Sat.Aug 20, 2022 - Fri.Aug 26, 2022

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Overcoming mental health’s drug development challenges with AI

PharmaVoice

PsychoGenics is leveraging AI-driven drug discovery platforms to advance mental health treatments for schizophrenia, bipolar disorder and treatment-resistant depression.

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Blister material as a source of nitrosamine impurities

European Pharmaceutical Review

Following numerous recalls, the industry is striving to investigate the causes, sources and ways to mitigate carcinogenic nitrosamine impurities. In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.

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New study use musical tests for early detection of cognitive decline

Pharma Times

Researchers at Tel Aviv University used a portable brain activity-measuring device to detect cognitive decline in older people

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Long COVID but short on treatment options

pharmaphorum

With COVID-19 vaccines and therapeutics developed in rapid time, Ben Hargreaves investigates why this has not been the case with the creation of a treatment for Long COVID. The condition is more common than might be thought and presents a significant burden to patients, and yet the pipeline of potential therapies remains relatively sparse. When the pandemic first struck, the gravity of the situation did not take long to set in.

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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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First 90 Days: Agios Pharmaceuticals’ Brian Goff

PharmaVoice

The rare disease veteran and first-time CEO is bringing his expertise to the company as it launches the first FDA-approved treatment for pyruvate kinase (PK) deficiency.

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Non-viral CRISPR could overcome cell and gene therapy bottlenecks

European Pharmaceutical Review

Scientists from the Gladstone Institutes and University of California San Francisco (UCSF) say a new variation of the CRISPR-Cas9 gene editing system enables especially long DNA sequences to be introduced to precise locations in the genomes of cells with remarkably high efficiency without the need for viral vectors. “One of our goals for many years has been to put lengthy DNA instructions into a targeted site in the genome in a way that doesn’t depend on viral vectors,” commented Alex Marson, MD

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Sword’s digital musculoskeletal care approach improves mental health; study

pharmaphorum

A clinical trial has found that a digital care programme for people with musculoskeletal pain developed by Sword Health can improve their productivity at work, even if they also have mental health issues. Sword Health’s virtual musculoskeletal programme care programme pairs patients with a physical therapist they can talk with via telehealth, guiding them through exercises to address pain and other symptoms and also provides cognitive behavioural therapy (CBT) modules to help them develop

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With market success at stake, can tech help solve the diversity problem in clinical trials?

PharmaVoice

Diversity in clinical trials isn’t only important for the health of the overall patient population — it can save millions in lost profits.

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Oncolytic viruses: past and present

European Pharmaceutical Review

IN 2022, treating glioblastoma (GBM) remains an uphill battle. Current therapeutic options show limited success and neuro-oncology teams often struggle to balance their benefits with a patient’s quality of life. Cutting-edge strategies, however, are now revisiting the use of oncolytic viruses – viruses that selectively infect and kill cancer cells – which may broaden and advance the therapeutic landscape.

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Roche launches digital PCR system for ultra-rare and emerging diseases

Pharma Times

Using the system, the researchers are able to divide DNA and RNA from an already extracted clinical sample into as many as 100,000 microscopic individual reactions

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Roctavian okay sets up another gene therapy test for Europe

pharmaphorum

BioMarin Pharma has its landmark first approval for Roctavian – the first for a haemophilia gene therapy – and will now have to see if that can convert that into a viable business in Europe. The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII.

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The story behind the PharmaVoice 100

PharmaVoice

Taren Grom, our editor-in-chief emeritus, explains how the coveted PharmaVoice 100 awards got its start and what makes it stand out in the industry.

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EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).

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MIT’s AI model can detect Parkinson’s by tracking breathing patterns

Pharma Times

The tool uses a series of connected algorithms that can assess if someone has PD from their nocturnal breathing

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Merck chases Bayer/Ionis with fast track for Factor XI drug

pharmaphorum

The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short over the bows of a rival programme in development at Ionis and Bayer. The anticoagulant – codenamed MK-2060 – is a monoclonal antibody designed to inhibit Factor XI and is currently in a phase 2b trial in ESRD patients on dialysis, who often need to be treated with anticoagulants to prevent blood clots.

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Patents, pandemics and pricing: a peek at the top drug from every big pharma

PharmaVoice

A look at how the biggest pharma companies in the world and their top-selling drugs fared in the first half of the year.

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Environmental Monitoring In-Depth Focus 2022

European Pharmaceutical Review

A strategic approach to optimisations of testing bacterial endotoxins. Given industry’s recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise.

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Pfizer’s RSV vaccine candidate shows promise in older adults study

Pharma Times

It is estimated that RSV infections in older adults account for 177,000 hospitalisations and 14,000 deaths each year in the US alone

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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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Bayer unit BrainVectis cleared to start Huntington gene therapy trial

pharmaphorum

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease. The phase 1/2 study is due to get underway before the end of the year and will test BrainVectis’ one-shot BV-101 gene therapy, which will be delivered using an adeno-associated virus (AAV) vector directly to areas of

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Flipping the script to disrupt, redefine and accelerate the patient care journey

PharmaVoice

A new, digitally innovative care model empowers patients and expedites their access to treatment.

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European Pharmaceutical Review Issue 4 2022

European Pharmaceutical Review

Included in this issue: NITROSAMINES. Risks presented by active pharmaceutical ingredient nitrosamines. David Elder, David P Elder Consultancy. ENVIRONMENTAL MONITORING. Progress in the implementation of biofluorescent particle counters. Hannah Balfour with comment from Mike Russ at Genentech. REGULATORY INSIGHT. The EU HTA regulation: a new frontier for access to innovative technologies.

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Jazz Pharmaceuticals’ epilepsy drug advances into phase 3 trial

Pharma Times

Epidiolex may ease symptoms associated with Doose syndrome, a rarer type of childhood-onset epilepsy

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Novartis decides Sandoz’ future – and it’s a spin-out

pharmaphorum

After months of deliberation, and no formal offers from a buyer, Novartis has decided that its generics business Sandoz will be spun out into an independent company. The Swiss pharma group said this morning that the separation “is in the best interest of shareholders” and will create the number one generics company in Europe and a leader in biosimilars, whilst allowing Novartis to focus on its patented medicines business.

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Woman of the Week: Glympse Bio’s Dr. Tram Tran

PharmaVoice

How the chief medical officer of the emerging diagnostic company is using the patient perspective as a guiding light.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations. Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – account

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Outsourcing strategists thinking farther ahead than ever: CPHI

Outsourcing Pharma

The groupâs latest report glimpses inside the minds of pharma leaders, who are looking at a productâs full life-cycle development at the preclinical stage.

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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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Takeda gets first approval for its dengue vaccine

pharmaphorum

Japan’s Takeda has secured its first regulatory approval – in Indonesia – for its dengue fever vaccine TAK-003, which has been tipped as a potential blockbuster product. Indonesia’s National Agency for Drug and Food Control (BPOM) has approved the vaccine as Qdenga to protect against the virus in people aged six to 45, on the back of data showing that it can cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic illness seen up to three years aft

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Moderna, Eli Lilly and Schrödinger seek to boost financial and people strategies with key new hires

PharmaVoice

How the latest personnel shifts are impacting each company and the industry at large.

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Actualising the power of antibody-drug conjugates as cancer therapeutics

European Pharmaceutical Review

ANTIBODY-DRUG conjugates (ADCs) are therapeutic molecules designed as highly targeted medicines with the promise of changing the way we treat cancer and other diseases. An ADC combines the specificity of an antibody and the potent power of an anti?cancer agent or disease-relevant toxin. In total, there are 14 approved ADCs on the global market, all for oncology indications, and over 140 ADCs currently in clinical development. 1 While the first successes underscored the potential of this class of

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Management is Messy

The Honest Apothecary

I am convinced that one of the reasons why so many healthcare professionals struggle when transitioning to management roles is the sheer messiness of it all. Medical folks are trained to insist upon good order, and rightly so. Chaos is the enemy of workplace safety and patient care. Doctors, nurses, and pharmacists generally prefer consistent and well-defined workflows and have a low tolerance for ambiguity.

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To build diversity into clinical trials, collaborate at the community level

pharmaphorum

Diversity in clinical trials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinical trial participation for underserved groups is an essential part of addressing health inequalities. Getting there, however, is easier said than done. The Food and Drug Administration’s (FDA) draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials , recommends sponsors