Sat.Mar 16, 2024 - Fri.Mar 22, 2024

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Should the DOJ Break Up UnitedHealth Group?

MedCity News

The U.S. Department of Justice has reportedly recently launched an antitrust investigation of UnitedHealth Group, which begs the question of whether the healthcare giant should be broken up. Experts have varying opinions.

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BioNTech's shares tumble—again—amid continued COVID vaccine sales slide

Fierce Pharma

Four months ago, when BioNTech slashed its 2023 revenue projection from 5 billi | When BioNTech reported its fourth-quarter earnings Wednesday, it was another harsh reminder of the plummeting demand for COVID-19 vaccines. Sales came to 1.5 billion euros ($1.6 billion) for the fourth quarter and 3.8 billion euros ($4.1 billion) for 2023, coming up short of expectations.

Sales 336
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Akums introduces Hydroxyurea oral suspension for sickle cell disease

Pharmaceutical Technology

Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.

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The Impact of AI in Healthcare

PM360

AI-driven healthcare is making its way into our lives and with it comes positive changes Imagine a world where my AI emails your AI and they join forces to schedule our coffee chat. Next thing you know, we’re discussing campaign strategies over lattes, courtesy of our digital matchmakers. Welcome to the future, where AI in healthcare marketing isn’t just a concept— it’s the new normal.

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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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AstraZeneca Joins Radiopharma Deals Spree With $2B Fusion Acquisition

MedCity News

AstraZeneca’s Fusion Pharmaceuticals acquisition is the latest in a wave of M&A activity that includes recent deals by Eli Lilly and Bristol Myers Squibb. The lead Fusion program is in mid-stage clinical development for treating advanced prostate cancer.

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Novo Nordisk closes in on EU approval for its once-weekly insulin Awiqli

Fierce Pharma

Sales are booming for Novo Nordisk’s GLP-1 treatments for diabetes and obesity. But that doesn’t mean the Danish company has moved on from its previous generation of blood sugar modulators. | With a positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMP), Novo has come a step closer to bringing its revolutionary Awiqli (once weekly basal insulin icodec) to the market.

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Clasp emerges with $150m for safer T cell engagers

pharmaphorum

Clasp Therapeutics has burst onto the T-cell engager (TCE) scene with $150 million in funding for a platform that aims to improve the safety of the class, which is currently gaining traction in cancer immunotherapy.

Safety 99
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Stand Tall: Lowering Health Risks for the Aging Population

MedCity News

Today, new digital solutions are emerging that provide tailored exercise programs and encourage small changes to daily life that can lead to significantly lower fall risk.

Leads 112
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Riding GLP-1 wave, Novo Nordisk lays out $560M to boost drug production in China

Fierce Pharma

This year marks Novo Nordisk’s 30th anniversary in China, and it could also be the year the company's red-hot weight loss injection Wegovy (semaglutide) wins approval in the populous East Asian nat | 2024 marks Novo Nordisk’s 30th anniversary in China, and it could also be the year the Danish drugmaker’s red-hot weight loss injection Wegovy (semaglutide) wins approval in the populous East Asian nation.

Medicine 324
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PAP 2024: Amy Niles Discusses Goals of the PAN Foundation

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Amy Niles, Chief Mission Officer, The PAN Foundation discusses the overall mission of the organization.

Pharma 105
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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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IN MEMORIAM Rob Likoff

PM360

It is with immense sadness that I write this. A one of a kind, loyal, and generous friend and mentor. I will miss his humor, unrivaled intelligence, guidance, wisdom—and I can’t leave out his fashion sense, especially those killer shoes. Rest in peace my very dear friend.

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Intermountain Health CISO: The Industry Needs Better Transparency After Cyberattacks

MedCity News

After a healthcare cyberattack, the impacted organization often doesn’t want to divulge a lot of information, Intermountain Health CISO Erik Decker said last week at HIMSS. However, he thinks healthcare organizations should be more transparent with their peers after an attack because “no one system operates independent of everybody else.

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Johnson & Johnson accuses former employee of taking thousands of files to new role at Pfizer

Fierce Pharma

As two of the world’s largest pharmaceutical companies, Johnson & Johnson and Pfizer have long been rivals in various therapeutic areas. | The company is accusing former employee Andrew Brackbill of downloading thousands of confidential strategy-related files before leaving for rival Pfizer.

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Reading the Tea Leaves on Recent Surge in Pharma Dealmaking

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, discusses the positive signs from rising activity levels in biopharma M&A— and what the momentum may mean for industry dealmaking and partnership efforts in the months ahead.

Biopharma 105
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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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Bionomics to advance non-SSRI PTSD candidate to Phase III

Pharmaceutical Technology

Bionomics plans to meet with the FDA following positive topline data from the Phase IIb ATTUNE trial of the post-traumatic stress disorder (PTSD) drug BNC210.

FDA 105
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Why Health System Execs Say You Can’t Separate ‘Patient’ from ‘Consumer’

MedCity News

Many people don’t take well to the term “healthcare consumer,” or have expressed that they prefer to be referred to as a patient rather than a consumer. But in the U.S., it’s a plain fact that people have choices when it comes to their healthcare. In this piece, three health system executives give their take on why “patient” and “consumer” are often one in the same — and why hospitals need to be mindful of this.

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Idorsia's Tryvio crosses FDA finish line, offering new mechanism to treat hypertension

Fierce Pharma

After Johnson & Johnson last year changed its mind on its 2017 purchase of ap | Idorsia's Tryvio is the first oral anti-hypertensive therapy that uses a new therapeutic mechanism in nearly 40 years, suggesting the dawn of "a new era of endothelin research," the company said.

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Vicore’s lung disease digital therapy gets breakthrough tag

pharmaphorum

Vicore gets FDA breakthrough status for Almee, a cognitive behavioural therapy (CBT) digital health therapy used to support people with pulmonary fibrosis

FDA 106
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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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Best SaaS Marketing Examples for 2024

Clear Pivot

If you’re in the SaaS business, you know how incredibly tough the competition is. There are startups that seemingly never sleep. There are huge, legacy solutions that so many enterprises are locked into, we may wonder how to even begin to reach that echelon of success. Somewhere in the middle are most SaaS companies. You’ve got a great solution, have made some progress, are consistently adding users and delighting them, but you’re always looking to improve.

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Why Every Hospital Needs a Chief Pharmacy Officer in the C-Suite

MedCity News

A CPO in the C-suite determines how a health system can move from a cost center to a revenue center with healthy operating margins by investing in specialty pharmacy services that reduce burden for healthcare staff and improve care for patients.

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After Kyowa Kirin buyout, Orchard scores FDA approval for first MLD gene therapy in the US

Fierce Pharma

Kyowa Kirin’s bet on Orchard Therapeutics has paid off, furnishing the Japanese drugmaker with a newly approved gene therapy in the U.S. | The FDA on Monday gave a thumbs up to Lenmeldy as the first gene therapy in the U.S. for kids with certain types of metachromatic leukodystrophy (MLD).

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CAR-Ts set to move earlier in multiple myeloma therapy

pharmaphorum

FDA advisors have said that two BCMA-targeted CAR-T therapies can be used earlier in the treatment pathway for multiple myeloma, setting up FDA approvals for use in a broader patient population.

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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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Novartis acquisition to address inflammation-driven diseases

European Pharmaceutical Review

Under a new deal, Novartis has agreed to acquire US-based biopharma company IFM Therapeutics, for a total of up to $835 million. As part of this new agreement, Novartis has exercised its option to acquire all outstanding capital stock of IFM Due, a subsidiary company of IFM. Therefore, under the acquisition, Novartis has full rights to IFM Due’s portfolio of small molecule Stimulator of Interferon Genes (STING) antagonists, IFM confirmed.

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What ‘Digital Transformation’ Means to 3 Health System Execs

MedCity News

During a panel at HIMSS, three health system leaders explained what digital transformation means to them and how they’re seeking it play out at their organizations.

Medical 106
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Orchard sets new gene therapy price tag at $4.25M—the steepest of any drug in the US

Fierce Pharma

After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy (MLD) in the U.S., Kyowa Kirin and its subsidiary Orchard Therapeutics have | After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy in the U.S., Kyowa Kirin and its subsidiary Orchard Therapeutics have broken new boundaries in pricing, too.

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Heart claims unlock Medicare coverage of obesity drugs

pharmaphorum

Medicare has loosened restrictions on the reimbursement of obesity drugs, thanks to clinical data showing they can improve cardiovascular outcomes, but their price could be up for negotiation.

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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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Mould study highlights safer far-UVC light cleaning alternative

European Pharmaceutical Review

A study has determined that intermittent low-intensity far-UVC light can inhibit mould growth below the threshold limit value of 23 mJ/cm 2. At 222nm, far-UVC light was shown to prevent development of common mould-producing fungi , specifically Penicillium candidum. The on-off duty cycle pattern of the far-UVC light used in the study is “consistent with its use in real-world settings”, the corresponding paper stated.

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Precision Medicine Startup Mirador Unveils $400M for R&D of New I&I Drugs

MedCity News

Mirador Therapeutics applies machine learning to human data to discover new immunology and inflammation drugs. The startup’s management includes several from the executive team of Prometheus Biosciences, an immunology biotech bought by Merck last year.

Medicine 102
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Pfizer set to collect roughly $2.6B in selloff of Haleon shares, reducing stake from 32% to 24%

Fierce Pharma

Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is | Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is prepared to do the same with a larger selloff, according to the consumer healthcare company. Pfizer is set to reduce its stake in Haleon from 32% to 24% by selling 630 million shares in a public offering.

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Digital diabetes tools ‘of little benefit and raise costs’

pharmaphorum

First report from PHTI concludes that digital health technologies for diabetes management deliver minimal clinical benefit and raise healthcare costs

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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.