June, 2021

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BioNTech takes its first cancer vaccine into phase 2

pharmaphorum

It would be easy to forget that back in 2019, BioNTech was an early-stage biotech firmly focused on cancer vaccines, before being catapulted onto the world-stage with its COVID-19 shot. Now, the German company has issued a reminder of its original R&D mission with the start of the first phase 2 trial of BNT111 – the first of several cancer vaccine candidates – in patients with skin cancer.

Vaccines 145
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Novartis reports 'clinically relevant' survival data for Lutathera

Pharma Times

The radioligand therapy was linked with a significant increase in progression-free survival and a clinically relevant increase in overall survival in patients with midgut neuroendocrine tumours

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Phesi COVID-19 study indicates obesity a major complicating factor

Outsourcing Pharma

The virtual clinical development firmâs analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.

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New patent expiration for Merck Sharp drug CLARINEX

Drug Patent Watch

Annual Drug Patent Expirations for CLARINEX Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. It is available from two suppliers. There are four…. The post New patent expiration for Merck Sharp drug CLARINEX appeared first on DrugPatentWatch - Make Better Decisions.

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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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The Rise of Audio Social Networks – Where Pharma Can Make an Impact

Pharma Marketing Network

Anyone with a smart device has been feeling the grueling effects of social isolation and screen fatigue since the start of the COVID-19 outbreak. Recently, we have witnessed a flood of new “audio-social apps” and audio features on social media platforms, aiming to finds new ways to connect, curb loneliness and cut excessive screen exposure. What are some of these audio-focused platforms and where can pharma play a role?

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F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

NY Times

Aducanumab is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say there’s not enough evidence it can address cognitive symptoms.

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NHS England announces extra funding for young people’s mental health services

Pharma Times

An extra £40m will go toward enhancing mental health services for children and young people

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FDA approves Biogen’s Alzheimer's drug, Aduhelm

Outsourcing Pharma

The US Food and Drug Administration (FDA) has approved Biogenâs Aduhelm (aducanumab) for the treatment of Alzheimerâs: making it the first new treatment approved for the disease since 2003.

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New patent for Vifor Fresenius drug VELPHORO

Drug Patent Watch

Annual Drug Patent Expirations for VELPHORO Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Vifor Fresenius drug VELPHORO appeared first on DrugPatentWatch - Make Better Decisions.

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Digital fabric could be used to measure health data

pharmaphorum

Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness. The team from Massachusetts Institute of Technology (MIT) claim this is the first example of a fabric which can record data in a digital rather than in an analogue format, allowing it to be programmed like any other digital device.

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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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Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

pharmaphorum

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year.

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Artificial pancreas will be piloted in 1,000 diabetics, says NHS CEO

pharmaphorum

NHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot study of the technology, according to chief executive Sir Simon Stevens. The diabetics will be offered the closed-loop systems, which continually monitor glucose levels in the blood and uses the data to automatically adjust the dose of insulin delivered by an externally worn pump, at around 25 specialist centres across England.

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Mix and match regimen of AZ and Pfizer COVID jabs works well

pharmaphorum

Giving one dose each of AstraZeneca and Pfizer COVID-19 vaccines provides good protection against the SARS-CoV-2 virus, but may be associated with more adverse reactions, according to new clinical trial data. The Com-COV trial compared two shots with Pfizer/BioNTech’s Comirnaty, two doses of AstraZeneca’s Vaxzevria, and a mixed regimen of one of each jab, and found that all were effective at stimulating a “robust” immune response against the coronavirus, according to the

Vaccines 128
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Ensuring accessibility: Crossing the digital divide in healthcare

pharmaphorum

“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience voices. The experts discussed the benefits and merits of co-creation during a session on bridging the digital divide, held during the recent Patient Experience Digital Summit.

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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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Janssen’s myeloma CAR T therapy cilta-cel demonstrates ‘sustained efficacy’

Pharma Times

Updated study results showed an overall response rate of 98% with a longer-term follow-up at a median of 18 months

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AZ’s COVID jab tackles delta variant, but antibody fails clinical trial

pharmaphorum

The delta variant of COVID-19 may be holding back the lifting of lockdown restrictions in the UK, but there is some good news – the AstraZeneca/Oxford University vaccine seems to offer a high level of protection against it. Real-world data from Public Health England (PHE) suggests that the vaccine prevents 92% of hospitalisations in patients infected with delta (B.1.617.2, formerly known as the Indian variant), with no deaths recorded, according to AZ.

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Daiichi Sankyo claims first okay for oncolytic virus in Japan

pharmaphorum

Daiichi Sankyo has made a little bit of pharma industry history, becoming the first drugmaker to win approval in Japan for a therapy for cancer based on a virus that selectively kills malignant cells. Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted a conditional approval to the company’s Delytact (teserpaturev) for the treatment of patients with malignant glioma, an aggressive form of brain cancer that affects around 2,500 people in Japan.

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Amicus' Pompe disease therapy joins early access scheme

Pharma Times

The MHRA has issued an EAMS scientific opinion opening the door to use of cipaglucosidase alfa with miglustat in eligible patients with Pompe disease

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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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AZ, Pfizer/BioNTech vaccines ‘highly effective’ against Delta variant

Pharma Times

New real world data from PHE shows vaccines can protect against hospitalisation caused by variant

Vaccines 154
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Blockchain: Ready to revolutionise medicinal cannabis research?

pharmaphorum

Robert Galarza outlines how blockchain technology can be utilised to verify, validate and standardise the efficacy of medical cannabis and other plant based therapies in clinical trials. . The Chinese surgeon Huo Tuo first mixed powdered cannabis with wine to make an anesthetic sometime between 140 and 208 CE. Indeed, the Chinese term for “anesthesia” (mázui ??

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Transforming pharma R&D with a scientist-centric approach to AI & automation

pharmaphorum

As biopharmaceutical products have become increasingly complex, both in design and in regulatory requirements, we need a new way of working. Markus Gershater looks at how automation and artificial intelligence (AI) can transform pharma R&D. Due to increasing complexity in R&D, pharma teams are under pressure to drive down costs and speed up time to market whilst improving outcomes, and most recognise that incorporating automation and AI into their workflows will be game-changing.

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'Indian' variant of coronavirus now dominant strain in the UK

Pharma Times

Officials warned that early evidence suggests there may be an increased risk of hospitalisation for Delta compared to the Alpha (Kent) strain

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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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NICE recommends Tecentriq for first-line NSCLC

Pharma Times

Tecentriq is indicated for adults with metastatic NSCLC if their tumours have PD-L1 expression on at least 50% of tumour cells or 10% of tumour-infiltrating immune cells

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Trial finds Orion digital therapeutic helps chronic pain sufferers

pharmaphorum

A digital therapeutic aimed at people with chronic lower back pain based on virtual reality (VR) has shown encouraging results in a clinical trial, helping patients manage the fear of movement that can reduce their activity and impede recovery. The therapy uses a VR headset to guide people with chronic pain through a series of cognitive behavioural therapy (CBT) exercises that are designed to help them overcome the fear of movement – also known as kinesiophobia.

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BioMarin resubmits haemophilia A gene therapy to the EMA

Pharma Times

Company initially withdrew a marketing authorisation application for the gene therapy last year

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Pandemic paves way for innovative hybrid healthcare

pharmaphorum

While the heroic abilities of the NHS have been on display throughout the COVID-19 pandemic, the last year has also exposed the longstanding limitations and frailties of our underfunded healthcare system, says Maya Ward. With an estimated 100,000 unfilled posts and staff turnover expected to increase due to emotional exhaustion, the health service’s workforce stands to be further stretched by an ageing population.

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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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Keeping clinical trial data safe – handling cybersecurity in a risky world

pharmaphorum

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. However the increased complexity and involvement of different parties, exposes manufacturers to heightened threat levels. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats.

Vaccines 111
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What’s affordable anyway? The future of NHS drug spending

pharmaphorum

The single biggest monetary difference that can be made to the successor to the UK’s 2019 Voluntary Scheme for branded medicines pricing and access (VPAS) is to address the question of how the allowable growth rate for branded medicines is set. Now that VPAS has hit the mid-point and stakeholders are already thinking ahead to the next deal, Leela Barham delves further.

Hospitals 111
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Opdivo, Yervoy combination approved to treat malignant pleural mesothelioma

Pharma Times

Combination immunotherapy treatment approved in the EU for first-line treatment of adults with unresectable MPM

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Renal disease: the big picture

pharmaphorum

Renal diseases represent a formidable challenge on public health systems around the world. They are costly in terms of economic burden and quality of life, especially among older patient populations, and are closely linked to other chronic conditions such as cardiovascular disease and diabetes. Joan Perelló and Adam Levy explore the advancement of treatments in the renal space.

Diabetes 105
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ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data

pharmaphorum

Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing ASCO conference revealed a 71% complete response rate with the CAR-T in heavily pre-treated adult patients with B-cell precursor ALL.

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