Fri.Jan 20, 2023

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FDA Grants Priority Review Designation to OPNT003 Nasal Nalmefene for Opioid Overdose

Drug Topics

The PDUFA date has been set for May 22, 2023.

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The impact of climate change on the pharma supply chain

Pharmaceutical Technology

Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution. Whether it’s soaring temperatures, extreme cold snaps, or devastating floods, pharmaceutical logistics providers must ensure that shipments reach their destination in their intended condition without defect or delay.

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Obeticholic Acid NDA Accepted by FDA

Drug Topics

There are no currently approved medications for the treatment of NASH.

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Dollar General pilots mobile clinics as it targets a bigger presence in healthcare

Fierce Healthcare

Dollar General pilots mobile clinics as it targets a bigger presence in healthcare hlandi Fri, 01/20/2023 - 18:25

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Zanubrutinib Approved in First-line or Relapsed/Refractory CLL/SL

Drug Topics

The approval makes zanubrutinib available to all patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whether they are newly diagnosed or previously treated.

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Pharmacists Play Key Role in Encouraging COVID-19 Booster Uptake

Pharmacy Times

Educating patients, posting on social media, and countering misinformation are critical strategies.

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More Trending

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Pharmacy Focus - Big Picture for Health-System Pharmacies

Pharmacy Times

Carina Dolan, PharmD, BCOP, senior director for Clinical Oncology and Pharmaceutical Outcomes at Vizient Inc, discusses the highlights and big picture moving forward for hospitals and health-system pharmacies.

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Biologics Provide Great Results for Psoriasis, but for a Price

Drug Topics

Highly effective medications for severe disease are expensive and administered invasively, while the development of treatments for milder disease has lagged, a new review on psoriasis clinical trials concludes.

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Employers should carefully weigh benefits of high-deductible health plans: study

Fierce Healthcare

Employers should carefully weigh benefits of high-deductible health plans: study fdiamond Fri, 01/20/2023 - 07:19

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DEA Joins Health Care Organizations in Applauding Repeal of X-Waiver Program

Drug Topics

New legislation removes what many perceived as a barrier to treating opioid use disorder.

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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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UBC crowns Bekki Brown as its new CEO with a clear mandate to grow

PharmaVoice

The first-time CEO is tapping into decades of operational expertise to help bring real-world data into the mainstream.

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New Blues network spinout Lucet aims to simplify mental health benefits for payers

Fierce Healthcare

New Blues network spinout Lucet aims to simplify mental health benefits for payers pminemyer Fri, 01/20/2023 - 15:28

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Dentists Not Associated with Changing Duration of Opioid Prescriptions, Despite Statewide Limits

Pharmacy Times

Dental opioid prescriptions are associated with risk of addiction and overdose, but most states are enacting policies that limit the duration of prescriptions for acute pain.

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Iterative Health, Gastro Health partner over AI-enabled GI care and precision medicine R&D

Fierce Healthcare

Iterative Health, Gastro Health partner over AI-enabled GI care and precision medicine R&D aburky Fri, 01/20/2023 - 13:55

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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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FDA Grants Accelerated Approval to Tucatinib Combination for Patients with HER2-Positive Metastatic Colorectal Cancer

Pharmacy Times

This is the first indication for tucatinib that extends beyond the treatment of advanced unresectable or metastatic HER2-positive breast cancer.

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MHRA authorises BRUKINSA® in Great Britain for two cancers

European Pharmaceutical Review

Two marketing authorisations for BRUKINSA ® (zanubrutinib) have been granted in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). The indications are for adults with chronic lymphocytic leukaemia (CLL) and for adults with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The MHRA’s authorisation is significant “… as there is no targeted treatment currently authorised for MZL patients other than chemoimmunotherapy

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Cancer Survivor: ‘I Wish I Could Have Spoken to a Pharmacist,’ Received More Pain Management Support

Pharmacy Times

Sarah McDonald, cancer survivor and author of The Cancer Channel, discusses her experience battling 2 different unrelated cancers and the value oncology pharmacists could have provided with a greater presence on her care team.

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JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets

Fierce Pharma

JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets zbecker Fri, 01/20/2023 - 14:48

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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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Study: Black, Hispanic Individuals With Epilepsy Are Less Likely to be Prescribed Newer Drugs

Pharmacy Times

Inequities were also apparent between those who saw and did not see neurologists, analysis shows.

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Increased Cyber Budget Calls for Healthcare to Invest in Digital Identity

Fierce Healthcare

Increased Cyber Budget Calls for Healthcare to Invest in Digital Identity jpiatt Fri, 01/20/2023 - 14:38

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Multiple Myeloma Therapy Often Causes Cardiovascular Complications

Pharmacy Times

Many patients have baseline risk factors present at diagnosis because of older age and disease-related elements.

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Study: Pharmacists can start patients on road to recovery from opioid-use disorder

Drug Store News

​​​​​​​A study in the New England Journal of Medicine showed that pharmacies can offer a safe and accessible treatment starting point for patients with opioid-use disorder and keep them better engaged.

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Aledade, Mark Cuban's drug company and a handful of others are public benefit corporations. Could it be the Rx to improve healthcare?

Fierce Healthcare

Aledade, Mark Cuban's drug company and a handful of others are public benefit corporations. Could it be the Rx to improve healthcare?

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Crossed wires? Mixed messages on medicines

pharmaphorum

Leela Barham argues that the latest operational guidance for the NHS in England continues to illustrate a disconnect between the messages in big-ticket policy documents from the central government and the messages from the NHS in England on medicines. With a successor for the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) being negotiated and a refresh of the NHS Long-Term Plan being on the to-do list for 2023, there is a chance for more alignment.

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Walgreens to pay West Virginia $83M for alleged role in opioid crisis

Drug Store News

The settlement with Walgreens brings the total West Virginia amount brought in from opioid litigation to more than $950 million.

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Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban

Fierce Pharma

Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban fkansteiner Fri, 01/20/2023 - 15:34

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Opinion: Even with lawsuits and copay caps, will insulin ever be affordable?

STAT

In an attempt to tackle the root causes of inflated insulin prices, the state of California filed a lawsuit last week accusing drug manufacturers and pharmacy benefit managers of artificially and illegally jacking up the price of insulin. The sausage-making of how insulin is priced is not for the faint of heart. It’s a complex tangle of drug manufacturers who’ve been resisting generics , health insurance companies trying to keep up impressive profits , plus the wholesalers who dist

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Ipsen's Onivyde proves its worth in aggressive pancreatic cancer

Fierce Pharma

Ipsen's Onivyde proves its worth in aggressive pancreatic cancer zbecker Fri, 01/20/2023 - 10:48

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STAT+: FTC wants ‘pharma bro’ Martin Shkreli held in contempt for violating lifelong ban on working in pharma

STAT

The U.S. Federal Trade Commission asked a federal judge to hold “pharma bro” Martin Shkreli in contempt for failing to provide the agency with information needed to determine whether he is violating an order that permanently banned him from working in the pharmaceutical industry. In a motion filed federal court in New York, the FTC and seven state regulators argued that Shkreli has failed to comply with their requests to provide documents and sit for an interview as part of their i

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What are authorized generics?

The Checkup by Singlecare

Chances are, you’ve taken a generic or authorized generic medication, and for good reason—according to the U.S. Food and Drug Administration (FDA), generic medications cost 80%-85% less than brand-name drugs. An estimated 90% of prescriptions filled in the United States are for commonly prescribed generic drugs. Examples include lisinopril for high blood pressure , levothyroxine for hypothyroidism , atorvastatin for high cholesterol , Type 2 diabetes medications like metformin , and others.

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Is mesothelin a key to tackling solid tumors? Some biotech companies are betting that it is

STAT

On Target is a recurring feature from STAT that dives deep into the most promising drug targets in oncology. This column is adapted from a new STAT report , “Targeting cancer: the new frontier of immunotherapy and precision oncology.” Scientists working to produce immunotherapies for solid tumor cancers have spent decades searching for biological targets that can help them distinguish between healthy cells and cancerous ones.

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Dr. Lauren F. Lyles-Stolz joins NACDS to focus on reimbursement, innovation and advocacy

Drug Store News

Last year, Dr. Lauren F. Lyles-Stolz, PharmD joined the staff of the National Association of Chain Drug Stores as senior director of reimbursement, innovation and advocacy.

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STAT+: Pharmalittle: FDA rejects Lilly application for Alzheimer’s drug; Sanofi offers a warranty for a medicine

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still in the works. For now, we expect to engage in our usual ritual of promenading with the official mascot, take a drive in the countryside with the radio turned up, and hold another listening party with Mrs.

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