Fierce Pharma
SEPTEMBER 13, 2024
It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.
MedCity News
SEPTEMBER 13, 2024
This week, longtime healthcare veterans Amy Abernethy and Brad Hirsch teamed up to launch Highlander Health — a Dallas-based startup focused on accelerating clinical evidence generation. The post Why Former FDA & Verily Exec Amy Abernethy Is Launching a New Venture appeared first on MedCity News.
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Fierce Pharma
SEPTEMBER 13, 2024
When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.
pharmaphorum
SEPTEMBER 13, 2024
It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.The green light is for Hearing Aid Feature (HAF), an app compatible with Apple's AirPods Pro earbuds that amplifies sounds and can be used for people aged 18 and over with perceived mild to moderate hearing impairment.
Fierce Pharma
SEPTEMBER 13, 2024
Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the b | To bolster Enhertu's case in HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo have rolled out positive data for the antibody-drug conjugate in patients who have brain metastases.
MedCity News
SEPTEMBER 13, 2024
As we confront the sobering statistics and growing impact of colorectal cancer, it’s clear that more education about the various options for testing is needed to increase screening rates across the U.S. The post A Closer Look at FIT Tests – A Primer on the Various Options for Colorectal Cancer Screening appeared first on MedCity News.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
SEPTEMBER 13, 2024
Apple’s new Loud Sound Reduction capability scans the environment 46,000 times a second for sudden peaks in sound, reducing them to a safe level. The post The Apple AirPods Pro Have a New Hearing Feature, Yet the Biggest Impact May be to Protect Us All From Noise appeared first on MedCity News.
Fierce Pharma
SEPTEMBER 13, 2024
Even for Merck’s oncology powerhouse Keytruda, the emerging role of immunotherapies in gynecological cancer treatment represents a bit of a mixed bag. | The company unveiled new data from its KEYNOTE-A18 study in late stage cervical cancer and its failed KEYNOTE-B21 trial testing Keytruda as an adjuvant therapy in newly diagnosed endometrial cancer.
pharmaphorum
SEPTEMBER 13, 2024
Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above $2 billion and reinforcing the company's close ties to Ireland's pharma manufacturing sector.
Fierce Pharma
SEPTEMBER 13, 2024
As if a limited initial FDA approval was not bad enough, AstraZeneca’s Truqap has recorded a pivotal trial flop that could raise additional doubts around the first-in-class AKT inhibitor. | AstraZeneca is detailing Truqap's pivotal trial flop in triple-negative breast cancer, a result that could raise additional doubts around the first-in-class AKT inhibitor.
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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.
MedCity News
SEPTEMBER 13, 2024
Continuous Glucose Monitoring tools are revolutionizing the way diabetes is managed, offering unparalleled benefits for both healthcare providers and patients. By providing continuous, accurate data, CGM is especially useful for remote monitoring, enabling timely interventions and leading to better user health. The post Improved Access to CGM Data Empowers Providers and Patients to More Effectively Partner on Diabetes Management appeared first on MedCity News.
Fierce Pharma
SEPTEMBER 13, 2024
ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value added from new cancer approvals kdunleavy Fri, 09/13/2024 - 07:38
pharmaphorum
SEPTEMBER 13, 2024
The PM Society Digital Awards 2024, an annual event in the healthcare marketing industry sponsored by Twist Health, held its 15th ceremony at The Brewery in London on 12th September.
MedCity News
SEPTEMBER 13, 2024
Through a new partnership, students at schools within Cartwheel’s network in need of higher acuity care can access treatment through Charlie Health. The post Charlie Health Partners with Cartwheel to Address the Student Mental Health Crisis appeared first on MedCity News.
Pharmaceutical Technology
SEPTEMBER 13, 2024
The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.
PharmaVoice
SEPTEMBER 13, 2024
Three of the largest fundraising rounds in 2024 show where investors are willing to place their bets in biotech.
Pharmaceutical Technology
SEPTEMBER 13, 2024
R&D frameworks are in place for the next pandemic-causing pathogen, but ways to derisk development are unclear.
pharmaphorum
SEPTEMBER 13, 2024
Cellino Biotech has received funding from the US government to develop a scalable biomanufacturing platform for personalised regenerative medicines derived from patients' own stem cells.The $25 million award from the Advanced Research Projects Agency for Health (ARPA-H) will be used to develop Cellino's NEBULA system, which according to the firm's chief technology Matthias Wagner can "effectively print new cells and new tissues for patients using their own DNA.
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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 Technology
SEPTEMBER 13, 2024
Distribution of the self-amplifying mRNA vaccine Kostaive is set to align with a planned October 2024 Covid-19 vaccination campaign.
Quantified
SEPTEMBER 13, 2024
Introduction Sales enablement is transforming, driven by advancements in artificial intelligence (AI). Traditional sales training methods, while foundational, often fall short in delivering the speed, personalization, and realism required in today’s competitive market. AI is revolutionizing key pillars of sales enablement, particularly in onboarding new hires and conducting realistic role-play scenarios.
MedCity News
SEPTEMBER 13, 2024
Bicara Therapeutics’ IPO raised $315 million raised for Phase 3 testing of a bifunctional antibody drug with potential to become a first-line treatment for head and neck cancers. Zenas BioPharma and MBX Biosciences also went public; all three companies upsized their IPOs. The post 3 Biotech IPOs, $703M Raised for Clinical Trials in Cancer, Immunology & Endocrine Disorders appeared first on MedCity News.
pharmaphorum
SEPTEMBER 13, 2024
UK biotech F2G has raised $100 million as it prepares to refile its olorofim candidate for invasive fungal infections, which was turned down last year by the FDA.The Manchester-based company said the new cash will help it to complete the late-stage development of olorofim, a novel oral antifungal for invasive aspergillosis and other serious fungal infections, to support the company during the regulatory review process, and prepare for a commercial launch in the US.
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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
PharmaTech
SEPTEMBER 13, 2024
Descon Conveyor Systems is joining Pacteon’s portfolio, and its product will be shown alongside those from Schneider Packaging Equipment and Phoenix Stretch Wrappers.
PharmaTimes
SEPTEMBER 13, 2024
Innovative immunotherapy drug HTL0039732 shows potential in trials
PharmExec
SEPTEMBER 13, 2024
Subcutaneous Tecentriq Hybreza will provide patients and physicians increased flexibility for administration of the immunotherapy across approved indications for Tecentriq, including non–small cell lung cancer, small cell lung cancer, and hepatocellular carcinoma.
European Pharmaceutical Review
SEPTEMBER 13, 2024
The 13 September marks World Sepsis Day, a disease established as a global priority by the World Health Assembly (WHA) and World Health Organization (WHO). According to GlobalData, “there is a big unmet need for drugs that specifically target sepsis, as currently only symptomatic treatments are available. A lack of understanding of the underlying pathophysiological processes contributes towards this issue,” Anaelle Tannen , Infectious Disease Analyst at GlobalData commented.
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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
PharmExec
SEPTEMBER 13, 2024
As new litigation looms in the debate over use of copay accumulator programs, a look at potential next moves for payers—and steps drug manufacturers should take to ward off cost-driven non-adherence.
Pharmaceutical Commerce
SEPTEMBER 13, 2024
In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, shares implementation success stories, and provides an outlook on future of the space.
Clarify Health
SEPTEMBER 13, 2024
For healthcare providers, patient retention is crucial for both growth and profitability. High patient attrition can result in substantial financial losses and increased operational costs, as providers must continually invest in acquiring new patients rather than focusing on existing ones. Additionally, lost opportunities for follow-up care can lead to poorer health outcomes and diminished patient satisfaction.
PharmExec
SEPTEMBER 13, 2024
In this part of their Pharmaceutical Executive video interview, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss how UpScriptHealth is working to increase access to legitimate weight loss medications, especially for those in underserved communities.
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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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