promise cheaper drugs — but will it work?

PharmaVoice

Companies like Cost Plus Drugs and DiRx can bring generics directly to consumers at a fraction of the price, but whether it’s enough to fix the inflated U.S. healthcare system is yet to be seen.

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Pharmacy Focus: Public Health Matters- Self Care is the New Healthcare

Pharmacy Times

Pharmacists need to focus on taking care of themselves while they continue to take care of others in even bigger ways post-COVID-19 pandemic.

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How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

Across the economy, several industries have seen a significant increase in staff turnover due to several factors including the COVID-19 pandemic, burnout, and increasing demand for workplace flexibility. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. In particular, for the pharmaceutical industry, these talent shortages bring about a host of difficult challenges.

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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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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

The FDA Law Blog

By Sophia R. Gaulkin & Alan M. Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). Pfizer, Inc. v. U.S. Department of Health and Human Services et al. , July 25, 2022.

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Amgen splashes out on ChemoCentryx and its blockbuster hopeful

pharmaphorum

Ten months after ChemoCentryx scored an unexpected FDA approval for autoimmune disease therapy Tavneos, Amgen has swooped in with a $3.7 billion bid to buy out the company. The $52-per-share offer would give Amgen a drug that some analysts have described as a pipeline in a pill with $1 billion-plus sales potential, and is a sizeable premium on ChemoCentryx’ pre-deal announcement share price of just over $24.

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Emphasizing Electronic Medical Records in Toxicity Management

Pharmacy Times

Exploring the significant role of electronic medical records (EMR) in toxicity management for patients with HR+/HER2– breast cancer.

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Embracing the Renaissance of Small Molecule Drug Discovery

PharmExec

Pharma companies may benefit from meeting challenges and embracing small molecule drug discovery.

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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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Daily Medication Pearl: Brinzolamide/Brimonidine Tartrate (Simbrinza)

Pharmacy Times

Brinzolamide/brimonidine tartrate (Simbrinza) is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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Medical specialty societies can benefit from regulatory progress: IQVIA

Outsourcing Pharma

An expert from the trial tech firm explains how the 21st Century Cures Act and other recent regulatory advancements can elevate clinical data registries.

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Top Priority for Califf is Combating Health Misinformation

PharmExec

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

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Pfizer takes pipeline blow as it abandons cardiomyopathy drug

pharmaphorum

Pfizer has stopped development of a drug to treat cardiomyopathy caused by a rare form of heart disease, after it proved ineffective in a phase 3 trial. PF-07265803 – a p38 mitogen-activated protein kinase (MAPK) antagonist also known as emprumapimod – was being tested as a treatment for symptomatic dilated cardiomyopathy (DCM) due to a mutation in the LMNA gene in the REALM-DCM trial.

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Sinovac’s Covid-19 vaccine gets approval for use in children in Hong Kong

Pharmaceutical Technology

Sinovac Biotech has reported that its Covid-19 vaccine, CoronaVac, obtained approval from the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People's Republic of China for usage in children of the age six months to three years. The consensus interim recommendations on Covid-19 vaccine use in children aged six months or above in Hong Kong were released by the Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zo

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Healthcare Needs Managers!

The Honest Apothecary

If you were to ask me what I honestly believe the most desperately needed role in healthcare today is, I think most people would be surprised. I love doctors, nurses, physician’s assistants and pharmacists…but none of those are it. I love physical therapists, and radiologists and technicians, but while important, those aren’t the greatest need.

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Daily OTC Pearl: SilverSeal

Pharmacy Times

SilverSeal provides topical management of minor superficial wounds, lacerations, and abrasions, as well as minor first-degree burns.

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Poseida and Roche to develop cell therapies for hematologic cancers

Pharmaceutical Technology

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. The research and development (R&D) of various present and new ‘off-the-shelf’ cell therapies against targets in B-cell lymphomas, multiple myeloma and other hematologic indications are included in this alliance.

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FDA Accepts BLA for Omidubicel for Individuals Who Need Bone Marrow Transplants

Pharmacy Times

If approved the drug will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers.

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People on the Move: August 2022

Outsourcing Pharma

This monthâs announcements of appointments, partnerships, expansions, and mergers include Curia, Thread, TFF Pharmaceuticals, and other notable companies.

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COVID-19 health concern increases in July: Poll

Pharmaceutical Technology

The health concern over COVID-19 in July 2022 increased averaging at 27.7%, compared to 23.9% recorded in June 2022 , shows the COVID-19 concern index, which is measured by responses to an ongoing poll Verdict launched in March 2020. The poll has been tracking how the concerns over coronavirus have been changing over time. The poll asked how concerned the respondents were about the spread of coronavirus and included five options to choose from - very concerned, slightly concerned, neither concer

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AZ, Merck get EU nod for Lynparza as adjuvant breast cancer therapy

pharmaphorum

The European Commission has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant treatment for breast cancer, extending its lead over would-be rivals in the PARP inhibitor class. The new approval is for use in patients with BRCA-mutated, HER2-negative early-stage breast cancer who have already been treated with chemotherapy – either before or after surgery – and are at high risk of the disease coming back.

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Business optimism declines in July 2022: Poll

Pharmaceutical Technology

Business optimism declined in July 2022 compared to June 2022, amid concerns over inflation as the cost-of-living pressures on households continued to grow in countries such as the UK, revealed the analysis of an ongoing poll by Verdict. Verdict has been conducting the poll to study the trends in business optimism during COVID-19 as reflected by the views of companies on their future growth prospects amid the pandemic.

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NHS unveils screening plan to eliminate hepatitis C virus

pharmaphorum

Thousands of people in the UK will be screened for hepatitis C virus in a new pilot aimed at expanding use of antiviral therapies to eradicate the infectious – and eliminate it altogether by 2030. The pilot will get underway next month and run until the spring of 2023, and will target the estimated 81,000 people in the UK who are infected with HCV but unaware they have the virus, and could spread it to others.

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Moderna reports total revenues of $4.7bn in Q2 2022

Pharmaceutical Technology

Moderna has reported total revenues of $4.7bn in the second quarter (Q2) of the fiscal year 2022 as against $4.4bn in the year-ago quarter. For the first half (H1) of the year, total revenue stood at $10.8bn, a growth from $6.3bn in the same period in 2021. The revenue growth was attributed to the rise in sales of the company's Covid-19 vaccine. For the three months ended on 30 June 2022, the basic earnings per share (EPS) stood at $5.55, a decline from $6.93 in Q2 last year.

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Realising the promise of genomic testing across oncology

pharmaphorum

Unlocking the secrets of the human genome has long been an ambitious pursuit for researchers around the world. Over the past two decades, innovative research efforts, such as the Human Genome Project and 100,000 Genomes Project, have vastly expanded our understanding of the human genome and its role in driving research and development in oncology. Understandably, these ground-breaking studies have captured the attention of many across the industry, acting as a catalyst for new research into the

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Managing Workplace Stress

PharmExec

In episode 114, Tiago Reis Marques, MD, PhD, CEO of Pasithea Therapeutics, discusses why it’s important to manage high levels of workplace stress, and how companies can help employees in need.

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Boehringer, Seqster ink 3-year health data deal to accelerate research

Outsourcing Pharma

The pharmaceutical company has forged a partnership with the life-sciences tech firm in an effort to elevate data collection and speed up clinical studies.

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Seqster, Boehringer Ingelheim, Partner up on Patient Engagement

Pharmaceutical Commerce

Multi-year deal aims to put patients at the center of their clinical data.

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ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual)

The FDA Law Blog

The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022. The conference will be held virtually. Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are g

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