Sat.May 11, 2024 - Fri.May 17, 2024

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It’s Past Time to Prevent Polypharmacy in U.S. Healthcare

MedCity News

The dangers of polypharmacy and its increasingly wide reach across the American population make it imperative that we enhance the accuracy and efficiency of medication reconciliation processes. The post It’s Past Time to Prevent Polypharmacy in U.S. Healthcare appeared first on MedCity News.

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As Bristol Myers reveals trial failure, AstraZeneca's Imfinzi stays king in stage 3 lung cancer

Fierce Pharma

Another attempt at improving upon AstraZeneca’s Imfinzi in stage 3, unresectable non-small cell lung cancer (NSCLC) has gone up in flames. | Following AstraZeneca's setback in attempting to improve upon Imfinzi's efficacy in unresectable stage 3 lung cancer, a Bristol Myers Squibb endeavor has gone up in flames, as well. Now, market watchers are turning their attention to upcoming readouts from Merck & Co. and Roche.

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Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

pharmaphorum

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

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Leading Through Change: Insights from a Keynote Inspirational Business Speaker

Scott Burrows

As a keynote inspirational speaker, I’ve had the privilege of addressing audiences from various industries and backgrounds, but there’s something uniquely invigorating about speaking at sales and leadership conferences. Recently, I had the opportunity to kick off a sales conference for a broker dealer that had just been acquired by the largest independent broker dealer in the U.S.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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SmarterDx Rakes In $50M For Its AI That Helps Hospitals Capture More Revenue

MedCity News

SmarterDx — an AI startup that provides clinical review and quality audits for medical claims — closed a $50 million Series B funding round, bringing its total funding to date to $71 million. The post SmarterDx Rakes In $50M For Its AI That Helps Hospitals Capture More Revenue appeared first on MedCity News.

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Amgen's 'watershed' lung cancer drug nabs FDA nod in deadly, tough-to-treat form of the disease

Fierce Pharma

Seven months after Amgen’s chief medical officer referred to trial | Seven months after Amgen’s chief medical officer referred to trial results for the company's investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC).

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LogiPharma Europe 2024: World Courier President Talks Mitigating Supply Chain Risks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno at LogiPharma Europe, Nick Porter, President, World Courier discusses mitigating supply chain risks, the future of artificial intelligence in pharma logistics, and more.

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Telehealth Is Far From Dead, Says Providence’s Virtual Care Chief

MedCity News

This year has been a messy one for virtual care companies, but that doesn’t mean that telehealth is dead, according to Eve Cunningham, Providence’s chief of virtual care and digital health. In her view, virtual care can definitely still be an important part of the care delivery model — but only if it is embedded into the greater healthcare delivery ecosystem.

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With 4-year data, Novo bolsters star power of obesity blockbuster Wegovy

Fierce Pharma

With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.

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Bayer cutbacks start to be felt with 1,500 jobs shed in Q1

pharmaphorum

Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold

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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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Impact of EU sustainability directive on supply chains

European Pharmaceutical Review

Eighty four percent of pharmaceutical and healthcare companies consider that the new EU Corporate Sustainability Due Diligence Directive (CSDDD) directive is an opportunity to “align human rights and environmental protection with their business objectives”, findings from a survey by supply chain specialist INVERTO has found. EU operations must comply with the new directive.

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Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval

MedCity News

Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. Analysts project the new Amgen drug will become a blockbuster seller. The post Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval appeared first on MedCity News.

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In Big Pharma's growth rankings, Lilly took top spot from Novo Nordisk in Q1

Fierce Pharma

The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. | The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. With 18 of the industry’s top 25 companies achieving year-over-year revenue gains, Q1 came close to matching the final quarter of last year, when 21 of the top 25 companies showed increases.

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GSK, UK govt put £130m into antimicrobial resistance fight

pharmaphorum

GSK has become the first founding partner of the new Fleming Initiative, which aims to tackle the rising threat of antimicrobial resistance (AMR) and is also backed by the UK government.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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FDA approves Amgen T-cell engager for small cell lung cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The drug received accelerated regulatory approval based on the “encouraging response rate and duration of response (DoR) observed in clinical studies,” Amgen said.

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Innovation Doesn’t Always Have To Involve The Latest Tech, MD Anderson Exec Says

MedCity News

While adopting new technology is obviously a big part of healthcare innovation teams’ work, there are plenty of worthwhile initiatives that don’t involve advanced technologies, pointed out Dan Shoenthal, chief innovation officer at MD Anderson Cancer Center. The post Innovation Doesn’t Always Have To Involve The Latest Tech, MD Anderson Exec Says appeared first on MedCity News.

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FDA snubs another China-made PD-1 with rejection of Elevar, Hengrui's liver cancer combo

Fierce Pharma

China-made PD-1 inhibitors just can’t get a clean pass through the FDA. | China-made PD-1 inhibitors continue to struggle at the FDA. This week, the U.S. agency rejected Elevar Therapeutics and Jiangsu Hengrui Pharma's PD-1 combination in liver cancer.

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Lung disease imaging AI from Brainomix gets FDA nod

pharmaphorum

Brainomix gets FDA approval for e-Lung, an AI tool that assists in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical images.

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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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Effective data quality governance: challenging five common myths

European Pharmaceutical Review

Everything in the pharmaceutical industry now seems to rely increasingly heavily on effective organisation and handling of data. But what needs to happen so that users/process owners can fully trust data’s quality, integrity, reliability, etc? Steve Gens (SG): The more critical data becomes to regulatory procedures, to safety processes, to clinical research, to manufacturing, and ultimately connecting all of those parts of the value chain more seamlessly, the greater the need for formal and cons

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DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference?

MedCity News

The U.S. Department of Justice recently launched a task force on healthcare monopolies. Experts have varying opinions on how it will impact the healthcare industry. The post DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference? appeared first on MedCity News.

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Bayer slashed 1,500 roles in Q1 as simpler organization takes shape

Fierce Pharma

When Bayer unveiled a restructuring in January, the company didn’t provide specifics on the number of planned job cuts. | When Bayer unveiled a restructuring in January, the company didn't provide specifics on the number of planned job cuts. Now, the size of the initial round of cuts shows that CEO Bill Anderson means business.

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FDA clears Roche self-collection system for HPV screening

pharmaphorum

The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Ensuring sterility of a novel anti-VEGF bispecific antibody

European Pharmaceutical Review

Research has demonstrated a cost-effective storage solution for compounded faricimab kept for a maximum of 28 days. Authors of the paper stated that it provides off-label use of the anti- vascular endothelial growth factor (VEGF)/angiopoietin-2 (Ang-2) biologic , “while maintaining safety in the treatment of patients”. Their study compared the stability, sterility, and binding affinity to VEGF and Ang-2 of faricimab.

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Sutter Health Partners with Millie to Incorporate Midwifery into Its Maternal Care Model

MedCity News

As more hospitals across the country shut down their maternity wards, a Sutter Health-owned hospital in Berkeley has taken proactive steps to ensure it can continue providing care for the pregnant people in its community. The hospital partnered with Millie, a Berkeley-based startup offering hybrid maternal care from midwives and doulas. The post Sutter Health Partners with Millie to Incorporate Midwifery into Its Maternal Care Model appeared first on MedCity News.

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After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi

Fierce Pharma

After suffering a setback with U.S. regulators last month, Eisai and Biogen’s effort to deploy a more convenient version of their Alzheimer’s disease drug Leqembi appears to be back on track. | Late Tuesday, Biogen and Eisai said they kicked off a rolling FDA submission for the subcutaneous version of Leqembi—which is currently infused—after winning a fast track tag from the agency.

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Home testing devices for sleep apnoea backed for NHS use

pharmaphorum

Five home-testing devices to diagnose sleep apnoea, which can affect the health of around 2.5 million adults in the UK, have been recommended for NHS use by NICE.

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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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Sanofi adds to biomanufacturing investment in France

European Pharmaceutical Review

Using an investment of over €1 billion, Sanofi plans to generate new bioproduction capacity at three sites in France, focusing on biologic medicines. The sites are in Vitry-sur-Seine (Val de Marne), Le Trait (Seine-Maritime) and Lyon Gerland (Rhône). This cash injection will create more than 500 jobs and “significantly strengthen” France’s present and future ability to control the full production process of essential medicines, the company stated.

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Right-to-Repair Laws Could Threaten Healthcare Safety

MedCity News

Healthcare devices must be exempted from general right to repair legislation. The post Right-to-Repair Laws Could Threaten Healthcare Safety appeared first on MedCity News.

Safety 118
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Shionogi's antiviral comes up short in global COVID-19 trial

Fierce Pharma

While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global sta | While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage.

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Cytokinetics prepares to take on BMS’ Camzyos in HCM

pharmaphorum

Cytokinetics has revealed the results from a phase 3 trial of its hypertrophic cardiomyopathy (HCM) drug aficamten that it hopes will allow it to compete with Bristol-Myers Squibb’s first-to-market Camzyos.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.