Sat.Sep 24, 2022 - Fri.Sep 30, 2022

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New Report: Nearly 800 medicines in development to treat chronic condition

PhRMA

Chronic conditions impose a substantial health and economic burden that affects millions of patients, families and communities across the United States each day. While these conditions come with different origins, symptoms and treatments, they each can have a negative impact on a person’s physical and emotional well-being, quality of life and productivity.

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Supporting the Next Era of Independent Pharmacies in the US & Abroad

Drug Topics

The future of independent pharmacy requires the combination of what makes independent pharmacy special and the digital landscape found elsewhere in retail.

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Genomic Testing Framework for Chronic Kidney Disease Continues to Grow

Pharmacy Times

Investigators combine research discovery with technological development to determine whether the role of genomics in nephrology should remain with subspecialists or be integrated into general nephrology.

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Fungi find their way into cancer tumors, but what they’re doing there is a mystery

STAT

For a while, scientists thought the trillions of microbes on our bodies lived in landscapes connected to the outside world — our skin, hair, and gut — but research in the last few years has shown that’s not so. When Ravid Straussman, a cancer biologist at the Weizmann Institute of Science in Israel, looked deeper, he and several other research groups around the world found bacteria in the milieu of tumors.

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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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Mass producing biodegradable stem cell therapy microrobots

European Pharmaceutical Review

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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More Trending

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Opinion: Doctors who knowingly spread Covid-19 lies should be held accountable

STAT

The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.

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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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People on the move … Sept. 29

Drug Store News

Important personnel changes you should know this week.

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New Bivalent Omicron-Containing Booster Vaccine May Elicit Higher Antibody Response Against COVID-19

Pharmacy Times

Patients could have a better immune response against the omicron variant of COVID-19 with a second booster of the bivalent mRNA-1273.214 vaccine at a 50 ?g dose.

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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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Where caregiving is a family affair, Alzheimer’s places a heavy burden on children and spouses

STAT

HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside

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Lava fires up a $700m cancer licensing deal with Seagen

pharmaphorum

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. Seagen is paying $50 million upfront for global rights to the programme, a bispecific T cell engager intended as a treatment for EGFR-positive solid tumours, with another $650 million at the back end in milestone payments.

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Food Lion expands grocery pickup service to 24 additional stores

Drug Store News

Food Lion To Go, beginning Sept. 26, will service customers in 24 additional stores throughout North Carolina and Kentucky.

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FDA Approves Dupilumab for Adult Patients With Prurigo Nodularis

Pharmacy Times

Dupilumab is the first and only medicine approved specifically for the treatment of prurigo nodularis in the United States.

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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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On the Texas-Mexico border, a bold plan to diversify Alzheimer’s research takes shape

STAT

BROWNSVILLE, Texas — Gladys Maestre is on a scouting mission. The Alzheimer’s disease researcher is driving through Southmost, a Mexican American neighborhood just north of looming sections of the border wall and a checkpoint that leads to Mexico. She passes barking dogs and “no trespassing” signs, but doesn’t see a single person outside, despite the comfortable stuffed recliners, refrigerators, and shade canopies that furnish many yards.

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Sarepta files Duchenne muscular dystrophy gene therapy with FDA

pharmaphorum

Sarepta Therapeutics has followed through on its promise to file for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD), as it aims for a launch in the middle of 2023. Roche-partnered SRP-9001 (delandistrogene moxeparvovec) has been submitted for approval to treat ambulatory (walking) patients with DMD, a genetic disorder characterised by progressive muscle degeneration due to alterations in a protein called dystrophin that helps keep muscle cells intact.

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Is TEE the key for novel antibiotics?

European Pharmaceutical Review

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.

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Monkeypox in Populations Presenting with Neurologic Syndromes Require Diagnosis

Pharmacy Times

Included in the literature review were the known neurologic complications of smallpox, including encephalitis, transverse myelitis, and acute disseminated encephalomyelitis.

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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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Ebola experimental vaccine trial may begin soon in Uganda

STAT

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon

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Biogen, Eisai say lecanemab has aced phase 3 Alzheimer’s study

pharmaphorum

Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial. The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the

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Why precision medicine could be the next frontier in treating autism

PharmaVoice

Swiss-based Stalicla is banking on an AI-driven precision medicine discovery platform to deliver needed therapies in the autism space.

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Study: Multivitamin Mineral Supplements Have Potential to Improve Cognition

Pharmacy Times

In a study of 2262 individuals, investigators also found that cocoa extract had no effect on cognition.

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STAT+: Biotech turns to new and strange viruses to overcome gene therapy’s limitations

STAT

CAMBRIDGE, Mass. — The fluorescent orange sticker atop the white machine reads “BIOHAZARD,” but it’s a bit of a misnomer. Although Earth abounds with pathogens that can maim, kill, paralyze, and poison, the specimens inside this machine — being pipetted left and right behind glass for sequencing — are probably the most innocuous human viruses you will ever encounter.

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NICE backs ‘real-world’ wearable devices for Parkinson’s disease

pharmaphorum

Five wearable devices that monitor patients with Parkinson’s disease as they go about their lives have been given a provisional recommendation from NICE, making them available via the NHS while additional data is collected. The UK health technology assessment (HTA) organisation said the devices may be more accurate at making a clinical assessment of a patient’s symptoms and disease progression compared to intermittent, in-person appointments at the clinic.

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HPLC-MS/MS for NDMA impurity determination in sartans

European Pharmaceutical Review

In a study published in the Microchemical Journal , investigators outlined the development and validation of a HPLC-MS/MS (high-performance liquid chromatography-mass spectrometry) for the determination and quantification of N -nitrosodimethylamine (NDMA) in olmesartan medoxomil. The method was able to detect, separate and quantify NDMA in the active pharmaceutical ingredient (API), manufactured tablets and marketed tablets.

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FDA Fast Tracks Treatment for for Select Stage IIB to IV Malignant Melanoma

Pharmacy Times

KIN-2787 is a potential treatment for BRAF class II or III alteration-positive and/or NRAS mutation-positive, metastatic or unresectable, stage IIB to IV malignant melanoma.

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‘Disaster to disaster’: Underinvestment in public health systems obstructs response to Covid, monkeypox, Walensky says

STAT

For the record, Rochelle Walensky, director of the Centers for Disease Control and Prevention, would take the job again.   “I’m a clinician, a physician at heart,” she said Friday. “And when somebody calls you for help, you run.

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Influencer Marketing and Social Health: Optimizing Pharma’s Impact

pharmaphorum

Social health—the dynamic, real-time action people take to find meaningful connections and share information that impact the health journey—has dramatically shifted the ways in which healthcare marketers can, and should, reach their desired audiences. . Through Health Union’s unique and expansive Social Health Network of more than 100,000 patient leaders; and millions of engaged patients and caregivers across a growing portfolio of more than 40 condition specific online health communities, this

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Injection could help postpartum depression, says study

European Pharmaceutical Review

Brii Biosciences , a multi-national drug development company, has published top-line results from a Phase I study evaluating its long-acting, single-dose, intramuscularly injected drug BRII-296 in postpartum depression (PPD). “We are encouraged by the possibility of providing a novel treatment option to the 900,000 people in the US affected by postpartum depression each year in which the current standard of care is suboptimal, often requiring hospitalisation, repeat therapy and daily doses of tr

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Pharmacists Are Empowered Yet Again

Pharmacy Times

FDA revises emergency use authorization to grant prescribing authority for Pfizer’s Paxlovid antiviral treatment for COVID-19.

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Early analysis suggests monkeypox vaccine is reducing risk of infection in U.S.

STAT

A very preliminary analysis of data from 32 states appears to suggest that the monkeypox vaccine being used in the United States is reducing the risk of infection among vaccinated people, Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said Wednesday. Walensky said the analysis showed that people who were eligible to be vaccinated against monkeypox because of their personal level of risk but who had not received the vaccine were 14 times more likely to contract

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As Apple Rolls Out Medication Tracking to all iPhones, Pharma Must Embrace Connectivity

pharmaphorum

Imagine visiting your doctor’s office. Instead of swiping a co-pay card and filling out a paper form by hand, the receptionist says, “Please bring your phone closer. We take Apple Health here.” You wave your iPhone over a digital kiosk, instantly uploading your current medical record and insurance information. Your co-pay is then deducted from a Health Savings Account.

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Akorn to pay $7.9M to resolve allegations of fraudulent billing

Drug Store News

Akorn caused Medicare Part D to pay for three Akorn generic drugs that were no longer eligible for Medicare coverage.

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