Sat.Jan 27, 2024 - Fri.Feb 02, 2024

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Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month

Fierce Pharma

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. | Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.

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We’ve Actually Treated Tens of Thousands of People on Ozempic to Date – Here’s What Really Happens and What It Likely Means for Solving Our Obesity Epidemic

MedCity News

We and our collective organizations’ providers have treated 10,000’s of Americans, who suffer from obesity and/or Type 2 diabetes with GLP-1 drugs. And we believe we have important observations to share.

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Merck is on the lookout for more opportunities within immunology

Pharmaceutical Technology

At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.

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The Path for Prescription Drug Sales

Pharmaceutical Commerce

A dive into this market reveals that the latest numbers yield promising results—a global value of a worldwide $1.6 trillion—but it will continue to be attributed to past, present, and future healthcare spending.

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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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Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

Fierce Pharma

More than two years after Aduhelm's controversial and ill-fated FDA accelerated approval, Bi | Biogen is discontinuing its first Alzheimer's disease therapy, Aduhelm, after walking a rocky path. The company is taking a $60 million charge, halting sales and terminating a confirmatory trial.

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‘Food Equity Can’t Be a Side Gig’: How Food as Medicine is Becoming A Core Team Capability

MedCity News

As the food as medicine movement grows, some payers and healthcare organizations are carving out specific roles and teams dedicated to food and nutrition. Doing so can be beneficial considering the significant impact diet can have on health outcomes.

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Lundbeck study knocks confidence in alpha-syn as CNS target

pharmaphorum

A phase 2 trial of Lundbeck’s alpha-synuclein-targeting drug Lu AF82422 has failed to reach statistical significance in patients with multiple system atrophy (MSA), although the company says there are encouraging “signals of efficacy” in the data.

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FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Fierce Pharma

Mark your calendars, oncology drug and CAR-T therapy developers. | Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti.

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How Artificial Intelligence Could Be the Ultimate Weapon Against Cancer

MedCity News

Even just a year ago, we couldn’t fathom a cure for cancer. Now, we can. Artificial intelligence (AI) is rapidly transforming the healthcare industry, with its ability to process and analyze vast amounts of data. Cancer treatment is one area that could benefit significantly from AI, as it can aid in early detection, precise diagnosis, and personalized treatment plans.

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Ron Lanton, Partner, Lanton Law PLLC, Discusses New Drug Plus Pricing Models

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.

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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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Digital prescriptions added to NHS App

pharmaphorum

From today, a new feature added to the NHS App used in the UK will allow millions of people to submit and view prescriptions, in a bid to save time for patients and doctors. The digital prescription function, which does away with the need for paper scrip, was put through its paces in a pilot trial last year involving a million users of the app, now being used by three-quarters of the UK population or around 33.5 million people.

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GSK confirms Arexvy is a blockbuster but says the RSV battle has just begun

Fierce Pharma

Beaten to the punch by Pfizer in developing a vaccine for COVID, GSK has regained some of its lost luster as a vaccine powerhouse with its advancement of respiratory syncytial virus (RSV) shot Arex | GSK's RSV vaccine Arexvy generated $1.5 billion in sales in 2023 compared to $890 million for Pfizer's Abrysvo. But the British pharma major says that the successful launch represents just one round of a boxing match, and much is still to be decided, especially with Moderna expected to joi

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Simplifying the Maternal Care Network

MedCity News

A new era in maternal care is emerging with the advent of maternity care management platforms. Innovative organizations are centralizing the coordination of all patient care aspects, seamlessly integrating with providers’ electronic health records, existing workflows, and health information exchanges.

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Immunotherapy changed the cancer treatment landscape. Is the gut microbiome the next frontier?

PharmaVoice

The president of L.A.’s City of Hope Cancer Center believes the current state of cancer treatments can be greatly improved with a peek into the gut’s many mysteries.

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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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Grifols sues Gotham City over fraud allegations

pharmaphorum

Spanish drugmaker Grifols has hit back at hedge fund Gotham City Research, which claimed it had fraudulently manipulated its financial reporting, with a lawsuit filed in New York. The complaint has been brought against Gotham City and co-founders Daniel Yu and Cyrus de Weck, along with other defendants, and accuses them of being “predatory short sellers…who illicitly profit from their rigged short-and-distort schemes.

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WuXi Biologics plays defense after US bill brands certain Chinese biopharmas as security threats

Fierce Pharma

New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. | New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. WuXi Bio, for its part, says it's not affiliated with the military in China.

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Neuro Biotech Alto Adds $128M in IPO Cash for Biomarker-Based Psych Drugs

MedCity News

Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company’s two most advanced programs are depression drugs in mid-stage development.

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Moderna leads the development of mRNA vaccines in infectious diseases

Pharmaceutical Technology

The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.

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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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Novartis calls time on Tim3 drug sabatolimab in MDS

pharmaphorum

Novartis ends development of Tim3 antibody sabatolimab in myelodysplastic syndromes after failed phase 3 trial.

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Who's No. 1? With $25B in sales, Merck's Keytruda looks to be the top-selling drug of 2023

Fierce Pharma

With Merck reporting a whopping $25 billion sales haul for | With Merck reporting a whopping $25 billion sales haul for Keytruda on Thursday, the PD-1 cancer superstar appears to be the world’s top-selling drug in 2023. Keytruda looks set to take over the top spot from Pfizer and BioNTech’s Comirnaty, which ruled the previous two years, scoring sales of $55.9 billion in 2022 and $55.1 billion in 2021.

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Cigna MA Sale to HCSC Could Still Clear Way for Humana Acquisition, Expert Says

MedCity News

Despite Cigna and Humana ditching their pursuits to combine in December, one industry expert believes there’s still a chance after Cigna announced its plan to sell its Medicare Advantage business to Health Care Service Corp.

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KOL Engagement Trends Webinar

Impetus Digital

Register for one of Impetus’ upcoming webinars between February 26-28: Top-5 Trends in Virtual KOL Engagement About the webinar We’re taking a look at the top trends from 2023 and share our predictions for the new year. Our expert speakers will share their unique industry insights and the “best of the best” virtual collaboration and insight-gathering programs from 2023.

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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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Novo Nordisk sales surge drives value towards $500bn

pharmaphorum

A surge in 2023 sales and profits fuelled by diabetes and obesity drugs has driven Novo Nordisk's valuation toward $500bn

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Merck still in the market for deals in the $1B to $15B range, CEO says

Fierce Pharma

Even after the acquisitions of Prometheus and Acceleron, Merck is ready to make more deals in the $1 to $15 billion range, according to CEO Rob Davis.

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Pharma Just Increased the Price of Hundreds of Drugs. PBMs are Minimizing the Impact for Health Plans, Employers and Patients

MedCity News

While pharmaceutical companies continue to raise list prices year-over-year, we work behind the scenes to fight the trend by driving competition, negotiating with drugmakers and incentivizing the use of less expensive medicines that deliver the same clinical value.

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Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release

PharmaTech

This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.

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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 subcutaneous Opdivo clears first phase 3 trial

pharmaphorum

Bristol-Myers Squibb is getting closer to offering a subcutaneous version of its cancer immunotherapy Opdivo to patients after it matched the current intravenous formulation in a head-to-head trial in kidney cancer.

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In Medicare negotiation process, HHS sends 1st price offers as industry blasts lack of transparency

Fierce Pharma

Despite litigation and denouncements from the biopharma industry, Medicare price negotiations under the Inflation Reduction Act are rolling on. | Despite litigation and denouncements from the biopharma industry, Medicare price negotiations under the Inflation Reduction Act are rolling on. And today, the government is sending out its first round of offers on affected drugs.

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Why Startups Are Seeking Out Health Systems’ VC Arms

MedCity News

Health system VC arms appear to have a lot more to offer to startups than traditional VC funds. Startup founders say that the tech pilots they launch with their health system partners end up being more effective because they are more incentive-aligned. For health systems, investing in a startup allows them to have a hand in shaping the tools they will eventually deploy across their enterprises to solve issues like burnout, payment delays and excessive hospital readmissions.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

N-Nitrosamines By far the biggest issue bedevilling industry during 2023 was the continuing N-nitrosamine contamination saga, which was covered in the third issue of EPR 2023. 1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way t

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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.