Fierce Pharma

MAY 8, 2024

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.

Leads 358

Leads Pharmaceutical 358

Clarivate

MAY 8, 2024

Discover how the Web of Science Research Intelligence platform will revolutionize research evaluation by driving responsible innovation and demonstrating societal impact. At Clarivate , we recognize the pivotal role that research plays in shaping the future. That’s why we’re excited to announce the development of Web of Science Research Intelligence , a next-generation software solution powered by AI that will empower researchers to accelerate breakthroughs and research institutions to better me

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Competition Management Prospecting Networking 131

Fierce Pharma

MAY 8, 2024

Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European | Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).

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Marketing Medicine 330

MedCity News

MAY 8, 2024

Otsuka Pharmaceutical is launching a subsidiary that will commercialize its digital therapeutic Rejoyn — as well as other digital therapeutics and connected health products down the line. Last month, Rejoyn became the first FDA-cleared digital therapeutic for patients with depression. The post Otsuka Launches New Company to Commercialize Rejoyn, the First Digital Therapeutic for Depression appeared first on MedCity News.

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FDA Pharmaceutical Patients Biopharma 116

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Fierce Pharma

MAY 8, 2024

Amid a U.S. | In a letter to FDA Commissioner Robert Califf, M.D., the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.

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FDA Pharmaceutical 290

PharmaTech

MAY 8, 2024

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

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European Pharmaceutical Review

MAY 8, 2024

New data from a Phase IIa trial in moderate-to-severe atopic dermatitis has demonstrated that a novel monoclonal antibody (mAb) could facilitate dosing every 12 weeks for induction therapy. This is due to a 31-day half-life at anticipated therapeutic dose levels, Inmagene Biopharmaceuticals confirmed. Humanised anti-OX40 IgG1 mAb IMG-007 works via a silenced antibody -dependent cellular cytotoxicity (ADCC) function, Inmagene explained.

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Safety Patients Medicine Medical 117

Fierce Pharma

MAY 8, 2024

After bringing slow-release schizophrenia drug Uzedy to market last year, Teva and France’s MedinCell are using the same playbook for a similar candidate. | The companies second go at a long-acting schizophrenia med uses popular antipsychotic olanzapine, which Eli Lilly first marketed in the 90s but found safety issues with its own long-acting version.

Safety 218

Safety Marketing 218

pharmaphorum

MAY 8, 2024

Regeneron’s gene therapy for otoferlin-related hearing loss restored hearing to normal levels in one profoundly deaf child within just 24 weeks

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Fierce Pharma

MAY 8, 2024

As U.S. drug shortages run rampant, lawmakers are getting creative with their attempts to ease the situation. | Under the framework, hospitals, purchasers and generic drugmakers could earn incentive payments after meeting new contracting and purchasing standards. The lawmakers proposed supply contracts with longer timelines, greater supply commitments and contingency deals with alternative manufacturers.

Manufacturing 216

Manufacturing 216

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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

MAY 8, 2024

Transcarent recently announced that it raised $126 million in Series D funding led by General Catalyst and 7wireVentures. When asked what his exit strategy is, CEO Glen Tullman said he does not want to sell Transcarent, but sees an initial public offering as an option. The post Glen Tullman Has ‘No Interest’ In Selling Transcarent, But IPO Is a Possibility appeared first on MedCity News.

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Fierce Pharma

MAY 8, 2024

As the pharmaceutical and biopharma sector increasingly focuses on value-based pricing, sustained profitability and expanding market access, the need to leverage products as they mature has intensi | Understanding how to energize, extend and capitalize the lifespan of mature drugs

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Biopharma Pharmaceutical Marketing 173

pharmaphorum

MAY 8, 2024

The first commercial sales of Spectral AI's DeepView wound imaging system for burns are due to start in the UK, its first market, later this year

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Sales Marketing 111

Fierce Pharma

MAY 8, 2024

Apellis’ geographic atrophy drug Syfovre delivered what CEO Cedric Francois called “robust” growth in the first quarter, as its sales topped analysts’ expectations. | Apellis’ geographic atrophy drug Syfovre delivered what CEO Cedric Francois called “robust” growth in the first quarter, as its sales topped analysts’ expectations. But investors still dragged the company’s shares down by 10% on Tuesday.

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Sales 148

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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

MedCity News

MAY 8, 2024

Balancing the promise of personalized medicine with proper payment accuracy The post Navigating the Complexities of Payment for Genetic Testing appeared first on MedCity News.

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Medicine 91

Fierce Pharma

MAY 8, 2024

In about a year after launching a revamp strategy under CEO Richard Francis, Teva has managed to return its generics business to growth, secure approvals for a pair of high-profile biosimilars | While CEO Richard Francis caveated that Teva still has a “long way to go,” he figures the company has shown it can execute on its "Pivot to Growth" transformation strategy “very well,” and is “consistently doing so quarter on quarter.

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Management 139

Pharmaceutical Technology

MAY 8, 2024

AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.

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pharmaphorum

MAY 8, 2024

Selective serotonin reuptake inhibitors (SSRIs) are the first-line drug therapy of choice for most people suffering from depression but often fail to work effectively. Now, a study suggests simple blood test could help predict those who will benefit.

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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

PharmaVoice

MAY 8, 2024

Partnerships have been key to building the company’s AI capabilities and patient-focused R&D, said AstraZeneca’s head of U.S. oncology.

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Patients 98

Pharmaceutical Technology

MAY 8, 2024

Coinfections can complicate disease management and hence continued surveillance and targeted intervention strategies are needed.

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Management 105

pharmaphorum

MAY 8, 2024

FDA advisors will meet on 10th June to discuss Eli Lilly's Alzheimer's candidate donanemab, shortly after casting an eye over Lykos' MDMA-based psychedelic for PTSD.

FDA 84

FDA 84

European Pharmaceutical Review

MAY 8, 2024

US researchers have reported successful complete biosynthesis of the molecule QS-21, which is the active ingredient of soap bark, in engineered yeast. This method enable QS-21 to be a more cost-effective and environmentally sustainable option as an adjuvant in vaccines, they explained. [The yeast-based method] enables a more cost-effective and environmentally sustainable option as an adjuvant in vaccines” Derived from the Chilean soapbark tree (Quillaja saponaria), over the past 25 years,

Engineering 82

Engineering Leads Pharmaceutical 82

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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

MAY 8, 2024

Gossamer’s seralutinib is designed to treat pulmonary arterial hypertension and other indications

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pharmaphorum

MAY 8, 2024

Our round-up of biotech financings is headed by a $200m round for Zenas, with Cellectis, Reunion, Karius, Context, and Enlaza also raising nine-figure sums

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PharmaTimes

MAY 8, 2024

The findings could potentially lead to new therapies and could stop the growth of cancers

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Leads Medicine 91

PharmaTech

MAY 8, 2024

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

Pharmaceutical products 59

Pharmaceutical products Pharmaceutical 59

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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

MAY 8, 2024

The latest news for pharma industry insiders.

Pharma 102

Pharma 102

Spotio

MAY 8, 2024

It doesn’t matter what you sell, territory management is essential to your success. This is especially true in the distribution industry. Proper territory management will help your sales team optimize sales coverage, provide better customer service, boost efficiency, and more. The question is, how do you manage your territories effectively? That’s what we’ll discuss in this article!

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Management Prospecting Sales territory Sales 52

Quantified

MAY 8, 2024

Along with our partners from LTEN (Life Sciences Trainers and Educators Network), Quantified recently hosted a webinar titled “ How AI is Transforming Learning in Life Sciences: Expert Practitioners Speak.” Industry leaders spoke up and shared their perspective on adoption of generative AI by life sciences training teams. We heard from: Kevin Kutler, the current Head of Sales Training at Regeneron and former head of US Training at Novartis.

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Training Competition Marketing Sales 52

Pharmaceutical Commerce

MAY 8, 2024

IQVIA report explores the latest spending tendencies in the United States, while providing additional clarity as to why COVID-19 vaccines and therapeutics continue to experience a decline in volume.

Healthcare 52

Healthcare Healthcare 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