Fierce Pharma
SEPTEMBER 3, 2024
Late last year, Novo Nordisk responded to a growing shortage of popular Ozempic with a plan to cut down on production of its older diabetes med Victoza to make room for more Ozempic. | The company and the European Medicines Agency warned European healthcare providers to continue limiting new patient prescriptions until the shortages let up.
Pharmaceutical Commerce
SEPTEMBER 3, 2024
In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.
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Fierce Pharma
SEPTEMBER 3, 2024
Semnur Pharmaceuticals, which is working on a non-opioid prospect for sciatica, has agreed to merge with special purpose acquisition company Denali Capital Acquisition Corp. | Semnur Pharmaceuticals is following in its parent company Scilex's footsteps with a special purpose acquisition company (SPAC) merger.
MedCity News
SEPTEMBER 3, 2024
We must empower health plan members with culturally and linguistically-relevant information about their benefits and health – tools that in turn encourage them to adopt a proactive and informed approach to their well-being. The post Health Literacy Is Not a Multi-Language Insert appeared first on MedCity News.
Fierce Pharma
SEPTEMBER 3, 2024
Dr. Reddy’s has been cut off from China’s bulk-buy drug procurement program after an inspection turned up “serious defects” in the company’s manufacturing operations. | Following a remote inspection of a Dr. Reddy’s formulations production plant, China’s National Medical Products Administration has suspended the import, sale and use of the Indian drugmaker’s atomoxetine hydrochloride capsules for ADHD.
pharmaphorum
SEPTEMBER 3, 2024
EU had no grounds to probe Illumina's takeover of Grail, says ECJ, but while spinoff has already taken place Illumina can now avoid a €432m fine
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 3, 2024
A digital version of the NHS Health Check offered to older people in the UK will be piloted in some areas of England early next year, according to the government.The Department of Health and Social Care (DHSC) has said the digital alternative to the current system of in-person health checks will be ready for testing in early 2025, with pilots planned for Norfolk, Medway, and Lambeth in London.
Pharmaceutical Technology
SEPTEMBER 3, 2024
In clinical supplies, the Importer of Record (IoR) provides a critical service in facilitating logistics and easing the burden for sponsors.
pharmaphorum
SEPTEMBER 3, 2024
New data for Valneva and Pfizer's Lyme disease vaccine bolsters the case for the shot as the results of a phase 3 programme are awaited.
MedCity News
SEPTEMBER 3, 2024
The European Union’s highest court sided with Illumina, agreeing that the European Commission had no authority to review the acquisition of liquid biopsy company Grail. The ruling comes after Illumina stopped challenging antitrust litigation, opting to instead spin out Grail as a standalone company. The post Illumina’s European Court Victory Can’t Salvage Grail Acquisition, But It Nullifies Hefty Fine appeared first on MedCity News.
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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.
pharmaphorum
SEPTEMBER 3, 2024
EU follows through on plan to revoke approval for Advanz Pharma's Ocaliva for rare disease primary biliary cholangitis (PBC)
MedCity News
SEPTEMBER 3, 2024
As Gen AI continues to mature, there will be ways to employ these technologies thoughtfully and safely in healthcare today. The key is to continue to embrace new breakthroughs – with strong guardrails for safety, privacy and transparency. The post Eliminating the AI ‘Black Box’ to Make Clinical Data Usable appeared first on MedCity News.
Pharmaceutical Technology
SEPTEMBER 3, 2024
There are currently no approved treatments that can halt or reverse photoreceptor degeneration in patients with retinitis pigmentosa.
MedCity News
SEPTEMBER 3, 2024
Sounder Benefits, which was built at Redesign Health, launched last week with $7.5 million in funding. The company is a health tech startup specializing in benefits for employers with fewer than 1,000 employees. The post Sounder Benefits Launches To Advance Employee Health Benefits appeared first on MedCity News.
pharmaphorum
SEPTEMBER 3, 2024
Vaxcyte's new pneumococcal vaccine may only have phase 1/2 results behind it, but analysts are already predicting it could be a major competitor to rival shots from Pfizer and MSD.Just-reported data from that study has shown that Vaxcyte's VAX-31 shot was able to stimulate a strong immune response against all 31 serotypes of Streptococcus pneumoniae included in the formulation, in adults aged 50 and over.
Pharmaceutical Commerce
SEPTEMBER 3, 2024
How can industry stakeholders ensure the quality and supply chain security of existing product?
pharmaphorum
SEPTEMBER 3, 2024
Researchers in the Netherlands have developed 3D-printed 'mini tumours' that behave like real cancerous tissue and can be used to test new treatments, including drug and cell-based immunotherapies.The team from the Leiden Academic Centre for Drug Research say the models are an alternative to the current approach of testing immunotherapies by culturing tumour cells in a petri dish alongside T cells, or drugs such as antibodies, and seeing how they interact.
PharmaVoice
SEPTEMBER 3, 2024
As the agency considers eliminating adcomm votes from the approval process, members vie to have their voices heard.
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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.
European Pharmaceutical Review
SEPTEMBER 3, 2024
Researchers from Sanofi Vaccines have developed an automated end-to-end process that enables real-time in-line monitoring and control of metabolites during bioprocess development. Utilising process analytical technology (PAT) and quality by design-focused principles, the metabolite feed-back control system offers an improved upstream fermentation process in stirred-tank fermentors.
Pharmaceutical Commerce
SEPTEMBER 3, 2024
The latest news for pharma industry insiders.
PharmaTech
SEPTEMBER 3, 2024
Bio/pharma companies should be approaching their decarbonization journey as a strategic business move for the future as industry stakeholders are placing greater value on sustainability.
PharmExec
SEPTEMBER 3, 2024
Results from the Phase III EXPLORER-LTE study found that Camzyos maintained effectiveness in treating symptomatic obstructive hypertrophic cardiomyopathy after 3.5 years of 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
Infuse Medical
SEPTEMBER 3, 2024
In today’s rapidly evolving digital landscape, pharmaceutical sales teams face unparalleled challenges. The complexity of managing vast amounts of product information, engaging with increasingly informed healthcare professionals, and adhering to strict regulatory requirements has made traditional sales methods less effective. As a result, sales reps often struggle to deliver personalized, impactful presentations that resonate with their audience.
Pharmaceutical Technology
SEPTEMBER 3, 2024
RGX-121 has been evaluated in the Phase I/II/III CAMPSIITE study as a one-time gene therapy treatment for Hunter syndrome.
PharmaTech
SEPTEMBER 3, 2024
A coordinated and international response is needed to help control the latest mpox outbreak in Africa.
PharmExec
SEPTEMBER 3, 2024
OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.
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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
Pharmacy Times
SEPTEMBER 3, 2024
Patients with DLBCL on Medicaid had worse survival outcomes than those on commercial insurance, but there were no statistically significant differences in survival between races.
PharmExec
SEPTEMBER 3, 2024
OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.
Pharmaceutical Technology
SEPTEMBER 3, 2024
New data provides more evidence on choosing the ideal approach for prescription of beta blockers for myocardial infarction.
PharmExec
SEPTEMBER 3, 2024
OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.
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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.
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