Fri.Jul 15, 2022

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Pharma’s platinum handcuffs

World of DTC Marketing

To address the “retention” problem, pharma companies are paying employees exorbitant salaries. The problem with that system is that people do whatever they need to to “hold onto” their high-paying jobs and become employees who are content not to excel. This is NOT what pharma needs. Last week I briefly chatted with someone in the industry evaluating another job offer.

Pharma 257
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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative.

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Trending Sources

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Texas sues HHS, claims the agency is trying to turn ERs into abortion clinics

MedCity News

The attorney general of Texas says the recent federal mandates and guidance issued to healthcare providers to protect abortion access are unconstitutional and conflict with state law.

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FDA clears Xalkori for inflammatory myofibroblastic tumours

pharmaphorum

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.

FDA 115
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Novartis turns to algorithms developer Anumana to apply AI to cardio conditions

MedCity News

Novartis is partnering with algorithms startup Anumana to develop a new artificial intelligence-based solution for cardiovascular diseases. The goal is to find ways to detect heart conditions years before symptoms develop in order to enable earlier intervention.

Biopharma 120
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AI in IVF: a fertile field

Pharmaceutical Technology

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.

Medical 105

More Trending

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Health Canada grants approval for Moderna’s Covid-19 vaccine in children

Pharmaceutical Technology

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

Safety 105
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Akili digital therapeutic shows promise in lupus patients

pharmaphorum

Akili looks like it could bring another digital therapeutic (DTx) to market after a clinical trial backed the efficacy of its AKL-T01 in patients with the autoimmune disorder systemic lupus erythematosus (SLE). The PureTech group company – which scored the first FDA and EMA approvals for a DTx for attention-deficit hyperactivity disorder (ADHD) – is developing AKL-T01 to tackle cognitive impairments that can affect people with SLE.

Patients 104
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Beat inflation with virtual meetings and programs

Impetus Digital

At the time of writing, the average inflation rate worldwide sits at 7.4% , the highest it’s been for decades. Here in Canada , the inflation rate is not forecasted to come back down to “normal” levels until 2024. As a life science service provider working with companies across the world, we are seeing firsthand how some companies are already tightening their budgets in response to the ongoing economic uncertainty and other world events such as the war in Ukraine.

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Preventing the next pandemic: Infrastructure and global equity

pharmaphorum

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.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Sustainable energy strategies for pharmaceutical manufacturers

European Pharmaceutical Review

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.

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NICE unlocks use of Amarin’s Vazkepa in 425k NHS patients

pharmaphorum

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

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Research calls for regulators to accelerate the approval of antibiotics

European Pharmaceutical Review

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.

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How and Why Your Resume Should be for TWO different audiences: Man and Machine

Legacy MEDSearch

Resume writing advice is everywhere online. There are guides that proudly proclaim how important resume titles are, or how your Times New Roman font is preventing you from finding your next job, to guides that insist you use a professional service to “set yours apart from the rest.”. The popular conception is that there’s stack of printed-off resumes sitting on some poor Human Resources Manager’s desk that they’re going through one by one and putting into one or two files.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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StartUPDATES: New developments from healthcare startups

MedCity News

Check out news from Equiva, Canvas Medical, Particle Health, Fold Health, and Nucleus Genomics.

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Roche’s combination breast cancer treatment delivers positive results

PharmaTimes

Data from APHINITY study shows Roche’s Perjeta-based regimen reduces the risk of disease returning for people with HER2-positive early breast cancer

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First 90 Days: Anjarium Biosciences' Stephen Yoo

PharmaVoice

The incoming CEO aims to build on the buzz around the company’s leading-edge gene therapy tech.

Leads 98
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Brazil grants authorisation for Sinovac’s Covid-19 vaccine in children

Pharmaceutical Technology

The Brazilian Health Regulatory Agency (Anvisa) has granted emergency use authorization for Sinovac Biotech’s Covid-19 vaccine, CoronaVac, in children aged three to five years. Subjects in this age group can receive the same vaccine dosage authorised in patients aged six to 17 years, as well as adults. Furthermore, there exists no restriction on vaccine usage in immunosuppressed children aged three to five years.

Medical 64
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Pharmaceutical Executive Podcast Wins APEX Award of Excellence

PharmExec

Podcast recognized for its excellence in apps and podcasts category.

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UK NICE recommends Novartis’ combination therapy for breast cancer

Pharmaceutical Technology

The UK National Institute for Health and Care Excellence (NICE) has recommended Novartis Pharmaceuticals UK’s Piqray (alpelisib) along with hormonal therapy fulvestrant to treat hormone receptor+, HER2-, PIK3CA-mutated locally advanced or metastatic breast cancer. In the final draft guidance, NICE noted that the combination treatment is intended for such patients with tumour growth following the usage of combined hormonal therapy and a cancer growth inhibitor.

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Kyowa Kirin drops Nourianz follow-up KW-6356 for Parkinson’s

pharmaphorum

Despite reporting proof-of-concept results in a mid-stage trial, Kyowa Kirin has decided to discontinue development of its Parkinson’s disease candidate KW-6356, a drug in the adenosine A2A receptor antagonist class. The Japanese drugmaker said (PDF) the decision wasn’t taken for clinical reasons, as trials suggested the drug had potential as a monotherapy and in combination with levodopa in relieving both motor and non-motor symptoms of Parkinson’s.

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Master Influence Skills to Impact Net-Zero Transformation

ALULA

Video discussion with John Dale, Global Energy Practice Lead and Kacie Linegar, Business Transformation Expert. When leading an organization through the interconnected changes that are crucial to decarbonization/net-zero, it’s common to face resistance, confusion, or distraction from your workforce. Still, you need to sustain a sense of urgency and high performance.

Leads 52
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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Ophthalmic Drugs Conference

pharmaphorum

SAE Media Group’s 5th Annual. Ophthalmic Drugs Conference. 21 – 22 November 2022 | London, UK. [link]. Delving into advanced R&D and Delivery of Ocular Therapeutics. SAE Media Group’s 5th Annual Ophthalmic Drugs Conference will explore advancements in ophthalmic treatments and variety of novel drugs, which are showing good clinical trial data.

Media 52
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13th Annual PING Conference Highlights Future of UK Pharma Industry

PharmExec

Industry leaders discuss new technologies, research, and investment strategies.

Pharma 72
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Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

pharmaphorum

Teva has asked the Supreme Court to look at a judgment in a $235 million patent dispute with GSK that it claims could undermine the ability of generic drugmakers to bring new products to market, and thereby help reduce drug prices. The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-cal

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Bristol Myers Squibb’s Opdivo recommended by NICE for malignant pleural mesothelioma patients

PharmaTimes

Armed forces veterans and people who were exposed to asbestos could benefit from the therapy

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Commission can rule on Illumina, Grail merger, says EU court

pharmaphorum

Illumina’s attempt to prevent the European Commission from carrying out an antitrust review of its $8 billion takeover last year of cancer diagnosis firm Grail has been defeated in an EU court. The EU General Court has ruled that the Commission can investigate the merger, unswayed by Illumina’s argument that it should have no jurisdiction over the deal because Grail does not currently have a commercial presence within the EU.

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Study: Intermittent Fasting Associated with Less Severe COVID-19 Complications

Pharmacy Times

People who regularly fasted for decades had lower risk of hospitalization or death from COVID-19, adding to the potential health benefits of intermittent fasting.

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Sonoco ThermoSafe and Turkish Cargo Sign Global Master Lease Agreement

Pharmaceutical Commerce

Partnership allows for distribution of packager’s temperature-controlled container.

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Expert Discusses Advanced Roles for Pharmacy Technicians

Pharmacy Times

Ryan Burke, PharmD, director of professional affairs at Pharmacy Technician Certification Board, discusses more advanced roles for pharmacy technicians and how they can continue to grow beyond their current roles.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.