Sat.May 29, 2021 - Fri.Jun 04, 2021

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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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Novartis, Molecular Partners launch trial to test ensovibep as COVID treatment

Outsourcing Pharma

The EMPHATHY clinical trial will enroll patients with COVID-19 to test the drugâs effectiveness in preventing worsening of symptoms and hospitalization.

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ASPA and Messe Frankfurt India to unite experts to discuss ideas for securing the pharmaceutical supply chain

Pharma Mirror

Increasing instances of substandard, falsified and counterfeit medical products continue to pose a major challenge to the global healthcare system which is already suffering from the dire impact of COVID-19. To address this issue, ASPA and Messe Frankfurt India will unite leading experts from the pharmaceutical segment for a live panel discussion on 11 June 2021.

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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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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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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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Skin-patch COVID-19 vaccine could offer enhanced antibody responses, according to preclinical data

Outsourcing Pharma

COVID-19 vaccination via Vaxxasâ novel high-density microarray patch showed 'significantly enhanced' T-cell and spike-specific antibody responses compared to needle delivery, according to a pre-print preclinical study published this week.

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Medications That Falsely Raise Creatinine

Med Ed 101

There are many medications that falsely raise creatinine. This can be indicative of worsening renal function, but in some situations, it may not be an issue at all. Here’s a case scenario where we look at medications that can falsely raise creatinine by interfering with secretion in the kidney. A 63-year-old female has a history […]. The post Medications That Falsely Raise Creatinine appeared first on Med Ed 101.

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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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Despite COVID-19, pharma R&D funding at all-time high: IQVIA

Outsourcing Pharma

According to the clinical research solutions firm, disruptions due to the pandemic did not stop the industry from fueling R&D at unprecedented levels.

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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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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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Thiazides and Hyperglycemia – Is It Significant?

Med Ed 101

I was asked about the clinical of thiazides and hyperglycemia. To be honest, studies aren’t that great surrounding this question, and the main ones I’m aware of and could find were very old. Here’s a quick breakdown of a couple of studies on the risk of thiazides contributing to hyperglycemia. The original study that was […].

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UK is talking to AstraZeneca about beta variant COVID jab

pharmaphorum

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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AstraZeneca taps Reify Health platform to boost breast cancer trials

Outsourcing Pharma

The pharma firm plans to use the StudyTeam platform to accelerate development, ease site burdens and improve patient matching for breast cancer studies.

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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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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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Supporting innovation: NICE’s role in establishing clear approval pathways and evidence standards for artificial intelligence-driven digital health technologies

NICE

The significant growth and advancement of data-driven technologies and the possibilities being unleashed by AI have the potential to revolutionise health and social care delivery. But through my role as NICE’s director of scientific advice, I’ve seen first-hand the problems innovators face when navigating the path to market. They can end up missing important steps or focusing their time and resources in the wrong areas.

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ASCO21: Lynparza aces adjuvant breast cancer therapy trial

pharmaphorum

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.

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Italy sees hike in biotech R&D investments, at rate higher than EU average

Outsourcing Pharma

A robust research and innovation ecosystem makes Italy an attractive life sciences hotspot, according to a post from an Italian trade delegation at Bio Digital 2021.

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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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Avantor Acquires RIM Bio; Expands Bioproduction Footprint into China

Pharma Mirror

Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences and advanced technologies & applied materials industries, announced today that it has acquired RIM Bio, a leading China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications.

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Prostate Cancer Drug Development Summit

pharmaphorum

The inaugural Prostate Cancer Drug Development Summit is the only industry-led meeting uniting large pharma, biotech and pioneering academics with the ambitious objective of accelerating the clinical development of safe and effective therapies to treat prostate cancer. With sessions on both early and advanced stages of prostate cancer (Non-Metastatic Castrate-Resistant Prostate Cancer (nmCRPC) and Metastatic Castrate-Resistant Prostate Cancer (mCRPC) , this is a conversation not to mi

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‘HIV remains a pandemic of inequalities’: The fight against HIV/AIDS, 40 years on

Outsourcing Pharma

June 2021 marks the 40th anniversary of the publication of the first reported cases of AIDS in the US. A session at BIO Digital â featuring Dr. Anthony Fauci, Director of NIAID at the US NIH â will focus on four decades of innovation as well as the critical importance of collaboration and investment moving forward.

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FDA approves Alkermes’ Lybalvi for schizophrenia and bipolar I disorder

Pharma Times

Alkermes said that it is expecting to make Lybalvi available for patients in the fourth quarter of 2021

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Time for a NICE change

pharmaphorum

The National Institute for Health and Care Excellence (NICE) is world-renowned for their work assessing the clinical and cost-effectiveness of new treatments. In recognition of how the world has changed over its history, NICE is coming to the end of a period of review and consultation on their processes and methods. Leela Barham takes stock. This article appears in our digital magazine Deep Dive: Market Access 2021.

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EU’s COVID jab certificate scheme goes live in seven countries

pharmaphorum

The first batch of EU countries have started recognising the vaccination status of travellers using digital vaccine certificates as the bloc moves towards freeing up travel ahead of the summer period. Germany, Greece, Bulgaria, Czech Republic, Denmark, Croatia and Poland are the first to start using the scheme, which will allow people who have been fully vaccinated against COVID-19, tested negative recently, or recovered from the disease to travel without restriction within the EU.

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ASCO21: Novartis’ prostate cancer radiotherapy extends survival

pharmaphorum

Novartis’ big investment in radiopharmaceuticals for cancer seems to have paid off, after lead candidate 177Lu-PSMA-617 helped men with advanced prostate cancer and few treatment options live longer in a phase 3 trial. New data from the VISION study showed that 177Lu-PSMA-617 on top of standard care reduced the risk of death by 38% compared to standard care alone in men with PSMA-positive metastatic castration-resistant prostate cancer (CRPC) who had progressed after three or more anti-and

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BIO-Europe Spring Digital: Big data and AI panel discussion

pharmaphorum

The combination of big data and artificial intelligence/machine learning is a powerful one and nowhere more so than in healthcare. As part of BIO-Europe Spring Digital , pharmaphorum founder Dr. Paul Tunnah moderated a panel discussion about big data, AI and applications in the real world. The expert panel explored the evolving applications of big data and AI within the industry, looking beyond drug discovery to new ways these technological approaches can transform healthcare delivery.

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Bayer props up sagging radionuclide business with Noria acquisition

pharmaphorum

Bayer has agreed to buy Noria Therapeutics and its subsidiary PSMA Therapeutics, adding to its pipeline of radionuclide drugs for cancer as sales of its lead product in the category – Xofigo – continue to decline. . Just over three years ago, Bayer was forced to concede that its blockbuster expectations for Xofigo (radium Ra 223 dichloride) would come to nothing, after the castration-resistant prostate cancer drug was linked to more fractures and deaths when combined with Zytiga (abiraterone ace

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Novartis halts three trials of Beovu eye drug on safety concerns

pharmaphorum

Prospects for Novartis’ ophthalmology drug Beovu have taken another dive after the drugmaker reported toxicity issues in a new phase 3 trial in wet age-related macular degeneration (AMD). On the plus side, Beovu (brolucizumab) met its efficacy objectives in the MERLIN study, but that was offset by higher rates of inflammatory reactions in the eyes – some of which could be sight threatening – compared to rival anti-VEGF therapy Eylea (aflibercept) from Bayer and Regeneron.

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MorphoSys offers $1.7bn for Constellation, but investors see stars

pharmaphorum

Shares in German biotech MorphoSys have gone on the slide after it announced a $1.7 billion deal to buy its US rival Constellation Pharma and its pipeline of cancer and haematology therapies. MorphoSys said the $34 per share deal would accelerate growth by adding two clinical-stage drug candidates, namely BET inhibitor pelabresib (CPI-0610) in phase 3 trials for myelofibrosis and second-generation EZH2 inhibitor CPI-0209 in mid-stage testing for blood cancers and solid tumours.

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Babylon Health may go public via blank cheque company merger; report

pharmaphorum

Digital health player Babylon Health is exploring a merger with a so-called ‘blank cheque’ company as a route to a public listing, according to a Swedish investment group. Kinnevik AB – which holds a 16% stake in Babylon – said that a transaction with a special-purpose acquisition company (SPAC) is being explored and may or may not take place, adding that it would not comment further on the matter for the time being.

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Pharma Supply Chain Conference Virtual

pharmaphorum

Join us for an interactive, one-day digital event , where VPs, Directors and Heads of Supply Chain and Logistics come together to share their experiences, brainstorm challenges and take advantage of new opportunities in the global pharma supply chain industry. Helping you transform, redefine and innovate your supply chain strategy during these unprecedented times and beyond. • For more information on the event, including details of how to register and its program, visit: Pharma Supply Chain Conf

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Value-based healthcare: Pandemic learnings and future musings

pharmaphorum

In the second part of our series from the ‘Patient Experience: Empathy and Innovation’ Digital Summit, we look at what COVID-19 can teach us about designing truly value-based healthcare. . Discussions of value-based healthcare provider contracts are often technical and far removed from the patient – but COVID has given us a chance to connect the dots.

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The Bloc hires Stuart Goldstein as COO

pharmaphorum

Stuart Goldstein has been hired as the chief operating officer at New-York-based healthcare creative agency The Bloc. In the newly-created role, Goldstein will oversee the execution of 4,500 projects per year across The Bloc’s US client business. He will be responsible for project management and identifying metrics to increase efficiency and profitability.

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G7 health summit highlights Oxfordshire’s thriving life sciences sector

pharmaphorum

The arrival of G7 health ministers to Oxford this week (Thursday 3 June) will shine a spotlight on Oxfordshire’s considerable achievements in the life sciences sector – and, according to the county’s Local Enterprise Partnership, there couldn’t be a better location globally for this summit to be held. “Oxfordshire’s global role in the scientific response to the Covid-19 pandemic has further strengthened our reputation for establishing and attracting world-leading life sciences businesses and inn