Sat.Feb 03, 2024 - Fri.Feb 09, 2024

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AstraZeneca invests $300m to build new facility in US

Pharmaceutical Technology

AstraZeneca is investing $300m in a facility in Rockville, US - a significant step in launching its cell therapy platforms in the country.

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PBMs take bulk of blame as senators question BMS, J&J and Merck CEOs on high drug prices in US

Fierce Pharma

Thursday, when senators questioned three Big Pharma CEOs about the high price of drugs in the U.S., Health, Education, Labor and Pensions (HELP) committee chairman Bernie Sanders, I-Vermont, put th | CEOs from Bristol Myers Squibb, Johnson & Johnson and Merck faced tough questions from senators on why prices for drugs in the U.S. exceed those in other countries.

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Trending Sources

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Overcoming Hearing Healthcare Barriers to Realize Gene Therapy Promise

MedCity News

The preliminary results from three clinical trials administering gene therapy to address deafness from otoferlin mutations mark inspiring and incredible progress in hearing healthcare.

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Drug/software combination improves blood pressure control

pharmaphorum

The combination of drugs for hypertension and software to personalise dosing to an individual patient has been shown to deliver improved blood pressure control and adherence to therapy in a pilot study.

Patients 112
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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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Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

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AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires

Fierce Pharma

Following a slew of cell therapy biotech team-ups, AstraZeneca is taking manufacturing into its own hands. | AstraZeneca is plugging $300 million into a new facility in Rockville, Maryland, to launch its cell therapy platforms in the United States for cancer trials and future commercial supply. In turn, AZ will create more than 150 new jobs.

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Gilead drops CD47 drug magrolimab for blood cancers

pharmaphorum

Gilead Sciences has said it will no longer develop its CD47-targeting antibody magrolimab in blood cancers after data suggested that patients taking the drug in clinical trials were more likely to die than those in control groups.

Patients 113
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The Correlation Between a New York State Law Repeal and Vaccine Coverage in Schools

Pharmaceutical Commerce

A cohort study investigates the impact of Senate Bill 2994A and answers the question: does the repeal of school-entry nonmedical vaccination exemptions result in a rise in school vaccinations?

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AstraZeneca hit CEO Pascal Soriot's $45B revenue goal after all. But is Enhertu approaching a plateau?

Fierce Pharma

With $45.8 billion in 2023 revenues, AstraZeneca has met the $45 billion-by-2023 goal CEO Pascal Soriot established in 2014 when he was fending off a takeover bid from Pfizer. | AstraZeneca has met the $45 billion-by-2023 revenue goal that CEO Pascal Soriot established in 2014. But questions have emerged for one of the company's key growth drivers.

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Mayo Clinic Is Helping Develop a Tool Providers Can Use to Curb Clinical Bias

MedCity News

Mayo Clinic has entered into a collaboration with TruLite Health — Mayo is helping the Phoenix-based startup develop its software platform designed to address providers’ clinical bias. The health system said it chose to collaborate with TruLite because of the platform’s potential to mitigate health inequities and enhance patient outcomes at the point of care.

Patients 133
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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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Jazz buys KRAS inhibitors from Redx in $880m deal

pharmaphorum

Jazz Pharmaceuticals has agreed another pipeline-building deal, this time paying $10 million upfront for rights to a KRAS inhibitor programme from UK biotech Redx Pharma, continuing a move into targeted cancer therapies. Under the terms of the deal, Jazz will acquire Redx’s KRAS inhibitor programme outright, including multiple preclinical-stage drug candidates, and will take responsibility for ushering the most promising compounds through clinical trials and onto the market.

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Study Highlights the Value of Patient Support Programs

Pharmaceutical Commerce

Researchers explore the proportion of approved drugs in the Canadian marketplace that utilize manufacturer-sponsored patient support programs, along with the types of medications that are more likely to do so.

Patients 105
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Novartis CEO’s 2023 pay rises 21% as Roche's helmsman nets $11M in his first year

Fierce Pharma

After leading Novartis and Roche through pivotal years in 2023, the CEOs of the Swiss drug giants each netted multimillion-dollar compensation packages. | After leading Swiss drug giants Novartis and Roche through pivotal years, their CEOs have each netted multimillion-dollar compensation packages for 2023.

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Five Ways AI Will Impact Clinical Trials This Year

MedCity News

The integration of AI technologies holds promise for enhancing outreach efforts, streamlining recruitment processes, and addressing long-standing barriers and biases that hinder diversity and inclusion in clinical trials.

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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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Cedars-Sinai mental health app launches on Apple Vision Pro

pharmaphorum

Right after the official launch of the new Apple Vision Pro mixed reality headset, Cedars-Sinai has launched a generative artificial intelligence (genAI) app that will use the technology to provide mental health support for patients.

Patients 105
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RegenxBio advances two candidates to make waves in the CNS space

Pharmaceutical Technology

AFFINITY data has spurred RegenxBio towards a pivotal study for DMD while pivotal CAMPSIITE data has the company moving towards an FDA BLA.

FDA 111
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Already rolling in diabetes and obesity, Eli Lilly touts tirzepatide's midstage MASH win

Fierce Pharma

In a midstage trial, Eli Lilly’s star diabetes and weight-loss drug tirzepatide showed promise in fatty liver disease, a difficult-to-treat condition that doesn’t yet have an FDA-approved therapy.< | Eli Lilly's star diabetes and weight loss drug tirzepatide showed promise in fatty liver disease with a massive anti-MASH benefit accompanied by a "clinically meaningful" anti-fibrosis effect.

FDA 286
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Moderna & Ionis-Partnered Biotech Lands $94M in IPO Cash for Gene-Editing R&D

MedCity News

Metagenomi finds novel gene-editing tools by mining microbial samples from around the world. Already partnered with Moderna and Ionis Pharmaceuticals, the company said its IPO cash will support ongoing preclinical research.

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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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Roche gets first world okay for PNH drug crovalimab

pharmaphorum

China has become the first country in the world to approve Roche’s anti-complement C5 antibody crovalimab, the only treatment for the rare disorder paroxysmal nocturnal haemoglobinuria (PNH) that can be given by subcutaneous injection.

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What Goes into Planning LogiPharma Europe?

Pharmaceutical Commerce

A dive into the intricacies of how to ensure a long-running event stays fresh and relevant to the needs of the pharmaceutical industry.

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Astellas' sales expectations are up for Padcev, down for Veozah

Fierce Pharma

Less than two months after the FDA approved the combination treatment of Astellas and Pfizer’s Padcev and Merck’s Keytruda in first-line bladder cancer, the Japanese company has

Sales 286
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Novo Holdings Bolsters GLP-1 Production Capacity With $16.5B Catalent Buyout

MedCity News

After Novo Holdings acquires Catalent, it will sell three of the contract manufacturing giant’s sites to Novo Nordisk. Those facilities already make Novo Nordisk’s GLP-1 drugs for metabolic conditions, and they will help the company meet projected demand for these products in years to come.

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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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Astellas raises Padcev forecasts on bladder cancer data

pharmaphorum

A bladder cancer study prompts Astellas to lift peak sales prediction for Padcev, although its menopause therapy Veozah isn’t ramping up as hoped.

Sales 111
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US Senate committee interrogates big pharma on “outrageously high” drug prices

Pharmaceutical Technology

Pharma CEOs defended their high prescription drug costs, stating that the current prices are necessary for continued innovation.

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Eli Lilly mounts clinical and commercial case for tirzepatide as Mounjaro, Zepbound chalk up major gains

Fierce Pharma

Locked in a heated battled with Novo Nordisk’s semaglutide franchise, Eli Lilly’s tirzepatide is beginning to come into its own—both with regards to sales and amid attempts to show the dual GIP/GLP | Locked in a heated battled with Novo Nordisk’s semaglutide franchise, Eli Lilly’s tirzepatide is beginning to come into its own—both with regards to sales and amid attempts to show the dual GIP/GLP-1 agonist can strike out beyond diabetes and obesity.

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Upsized Kyverna IPO Gets $319M to Bring CAR T-Therapy to Autoimmune Diseases

MedCity News

Cell therapies were first validated in cancer, but Kyverna Therapeutics aims to show they’re safe enough for autoimmune diseases. The biotech plans to deploy its IPO cash across clinical trials in lupus nephritis, multiple sclerosis, systemic sclerosis, and myasthenia gravis.

Biopharma 117
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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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AbbVie’s new drugs keep post-Humira prospects on track

pharmaphorum

Better-than-expected sales of some of its new products, including Skyrizi and Rinvoq, helped AbbVie handle a sharp decline in sales of former cash-cow product Humira in the last quarter of 2023.

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Novo Nordisk $11b acquisition to support manufacturing capacity

European Pharmaceutical Review

Novo Nordisk is set to acquire three fill-finish manufacturing sites from Novo Holdings A/S (Novo Holdings) for $11 billion. This agreement is part of a transaction in which Novo Holdings agreed to acquire the contract development and manufacturing organisation (CDMO) Catalent. The three manufacturing sites in Anagni in Italy, Brussels in Belgium and in Bloomington, Indiana in the US, specialise in the sterile filling of drugs.

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Novo Nordisk settles with 2 Florida sellers of compounded Ozempic

Fierce Pharma

Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday. | Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday.

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Why Experts Saw Cano Health’s Bankruptcy Coming From A Mile Away

MedCity News

Cano Health filed for bankruptcy this week — about three years after going public $4.4 billion SPAC merger. The industry reacted without surprise, with experts calling the bankruptcy a direct result of mismanagement, a quixotic growth strategy and poor market selection.

Marketing 117
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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.