Fierce Pharma

JANUARY 19, 2024

A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.

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MedCity News

JANUARY 19, 2024

The former Pfizer statistician worked on the clinical trial for the Covid-19 drug Paxlovid. A jury found the employee guilty of insider trading for transactions made before clinical data for the antiviral were publicly announced.

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Biopharma Pharma 143

Fierce Pharma

JANUARY 19, 2024

Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. | Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. The lawsuit marks the latest move in Pfizer’s campaign to press countries to honor COVID-19 vaccine contracts inked by the European Commission in May 2021.

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MedCity News

JANUARY 19, 2024

AI, health equity and merger and acquisition activity are among the trends to watch in 2024, according to a recent report from Deloitte.

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Healthcare Healthcare 139

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Fierce Pharma

JANUARY 19, 2024

More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnose | More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients.

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Clarivate

JANUARY 19, 2024

Over half of research office leaders say researchers are disengaged. How can you close the gap to win more funding? In late 2023, Research Professional News, an editorially independent part of Clarivate , surveyed research office leaders and staff as well as researchers around the world, taking a close look at the challenges facing them today and in the future.

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Leads Competition Government 114

MedCity News

JANUARY 19, 2024

Innovation in the HIV treatment landscape is playing a role in addressing medication adherence. In recent years, long-acting injectable antiretroviral monthly and bi-monthly treatment options have been approved – a welcome alternative for people living with HIV.

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Medical Patients Biopharma 108

Fierce Pharma

JANUARY 19, 2024

Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. | Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. The U.S. regulator has added a boxed warning for the blockbuster treatment, which has been on the market for 14 years and loses patent protection next year.

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MedCity News

JANUARY 19, 2024

The psychiatric collaborative care model offers an opportunity to mitigate burnout by reducing the burden placed on primary care providers (PCPs) and more effectively supporting their patients with behavioral health needs.

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Patients Physicians 101

Fierce Pharma

JANUARY 19, 2024

Injectable formulations are the fastest growing segment in the pharmaceutical industry. According to Precedence Research, the global injectable drug delivery market reached U.S. | Simplifying the administration of complex injectables for reconstitution, liquid/liquid mixing and the sequential delivery of multiple liquid drugs.

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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

JANUARY 19, 2024

Hospitals weathered one of their most challenging years in 2022, with median operating margins staying in the red throughout most of the year. Those money problems proved to be a major factor shaping last year’s M&A transactions — financial pressures influenced 28% of hospital M&A deals last year, up from 15% in 2022, a new report showed.

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Referral MD

JANUARY 19, 2024

How do healthcare providers benefit from patient engagement tools and other healthcare software solutions? Patient-centric care is more critical than ever in today’s fast-paced healthcare landscape. Healthcare providers must deliver high-quality medical services and engage with patients effectively and efficiently. Patient engagement, referral management, and Customer Relationship Management (CRM) software have become powerful tools to achieve these goals.

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Management Patients CRM Customer Relationship Management 94

European Pharmaceutical Review

JANUARY 19, 2024

According to GlobalData, with demonstrated efficacy against carbapenem-resistant Acinetobacter Baumanni (CRAB), Roche’s zosurabalpin “has the potential to treat lethal hospital infection,” Anaelle Tannen, Infectious Disease Analyst at GlobalData explained. Currently in Phase I development , the antibiotic’s novel mechanism of action was showcased through its effectiveness against the pathogen in in vitro studies.

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MedCity News

JANUARY 19, 2024

By adopting integrated care models, providers and payors can ensure a seamless continuum of care for older adults.

Physicians 113

Physicians 113

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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

pharmaphorum

JANUARY 19, 2024

AstraZeneca gets its first approval for oral Factor D inhibitor danicopan, in Japan, for treatment of paroxysmal nocturnal haemoglobinuria

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European Pharmaceutical Review

JANUARY 19, 2024

The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Pfizer’s TALZENNA ® (talazoparib) for HER2- negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations. An important advance in treating breast cancer The pharmaceutical company shared that its oral small molecule poly (ADP-ribose) polymerase (PARP) inhibitor is indicated in adults who have had an anthracycline or a taxane, or both, if suitable,

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Pharmaceutical Commerce

JANUARY 19, 2024

Experts explore ways in which the financial sector refined the healthcare landscape, including its evolutions throughout the years.

Healthcare 100

Healthcare Healthcare 100

pharmaphorum

JANUARY 19, 2024

Manufacturing problems have scuppered Satsuma Pharmaceuticals’ chances of a timely FDA approval for its intranasal migraine therapy STS101. The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without aura, in adult patients.

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FDA Manufacturing Pharmaceutical Patients 79

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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

Pharmaceutical Technology

JANUARY 19, 2024

BridgeBio Pharma has secured strategic financing of $1.25bn from Blue Owl Capital and CPP Investments for genetic therapies.

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Pharma 98

pharmaphorum

JANUARY 19, 2024

CG Oncology joins the queue of US biotech companies hoping to complete an IPO, aiming to raise $181m for its late-stage bladder cancer therapy.

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Pharmaceutical Commerce

JANUARY 19, 2024

All healthcare stakeholders must participate to dismantle barriers and ensure access to medicines that save lives.

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Medicine Patients Healthcare Healthcare 80

Clarivate

JANUARY 19, 2024

Planning for the year ahead in the intellectual property (IP) space is increasingly challenging. While the unknowns of AI are top of mind, there are many variables in the IP legal industry projected to influence 2024. Practitioners can expect to see more integrations and toolsets that combine previously separate workflows; China will continue to influence the IP and innovation landscape; litigation is predicted to rise with the increase of infringing products; and new jurisdictions, such as the

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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

PharmaTimes

JANUARY 19, 2024

New stroke therapy delivers electrical pulses to the brain

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Pharmaceutical Technology

JANUARY 19, 2024

The layoffs will free cash resources that will extend financial runways and focus pipeline developmental efforts.

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Pharma 69

PharmaTimes

JANUARY 19, 2024

Company will present vital findings at SRI annual meeting

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Referral MD

JANUARY 19, 2024

Accurate information for personalized, value based care In a world where value-based care is prioritized, healthcare providers ACOs, FQHCs, Healthcare Systems, and Hospitals must comprehensively understand a patient’s health to effectively manage costs, mitigate risks, and deliver high-quality, personalized care. A key aspect of achieving these goals is ensuring that the patient’s health conditions are accurately and wholly coded, as this plays a crucial role in determining appropria

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Healthcare Provider Healthcare Healthcare Management 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

Pharmaceutical Commerce

JANUARY 19, 2024

Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.

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FDA Patients 52

PharmExec

JANUARY 19, 2024

Today's FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.

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FDA Patients 52

ALULA

JANUARY 19, 2024

There’s a reason why behavior change is so difficult : life. At some point during the quarter, week, or day when you’re diligently making progress on a behavior change, you’re going to hit a wall. L ife is going to get difficult. It’s going to derail your best laid plans and mak e it possibl e – even easy – to let go of the behavior change you were so eager to embrace for the long haul.

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Clarify Health

JANUARY 19, 2024

Generative AI: The New Frontier in Healthcare Technology Healthcare Unbound episode recap: We know that AI is a transformative technology already reshaping almost every kind of business, and healthcare is no exception. But what does the future of AI in healthcare look like? On this episode of Healthcare Unbound , Clarify Health President and Co-founder Todd Gottula discusses how artificial intelligence (AI) can help healthcare professionals deliver more efficient and effective care by helping en

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Healthcare Healthcare Physicians Patients 52

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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