Tue.Jan 17, 2023

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WTAS: Inflation Reduction Act already impacting R&D decisions

PhRMA

The Inflation Reduction Act’s (IRA’s) drug price setting provisions, as predicted, are already impacting biopharmaceutical research & development (R&D) decisions. Whether you are looking at estimates of how many fewer medicines or indications will be developed, or noting shifts away from areas of unmet patient need because the law is signaling those innovations are not valued, the IRA’s price setting provisions are a loss for patients everywhere.

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Urgent Need to Increase Vaccinations in Children

Drug Topics

Childhood vaccinations took a downturn during the pandemic. Now is the time to get them done and pharmacists can help.

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Trending Sources

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Biden administration should prioritize innovation in U.S.-Taiwan Initiative on 21st-Century Trade

PhRMA

Last summer, the United States and Taiwan launched the U.S.-Taiwan Initiative on 21st-Century Trade to deepen economic and trade relations. In detailed comments to the U.S. Trade Representative (USTR), PhRMA encouraged the Biden administration to pursue an agreement that is as comprehensive and ambitious as possible to the benefit of both American and Taiwanese citizens.

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Recommended Immunization Schedules for 2023

Drug Topics

The updates include new recommendations for COVID-19 and pneumococcal vaccines.

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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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AI Could Improve Blood Sugar Management in Type 1 Diabetes

Pharmacy Times

An app using AI to evaluate blood sugar data, concerning trends, and recommend management tools will be a part of a clinical trial in 2024 for further assessment.

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How to meditate for anxiety and depression

The Checkup by Singlecare

When most people hear the word meditation, they probably imagine someone sitting perfectly still in a quiet room, legs crossed, zoned out in a state of total bliss. But meditation can be performed in many different ways, and while it does take some practice to get the hang of it, even just a few minutes a day can help reduce some symptoms of common mental health conditions like anxiety and depression.

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Cardiovascular Disease Risk Not Significantly Increased ADHD Medications

Drug Topics

A recent study found that the risk of cardiovascular diseases was not significantly greater in patients taking medications for attention-deficit/hyperactivity disorder (ADHD), but investigators were not able to rule out a mild risk increase.

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Study: Most Long COVID-19 Symptoms Resolve Within a Year After Mild Infection

Pharmacy Times

COVID-19 infection was significantly associated with increased risks of several conditions, including loss of smell and taste, concentration, and memory impairment.

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Real-Time Clinical Decision Support Can Change Pharmacy Practice for the Better

Drug Topics

The shift in immunization from primary care to pharmacy is your opportunity to improve outcomes and grow your business. Solutions that integrate directly with pharmacy management systems enable clinical decision support at the point of care. The return on investment is significant — in one study, resulting in a 24% increase in revenue per patient encounter.

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HSV Offers Promising Target for Preventive, Therapeutic Vaccines

Pharmacy Times

Vaccination provides an opportunity to prevent and treat herpes simplex virus infection.

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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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The addiction crisis is causing a spike in endocarditis cases. Hospitals are struggling to respond

STAT

Increased injection drug use has led to a spike in cases of the life-threatening heart condition endocarditis , with cases rapidly accelerating since the onset of Covid-19. The increased case count is one of the lesser-known side effects of the deadly addiction epidemic. But patients with endocarditis, an inflammation of the heart lining caused by infection, require complex, thoughtful care — care that the U.S. health system is ill-equipped to provide.

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European Generic Medication Shortages Raise Concerns About US Drug Supply

Pharmacy Times

Energy crisis in Europe puts strain on production and could have ramifications that extend beyond the continent's borders.

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STAT+: Moderna says RSV vaccine worked, setting stage for competition with GSK and Pfizer

STAT

Moderna’s vaccine against the respiratory syncytial virus, or RSV, reduced the rate of lower respiratory disease in people over 60 in a Phase 3 trial, the company said Tuesday. The result will increase competition in a soon-to-be crowded market. The drug giants Pfizer and GlaxoSmithKline have already presented results for their RSV vaccines in older individuals, and have been preparing for what could be a brisk marketing battle.

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FDA Approves Adacel Vaccine During Pregnancy to Protect Infants Against Pertussis

Pharmacy Times

The vaccine was 88% effective at preventing pertussis among infants younger than 2 months when administered during the third trimester of pregnancy.

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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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CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Fierce Pharma

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. zbecker. Tue, 01/17/2023 - 11:49.

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Phase 3 Trial of Valoctocogene Roxaparvovec Finds Stable, Durable Annualized Bleed Control for Severe Hemophilia A

Pharmacy Times

The mean annualized bleed rate was reduced by 80% from baseline and Factor VIII usage was reduced by 94% in year 3 compared to baseline.

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Hospital Universitario and Josep Carreras develop cell therapy for leukaemia

Pharmaceutical Technology

Spain’s Hospital Universitario 12 de Octubre researchers, along with the Josep Carreras Leukaemia Research Institute, have developed a new cell therapy based on STAb cells to treat a type of leukaemia. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development. It could be used for T-Cell Acute Lymphoblastic Leukaemia (T-ALL) treatment in patients for whom bone marrow transplantation and chemotherapy failed to work.

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Research Suggests Gut Bacteria Could Play a Role in Diabetes

Pharmacy Times

It is too early to know how patients could potentially change their microbiome to reduce their diabetes risk.

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AstraZeneca backs AI-based lung cancer diagnosis pilot in UK

pharmaphorum

Drugmaker AstraZeneca has teamed up with Indian digital health specialist Qure.ai and a clinical group in the UK to test an artificial intelligence-powered technology to help radiologists detecting lung cancer in chest X-rays. The aim of the pilot is to scan and review more than 250,000 images generated at clinics in the Greater Manchester Cancer Alliance, to see if Qure.ai’s qXR software can make faster and more accurate diagnoses of lung cancer.

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AmerisourceBergen Foundation, Good Neighbor Pharmacy Launch Scholarship to Support Pharmacists of Color

Pharmacy Times

The scholarship is accepting applications until February 28, 2023, and 4 pharmacy school students will be announced in April.

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Telehealth patients are scrambling for in-person care amid crackdown on online controlled substances

STAT

Catherine was getting nervous about her ADHD prescription. In 2022, the 29-year-old New Yorker had started using Done, a direct-to-consumer telehealth company that treats attention deficit hyperactivity disorder. The medication her provider had prescribed, a stimulant called Vyvanse, was helping her manage distraction so severe that she frequently had car accidents.

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Walgreens removes online only purchase limits for OTC pediatric fever-reducing products

Drug Store News

In late December, CVS and Rite Aid instituted product limits as cases of COVID-19, flu and RSV ticked up, amid a scarcity of OTC children’s pain relief products at certain retail locations, including Walgreens.

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Cambridge Cognition buys vocal biomarker firm Winterlight

pharmaphorum

UK digital brain health company Cambridge Cognition has bolstered its speech analysis capabilities with the acquisition of Winterlight Labs of Toronto, Canada, in a cash and stock deal worth £7 million ($8.6 million). The deal extends Cambridge Cognition’s technology in the area of the use of voice-based assessments that can be used to detect and monitor health conditions, and according to the company gives it a platform “that can deliver most of the voice tasks used today by psychol

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Opinion: Stop blaming Biogen for putting profit at the expense of patients. Blame the systems that enabled it

STAT

Two congressional committees recently released damning results of an 18-month investigation into the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, Aduhelm. The systems that enabled Biogen’s actions, however, went largely unscrutinized. The report listed extensive and serious concerns about Aduhelm’s rollout, including “atypical” interactions and collaboration between the FDA and Biogen; inappropriate use of th

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UK ATMP clinical trials report 2022 published

European Pharmaceutical Review

The Cell and Gene Therapy (CGT) Catapult has published its ‘ UK Advanced Therapy Medicinal Products (ATMP) Clinical Trials Report 2022 ’. In the data, T cells were revealed as the most commonly investigated cell type continuing to increase. The research observed this cell type took up 58 percent of UK ATMP clinical trials in 2022. . Matthew Durdy, Chief Executive of CGT Catapult commented: “It is encouraging to see continued growth of UK clinical trial activity, demonstrating the UK as a favoura

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STAT+: Major purchasers predict expensive new therapies will keep driving drug price hikes

STAT

More than two dozen big buyers of prescription medicines expect that prices will rise by an average of 8% annually over the next three years, a slight uptick from a year ago. And 19% believe that a “substantial portion” of the anticipated increases can be attributed to a shift to newer, pricier therapies, which is up from 8% a year ago, a new survey found.

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In a tough fundraising climate for startups, conversations at JPM 2023 shift to partnerships

Fierce Healthcare

In a tough fundraising climate for startups, conversations at JPM 2023 shift to partnerships. hlandi. Tue, 01/17/2023 - 16:11.

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STAT+: After four years of big talk, mega startup Sana prepares to deliver some data

STAT

SAN FRANCISCO — The last time Sana CEO Steve Harr was here for the J.P. Morgan Healthcare Conference, his company had only recently shrugged off the unprintable code name its founders used privately: FD Therapeutics, short for “F— Disease.” Little was known about the then-mysterious cell therapy startup, except that it would pursue ideas “ that will seem unconnected to the current reality ” and, rumor had it, potentially raise an over $1 billion Series A

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NACDS applauds intro of Texas bill to protect patient access to pharmacy-based care

Drug Store News

Texans rank pharmacies as the most accessible healthcare destination and support policies that allow patient choice when it comes to accessing services, NACDS said.

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STAT+: Large health insurers lowered barriers to fair access to some drugs, analysis finds

STAT

Most of the largest health plans in the U.S. generally provide “fair access” to 19 treatments for a handful of serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis found. Almost uniformly, the 18 health plans and benefit managers examined make the medications available fairly when judged on three criteria: prescriber restrictions, eligibility based on clinical data, and step therapy, which requires patients to try other med

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Driving clinical trial innovation forward with precision medicine

pharmaphorum

Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool. Already, it is operating at scale across the company, used in more than 28 countries and available in 62 languages.

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STAT+: Pfizer says it will widen access to hundreds of off-patent medicines in low-income countries

STAT

In another bid to widen access to its medical products, Pfizer plans to provide roughly 500 medicines and vaccines — many of which are no longer protected by patents — at not-for-profit prices t0 45 mostly low-income countries. The goal is to make it possible for the countries to purchase the drugs and vaccines at substantially lower prices than they might otherwise.

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Thermo Fisher to become founding sponsor of Momentum Labs

Pharmafile

Thermo Fisher Scientific has announced that it has become a founding sponsor of Momentum Labs in Alachua, Florida, US. The company has taken on this role in an attempt to support emerging biotechnology companies, and Momentum Labs aims to work as a collaborative laboratory and office space for a variety of expanding biotechs in the region. read more.

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Opinion: STAT+: 4 concrete steps to realize the AI Bill of Rights for clinical decision support software

STAT

The Blueprint for an AI Bill of Rights the White House recently published didn’t come a moment too soon for the health care industry. The number of health care-related artificial intelligence models on the market has increased steadily over the past decade, with the health care AI market expected to grow from $7 billion today to $67 billion in 2027.

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