Fierce Pharma

MARCH 25, 2024

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

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MedCity News

MARCH 25, 2024

AbbVie is acquiring Landos Biopharma, whose lead drug is a small molecule that takes a novel approach to treating ulcerative colitis. Preliminary proof-of-concept data from a Phase 2 study are expected later this year.

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Fierce Pharma

MARCH 25, 2024

In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.

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Sales 359

MedCity News

MARCH 25, 2024

Novo Nordisk’s strategy to grow beyond metabolic diseases includes expanding into adjacent areas such as cardiovascular disease. Acquiring Cardio Pharmaceuticals adds a novel RNA-based therapy that is a potential heart failure treatment.

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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

Distribution

Fierce Pharma

MARCH 25, 2024

With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a | With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.

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MedCity News

MARCH 25, 2024

During an interview this month at HIMSS24, David Vawdrey — Geisinger’s chief data and informatics officer said health systems should spend more time designing their plan for evaluating success when it comes to tech pilots.

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Healthcare Healthcare 119

MedCity News

MARCH 25, 2024

Data strategy requires understanding all data feeds and ensuring secure, privacy-compliant data access and governance. How you use your data is the primary concern. The systems and tools are secondary.

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Fierce Pharma

MARCH 25, 2024

The four years since the start of the COVID-19 pandemic have yielded many advances against the coronavirus, including Moderna and Pfizer’s groundbreaking mRNA vaccines. | The agency granted emergency use authorization to Invivyd's Pemgarda, a monoclonal antibody for those who are immunocompromised and unlikely to receive adequate protection from marketed mRNA vaccines.

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MedCity News

MARCH 25, 2024

It’s a complex, multifaceted problem that no magic bullet will solve — but more visibility into the data behind hiring and salaries for RNs may help. Here’s a look at how.

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Fierce Pharma

MARCH 25, 2024

When it comes to questioning drug patents, the U.S. Federal Trade Commission (FTC) isn’t backing down. | After filing a challenge in November against more than 100 patents in the FDA’s Orange Book—and persuading several drugmakers to retract their intellectual property (IP) protections in the process—the U.S. Federal Trade Commission is now calling out uncooperative companies in court.

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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.

Safety

MedCity News

MARCH 25, 2024

Many women going through menopause suffer brain fog, but some may be worried about a more serious cognitive condition like dementia. Because of this, Midi Health and Neurotrack partnered to offer a cognitive assessment to patients.

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pharmaphorum

MARCH 25, 2024

Novo Nordisk has agreed to buy Cardior Pharmaceuticals for $1.1 billion, adding expertise in RNA therapeutics and a heart failure therapy in mid-stage trials.

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Pharmaceutical 114

MedCity News

MARCH 25, 2024

David Kereiakes, managing partner with Windham Venture Partners, shared his perspective of the health tech sector and investment trends he’s seeing.

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PharmaVoice

MARCH 25, 2024

As the new weight loss drugs take the world by storm, companies in other areas are battening the hatches for when slimmer patients need fewer medical interventions.

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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.

Specialization

pharmaphorum

MARCH 25, 2024

FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma

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European Pharmaceutical Review

MARCH 25, 2024

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a marketing authorization for antibiotic combination Emblaveo® (aztreonam-avibactam) for treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of aerobic Gram-negative bacteria. “Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients very ill and at high risk of severe complications, including mo

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pharmaphorum

MARCH 25, 2024

Three digital health technologies (DHTs) used to support patients with psychosis can be used by the NHS while additional evidence of their benefits is gathered.

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Patients 101

Pharmaceutical Technology

MARCH 25, 2024

The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.

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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.

Safety

pharmaphorum

MARCH 25, 2024

The March meeting of the EMA’s human medicines committee saw an approval recommendation for Novartis’ Fabhalta, on track to become the first oral monotherapy for rare disease paroxysmal nocturnal haemoglobinuria (PNH) in the EU.

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Pharmaceutical Technology

MARCH 25, 2024

Cancer Research UK and the CRIS Cancer Foundation have awarded a £1.7m ($2.1m) grant for developing the lung cancer vaccine LungVax.

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PharmaVoice

MARCH 25, 2024

Deborah Reardon is leading a new pillar that asks, ‘Are we looking at this from a patient lens and not from a Boehringer lens?

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Pharmaceutical Technology

MARCH 25, 2024

The FDA granted accelerated approval for the drug back in November 2022, and granted priority review in December 2023.

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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.

Management

PharmExec

MARCH 25, 2024

Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.

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Pharmaceutical Technology

MARCH 25, 2024

The CRISPR-based assay significantly accelerates the current diagnostic process, which can last for months and could revolutionise the way NTM infections are diagnosed.

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PharmaTech

MARCH 25, 2024

In this episode of the Drug Solutions Podcast, Jan Bekkar, director of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

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Marketing 52

Spotio

MARCH 25, 2024

Want to succeed in the solar industry? You need to optimize your company’s solar sales funnel. If you don’t, you won’t be able to attract qualified prospects, close deals, and drive revenue. Of course, wanting to improve your solar sales process and actually doing it are different things. To help, we’ve put together this comprehensive guide, which will help you understand the unique aspects of selling solar products, the four distinct stages of the solar sales funnel, bes

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Sales Prospecting Sales process Sales pitches 52

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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

Leads

Impetus Digital

MARCH 25, 2024

This is a guest article and does not necessarily reflect the views and values of Impetus Digital. Data breaches can happen in any industry, and unfortunately, pharmaceutical companies aren’t immune to this threat. With a handful of big names responsible for dispensing billions of prescriptions across the US each year, Pharma companies are the keepers of vast amounts of data and, as such, are attractive targets for cybercriminals.

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Penrod

MARCH 25, 2024

The ideal healthcare ecosystem is one where the patient thrives and the hospital functions at peak efficiency. However, this is only sometimes a reality, as miscommunication, wasted resources, and missed opportunities plague operations. Disparate systems often cause inefficiencies – hospitals cannot harness the power of their data because that data is not unified.

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Pharmaceutical Commerce

MARCH 25, 2024

In an interview with Pharma Commerce Associate Editor Don Tracy, Adrianna Nava, PhD, MPA, MSN, RN, President, National Association of Hispanic Nurses (NAHN) talks about the organization's mission and goals.

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Pharma 52

Penrod

MARCH 25, 2024

In this article, I’ll interpret the updated guidance and describe what has changed – and what hasn’t. The updated guidance covers three main points: Defining tracking technologies The differences between tracking on authenticated pages, unauthenticated pages, and mobile apps Your obligations under HIPAA What are tracking technologies? The updated guidance starts by redefining tracking technology – and this is smart because I get tons of questions from healthcare providers about wheth

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients