Why a 'fundamental shift' in regulatory submissions is on the way
PharmaVoice
JULY 11, 2022
Deloitte's senior manager of R&D and regulatory practices explains how technology and strategy must converge to smooth out the bulky drug approval process.
Sat.Jul 09, 2022 - Fri.Jul 15, 2022
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Combining Pharmacy and Public Health
Pharmacy Is Right For Me
JULY 11, 2022
There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! To highlight some of the more unique career settings in the industry, we’re introducing a new page on our website— Novel Pharmacy Practice Settings —where you can explore these unique career pathways. In addition to learning more about unique pathways on our new webpage, we’ll also be featuring pharmacists who work in these unique settings on our blog.
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FDA clears Xalkori for inflammatory myofibroblastic tumours
pharmaphorum
JULY 15, 2022
Pfizer’s tyrosine kinase inhibitor Xalkori has picked up a fourth approval from the FDA, adding a new use in the treatment of a rare form of benign tumour that typically affects children and young adults. Xalkori (crizotinib) has been cleared for inflammatory myofibroblastic tumours (IMT), which appear in organs like the lung, stomach, bladder or liver.
ViiV, Roche and Pfizer top in ESG, according to patients
European Pharmaceutical Review
JULY 12, 2022
According to a recent survey of patient groups, Roche, Pfizer, ViiV Healthcare and Gilead Sciences are among the top companies for implementing and reporting progress on environmental, social, governance (ESG) activities. However the survey of 1,500 patient groups also found that 55 percent were not aware of pharma’s ESG programmes, suggesting pharma needs to better include and consider the patient perspective in establishing their ESG goals.
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
Janssen extends LGBTQ mental health outreach beyond Pride Month
PharmaVoice
JULY 14, 2022
The pharma giant’s ‘Depression looks like me’ campaign assembles a ‘one stop shop’ of resources to help combat high rates of severe depression in the LGBTQ community.
Vertex signs agreement to acquire ViaCyte for $320m
Pharmaceutical Technology
JULY 12, 2022
Vertex Pharmaceuticals has signed a definitive agreement for the acquisition of biotechnology company ViaCyte in a deal totalling $320m in cash. ViaCyte focuses on offering new stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D). Through the acquisition, Vertex plans to advance its potentially curative VX-880 programmes in T1D.
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Ensuring adequate sanitisation: disinfectant-resistant microbes in cleanrooms
European Pharmaceutical Review
JULY 12, 2022
Microbes developing resistance to disinfectants is a major emerging problem in pharmaceutical manufacturing cleanrooms and, if left unchecked, could present a threat to drug quality and, therefore, human health. More than 480 warning letters solely related to the failure to produce aseptic conditions because of deficient cleaning and disinfection systems for cleanrooms and their equipment, were issued by regulators between 2013 to 2018.
The power of the underdog: A rare disease nonprofit working to help patients win against the odds
PharmaVoice
JULY 13, 2022
Elizabeth Izard Apelles is finding innovative ways to champion rare disease patients through an emerging platform from Honeycomb Health.
AI in IVF: a fertile field
Pharmaceutical Technology
JULY 15, 2022
Despite entering its fourth decade of availability, in vitro fertilization (IVF), a medical technique used to facilitate the conception of a baby for those facing fertility problems, remains an elusive dream for many. Artificial intelligence (AI) could change this, with many researchers looking to harness the technology to increase IVF’s reliability, affordability, and availability.
Preventing the next pandemic: Infrastructure and global equity
pharmaphorum
JULY 15, 2022
In the final piece of a three-part series, Ben Hargreaves explores how manufacturing infrastructure was rapidly built up to the required capacity to ensure sufficient supply of COVID-19 vaccines, and what still remains to be done to improve vaccine equity globally. During the early stages of the current pandemic, much of the focus was taken by the possibility of developing a successful vaccine and around the R&D efforts required to achieve this.
Why Every Small Business Needs an HCM Solution: A Comprehensive Guide
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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.
Pilot scheme to analyse raw trial data launched by EMA
European Pharmaceutical Review
JULY 14, 2022
A new pilot project by the European Medicines Agency (EMA) will assess whether the analysis of ‘raw data’ from clinical trials improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications. The project will also evaluate the practicality of such submissions and analyses. Raw data constitutes individual patient data from clinical studies in electronic structured format that is directly accessible for analysis and visualisation.
COVID won't evolve to become 'less deadly' — and RedHill is prepping for the long haul
PharmaVoice
JULY 12, 2022
RedHill Biopharma’s chief operating officer, Guy Goldberg, says the company’s oral COVID-19 therapy could still be needed on a global scale.
Health Canada grants approval for Moderna’s Covid-19 vaccine in children
Pharmaceutical Technology
JULY 15, 2022
Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. So far, children aged below five years were not eligible to receive the Covid-19 vaccine in Canada. The two-dose initial vaccine regimen in children of this age group is completed in one month, which is the same dosing schedule in adults, adolescents and children aged above
Beyond the pill in an outcomes-based world
pharmaphorum
JULY 12, 2022
Going beyond the pill is proving to be a win/win for patients and pharma alike – because improved outcomes are better for everyone. With growing numbers of people around the world living with long-term conditions, the pharmaceutical industry has a golden opportunity to use its expertise to truly enhance lives. But innovative new products are only part of the equation, because even the most efficacious drugs will only work as part of a holistic programme of care that includes mental health suppor
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.
Sustainable energy strategies for pharmaceutical manufacturers
European Pharmaceutical Review
JULY 15, 2022
The pharmaceutical sector is not typically seen as a highly polluting, ‘heavy industry’ but it is far from green. In its 2021 report Delivering a ‘Net Zero’ National Health Service , the UK’s NHS attributes as much as a quarter of its carbon footprint to medicines. A deep carbon footprint is a common hallmark of energy intensive manufacturing processes – and the manufacture of pharmaceuticals is no exception.
Woman of the Week: Kura Oncology's Kirsten Flowers
PharmaVoice
JULY 13, 2022
How the chief commercial and corporate strategy officer is embracing a ‘full-cup’ philosophy to build a better leadership toolbox.
Merck and Orion enter partnership to develop ODM-208 for prostate cancer
Pharmaceutical Technology
JULY 13, 2022
Merck (MSD outside North America) and Orion have entered an international agreement to develop and market the latter’s investigational candidate ODM-208 to treat metastatic castration-resistant prostate cancer (mCRPC). Under the deal, the companies will also develop various other drugs that act on cytochrome P450 11A1 (CYP11A1), an enzyme vital for steroid production.
Roche’s combination breast cancer treatment delivers positive results
Pharma Times
JULY 15, 2022
Data from APHINITY study shows Roche’s Perjeta-based regimen reduces the risk of disease returning for people with HER2-positive early breast cancer
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.
Hospira recalls lot of Propofol Injectable Emulsion
European Pharmaceutical Review
JULY 14, 2022
Pfizer’s Hospira is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100ml Single Patient Use Glass Fliptop Vial; lot DX9067, to the user level due to a visible particulate observed in a single vial during annual examination of retain samples. According to a statement released by Pfizer, patients receiving the impacted product are at risk of experiencing life-threatening adverse clinical effects, including blockage of blood vessels (with potential t
Behind the new topical treatment set to disrupt the psoriasis market
PharmaVoice
JULY 11, 2022
Phil Brown, Dermavant’s chief medical officer, discusses VTAMA — the first topical cream approved for psoriasis in 25 years.
PulmCrit – Myth-busting the conditional nephrotoxicity of piperacillin-tazobactam
EMCrit Project
JULY 14, 2022
Most medical myths arose decades ago, prior to the era of modern evidence-based medicine. When investigating the origin story of those myths, we wind up reading grainy old papers from the 1950s. Surely, we think, such myths wouldn’t arise today – not in our shiny, interconnected, science-based, hyper-argumentative medical world. Unfortunately, new myths do continue […].
NICE unlocks use of Amarin’s Vazkepa in 425k NHS patients
pharmaphorum
JULY 15, 2022
Health technology assessment (HTA) agency NICE has finalised its guidance on Amarin’s Vazkepa, clearing the path for GPs to start prescribing the drug in up to 425,000 NHS patients at high cardiovascular risk because of raised triglyceride levels. The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 m
Enhance Healthcare Efficiency With Top Payroll & HCM Services
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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.
Research calls for regulators to accelerate the approval of antibiotics
European Pharmaceutical Review
JULY 15, 2022
A report assessing the current climate for antimicrobial innovation in Brazil, India, and South Africa, reveals that removing regulatory hurdles to accelerate the approval of new antibiotics will help to improve their development and access. Antimicrobial resistance (AMR) is a growing challenge to the healthcare sector, as antibiotics are a linchpin of modern medicine.
Alkermes looks to fill cancer treatment gaps with new immune pathways
PharmaVoice
JULY 14, 2022
The company’s chief medical officer discusses its lead candidate and how it fits into wider oncology trends.
Supply chain & logistics innovation among pharma companies has dropped off in the last year
Pharmaceutical Technology
JULY 11, 2022
Research and innovation in supply chain & logistics in the pharmaceutical sector has declined in the last year. The most recent figures show that the number of supply chain and logistics related patent applications in the industry stood at 17 in the three months ending May - down from 21 over the same period in 2021. Figures for patent grants related to supply chain and logistics followed a similar pattern to filings - shrinking from 2 in the three months ending May 2021 to 1 in the same per
Verve starts trials of cholesterol drug in test of base editing technique
pharmaphorum
JULY 13, 2022
Verve Therapeutics has started dosing patients in a phase 1b trial of its in vivo gene-editing drug for high cholesterol, designed to permanently switch off the PCSK9 gene with a one-shot treatment. The heart-1 study is enrolling patients with an inherited form of very high cholesterol – heterozygous familial hypercholesterolaemia (HeFH) – that predisposes them to early development of heart disease.
5 Reasons to Upgrade Your Pharmacy Management Software
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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.
AstraZeneca to acquire TeneoTwo and its blood-cancer therapeutic
European Pharmaceutical Review
JULY 12, 2022
AstraZeneca will acquire all outstanding equity of TeneoTwo for an upfront payment of $100 million on closing. The pharmaceutical giant will make further milestone-related payments of up to $805 million related to R&D and up to $360 million on achievement of commercial milestones. The acquisition of TNB-486 further diversifies AstraZeneca’s haematology pipeline, which spans multiple therapeutic modalities and mechanisms to address a broad spectrum of blood cancers.
First 90 Days: Anjarium Biosciences' Stephen Yoo
PharmaVoice
JULY 15, 2022
The incoming CEO aims to build on the buzz around the company’s leading-edge gene therapy tech.
Which pharmaceutical drugs have the most drug patents in Yugoslavia?
Drug Patent Watch
JULY 13, 2022
This chart shows the drugs with the most patents in Yugoslavia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Yugoslavia? appeared first on DrugPatentWatch - Make Better Decisions.
New York says Teva lied about role in opioid epidemic
pharmaphorum
JULY 13, 2022
New York’s attorney general has accused Teva of lying to evade responsibility for its alleged role in fuelling the opioid epidemic in the state and is asking for a case against the company to be reopened. AG Letitia James says the Israeli drugmaker “made significant and intentional misrepresentations” to her office and the court about its involvement with its US subsidiary in order to evade legal action and accountability.
CEPI provides $30m to advance novel coronavirus vaccine
European Pharmaceutical Review
JULY 11, 2022
The novel coronavirus vaccine has been developed at Caltech and The University of Oxfor d. Funding of up to $30 million will support vaccine design, its development through Phase I trials and regulatory activities. . Manufacturing efforts for the project will be led by the UK’s Centre for Process Innovation ( CPI ) using microbes engineered by biotechnology Ingenza Ltd.
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