Fierce Pharma
AUGUST 19, 2024
Genmab is revamping its executive team as the Danish antibody specialist expands its commercialization efforts and looks to evolve into “a fully integrated biotech innovation powerhouse.” | Genmab is revamping its executive team as the Danish antibody specialist expands its commercialization efforts and looks to evolve into “a fully integrated biotech innovation powerhouse.
MedCity News
AUGUST 19, 2024
Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. The post Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut appeared first on MedCity News.
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Fierce Pharma
AUGUST 19, 2024
Liquidia and its dry powder Yutrepia is back in FDA limbo after the agency opted for a tentative approval as opposed to a standard nod. | The agency granted a broad regulatory exclusivity to rival United Therapeutics and its Tyvasvo DPI, leaving Liquidia's Yutrepia, which uses the same active drug, in FDA limbo until 2025.
MedCity News
AUGUST 19, 2024
Cresilon snagged its second FDA clearance for human use. The FDA granted 510(k) clearance to Traumagel, the startup’s gel that can stop bleeding in just seconds, for temporary external use to control moderate to severe bleeding. The post FDA Clears Gel That Can Stop Bleeding In Seconds appeared first on MedCity News.
Fierce Pharma
AUGUST 19, 2024
Industry watchers largely breathed a sigh of relief last week after the Medicare price cuts for certain costly drugs under the Inflation Reduction Act initially appeared better than expected. | The magnitude of price cuts under the Inflation Reduction Act initially appeared better than expected. However, that rosy view may have missed an important point, one analyst team contends.
pharmaphorum
AUGUST 19, 2024
Walgreens has signed a $100m contract with the US government's BARDA agency for access to its decentralised clinical trials network
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
AUGUST 19, 2024
We can’t wait for others to find a solution to high drug prices. It’s clear what should happen in a functioning drug pricing market federally and in California, but it is not happening today. The post Three Ways Drug Pricing Should Work in a Functioning Market, But Isn’t appeared first on MedCity News.
Fierce Pharma
AUGUST 19, 2024
Eight months after Visiox Pharmaceuticals was all set to go public via a special purpose acquisition company (SPAC) deal, the company has been
MedCity News
AUGUST 19, 2024
About 7.4% of prior authorization requests submitted to MA insurers were denied in 2022, according to a recent KFF report. Of these denials, only 9.9% were appealed. The post Report: MA Insurers Denied 3.4M Prior Authorization Requests in 2022 appeared first on MedCity News.
Pharmaceutical Technology
AUGUST 19, 2024
Eli Lilly has concluded the acquisition of Morphic Holding at $57 per share, bolstering its inflammatory bowel disease portfolio.
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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.
Copyright Clearance Center
AUGUST 19, 2024
The constantly evolving presence and role of AI in many parts of publishing will be a focus of several programming events at Frankfurt…
Pharmaceutical Technology
AUGUST 19, 2024
Cyril Ramaphosa, the president of South Africa, has asked the WHO to ensure African countries have equitable access to mpox vaccines.
pharmaphorum
AUGUST 19, 2024
Pfizer and BioNTech have a phase 3 mishap with their combined COVID-19 and influenza vaccine, handing Moderna an advantage
Pharmaceutical Technology
AUGUST 19, 2024
Looking to potentially market their flagship drug SPI-1005, Sound CEO Jonathan Kil is keen to retain WuXi AppTec as a partner.
PharmaVoice
AUGUST 19, 2024
With fewer side effects, the new wave of upcoming drugs could improve patient adherence, and the competition for a large projected market is getting fierce.
Healthcare Success
AUGUST 19, 2024
As healthcare leaders, you are under immense pressure to deliver exceptional care amid rising costs and operational complexities. That’s why so many businesses leverage the power of SMS marketing. Text messaging is a fast and easy way to reduce missed appointments and medication non-compliance. Plus, 20% of patients prefer receiving health information via text message, according to the HIPAA Journal.
pharmaphorum
AUGUST 19, 2024
The EMA has started a review of AstraZeneca and Daiichi Sankyo's antibody-drug conjugate (ADC) that could see the drug being used in advanced breast cancer with even lower levels of the HER2 biomarker.
PharmaTimes
AUGUST 19, 2024
In the UK study, researchers analysed 2,023 bowel cancers from the 100,000 Genomes Project
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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.
Pharmaceutical Commerce
AUGUST 19, 2024
In an interview with Pharma Commerce Editor Nicholas Saraceno, Matt Hawkins, CaryHealth’s Chief Technology Officer, describes how artificial intelligence can not only diagnose patients, but also deliver accurate medical advice.
PharmaTimes
AUGUST 19, 2024
The contract concerns profiling Immunoglobulin E autoantibodies in blood serum
PharmExec
AUGUST 19, 2024
The combination treatment involves administering Imfinzi with neoadjuvant chemotherapy for non-small cell lung cancer before surgery and as monotherapy post-surgery.
Pharmaceutical Technology
AUGUST 19, 2024
The partners will conduct a study using blood samples and joint biopsies from various patient subgroups, focusing on those resistant to current treatments.
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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
PharmExec
AUGUST 19, 2024
Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients with chronic graft-versus-host disease.
PharmaTech
AUGUST 19, 2024
NexoBrid, a topically administered biological product, is now authorized for use in all age groups in the United States, European Union, and Japan.
PharmaVoice
AUGUST 19, 2024
The new factory, which Novo is committing some $220 million to build, will supply raw materials for the company’s chronic disease medicines.
PharmExec
AUGUST 19, 2024
Astellas Pharma’s chief people officer and chief ethics & compliance officer discusses the unique ways he’s brought DE&I to the workplace.
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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
AUGUST 19, 2024
The 86,000 square-foot Køge facility will be fully functional by 2027.
Pharmaceutical Technology
AUGUST 19, 2024
PT217 has received orphan drug designations from the FDA for the treatment of neuroendocrine carcinoma in addition to small cell lung cancer.
PharmExec
AUGUST 19, 2024
OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.
Pharmaceutical Technology
AUGUST 19, 2024
Daiichi Sankyo and AstraZeneca's ENHERTU has received FDA BTD status for the treatment of specific types of metastatic breast cancer.
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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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