Fierce Pharma
SEPTEMBER 8, 2023
AstraZeneca’s Tagrisso is the standard of care in newly diagnosed, EGFR-mutated non-small cell lung cancer (NSCLC). | AstraZeneca hopes to offer patients with first-line, EGFR-mutant lung cancer a new option in the combination of Tagrisso and chemotherapy. But the lack of a patient survival showing raises some questions for the combo.
MedCity News
SEPTEMBER 8, 2023
HHS released a new proposed rule to update nearly 50-year old regulations protecting people with disabilities from discrimination while seeking healthcare. With its new proposal, HHS is amending the regulations to be clearer in their language, as well as more aligned with the Americans with Disabilities Act, the Americans with Disabilities Amendments Act and amendments to the Rehabilitation Act.
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Fierce Pharma
SEPTEMBER 8, 2023
The legal kerfuffle over the FDA’s 2000 approval of Danco Laboratories’ abortion pill mifepristone, also known as Mifeprex, is heading to the Supreme Court. | Friday, Danco Laboratories asked the Supreme Court to overturn a recent U.S. Court of Appeals for the Fifth Circuit ruling that would severely limit access to the abortion pill mifepristone.
MedCity News
SEPTEMBER 8, 2023
Employers expect health benefit costs to increase 5.4% per employee on average in 2024, new data from Mercer shows. This is due to inflationary pressures and health system consolidation.
Fierce Pharma
SEPTEMBER 8, 2023
Three Japanese pharma companies lead our news stories from Asia this week. Astellas has abandoned its challenge against the Inflation Reduction Act. | Astellas has abandoned its challenge against the Inflation Reduction Act. Otsuka bought a Canadian psychedelic biotech. And Takeda is ordered to pay AbbVie nearly $480 million because of a manufacturing hiccup.
PharmExec
SEPTEMBER 8, 2023
With an organization's future commercial success under its remit, the NPP function has rapidly progressed to a prominent role in the biopharma industry—but evidence-generation strategies must evolve with an eye toward emerging trends and technologies.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
PharmaTimes
SEPTEMBER 8, 2023
The company will use its AI technology during a sub-study to analyse the effect of lansoprazole - News - PharmaTimes
PharmExec
SEPTEMBER 8, 2023
Lisa LeCointe-Cephas, SVP, chief ethics and compliance officer and office of general counsel, human health, Merck, uses her unique style of leadership—stop, drop, and roll—while elevating voices that need to be heard.
PharmaTimes
SEPTEMBER 8, 2023
Clinically significant results have emerged from trial evaluating the company’s AMO-02 candidate - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 8, 2023
Eloxx has submitted an IND for a pivotal trial to study its Alport syndrome therapy ELX-02 following a positive Phase II data readout.
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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
SEPTEMBER 8, 2023
A federal judge has issued a preliminary injunction blocking HB 900, the controversial “book rating” law from taking effect in Texas.
Pharmaceutical Technology
SEPTEMBER 8, 2023
In this issue: Digital jobs in UK life sciences, generative AI changes drug discovery, and how robotics is impacting gene therapy manufacturing.
European Pharmaceutical Review
SEPTEMBER 8, 2023
The section on environmental monitoring (EM) in Annex 1 states that “The adoption of suitable rapid or automated monitoring systems should be considered by manufacturers in order to expedite the detection of microbiological contamination issues and to reduce the risk to product”. 1 This article therefore considers some of the possible systems that can be applied in EM.
Pharmaceutical Technology
SEPTEMBER 8, 2023
The European Commission granted expanded indication approval for Merck’s Ebola vaccine, Ervebo, to include children aged one year or above.
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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
SEPTEMBER 8, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has provided data on its assessment of clinical trial authorisation (CTA) applications and substantial amendments for the period August 2022 to September 2023. Part of the main data highlighted included the performance metrics for regulatory CTA applications. In August 2023, the MHRA assessed 116 clinical trial authorisation (CTA) applications, its presentation revealed.
Pharmaceutical Technology
SEPTEMBER 8, 2023
The UK NICE has recommended Eli Lilly’s tirzepatide for the treatment of adult patients with inadequately controlled type 2 diabetes.
PM360
SEPTEMBER 8, 2023
First, some good news about diabetes. GoodRx is a leading resource for people with diabetes to find prescription savings and information, having helped almost 2.5 million Americans save more than $500 million on diabetes treatments to date. By offering invaluable access to affordable diabetes medicines and glucose monitors, accurate and digestible information about treatment options, and thorough research on diabetes and insulin prices, GoodRx is making it easier for people to afford their medic
PharmaTech
SEPTEMBER 8, 2023
The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.
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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.
Pharmacy Times
SEPTEMBER 8, 2023
Although findings indicate a relationship between vitamin D and mood disorders, further research is needed to clarify efficacy of specific vitamin D levels, as well as supplement dose and form.
Contrarian Sales Techniques
SEPTEMBER 8, 2023
The Essence of Identity Have you ever been introduced at a party and immediately been labeled by your profession? "This is Jamie, the salesperson." It's a common occurrence, but it made me ponder deeply. Before I don the badge of 'salesperson', I am first and foremost a person, complete with dreams, experiences, and stories that have nothing to do with my career.
Legacy MEDSearch
SEPTEMBER 8, 2023
Aquedeon Medical, Inc., a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. The study will be initiated in the second half of 2023, enrolling up to 20 patients at up to 5 clinical sites for the first stage of the trial.
Pharmaceutical Technology
SEPTEMBER 8, 2023
The Arena International Outsourcing in Clinical Trials UK and Ireland discussed how the UK’s clinical trial landscape has taken a hit and what improvements are needed to make it a more viable country for research.
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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.
PM360
SEPTEMBER 8, 2023
Each year industry leaders, pharma innovators, colleagues, and friends gather at the PM360 ELITE Awards Event to celebrate those 100 individuals that have had an impact on the life sciences as Disrupters, Environmental Champions, Patient Advocates, Philanthropic Heroes, and much more. The 2023 ELITE 100 features people working in all aspects of the life sciences who are making a real difference across the many sectors of healthcare, pharmaceuticals, medical devices, and diagnostics.
PharmaVoice
SEPTEMBER 8, 2023
The PASTEUR Act is likely heading for another legislative blow, but advocates say they see a future for the mechanism to fund the battle against antimicrobial resistance.
Pharmaceutical Technology
SEPTEMBER 8, 2023
In 2022, global regulatory authorities awarded a record ten review designations for respiratory syncytial virus (RSV)-indicated drugs.
Pharmacy Times
SEPTEMBER 8, 2023
Applying novel and effective behavioral economics for pre-exposure prophylaxis dissemination programs could help to tailor the programs to the populations and settings of high HIV burden areas.
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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 Technology
SEPTEMBER 8, 2023
Otsuka Pharmaceutical has entered a partnership with ShapeTX for the development of gene therapies to treat ocular diseases.
Pharmacy Times
SEPTEMBER 8, 2023
Correctly diagnosing specific follicular lymphomas and marginal zone lymphomas requires knowledge of the clinical context, including the site of involvement, age, and clinical presentation.
Pharmaceutical Technology
SEPTEMBER 8, 2023
The PD-1/PD-L1 inhibitor landscape is at the precipice of change with the approval of Roche’s subcutaneous formulation of Tecentriq.
Pharmacy Times
SEPTEMBER 8, 2023
In addition to improving risk evaluation in older adults at home, point-of-care testing may help clinicians manage patients with dementia who cannot communicate and those living in depopulated areas.
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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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