Mon.Dec 19, 2022

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What you should know about real-world evidence and drug development

PhRMA

Recently, industry leaders, regulators, academics, data partners, and patient advocates gathered in Washington, D.C., to discuss using real-world data and real-world evidence for regulatory decision-making. The discussion explored emerging analytical methodologies to address the challenge of mitigating sources of bias and confounding variables that come up in nearly all sources of real-word data.

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Experts Warn of Spread of Lung Infection-Causing Fungi

Pharmacy Times

Traditionally, endemic fungi are characterized by geographical distribution, however, disease-causing fungi may infect people beyond these havens.

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UK digital health project aims to tackle dysfunctional breathing

pharmaphorum

A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population. The Engineering and Physical Sciences Research Council (EPSRC) has set aside £400,000 (almost $490,000) for the project, which will help fund work at the Universities of Plymouth, Salford and Stirling, and the Glasgow School of Art.

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Study Results Suggest Exercise, Mindfulness Do Not Boost Cognitive Function in Older Adults

Pharmacy Times

Although physical activity and the practice of being present in the moment are associated with many benefits, analysis shows that neither led to measurable improvements in brain health.

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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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FDA approves Adstiladrin as first gene therapy for NMIBC

pharmaphorum

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours. Bladder cancer is one of the more common forms of cancer.

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Artificial Intelligence Shows Promise in Detection of Anxiety Disorders, Depression

Pharmacy Times

Investigators establish that audio and/or facial video features have been most analyzed by machine learning, followed by electroencephalography signals.

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More Trending

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Intravenous Immunoglobulin May Improve Severe OCD in Children

Pharmacy Times

Treatment observably eased obsessive-compulsive disorder symptom severity in young patients, however, symptoms still caused students to be absent from school at least 2 days every month.

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Could ketamine-assisted therapy help treat alcoholism?

European Pharmaceutical Review

A new £2.4 million Phase III trial will determine if ketamine-assisted therapy can help those with severe alcohol use disorder to stay off alcohol for longer. Led by the University of Exeter and funded by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), “[t]his is the largest trial of its kind in the world and builds on our earlier, smaller positive trial,” stated Professor Anne Lingford-Hughes, Professor of Addiction Biology at Imperial College

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FDA Approves Cariprazine for Major Depressive Disorder

Pharmacy Times

Cariprazine (Vraylar; AbbVie, Gedeon Richter) is indicated as an adjunctive therapy to antidepressants for treating adult patients with major depressive disorder.

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Sanofi and Innate Pharma extend cancer therapeutics partnership

Pharmaceutical Technology

Sanofi has extended the partnership with Innate Pharma for natural killer (NK) cell therapeutics in oncology. With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. Under the latest licence deal, Sanofi will make an upfront payment of $26.4m (€25m) to Innate.

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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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Monitoring for Treatment Complications in Patients With Hemophilia A

Pharmacy Times

An array of complications may arise associated with treatment of hemophilia A.

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Copay Caps for Insulin Lower Total Spending for Medicare Beneficiaries

Drug Topics

The Medicare Part D Senior Savings Model — a CMS effort to test $35 copays for insulin — led to lowered total costs for beneficiaries.

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Pharmacist Appreciation

Pharmacy Times

Tim Whitten, BSPharm, MBA, CEO & President of Taiho Oncology Inc discusses the critical impacts of pharmacists across the health care landscape.

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Atara makes history with world-first nod for allogeneic T-cell therapy Ebvallo

Fierce Pharma

Atara makes history with world-first nod for allogeneic T-cell therapy Ebvallo. fkansteiner. Mon, 12/19/2022 - 14:06.

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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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Albuminuria is More Prevalent in Type 1 Diabetes

Pharmacy Times

Age was a contributing factor of chronic kidney disease and albuminuria in patients with type 1 and type 2 diabetes.

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Congress reaches major health policy deal on Medicare, Medicaid, and pandemic preparedness

STAT

WASHINGTON — Leaders in Congress have reached a sweeping deal to ease Medicare pay cuts to doctors, make major changes to post-pandemic Medicaid policy, and to help prepare for future pandemics. Lawmakers are aiming to pass a health care policy package along with legislation to fund the federal government by Friday. The details of the omnibus spending package were confirmed by two lobbyists and two congressional aides.

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Immunotherapy Makes Major Strides for First-line Treatment of Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Pharmacy Times

Specific immune checkpoint inhibitors added to frontline chemotherapy have transformed modern clinical practice.

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Opinion: Lawmakers should act on the evidence and expand access to dental therapists

STAT

Northern Maine and southern California don’t seem to have a lot in common — until you start looking for affordable, accessible dental care. In such disparate communities, and thousands in between, millions of Americans can’t access the dental care they need. Not having access to dental care can lead to serious oral and overall health issues , not to mention more intensive care later on.

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Study Finds Positive Psychology Can Help Mediate Some Symptoms of Colorectal Cancer

Pharmacy Times

Identifying how survivors adjust to their cancer may help health care providers provide tailored self-management skills.

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Watch: Fentanyl test strips help prevent overdoses, why are they still controversial?

STAT

With much of the nation’s illicit drug supply contaminated by fentanyl, test strips that detect the dangerous synthetic opioid can help people who use drugs prevent a deadly overdose. These tests are inexpensive and effective, but they remain inaccessible for many people in the U.S. and are illegal in many states. In this video, learn about how fentanyl test strips work, how they can reduce harm from drug use, and why they are controversial around the country.

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Standard of Care in Treatment of Hemophilia A

Pharmacy Times

Atta Chowdhry, RPh, opens a discussion surrounding prophylactic treatment in patients diagnosed with hemophilia A.

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2023 forecast: Providers embrace start of new requirements on health equity

Fierce Healthcare

2023 forecast: Providers embrace start of new requirements on health equity. rking. Mon, 12/19/2022 - 15:28.

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We finally have new drugs for sickle cell disease. Why are so few patients taking them?

STAT

At first, Lena Harvey didn’t realize anything had changed. She just started doing strange, unexpected things: Cleaning her living room, for example, or playing with her puppy, a black schnauzer named Apollo. It hit her as she walked in from the patio one day. She looked at her husband, Anthony, and asked, “Honey, I haven’t been complaining about pain, have I?

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CHMP backs Amicus’ therapy for Pompe disease

pharmaphorum

Amicus Therapeutics could be just weeks away from getting EU approval for its new Pompe disease therapy Pombiliti after getting a positive opinion on the drug from the EMA’s human medicines committee. The CHMP said late last week it was recommending Pombiliti (cipaglucosidase alfa or ATB200) as an infused therapy for late-onset Pompe disease in adults given in combination with the enzyme stabiliser miglustat in a regimen known as AT-GAA.

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Pharma wins changes in bill regarding FDA’s accelerated approval

STAT

A bill that makes it easier for the Food and Drug Administration to withdraw drugs that were approved under an accelerated timeline also dropped provisions the industry had opposed, according to three drug lobbyists. The legislation was spurred by the fracas over the Alzheimer’s drug Aduhelm, which received a so-called accelerated approval. Nearly every member of an FDA advisory panel voted against approving the Biogen drug, though many advocates for patients with debilitating conditions

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Meijer expands on-demand grocery delivery across Midwest with Uber

Drug Store News

Shoppers across Michigan, Indiana, Illinois, Ohio, Wisconsin and Kentucky can access same-day delivery on grocery items, including fresh produce, prepared meals and more through Uber Eats.

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FDA approves first gene therapy for high-risk early bladder cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours. Dr Peter Marks, PhD, Director of the FDA’s Center for Biologics Evaluation and Research observed that Adstiladrin, the non-replicating adenoviral vector-based therapy provides “… an innovative tr

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Pemetrexed Injection Receives FDA Approval for Fifth Indication in NSCLC Treatment

Pharmacy Times

The additional indication expands its therapeutic role beyond advanced non-small cell lung cancer.

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STAT+: Even with gene therapy on the horizon, drugmakers join hunt for new sickle cell drugs

STAT

Next year, two curative gene therapies could be approved for sickle cell disease. Yet drugmakers are pouring billions into developing new and more conventional drugs for the disease, even if they are likely to be far less transformative for individual patients. The mismatch comes from the fact that current gene therapies take too steep a toll on the body to be given to more than a fraction of patients in the U.S. and Europe.

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Novartis prunes nearly 300 jobs in Garden State as corporate slimdown rolls on

Fierce Pharma

Novartis prunes nearly 300 jobs in Garden State as corporate slimdown rolls on. fkansteiner. Mon, 12/19/2022 - 10:53.

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Watch DSN: Kroger Health’s Lindholz highlights importance of Food as Medicine platform

Drug Store News

Colleen Lindholz, president of Kroger Health, discusses the Food as Medicine platform and its mission to help people enjoy food so they can live healthier lives.

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STAT+: Audit of FDA’s tobacco oversight underscores agency’s struggle to regulate the booming vaping market

STAT

WASHINGTON — The Food and Drug Administration’s Center for Tobacco Products is lacking clear goals — and that lack of vision is hampering its ability to regulate millions of tobacco products currently on the market, according to an external review of the center released Monday. “The Center’s current goals and priorities are unclear in communication and practice,” the review states.

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Epic plans to overhaul its app market, opens new 'connection hub' for developers. Here are key things to know

Fierce Healthcare

Epic plans to overhaul its app market, opens new 'connection hub' for developers. Here are key things to know. hlandi. Mon, 12/19/2022 - 11:56.

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AAM applauds CMS proposed rule requiring generic drugs to be covered on tiers

Drug Store News

CMS proposes that issuers of standardized plan options must place all covered generic drugs in the standardized plan options’ generic drug cost-sharing tier.

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