European Pharmaceutical Review

AUGUST 16, 2022

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster. The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. The decision was also endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after a careful review of the evidence.

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Safety Side effects Medicine Healthcare 103

PharmaVoice

AUGUST 16, 2022

Nasal vaccines under development by Codagenix, Xanadu Bio and others have the potential to finally help reduce virus transmission and breakthrough infections.

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Scott Burrows

AUGUST 16, 2022

The Human in the Loop is You When speaking to audiences in my role as an insurance and financial services motivational speaker, I am careful to differentiate the impact of technology from the critical role of the representative.

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European Pharmaceutical Review

AUGUST 16, 2022

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . Hepatocellular carcinoma, or HCC, is the sixth most common type of cancer worldwide. HCC accounted for more approximately 85 percent of the 900,000 new liver cancer cases in 2020, according to the Globocan 2020 database. .

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Food and Drug Administration Patients Safety Food 98

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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

Distribution

PharmaVoice

AUGUST 16, 2022

In balancing two roles — Lexitas CEO and practicing physician — George Magrath brings a patient-first perspective to developing and advancing eye treatments.

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pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. The US regulator has started a priority review of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a first-line treatment for metastatic castration-resistant prostate cancer (mCRPC) based on the results of the PROpel trial.

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FDA Patients Sales Marketing 94

MedReps

AUGUST 16, 2022

Having a solid work-life balance is important. However, it can be tough for working mothers to keep everything together. They have to work, care for their kids, keep up a home and more. Without a good balance between all of these tasks, a working mother can end up performing poorly at work, as well as not giving her kids the attention they deserve. It’s no secret that a medical sales career can be demanding.

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Medical sales Management Medical Sales 89

MedCity News

AUGUST 16, 2022

More than 2,000 mental health clinicians who work at Kaiser Permanente went on strike on Monday. The strike comes as a result of continued complaints about mental health care access at the health system — workers are saying patients must wait four to 11 weeks for a follow-up appointment. Through a new page posted on its website, Kaiser denies the union’s claims.

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Patients Healthcare Healthcare 95

European Pharmaceutical Review

AUGUST 16, 2022

The Queen’s Award for Enterprise is the UK’s highest accolade for business success and recognises the strength of Quay Pharma’s export sales, which, according to SGS, have comprised at least 55 percent of its business since 2010. The enterprise also noted that in the last three years its overseas sales had more than doubled. The International Trade category recognises those who have had a clear business strategy for entering new markets abroad, have overcome the challenges faced by exporte

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Pharma Sales Manufacturing Specialization 81

pharmaphorum

AUGUST 16, 2022

Merck & Co has ramped up its involvement in the RNA category, partnering with US biotech Orna Therapeutics in a deal valued at up to $3.5 billion, including $150 million upfront. It has also invested another $100 million in the three-year-old Cambridge, Massachusetts-based biotech, by participating in a $221 million Series B round. One of the unexpected consequences of the COVID-19 vaccine race was that some top-tier vaccine companies like Merck, GSK and Sanofi ended up trailing the field, a

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Manufacturing Pharma Patients 81

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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.

Safety

MedCity News

AUGUST 16, 2022

Today’s factory floors include production equipment that’s linked directly into those IT systems that are so often the victims of a cyberattack. This “operational technology” (OT) is critical for pharmaceutical manufacturing and R&D organizations.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Biopharma 83

Map My Customers

AUGUST 16, 2022

It is human nature to want to resist new and unknown things that we don’t immediately see a benefit from. Another layer of resistance is added to this when someone is telling us we HAVE to use (or do) this new and unknown thing. So, in the business/sales world, it is not uncommon for sales management to face some resistance when suddenly mandating that sales reps start using a new sales CRM or other sales enablement tools.

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Sales tools CRM Sales Healthcare 80

MedCity News

AUGUST 16, 2022

Merck aims to bolster its genetic medicines pipeline through a new research alliance with Orna Therapeutics, a startup whose technology forms RNA into a circle shape that brings several advantages for new therapies and vaccines. In addition to starting the partnership, the pharmaceutical giant also invested in Orna’s $221 million Series B financing round.

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Medicine Pharmaceutical Biopharma Pharma 82

Pharmaceutical Commerce

AUGUST 16, 2022

Three of the authors of a new EY study exploring the evolution of industry supply chain strategies and the long-term implications for healthcare delivery across three major trade regions discuss the report’s key findings and share their predictions as we move into Q3.

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Healthcare Healthcare 72

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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.

Specialization

MedCity News

AUGUST 16, 2022

Moximed snagged $40 million as it works to secure approval for its device, an implantable shock absorber for the knee designed to put off the need for full joint replacement. CEO Anton Clifford touts that the MISHA Knee System is the first of its kind.

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FDA 82

Pharmaceutical Technology

AUGUST 16, 2022

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Pack

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Food and Drug Administration Pharma Manufacturing Marketing 64

MedCity News

AUGUST 16, 2022

CareHarmony, a virtual care coordination startup, recently raised $15 million in Series A funding. The company will use the funds to further the development of its platform, which uses AI to analyze patient data and provide targeted care plan recommendations.

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Patients 82

PharmaTimes

AUGUST 16, 2022

Researchers are invited to apply to receive DNA that has been synthesised using Evonetix’s platform

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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.

Safety

MedCity News

AUGUST 16, 2022

Mobile health clinics are particularly effective in facilitating access to health care for marginalized groups. Not only do they advance health equity, but they also complement other objectives of health care organizations, such as building trust and expanding community reach.

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Healthcare Healthcare 81

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. This was followed by a further deal for the global development and commercialisation of another ADC, datopotamab deruxtecan (DS-1062) in 2020, with a deal value of up to $6bn.

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Food and Drug Administration Sales Patients Food 59

MedCity News

AUGUST 16, 2022

Biotech startup Senda Biosciences is developing technology that yields a new type of medicine with two programming components: one directs the therapy to go to a particular destination in the body while the second tells the therapy what to do once it gets there. With the Series C financing, Senda aims to reach the clinic in 2024.

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Medicine Biopharma Pharma 81

pharmaphorum

AUGUST 16, 2022

The UK’s Joint Committee on Vaccinations and Immunisations (JCVI) has said that Moderna’s bivalent COVID-19 vaccine should be used for the autumn booster campaign in adults. The new recommendations came hard on the heels of the authorisation of the new shot, which provides protection against the original strain of the virus and the Omicron variant, by the Medicines and Healthcare products Regulatory Agency (MHRA).

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Government Healthcare Healthcare Medicine 57

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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.

Management

MedCity News

AUGUST 16, 2022

These issues will likely be modest, Moody’s said in its August report. Unlike hospitals, insurers will be less exposed to supply chain issues, higher interest rates and labor shortages.

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Insurance 74

pharmaphorum

AUGUST 16, 2022

The FDA has started a review of Roche’s Polivy for people with previously untreated diffuse large B-cell lymphoma (DLBCL), as the drugmaker tries to move the drug further up the treatment pathway in the US. Polivy (polatuzumab vedotin) – an antibody-drug conjugate targeting CD79b – was cleared by the European Commission for the new indication in May, building on its earlier approval as a third-line treatment for DLBCL alongside rituximab and bendamustine.

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FDA Patients Marketing Medical 57

MedCity News

AUGUST 16, 2022

To err is human. However, to err in healthcare can cost human life. Here are four reasons why clinical decision support needs to be considered.

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Healthcare Healthcare 69

Clarify Health

AUGUST 16, 2022

Key takeaway: In order to remain competitive during an economic downturn, hospital executives need to prioritize specific levers of growth: – Increasing market share on specific high-spend service lines – Partnering with the right physicians that retain and capture the most volume in your market(s) – Uncovering patterns in consumer behavior to ensure you’re proactively meeting your patient’s care expectations Most hospitals entered 2022 with thinning margins, declining outpatie

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Physicians Competition Marketing Healthcare 52

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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

Leads

Scott’s Directories

AUGUST 16, 2022

Health care providers (HCPs) are extremely busy people; their job leaves them with barely any time to think about anything that’s not relevant to them. This makes targeting HCPs for marketing extremely difficult. Marketers have to put in a lot of thought and effort to develop a marketing strategy that’s good enough to grab the interest of HCPs. A database of high-net-worth health professionals, such as the Vancouver physician directory , is a fast and smart solution to this problem.

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Physicians Marketing Specialization Doctors 52

Storyvine

AUGUST 16, 2022

We’ve worked with several nonprofits and political campaigns who want to use video to raise awareness, fundraise, or educate. Our video templates perfectly lend themselves to these types of replicable stories. But time and resources can be scarce for nonprofits, so we put together this list of Best Practices to fully prepare you as you begin your filming program.

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Training Media Education 52

PharmExec

AUGUST 16, 2022

Wed, Aug 17, 2022 2:00 PM EDT Recent advances in both oncology drug development and novel digital technologies provide a ripe opportunity to enhance the clinical trial process. Join Colin Weller and Musaddiq Khan from Medable as they discuss the key considerations around these innovations.

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Clarify Health

AUGUST 16, 2022

Key takeaway: In order to remain competitive during an economic downturn, hospital executives need to prioritize specific levers of growth: – Increasing market share on specific high-spend service lines. – Partnering with the right physicians that retain and capture the most volume in your market(s). – Uncovering patterns in consumer behavior to ensure you’re proactively meeting your patient’s care expectations.

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Physicians Competition Marketing Healthcare 52

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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.

Patients