Wed.Sep 21, 2022

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FDA, Medtronic Alert Users to Cybersecurity Risk with MiniMed 600 Systems

Drug Topics

The risk could allow unauthorized users to change insulin levels.

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NF Community Day 9th Oct 2022

NF2 BioSolutions

We have been very busy organising the NF Community Day in Manchester with other NF organisations and in particular NF Patients United. Registration for the NF Community Day is now open from Sept 20th 2022! You MUST register & sign up via this link: [link]. There is a maximum of 100 registration places available. Location: Mercure Manchester Piccadilly Hotel, £5 Per person attending.

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Fecal Microbiota Transplantation (FMT) for Treatment of C. difficile Infection (CDI)

Pharmacy Times

Drs Tom Lodise and Bincy Abraham provide an overview of fecal microbiota transplantation and long-term safety of FMT use.

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STAT+: After early wins, CRISPR gene editing is about to get a lot harder

STAT

The short history of CRISPR gene editing in humans has, with rare exception, been a history of triumphant progress: A patient apparently cured of sickle cell in 2019, six patients with toxic DNA knocked out of their liver last year, another six patients with a different strand of toxic liver DNA knocked out last week.   The next era of CRISPR may not be so smooth.

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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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Nivolumab May Benefit Recurrence-Free Survival in Patients With Stage 2B/C Melanoma

Pharmacy Times

Nivolumab is a biomarker that has been shown to benefit the survival of patients with stage 2 melanoma patients compared with placebo.

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AstraZeneca’s Tezspire for severe asthma gets green light in EU

pharmaphorum

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. Tezspire (tezepelumab) has been cleared for use in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal produ

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To stem overdoses, Canada is offering safer opioids. Advocates want the U.S. to do the same

STAT

TORONTO — The Finks, married just a month earlier, sat down for their appointment, Kim dressed in head-to-toe pink and Chris in all black. He was taciturn, while she joked she couldn’t stop talking long enough to have her blood pressure taken. Jouvence Tshiyoyo Bukumba, a nurse, asked Kim, 46, about her cardiology appointment and Chris, 54, about his nerve pain.

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Integrate Services Into Virtual Ambulatory Care Clinics

Pharmacy Times

Assess for medication-related problems, monitor patients remotely, and use mobile tools to deliver consultations.

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Walmart to go on holiday hiring spree

Drug Store News

Walmart plans to add 40,000 associates for the holiday season and beyond.

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Pharmacy Measures and Policy Considerations for Pharmacy Practice

Pharmacy Times

There are several important policy issues that could impact pharmacists’ ability to positively affect the quality of care for patients through the use of pharmacy performance measures.

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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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STAT+: Researchers show they can quickly turn CAR-T cells on and off, raising hopes for safer cancer treatments

STAT

Researchers reported Wednesday that they could quickly and reliably turn CAR-T cells on and off in cancer patients, giving scientists an unprecedented level of control over this potent — but at times dangerous — oncology therapy. The findings, presented at the CAR-TCR Summit in Boston, come from an early-stage clinical trial by Scripps Research of patients with B cell cancers.

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Kellogg’s, Little Debbie roll out Nutty Buddy cereal

Drug Store News

The cereal features creamy chocolate and lightly roasted peanut butter flavors with fudge-covered pieces, Kellogg’s said.

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Is Your Demand Side Platform (DSP) Ready for the Cookieless Future?

PharmExec

A cookieless future is on the horizon, so marketers across all industries are being forced to rethink their strategies and plan for the future. What does that entail?

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STAT+: Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines

STAT

Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the U.S. Food and Drug Administration for a series of quality control failures at a facility in Bloomington, Ind., the same plant where the company helps produce two Covid-19 vaccines. The issues prompted the agency to delay distribution of Moderna booster shots, although their release has now reportedly been authorized.

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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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Patient centricity is becoming business critical for pharma

pharmaphorum

New book sets the pharmaceutical industry on a course for bridging the patient centricity optimism gap. Bridging the gulf between patient centricity ambition and reality has never been more important for pharma – luckily, this seemingly insurmountable goal isn’t as far out of reach as many envision. That’s according to Sharon Suchotliff, patient centricity lead at consultancy firm ZS Associates, which has just published a book on the art of patient involvement.

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People on the move … Sept. 21

Drug Store News

Important personnel changes you should know this week.

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Biden declared victory over big pharma – but is it enough to sway senior voters?

The Guardian - Pharmaceutical Industry

The Inflation Reduction Act aims to reduce the cost of drugs, but the law’s limitations may not help the Democrats in the midterms At a Labor Day speech in Milwaukee, Joe Biden declared nothing less than victory over the pharmaceutical industry. “We beat pharma!” Biden said, leaning into the microphone. “We beat pharma this year, and it mattered. We’re going to change people’s lives.

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A Growing Factor In Life Sciences Jobs: Cost of Living Differences

PharmExec

With more people working from home, employers should rethink how cost-of-living impacts salary negotiations.

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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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Tremfya Shows Higher Skin Clearance Rates With Earlier Treatment for Plaque Psoriasis

Pharmacy Times

Janssen’s GUIDE data demonstrate that patients treated with guselkumab less than 2 years after disease onset vs later are more likely to achieve “super-responder” at week 20 through 28.

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Takeda farms out cancer drug alisertib to Puma Biotech

pharmaphorum

Takeda has decided that there is a future for its aurora kinase A inhibitor alisertib after it failed a phase 3 trial in lymphoma – but the company won’t be taking the drug forward itself. Enter Puma Biotech, which is paying a modest $7 million upfront for rights to alisertib (formerly MLN8237) and plans to run clinical trials of the compound in breast and lung cancers.

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Genetically modified herpes combats advanced cancers

Pharma Times

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

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Hikma intros 2 injectables

Drug Store News

The company is offering bortezomib for injection 3.5 mg and ulvestrant injection 250 mg/5ml.

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Rocket agrees to acquire biotech firm Renovacor

Pharmaceutical Technology

Rocket Pharmaceuticals has entered a definitive agreement for the acquisition of biotechnology firm Renovacor in an all-stock equity deal worth nearly $53m, or $2.60 for each share. Renovacor focuses on offering precision treatments for genetic cardiovascular and mechanistically-related ailments. The most advanced programme of the company is adeno-associated virus (AAV)-based gene therapy, REN-001.

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ESMO 2022 Real-Time Roundup

InCrowd

The 2022 Annual Meeting of the European Society for Medical Oncology (ESMO) took place in person from September 9th to the 13th. InCrowd wanted to learn from those Medical Oncologists and Hematology-Oncologists who attended the following two objectives: Explore which tumor type/track had the most exciting data presented Understand what attendees found exciting about the tumor type data presented.

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How to Tell if a Wound is Healing or Infected

BuzzRx

Scrape on knees, minor cuts, animal bites, surgical incisions—wounds come in many shapes and sizes. Essentially, wounds are anything that break the skin. As soon as the skin is wounded, the body springs into action and starts the healing process. But how do you tell if a wound is healing properly? Please read on to learn some of the signs of healthy wound healing as well as an infected wound.

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AstraZeneca: Redefining Cancer Care

Pharmaceutical Commerce

AZ’s Greg Rossi talks about the company’s oncology activities and his vision for the future of cancer treatment.

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Medications That May Cause Edema (Swelling)

BuzzRx

Edema is the medical term for swelling, which occurs due to the accumulation of fluid in the body's tissues. Edema is usually in the lower leg region, such as in the feet and ankles, but it can involve any body part. Certain medications can cause edema as a side effect. Please continue reading to find out which medications can cause swelling and how to treat it.

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Pfizer and CytoReason extend partnership for AI-driven drug discovery

Pharmaceutical Technology

Pfizer and CytoReason have expanded their multi-year collaboration to leverage the latter’s artificial intelligence (AI) technology to discover and develop the former’s drug programmes. According to the deal, Pfizer will invest $20m in equity, hold options for licencing the platform and disease models of CytoReason, and provide additional funding for supporting supplementary projects.

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Novartis knocked back again in bid to block Gilenya generics in US

pharmaphorum

Novartis is running out of options in its bid to defend oral muscular sclerosis therapy Gilenya from early generic competition in the US. The US Court of Appeals for the Federal Circuit (CAFC) has denied the Swiss pharma group’s petition to rehear its decision on the validity of US Patent No. 9,187,405, granted in 2015, which covers a specific dosing regimen for Gilenya (fingolimod) in relapsing-remitting MS.

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Industrial automation hiring levels in the pharmaceutical industry rose in August 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for industrial automation related positions rose in August 2022 compared with the equivalent month last year, with 52% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 49.7% of companies who were hiring for industrial automation related jobs a year ago but a decrease compared to the figure of 58.3% in July 2022.

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FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach

The FDA Law Blog

By McKenzie E. Cato — On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) declared the outbreak of monkeypox virus a public health emergency (see announcement here ). On September 7, 2022, the Secretary of HHS declared that “circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-va

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AstraZeneca’s Tezspire approved in the EU for patients with severe asthma

Pharma Times

Tezspire is a maintenance therapy for patients with no phenotype or biomarker limitations

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J&J Opens San Francisco R&D Campus

Pharmaceutical Commerce

Will feature drug discovery, gene and RNA therapy technology.

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