Fierce Pharma
JANUARY 9, 2024
Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. | Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches.
European Pharmaceutical Review
JANUARY 9, 2024
Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. This article highlights the manifold applications of AI, particularly cutting-edge image recognition and computer vision systems, which profoundly impact quality control.
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Fierce Pharma
JANUARY 9, 2024
Two successful phase 3 trials put Astellas’ monoclonal antibody zolbetuximab on track to become the first approved therapy to treat one of the hottest targets in oncology—tumors that are claudin (C | Two successful phase 3 trials put Astellas’ monoclonal antibody zolbetuximab on track to become the first approved therapy to treat one of the hottest targets in oncology—tumors that are claudin (CLDN) positive.
MedCity News
JANUARY 9, 2024
XRHealth’s $6 million in funding was led by Asabys Partners and included participation from NOVA Prime Fund. The company will use the funding to support its recent merger with Amelia Virtual Care.
Fierce Pharma
JANUARY 9, 2024
San Francisco—Despite its recent $43 billion acquisition of Seagen, Pfizer is still on the lookout for deals centered on antibody-drug conjugates | Despite its recent $43 billion acquisition of Seagen, Pfizer is still on the lookout for deals centered on antibody-drug conjugates, Pfizer’s newly minted chief oncology officer Chris Boshoff, Ph.D., said in an interview.
MedCity News
JANUARY 9, 2024
Walgreens has agreed to pay Humana $360 million to settle a drug pricing dispute that has spanned nearly five years. The payout is roughly half of what Walgreens was originally ordered to pay when the issue was first resolved last year.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
PharmExec
JANUARY 9, 2024
Merck has acquired Harpoon Therapeutics with its clinical stage T-cell engager, whereas Johnson & Johnson acquired Ambrx Biopharma with its expertise in next generation antibody drug conjugates and targeted oncologic therapies.
MedCity News
JANUARY 9, 2024
Though GSK divested much of its oncology assets to Novartis in 2015, the company has built it back through a internal R&D and business development deals. GSK Senior Vice President, Global Head of Oncology, R&D Hesham Abdullah explained the company’s evolving cancer strategy in an interview during the J.P. Morgan Healthcare Conference in San Francisco.
Copyright Clearance Center
JANUARY 9, 2024
January 9, 2024 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing with the mission of advancing copyright, accelerating knowledge, and powering innovation, announces that RightFind XML , the company’s scientific article discovery solution, was chosen as the Bio-IT World 2023 Best in Show award honoree at its World Conference & Expo Europe in London.
MedCity News
JANUARY 9, 2024
Jill DeGraff, B.well Connected Health’s senior vice president of regulatory, believes the ONC’s new HTI-1 rule is a step in the right direction that will improve data exchange for providers, health tech vendors and patients. She applauded the rule for preserving TEFCA as a voluntary framework and for establishing FHIR-based interoperability as the industry’s de facto standard.
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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.
European Pharmaceutical Review
JANUARY 9, 2024
Chiesi Farmaceutici (Chiesi Group) and Oak Hill Bio, a clinical-stage neonatology and rare disease therapeutics company, have agreed to collaborate and develop , manufacture , and commercialise an investigational drug candidate for treating pre-term birth complications. OHB-607 is a human IGF-1 replacement of insulin-like growth factor-1 (IGF-1), a key driver of foetal growth and development, and its binding protein, IGFBP-3 for prevention of bronchopulmonary dysplasia in preterm infants, Chiesi
MedCity News
JANUARY 9, 2024
The healthcare industry stands to benefit greatly from stronger payer and provider partnerships. As the industry works to tear down the barriers that currently exist to bringing these stakeholders together, there are mutually beneficial opportunities that should be considered now.
pharmaphorum
JANUARY 9, 2024
Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug candidates for cancer.
MedCity News
JANUARY 9, 2024
The real-time, automated nature of green lighting offers precise control without the setbacks or manual efforts inherent to conventional gold carding programs.
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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
European Pharmaceutical Review
JANUARY 9, 2024
Pfizer’s oral poly ADP-ribose polymerase (PARP) inhibitor TALZENNA ® (talazoparib), in combination with XTANDI ® (enzalutamide) has been approved for prostate cancer by the European Commission (EC). TALZENNA the first and only PARP inhibitor licensed in the EU for use with XTANDI for patients with mCRPC, with or without gene mutations” The treatment is indicated for adults with metastatic castration-resistant prostate cancer (mCRPC) in individuals where chemotherapy is not clinically indi
pharmaphorum
JANUARY 9, 2024
Day 1 of JPM24 ended with no news on a rumoured takeover of Cytokinetics by Novartis, but Boston Scientific confirmed a $3.7bn bid for medtech specialist Axonics.
Pharmaceutical Commerce
JANUARY 9, 2024
Review article explores the latest developments surrounding expression and purification strategies.
pharmaphorum
JANUARY 9, 2024
Novo Nordisk Foundation has put $25m of funding into CARB-X, an initiative that aims to tackle antimicrobial resistance (AMR).
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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.
PharmExec
JANUARY 9, 2024
The Healthcare Businesswomen’s Association will honor the recipient at an event later this year in New York City.
pharmaphorum
JANUARY 9, 2024
Amazon has launched an initiative with Omada Health at JPM that makes it easier for patients to discover and enrol in digital health benefit programmes
PharmaTimes
JANUARY 9, 2024
The fertilised eggs could cultivate tumours for imaging within seven days
PharmExec
JANUARY 9, 2024
Industry stakeholders must come together to make meaningful changes to reimbursement and establish comprehensive policies that support essential healthcare providers.
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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.
Clarify Health
JANUARY 9, 2024
Hospitals today are complex businesses facing the dual challenges of growing revenue while maintaining operational efficiency. Provider organizations can use predictive analytics to fuel strategic growth, identify savings opportunities, and drive greater efficiency for staff and patients. Predictive analytics empower healthcare organizations to strategically expand by leveraging data to forecast future trends and identify potential areas for efficient growth.
PharmaTech
JANUARY 9, 2024
Bradley Grobler, Vice President of Sales, Pharma & Biopharma Europe, describes how Actylis meets global demands for (bio)pharmaceutical development and manufacturing programs during CPhI 2023.
Spotio
JANUARY 9, 2024
Have you worked in the solar industry for long? Then you know that very few customers purchase solar panels on the spot. Instead, they ask for proposals so they can compare offers. So, one of the best ways to close deals in this field is to produce quality proposals, then distribute them at lightning fast speeds. Enter: solar proposal software. In this article, we’ll explain what solar proposal software is, why it’s so beneficial to sellers like you, how to choose between the many op
PharmaTech
JANUARY 9, 2024
Ascendia Pharmaceuticals CEO, Jim Huang, describes how new opportunities in formulation development complement the company’s previous work in developing novel nanotechnologies to support biopharmaceutical development.
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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
Pharmaceutical Commerce
JANUARY 9, 2024
Astellas said it will work closely with the FDA and a third-party manufacturer to develop a timeline that will quickly resolve feedback from the complete response letter to a Biologics License Application for zolbetuximab.
PharmaTech
JANUARY 9, 2024
Robert Bloder, Chief Business Officer, Ascendia Pharmaceuticals, highlights traits that a (bio)pharmaceutical company look for when identifying a CDMO to support drug development and manufacturing programs.
PharmExec
JANUARY 9, 2024
The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
PharmaTech
JANUARY 9, 2024
Shaukat Ali, PhD, Senior Director of Scientific Affairs and Technical Marketing, Ascendia Pharmaceuticals, highlights the benefits of the company’s nanotechnologies in supporting formulation development of poorly soluble molecules.
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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.
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