Mon.Oct 16, 2023

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With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Fierce Pharma

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

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How Mayo Clinic Is Approaching Generative AI Risk Mitigation

MedCity News

At HLTH, Mayo Clinic Platform President John Halamka gave a window into how his health system is mitigating generative AI risks. Some of the measures Mayo is taking include running analyses on how well algorithms perform across various subgroups and training models only on internal de-identified data.

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Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Fierce Pharma

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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Microsoft’s Healthcare AI Efforts Holds Huge Promise for Patients

MedCity News

Microsoft rolled out several AI tools at the HLTH conference last week to enable providers to harness the power of data to be more efficient in their care delivery efforts. The overarching goal is to reduce costs, burnout and improve outcomes. Called Microsoft Fabric, which was rolled out broadly in May, the announcement on October 10 marks the availability of Fabric’s capabilities specifically for the healthcare vertical – to clinicians, administrators but perhaps, most importantly,

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bristol Myers Squibb's Opdivo reign expands with new earlier-stage melanoma nod

Fierce Pharma

Bristol Myers Squibb’s star Opdivo now can lay claim to an earlier melanoma stage with a new approval that “reinforces the company’s legacy” in treating the cancer type, it said. | Bristol Myers Squibb's Opdivo can now treat completely resected stage 2B or 2C melanoma, adding to its existing approvals in stages 3 and 4 tumors and setting up an expanded market battle with Merck & Co.'s star Keytruda.

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Novo Nordisk Strikes Deal for Late-Stage Hypertension & Kidney Disease Drug

MedCity News

The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes.

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What the Radiopharmaceutical Pipeline Means for Patient Care

MedCity News

With increased access to cutting-edge imaging, improved treatment options, greater personalization of treatment, reduced radiation exposure, and potential for future advances, patients can expect to receive more advanced medical care tailored to their specific needs through radiopharmaceuticals.

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AbbVie trumpets Skyrizi's resounding win against J&J's Stelara in Crohn's disease

Fierce Pharma

AbbVie already shared last month that its Skyrizi had trounced Johnson & Johnson’s rival biologic drug Stelara in Crohn’s disease. | AbbVie already shared last month that its Skyrizi had trounced Johnson & Johnson’s rival biologic drug Stelara in Crohn’s disease. Now, detailed trial results show just how decisive Skyrizi’s win is.

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Pfizer Shaves Revenue Projections, Starts Cost-Cutting Plan Amid Lower Covid-19 Product Demand

MedCity News

Pfizer lowered its revenue projections for 2023, a change it attributed to declining demand for its Covid-19 vaccine, Comirnaty, and antiviral drug, Paxlovid. Citing this revenue decline, Pfizer is implementing a companywide cost-cutting plan projected to save $3.5 billion.

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Has the science of anti-aging caught up with the dream of a longer life?

PharmaVoice

Billionaire investors and a new crop of longevity biotechs are betting big money on a lifespan-altering tipping point.

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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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What Will Rite Aid Need to Do to Recover from Bankruptcy?

MedCity News

Rite Aid filed for Chapter 11 bankruptcy protection on Sunday amid decreasing sales, billions of dollars in debt and more than a thousand lawsuits claiming the chain filled illegal prescriptions for opioids. In order for the company to get back on its feet, experts say it will have to start acting more like its competitors, such as Walgreens and CVS, by leaning more into care delivery, forging strong payer partnerships, and improving its digital offerings.

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Lonza to enhance commercial antibody-drug conjugate supply capacity

European Pharmaceutical Review

Lonza is planning to build a commercial-scale aseptic current good manufacturing practice (cGMP) filling line at its site in Stein, Switzerland. The new filling line will facilitate the aseptic filling of highly-potent antibody drug conjugates (ADCs) and lyophilisation under containment. The added capabilities will increase Lonza’s capacity to support clinical and commercial supply of bioconjugates.

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4 Trends Impacting the Patient Payment Experience

MedCity News

Patients are looking for a quick, seamless and simple payment experience from their medical providers.Here are four trends to follow that are impacting the patient payment experience today.

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UCL study suggests changes to improve MRI scans for prostate cancer

PharmaTimes

The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes

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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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Pfizer and BioNTech face 2023 revenue hits amid Covid product write-offs

Pharmaceutical Technology

Pfizer is launching a $3.5bn cost-saving programme and BioNTech expects 2023 revenues to decrease as demand for Covid treatments wanes.

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The PharmaVoice 100: Rare disease warriors

PharmaVoice

Biopharma leaders pounding away at rare diseases so patients with few other options can have healthier lives.

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CHMP recommends European authorisation for seven new drugs 

Pharmaceutical Technology

Pfizer’s Elrexfio and Astellas’ Veozah are among the seven drugs recommended for approval by the European regulatory committee.

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Synaffix partners with SOTIO Biotech in deal worth up to $740m

PharmaTimes

SOTIO will gain access to Synaffix’s three ADC technologies - News - PharmaTimes

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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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US FDA grants approval for BMS’ Opdivo for melanoma

Pharmaceutical Technology

The US FDA has granted approval for Bristol Myers Squibb’s (BMS) Opdivo to treat stage IIB or IIC melanoma patients.

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Novo Nordisk agrees $1.3bn hypertension acquisition

European Pharmaceutical Review

In a deal of up to $1.3 billion, Novo Nordisk has agreed to acquire ocedurenone for uncontrolled hypertension with potential application in cardiovascular and kidney disease from KBP Biosciences. The oral small molecule, non-steroidal mineralocorticoid receptor antagonist (nsMRA) medicine is currently being investigated in the CLARION-CKD Phase III trial in uncontrolled hypertension and advanced chronic kidney disease (CKD).

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Bayer adds QR code to pack to help blind patients

pharmaphorum

Bayer adds QR code to pack to help blind patients Phil.

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Bristol Myers Squibb Expands Oncology Portfolio with Mirati Acquisition

Pharmaceutical Technology

On October 9, Bristol Myers Squibb announced it had an agreement to acquire Mirati Therapeutics, a targeted oncology biotech company.

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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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AZ’s Tagrisso plus chemo get fast FDA review for lung cancer

pharmaphorum

AZ’s Tagrisso plus chemo get fast FDA review for lung cancer Phil.

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How to De-risk the Development of Highly Sensitive Injectables Using High-Performance Pre-fillable Syringe Systems

PharmaTech

Enrico Barichello, Stevanato Group, discusses the risks associated with the interaction between primary packaging and complex novel therapeutics and describes how to prevent or manage concerns utilizing newer, pre-sterilized syringe systems that have more unique characteristics.

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Unlock the Perfect Medical Rep Introduction: First Impressions Matter

Contrarian Sales Techniques

When I set out to craft my self introduction as a medical sales representative , I like to think of it as a mix of putting on my best professional attire, being crystal clear in my intentions, and adding a dash of my charming personality. My personal cheat sheet for making a memorable first impression in the world of medical sales: 1. Greeting and Personal Introduction: Address the recipient appropriately (e.g., "Dr.

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How to Streamline Your Workflow With These ChatGPT Prompts for Sales

Quantified

Since ChatGPT burst onto the scene in November of 2022, it’s had an ever-accelerating impact on businesses in all segments of the economy. That’s especially been the case in the sales arena where, according to a recent McKinsey report , the effect of ChatGPT and similar generative AI technologies has been nothing short of revolutionary. In all aspects of the selling process, from initial market research to post-sale follow-up activities, and especially in the realm of AI-assisted sal

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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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Proprio Announces Completion of World’s First Light Field-Enabled Spine Surgery Using its AI-Driven Technology Platform, Paradigm™

Legacy MEDSearch

Proprio , a Seattle-based medical technology company, announced today the successful first-in-human use of its surgical technology platform, Paradigm , by Dr. Richard J. Bransford, MD, a global leader in spine surgery and education at University of Washington Harborview Medical Center. With an initial focus on the 1.6 million spinal procedures performed each year in the US, Paradigm is a first-of-its-kind platform fusing light field imaging technology with artificial intelligence (AI) to give s

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Building Trust: Transparency and Authenticity in Pharma Digital Marketing

Pharma Marketing Network

In the modern world, trust is a critical factor in the success of any business. In the pharmaceutical industry, it is especially important to build trust with consumers, as this can have a direct impact on the reputation and success of the company. In order to establish trust, pharma digital marketing must focus on transparency and authenticity. By understanding transparency, leveraging authenticity, and developing trust, pharma digital marketing can be enhanced and become more effective.

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How to Factor AI Sales Technology into Sales Budgets Moving Forward

Quantified

Artificial intelligence is reshaping how sales organizations across every industry are doing business. It can increase revenue by speeding up response times, improving marketing and outreach with more personalized communications, and boosting closed-won rates by giving a sales team better insight into leads. Simultaneously, AI sales technology can reduce expenses by automating repetitive tasks, decreasing delays caused by bottlenecks and back-and-forth communications, and eliminating the need fo

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Harnessing the Power of Social Media in Pharmaceutical Marketing

Pharma Marketing Network

The pharmaceutical industry is increasingly turning to social media to reach patients, healthcare professionals, and other stakeholders. It is an effective way to increase brand awareness, engage with customers, and spread important public health messages. In this article, we’ll explore the power of social media in pharmaceutical marketing, and how to develop a successful strategy.

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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.