Sat.Sep 10, 2022 - Fri.Sep 16, 2022

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New data: The 340B program is driving up costs for patients and our health care system

PhRMA

Guess what? The 340B program grew, yet again, hitting a whopping $43.9 billion in sales at the discounted 340B price in 2021. But there has not been evidence of corresponding growth in care provided to vulnerable patients at 340B covered entities. And making matters worse, fresh data show that 340B may actually be driving up costs for some patients and our health care system as whole.

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Potential Impact of Inflation Reduction Act on Biosimilars

Drug Topics

Several provisions in the law are designed to protect and foster the biosimilar market. But some representatives of the sector see CMS drug price negotiation as a threat to profit margins.

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STAT+: USDA starts cracking down on companies that ship animals without timely inspections

STAT

Earlier this year, a leading animal rights group asked U.S. authorities to investigate medical research labs for allegedly violating federal law after finding numerous instances where nearly 2,000 monkeys were shipped between facilities without required veterinary inspections. Now, the federal government appears to be acting.

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Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

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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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Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines

PhRMA

As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline.

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The Evolution of the CBD Regulatory Landscape

Drug Topics

No federal agency has taken charge of regulating cannabidiol products, leaving decisions up to the individual states.

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More Trending

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Study: Anti-Depressants May Help Avoid Severe COVID-19 Symptoms

Pharmacy Times

Although serotonin is widely associated with feelings of happiness, a study suggests it may be associated with the severity of COVID-19.

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Navigating the patient experience: Burdens and barriers standing between patients and their care

PhRMA

Health care affordability is not the only hurdle facing patients, according to PhRMA’s third Patient Experience Survey (PES). The latest PES report exposes another crucial problem: the frustration and confusion people have around how to use their coverage. Administrative hurdles and other barriers imposed by health insurers and pharmacy benefit managers (PBMs), such as time-consuming paperwork or prior authorization, are a challenge for many insured Americans, including more vulnerable communiti

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Women and CBD: Increased Interest, but Caution Is Warranted

Drug Topics

CBD can be used to treat a myriad of women’s health conditions, but research is still limited.

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With increased virus activity, providers urged to be alert for signs of rare polio-like syndrome in kids

STAT

Pediatricians and top health officials are warning about an uptick in activity of a common virus that in rare cases can cause a polio-like syndrome in young children. The virus, an enterovirus known as EV-D68, is one of the bugs that regularly circulates and infects us from time to time, typically just causing colds. But occasionally, children infected with it will develop limb weakness and a progressive form of paralysis, what’s called acute flaccid myelitis , or AFM.

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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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Mirati Releases Promising Adagrasib Results for Advanced Colorectal Cancer

Pharmacy Times

Therapy shows positive clinical efficacy and favorable tolerability as a monotherapy and in combination with cetuximab in heavily pretreated patients who have a KRASG12C mutation.

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The future of AI drug discovery & development in immunology and GPCR research

pharmaphorum

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”.

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Babies Given Antibiotics May Have Adult GI issues

Drug Topics

New research adds further evidence that early in life antibiotic exposure can have lifelong impact.

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Opinion: 6 tactics to make artificial intelligence work on the frontlines

STAT

Artificial intelligence is a transformative tool in the workplace — except when it isn’t. For top managers, state-of-the art AI tools are a no-brainer: in theory, they increase revenues, decrease costs, and improve the quality of products and services. But in the wild, it’s often just the opposite for frontline employees who actually need to integrate these tools into their daily work.

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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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Interaction Considerations for Common OTC Drug Classes

Pharmacy Times

Although OTC medications are generally considered safe when used as directed, there are some key drug interactions for pharmacists to keep in mind when helping patients choose an OTC product.

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The Manufacturing Edge on Path to Market

PharmExec

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

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Researchers Investigating Two Novel Diabetes Treatments

Drug Topics

In the early stages of development, researchers find 2 treatments are efficacious for diabetes.

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STAT+: Intellia says CRISPR treatment safely corrects DNA of six patients with rare disease

STAT

Intellia Therapeutics said Friday the first six patients to receive its CRISPR-based treatment for a genetic swelling disorder have safely had small, corrective changes made to dysfunctional DNA inside their liver cells. Preliminary results from the study — just the second to show that CRISPR-based gene editing can be delivered systemically and performed in vivo, or inside the body — found that the treatment, NTLA-2002, reduced levels of the disease-causing protein, kallikrein, by

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FDA Accepts New Drug Application for Aripiprazole Long-Acting Injectable for Schizophrenia, Bipolar Disorder

Pharmacy Times

The New Drug Application for aripiprazole 2-month, ready-to-use, long-acting injectable could lead to the first FDA approval of a 2-month schizophrenia and bipolar I disorder antipsychotic treatment.

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Albertsons invests in pharmacy to support comprehensive immunization access

Drug Store News

Improvements to scheduling and pharmacy care will support co-administration of flu vaccine and new reformulated COVID-19 boosters at more than 1,700 pharmacy locations.

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Time to Glycemic Targets by 4-12 Weeks Reduced in Tirzepatide In Comparison to Other Therapies

Drug Topics

New research offers evidence that tirzepatide could help patients achieve glycemic goals.

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Biden appoints former government scientist as first leader of ARPA-H

STAT

President Joe Biden plans to appoint longtime biologist and former government scientist Renee Wegrzyn as the first director of the nascent Advanced Research Projects Agency for Health. Biden’s announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized.

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Continuing Education for Pharmacy Technicians Essential for Safe, Sterile Compounding

Pharmacy Times

Research indicates that poor technique or failure to follow up-to-date standards and protocols could lead to injury or even death of patients who need compounded medications.

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BJ’s Wholesale Club to accept online SNAP EBT payments chainwide

Drug Store News

When using its SNAP EBT cards to shop online at BJs.com or on the BJ’s mobile app, members have the option of selecting from multiple delivery methods, including free pickup, shipping and same-day delivery.

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How to Increase CBD Sales at Your Independent Pharmacy

Drug Topics

Tips to help your pharmacy stand out as a knowledgeable CBD retailer.

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STAT+: Alphabet spinout Verily raises $1 billion as it looks to harness health data

STAT

Alphabet’s life sciences offshoot Verily said Friday that it has raised $1 billion to fuel its next stage of development — one that will be steered by a new corporate leader as CEO Andy Conrad plans to shift to an advisory role. The eye-popping funding round was led by Alphabet, reinforcing Verily’s ties to its corporate parent even as it seeks to assert its independence and build a profitable business after years of sometimes scattershot projects and investments.

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Cabozantinib, Nivolumab, Ipilimumab Combination Does Not Reach PFS

Pharmacy Times

Triplet combination demonstrates a reduction in the risk of disease progression or death in individuals with previously untreated advanced intermediate- or poor-risk renal cell carcinoma.

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Gilead’s Veklury receives WHO recommendation to treat severe Covid-19

Pharmaceutical Technology

Gilead Sciences has received expanded recommendation under the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline for the use of Veklury (remdesivir) to treat severe Covid-19 patients. The guideline update comes after the treatment received recommendation from the health agency for treating non-severe Covid-19 in patients at increased risk of hospitalisation.

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Tips for Managing Diabetes Comorbidities

Drug Topics

Considering comorbidities is just as important as lowering patient HbA1c.

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Borrowing CAR-T tool from cancer therapy, lupus patients go into remission

STAT

Rheumatology — the study of immune-system-driven diseases of the bones, joints, muscles, and in-betweens — has inherited plenty of hand-me-downs from cancer research. For example, there are ways of squelching an immune system in order to shrink certain kinds of cancerous tumors. And scientists have found that, when retrofitted, those strategies can also alleviate some symptoms of autoimmune conditions.

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FDA Grants Breakthrough Therapy Designation to Group B Streptococcus Vaccine Candidate

Pharmacy Times

Decision is based on interim analysis of Pfizer’s GBS6 in healthy pregnant woman aged 18 to 40 years, who were vaccinated during their second or early third trimesters.

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CVS Heath's Aetna enters insurance exchange marketplace in 12 states

Drug Store News

Aetna CVS Health individual and family plans will be available in select counties in Arizona, California, Delaware, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, Nevada, Texas and Virginia.

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Addressing Burnout in Pharmacy

Drug Topics

The causes of burnout in pharmacy are multifactorial. The solutions need to be as well.

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At a fashion show for people with spinal muscular atrophy, models take back their own stories

STAT

NEW YORK — The scene: a fashion show on Fifth Avenue. The catwalk was not elevated, as it usually would be. People were packed tightly on benches alongside it in the dark. The first person to walk it was a singer/songwriter, James Ian, dressed in a flashy suit with a howling wolf embroidered in beadwork on the back. Ian walked with a slight limp.

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