Wed.Dec 13, 2023

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Pfizer warns of further sales decline for COVID products, plots $500M in additional cost cuts

Fierce Pharma

Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be | Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be finalized on Thursday—Pfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance. The company expects revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products.

Sales 351
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Who Really Benefits From Medicare Advantage Plans?

MedCity News

Health systems have been increasingly dropping MA contracts, saying that they cause their organizations to lose too much money and result in dangerous patient care delays. To mitigate this issue, experts think large MA plans need to delegate more utilization management duties to health systems rather than handling it themselves.

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Trending Sources

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After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

Fierce Pharma

After last year’s explosive ruling to overturn the historic abortion ruling reached in Roe v. Wade, abortion access is back up for debate in the Supreme Court. | The Supreme Court's final decision could have consequences beyond abortion access. That's because the original verdict questioned the FDA's decision-making authority, prompting amicus brief submissions from high-profile industry players.

Biopharma 224
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Report: Less than Half of Employers Are Confident In Integrity of Hospitals, PBMs

MedCity News

About eight in 10 employers think drug costs, high-cost claims and hospital prices are a “significant threat to affordability,” according to a new survey from National Alliance of Healthcare Purchaser Coalitions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novo Holdings' Xellia to lay off 80 workers at former Boehringer Ingelheim plant in Ohio

Fierce Pharma

After wrapping up a $200 million renovation at a former Boehringer Ingelheim plant near Cleveland, Ohio, several years back, Danish specialty drugmaker Xellia Pharmaceuticals is paring back its wor | After wrapping up a $200 million renovation at a former Boehringer Ingelheim plant near Cleveland, Ohio, several years back, Danish specialty drugmaker Xellia Pharmaceuticals is paring back its workforce in The Forest City.

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Google Unveils Suite of Healthcare-Specific Generative AI Models

MedCity News

Google introduced a new suite of healthcare-focused generative AI models designed to speed up workflows for clinicians and medical researchers. Health systems and medical research organizations, including HCA Healthcare and BenchSci, have been testing these models since April.

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Leveraging Personalized Digital Engagement to Elevate Medicare Advantage Star Ratings

MedCity News

With the Centers for Medicare & Medicaid Services (CMS) releasing annual changes that impact all facets of the MA Star Ratings program, health systems and providers need to stay ahead of these changes and navigate them effectively by leveraging technology that can guide and optimize the complete patient journey.

Patients 109
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Europe publishes first list of critical medicines

European Pharmaceutical Review

The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first Union list of critical medicines. The list contains more than 200 active substances that are considered “critical for healthcare systems” across the EU/EEA. Continuity of supply is seen as a priority for these substances and shortages should be avoided.

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Challenging the ‘Growth By Any Means’ Approach in Hospital Marketing

MedCity News

When it comes to organizational growth, the concept of “growth by any means” is hurting the hospital’s bottom line and pushing healthcare to a tipping point – adding expense to American healthcare without adding value.

Marketing 105
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A New Era in Clinical Trials

PharmExec

Current industry challenges present an opportunity for innovation and the adoption of new solutions, particularly in addressing barriers related to patient recruitment, engagement, and retention.

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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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How simulations help device makers meet booming autoinjector demand

Pharmaceutical Technology

Advanced simulation methods and tools are not only paving the way for more efficient manufacturing operations. At SHL Medical, they’re also speeding up the development of new production facilities around the globe.

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A former CDC head on key R&D areas, public trust and if we learned anything from COVID-19

PharmaVoice

Dr. Julie Gerberding, now president and CEO of the Foundation for the National Institutes of Health, shares lessons learned from a long career in academic, public health and industry.

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Trade & Channel Strategies 2023: A DSCSA Update

Pharmaceutical Commerce

The seminar examines where members of the pharma supply chain stand in terms of preparation, being that the act has officially been enacted.

Pharma 105
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AVIA Webinar Panelists Share Vision for How Health Systems Can Engage and Retain Patients [Sponsored]

MedCity News

The panelists for the digital flywheel in healthcare discussion included: Sara Vaezy of Providence; Justin Dearborn of Praia Health, Providence Digital Innovation Group; and Sonia Singh of AVIA, who served as the moderator.

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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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Study confirms safety of new flow-diverting stent to treat brain aneurysms

PharmaTimes

In England, ruptured brain aneurysms occur in around one in 15,000 people every year - News - PharmaTimes

Safety 112
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Eisai sets Leqembi price in Japan at a discount to US

pharmaphorum

Eisai and Biogen’s Alzheimer’s disease therapy Leqembi is due to be launched in Japan, its second market, on 20th December, and will be priced quite a lot lower there than in the US. The anti-amyloid antibody has been included in the Japan National Health Insurance (NHI) Drug Price List at just under JPY 3 million (around $20,500) per patient per year, whereas in the US its list price before discounts or rebates was set at $26,500.

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ACSR to use digitised pathology for HIV-associated malignancies

PharmaTimes

The software has reduced the time to provide pathology data from days to hours - News - PharmaTimes

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SCOTUS will rule on abortion pill access in landmark case

pharmaphorum

The Supreme Court of the US has said it will consider a lower court ruling that would restrict access to the abortion pill mifepristone and is considered to be tied to the standing and authority of the FDA.

FDA 77
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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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BMS agrees $8.4bn ADC collaboration with SystImmune

European Pharmaceutical Review

Bristol Myers Squibb has entered an exclusive license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). As part of the potential $8.4 billion deal the companies will jointly commercialise BL-B01D1 in the United States. Bristol Myers Squibb will also assume sole responsibility for development and commercialisation of the ADC in the rest of the world, outside of Mainland China.

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Pharma’s Business Case for RWE: Tapping the Full Value From These Insights

PharmExec

How drugmakers can better harness real-world evidence to drive their clinical and commercial objectives, while also providing greater clarity for healthcare providers and improved access to therapy for the patients they serve.

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EC approves treatment for rare haematological disorder

European Pharmaceutical Review

The European Commission has approved Blueprint Medicines’ Ayvakyt® (avapritinib) for treatment of adult patients with the haematological disorder indolent systemic mastocytosis (ISM). “Ayvakyt represents an important treatment breakthrough as the first medicine approved for patients living with ISM, and the only therapy designed to selectively target the primary genetic driver of the disease,” declared Jens Panse, Deputy Director of the Department of Haematology/Oncology of the University Hospit

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Pharnext hit again as rare disease drug flunks phase 3 test

pharmaphorum

Pharnext hit again as rare disease drug flunks phase 3 test Phil.

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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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First and Third-Party Cookies – Privacy Implications on Paid Media

Eversana Intouch

In the dynamic realm of digital marketing, leveraging first-party and third-party cookies is akin to navigating uncharted territories. And while these data sources have long been the bedrock of digital strategies, the landscape has drastically shifted with the surge in privacy legislation. In this POV, we outline how valuable data from first-party and third-party cookies fuel your paid media strategy as well as your larger digital ecosystem.

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Pfizer Clears Final Regulatory Hurdles to Acquire Seagen Inc

PharmExec

Pfizer Inc. expects to close its $43 billion acquisition of Seagen Inc., on December 14, 2023.

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Sanofi to Terminate Rare Disease Drug Licensing Agreement with Maze Therapeutics in Wake of FTC’s Challenge

PharmaTech

Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.

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Leveraging demand forecasting to make smarter healthcare investment decisions

Clarify Health

To beat the intense competition across the healthcare industry, it’s critical for providers to leverage demand forecasting to accurately forecast future healthcare utilization needs for their services and develop robust roadmaps for growth and success. For healthcare leaders, that means creating strategic plans to minimize patient leakage, relieve financial pressures, and retain and grow the patient populations they serve.

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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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Enhancing the Solubility of Active Pharmaceutical Ingredients Using Hot Melt Extrusion and Polyvinyl Alcohol (Dec 2023)

PharmaTech

Solubility of the active pharmaceutical ingredient (API) in an oral formulation is critical for absorption from the gastrointestinal (GI) tract and the intended therapeutic effect. Ensuring that an API has the necessary solubility can be challenging for drug developers and formulators. If limitations in solubility cannot be successfully addressed, a new chemical entity (NCE) is unlikely to advance in the development pipeline.

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FDA to Evaluate Application for MDMA to Become First Approved Psychedelic Drug for PTSD

Pharmaceutical Commerce

MAPS Public Benefit Corporation was previously granted Breakthrough Therapy Designation by the FDA for MDMA and is seeking a priority review for the NDA submission of the psychedelic treatment for post-traumatic stress disorder.

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MAPS Seeks Approval of First Psychedelic-Assisted Therapy for PTSD

PharmExec

MAPS Public Benefit Corporation filed a new drug application for MDMA (midomafetamine capsules) for use with psychological intervention for the treatment of post-traumatic stress disorder.

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Daiichi Sankyo taps Depixus to speed RNA drug discovery

pharmaphorum

Daiichi Sankyo taps Depixus to speed RNA drug discovery Phil.

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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.