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.

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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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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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Feeling Hot Hot Hot

Dr. Jamie Hardy: The Lifestyle Pharmacist

Heat stroke and heat exhaustion are serious, life-threatening conditions. More than 600 people in the United States are killed by the extreme heat every year, according to the Centers for Disease Control and Prevention. How to protect yourself from heat exhaustion and heat stroke. Protecting yourself from the dangers of heat exhaustion and heat stroke is a must.

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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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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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Privacy issues widespread with digital health apps, says BMJ

pharmaphorum

Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. The team from Macquarie University compared 15,000 free mobile health (mHealth) apps available on the Google Play store and compared their privacy practices to those found in 8,000 non-health apps, finding “serious problems with privacy and inconsistent privacy practices.” The range of apps put under scrutiny included tools for managing hea

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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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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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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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Trial finds Orion digital therapeutic helps chronic pain sufferers

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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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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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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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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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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.

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Sanofi and Translate take first mRNA flu vaccine into clinic

pharmaphorum

Sanofi and Translate Bio have started a first clinical trial of an mRNA-based seasonal flu vaccine, adding to the COVID-19 shot already in testing as part of their three-year old collaboration. Enthusiasm for mRNA vaccines is riding high amid the successful rollout of COVID-19 shots from Pfizer/BioNTech and Moderna, and attention is now turning toe the possibility of using the approach to tackle other infectious diseases.

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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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Biogen’s ambitions in gene therapy hit by another failed pivotal trial

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When Biogen acquired Nightstar Therapeutics in 2019, it added a pair inherited retinal disorder (IRD) gene therapies that it hoped would accelerate a push into the fast-evolving category. . Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal.

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Pricing, Profits and Progress: Pharma’s Post-COVID Priorities

pharmaphorum

As post-pandemic recovery begins, big pharma remains in the spotlight. Jesse Mendelsohn explores pharma’s priorities on pricing, profits and progress post-Covid. It goes without saying that if pharmaceutical companies are not profitable, they will not survive. The need for firms to make a reasonable profit is paramount in today’s world; healthy pharmaceutical research and manufacturing are the keys to ending disease, curing chronic conditions, and discovering new therapies and vaccines t

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Country focus: China & APAC’s growing medical needs bring opportunities and challenges

pharmaphorum

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. Home to over 60% of the world’s population, Asia Pacific (APAC) is not a region the biopharma industry can afford to ignore. Dr Jay Mei, founder and CEO of Antengene, notes that the region has rich innovation resources but also urgent medical needs, leading to both opportunities and uncertainties for the industry.

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

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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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What HCPs think about blood clots linked to COVID-19 vaccines

pharmaphorum

In the latest edition of What HCPs Think , CREATION.co’s Laura Marsh looks at what healthcare professionals are saying about blood clots linked to COVID-19 vaccines. The formation of blood clots is a necessary process in order for the body to repair damage caused by injury and to slow down bleeding. However, when blood clots form inappropriately, this limits blood flow through vessels and can pose a significant health risk.

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FDA grants swift approval to Cognoa’s digital device for autism diagnosis

pharmaphorum

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. Cognoa says the artificial intelligence (AI) based device is the first to be authorised by the US regulator that can help doctors diagnose autism in primary care, and will be launched “in the coming months” At the moment, autism can be difficult to diagnose as there are no medical markers to confirm its presence.

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Accord launches app to help cancer patients manage symptoms

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Accord Healthcare has introduced a new app in the UK designed to help people undergoing treatment for cancer maintain their physical and mental wellbeing. The Unify Health app helps patients understand their illness, track symptoms and treatment progress, receive tips on health habits and importantly can also be used to connect patients with local pharmacists who can provide additional advice and support.

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UK is talking to AstraZeneca about beta variant COVID jab

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The UK government is talking to AstraZeneca about ordering additional doses of its COVID-19 vaccine that will target the beta variant of SARS-CoV-2 virus first identified in South Africa, according to Health Secretary Matt Hancock. The AZ/Oxford University vaccine and other shots from Pfizer/BioNTech and Moderna are known to have less efficacy against the beta variant – also known as B.1.351 – which is estimated to be around 50% more transmissible than earlier strains.

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How the patient voice is becoming vital for drug approval

pharmaphorum

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read below for a preview!

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MHRA grants bluebird ‘innovation passport’ for sickle cell therapy

pharmaphorum

bluebird bio’s sickle cell disease (CD) gene therapy LentiGlobin is the latest recipient of an ‘innovation passport’ introduced in the UK earlier this year to speed up NHS access to promising new medicines. The designation means that LentiGlobin will be reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new innovative licensing and access pathway (ILAP) introduced last December.

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Altimmune ditches nasal COVID vaccine on weak trial data

pharmaphorum

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . It’s a big disappointment for Altimmune, which said back in February that it was hoping to find a more convenient alternative to injected COVID-19 vaccines – and one which would be stable at room temperature, making distribution and delivery easier.

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BMS pays $650m upfront for Eisai’s first ADC candidate for cancer

pharmaphorum

Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 billion. . BMS is making a hefty $650 million upfront payment to Eisai for global co-development and co-commercialisation rights to MORAb-202, which couples an anti-folate receptor alpha (FR?

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Biogen abandons tau antibody for Alzheimer’s after phase 2 miss

pharmaphorum

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit on cognition symptoms in patients with mild Alzheimer’s, despite being effective at clearing tau out of cerebrospinal fluid.

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Regeneron drug saves lives in severe COVID-19, but it’s not for all

pharmaphorum

People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data from the UK RECOVERY trial. The therapy significantly reduced the risk of death, the length of hospital stay and the need for a ventilator in the study , which involved around 1,000 subjects who were given a blood test to check whether they had made any antibodies of their own to fight the virus.

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Farxiga faces first heart failure rival as EU OKs Boehringer/Lilly’s Jardiance

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AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance. . The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.

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Climate change: The elephant in the waiting room of health

pharmaphorum

Pharma has both an opportunity and a responsibility to do its part in tackling climate change – and the time to act is now, according to speakers at a recent event. Amanda Barrell reports. The pharma industry has clearly stated its commitment to a net zero future, but where are we on that journey, what else can be done, and could organisations achieve more if they worked together?

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And then there were three: another FDA adcomm member quits over Aduhelm

pharmaphorum

The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest. . The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David Knopman who quit earlier this week.

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” Biogen meanwhile has bee

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NHS patient data upload delayed by two months, says UK

pharmaphorum

The UK’s decision to set back the start date of a new patient data-sharing scheme by two months has been welcomed by privacy campaigners, who have claimed it was being rushed through without sufficient public scrutiny. The centralised database of medical records from 55 million people was due to come online on 1 July, but the start date has now been pushed back to 1 September, according to Minister for Public Health, Primary Care & Prevention Jo Churchill.

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ASCO21: Lynparza aces adjuvant breast cancer therapy trial

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AstraZeneca and Merck & Co’s Lynparza is primed for even wider use in the treatment of breast cancer after a phase 3 trial showed it could extend the time for the cancer to return when used as adjuvant therapy. Giving Lynparza (olaparib) to women with BRCA-positive, HER2-negative breast cancer straight after chemotherapy and surgery to remove the tumour reduced the risk of recurrence, secondary cancers or death by 42% compared to placebo after 2.5 years of follow-up.