Fierce Pharma

JUNE 2, 2023

Lynparza may be the most popular PARP inhibitor, but a use restriction in ovarian cancer has been a thorn in AstraZeneca’s side. | AstraZeneca is bringing on Imfinzi to potentially help Lynparza reach a broader ovarian cancer population. But the lack of evidence for contribution from Imfinzi and a regulatory concern over the use of PARP inhibitors outside BRCA-mutant tumors could make it hard for AstraZeneca to win over the FDA.

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MedCity News

JUNE 2, 2023

Digital maturity will require shared data standards, strategies for streamlining data management and a collaborative approach that involves all players in the biopharma supply chain.

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Fierce Pharma

JUNE 2, 2023

As Bristol Myers Squibb braces for increasing generic competition this decade, the company is counting on its newer medicines to drive growth. | As Bristol's top-sellers creep toward the patent cliff, new launch Camzyos has picked up a key endorsement in England.

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MedCity News

JUNE 2, 2023

BioNTech and OncoC4 reported Phase 1/2 data in non-small cell lung cancer for an immunotherapy called gotistobart. Earlier this year, the German company inked a deal to share in the development of the drug in various types of solid tumors.

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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

JUNE 2, 2023

The Centers for Medicare and Medicaid Services has said it plans to cover Alzheimer's disease meds with the use of a registry to collect real-world data from physicians. Trade group PhRMA argues the move will "severely restrict" access.

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Physicians 162

MedCity News

JUNE 2, 2023

Digital biomarkers today serve as a valuable monitoring tool, providing details about a patient’s general health and response to treatment. But, as technology continues to develop, they could fuel predictive insights about a patient’s future health outcomes and disease trajectory, as well as demonstrate measurable quality of life improvements.

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Pharmaceutical Technology

JUNE 2, 2023

The European Commission (EC) has approved TG Therapeutics’ Briumvi (ublituximab-xiiy) to treat relapsing forms of multiple sclerosis (RMS) in adult patients. Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody.

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MedCity News

JUNE 2, 2023

A federal lawsuit brought to court by two transgender women alleges that Tennessee and its insurance committee are discriminatory because they denied the plaintiffs coverage for gender-affirming surgery.

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PharmaTech

JUNE 2, 2023

An increase in applications for gene therapies is putting stress on FDA’s resources.

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FDA 141

European Pharmaceutical Review

JUNE 2, 2023

A novel refractometry-based process analytical technology (PAT) system used to monitor HEK293T cell cultures during lentiviral vector (LVV) production in real time, was able rapidly identify a relationship between bioreactor pH and culture metabolic activity, a paper has found. Using PAT in the biotechnology and biopharmaceutical industries is a radical vision” Williams et al. stated that to their knowledge, the study represents the first time that pH has been incorporated into a metabolic

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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

PharmaTech

JUNE 2, 2023

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

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Manufacturing 98

European Pharmaceutical Review

JUNE 2, 2023

The Centre for Process Innovation (CPI) is set to establish a new UK Intracellular Drug Delivery Centre to develop new lipid nanoparticle (LNP) formulations for RNA medicine delivery, and a framework to advance next-generation nano delivery systems. Under the first-of-its-kind partnership in the UK, CPI will work with the Medicines Discovery Catapult, the University of Strathclyde, the University of Liverpool and Imperial College London using a £10 million, three-year grant funded by Innovate UK

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Manufacturing Medicine Training Networking 88

Impetus Digital

JUNE 2, 2023

A version of this article was previously published in the Journal of mHealth. Direct pharma-patient engagement used to be considered largely a “nice to have,” and was, at best, a rare occurrence at specific times during the pharmaceutical product life cycle. Now, this viewpoint is rapidly becoming outdated; patient engagement is becoming a regulatory requirement and more companies are realizing the benefits of engaging patients early and often.

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European Pharmaceutical Review

JUNE 2, 2023

Following its announced separation from Novartis in August 2022, Sandoz AG has declared plans to move its headquarters to Basel, Switzerland in mid-2024. With 2022 data by the Swiss federal government establishing that the trend for biotech companies to headquarter in Switzerland is continuing, Sandoz CEO Richard Saynor offered more evidence for this preference: “Basel is a global centre for the life sciences industry, attracting an unrivalled pool of talent and experience” Isma Hachi, D

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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

PharmaTech

JUNE 2, 2023

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

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Management 98

Copyright Clearance Center

JUNE 2, 2023

Across all sectors, US publishing sales in 2022 totaled $28.1 billion, according to the Association of American Publishers.

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Sales 98

PharmaTimes

JUNE 2, 2023

The final draft guidance recommends rimegepant for adults who have at least four migraine attacks per month, but less than 15 - News - PharmaTimes

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PharmaVoice

JUNE 2, 2023

Healthcare pros share the market drivers they believe are having the biggest impact on the industry.

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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

PharmaTech

JUNE 2, 2023

Nanotech-based delivery technologies are receiving significant attention.

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PharmaTimes

JUNE 2, 2023

BI-1910 is now the second of the company's anti-tumour necrosis factor receptor 2 programmes to enter clinical development - News - PharmaTimes

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Pharmaceutical Commerce

JUNE 2, 2023

The Medicare Part D cap in 2025 won’t solve patients’ need for financial assistance.

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Patients 98

Pharmacy Times

JUNE 2, 2023

Investigators found thinner ventricular walls, disorganized and ruptured myocardial fiber, mild inflammatory infiltration, and mild epicardia or interstitial fibrosis in the hearts of mice infected with COVID-19.

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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

Clarify Health

JUNE 2, 2023

From June 9 th – 11 th , we will be in Denver, Colorado for the American Association for Physician Leadership (AAPL) annual conference. As a leading healthcare analytics and insights company, we are excited to be part of this event, showcasing our innovative solutions that support health system growth strategies. While at the AAPL conference, join us for a compelling session with Keck Medicine of USC , where they will dive into a real-world case study on strategic physician outreach.

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Physicians Medicine Healthcare Healthcare 52

Healthcare Success

JUNE 2, 2023

Online reviews play a significant role in the success of any healthcare organization. In fact, patient reviews of doctors come in third as the most influential driver in consumers’ decisions 1 (after insurance acceptance and location). Today, virtually everyone should use reputation management software (RMS) to solicit, manage, and respond to reviews.

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PharmaTech

JUNE 2, 2023

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

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Safety Patients 52

Pharmaceutical Technology

JUNE 2, 2023

AB Science has secured a Canadian patent for its lead compound masitinib to treat amyotrophic lateral sclerosis (ALS), a fatal motor neuron disorder. The company stated that Canada’s patent office has issued a notice of allowance (NOA) for a patent relating to methods to treat ALS using the therapy. The patent offers protection until 2037 and completes the intellectual property (IP) coverage for ALS across all important geographic areas where the therapy can be marketed, including the US,

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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

Veeva

JUNE 2, 2023

As the industry continues to evolve at a rapid pace, ensuring that sales representatives are assigned the right tasks in the right geographical territory – also referred to as territory management, can be a daunting and costly task for many pharma organizations. Across multiple brands and field teams, the process of assigning sales representatives to specific territories has traditionally been undertaken with software like Excel spreadsheets and CRM platforms.

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Pharmaceutical Technology

JUNE 2, 2023

The European Commission (EC) and Pfizer/BioNTech have agreed to amend their current supply contract to deliver Covid-19 vaccines to the EU. The original contract, signed in May 2021, required the EU to purchase 900 million doses from Pfizer/BioNTech, with an option for an additional 900 million, by the end of 2023. Since demand significantly decreased after the contract was signed, at least 50% of the first 900 million doses were never delivered, leaving many member states with large financial l

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PharmaTech

JUNE 2, 2023

Makers of specialty biologics, gene therapies, and other personalized medicines are working to identify and reduce potential supply chain risks both upstream and downstream.

Medicine 52

Medicine 52

Pharmaceutical Technology

JUNE 2, 2023

Kicking off this year’s American Society of Clinical Oncology’s (ASCO) conference, Novartis has released data supporting the use of its CDK4/6 inhibitor Kisqali (ribociclib) as an adjuvant treatment for a group of early-stage breast cancer patients. Data from Novartis ’ Phase III NATALEE trial show that adding Kisqali to endocrine therapy lowered the risk of cancer recurrence by 25% in patients with hormone receptor-positive (HR+)/HER2- early-stage breast cancer (EBC).

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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