Fierce Pharma

AUGUST 22, 2024

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on a tumor’s PD-L1 expression.

FDA 309

FDA 309

MedCity News

AUGUST 22, 2024

A third health system has started using Cytovale’s early sepsis detection test. Froedtert & the Medical College of Wisconsin Health Network announced its plans to deploy the diagnostic test this week. The post Why Hospital EDs Are Adopting Cytovale’s Sepsis Test appeared first on MedCity News.

Networking 119

Networking Medical 119

Fierce Pharma

AUGUST 22, 2024

Once again, fueled by booming sales of their GLP-1 products, Eli Lilly and Novo Nordisk were the top performers in the biopharma industry in the second quarter. | The momentum the biopharma industry showed in the first quarter of 2024 continued into the second quarter as 21 of the industry's top 25 companies achieved year-over-year revenue increases.

Sales 269

Sales Leads Biopharma 269

MedCity News

AUGUST 22, 2024

The law amends the state’s “certificate of need” system, which allows existing hospitals and other health facilities to block would-be competitors’ plans to expand by arguing there’s insufficient need for their services. The post Bipartisan Effort Paves Way for Reviving Shuttered Hospitals in Georgia appeared first on MedCity News.

119

119

Advertisement

Fierce Pharma

AUGUST 22, 2024

Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts. | Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts, the company said.

Manufacturing 260

Manufacturing Pharma 260

MedCity News

AUGUST 22, 2024

For health systems that are already struggling with capacity and access issues, now is the time to consider specific actions to prepare for this season’s coming surge. The post How Health Systems Can Prepare for the Winter Surge with Virtual Care appeared first on MedCity News.

Physicians 115

Physicians 115

MedCity News

AUGUST 22, 2024

Mindset Care’s $13 million raise was led by Science Inc. and included participation from Wellington Management, Tubbs Ventures, Enable Ventures, XYZ and LivEdge Capital. The post Mindset Care Snags $13M to Simplify Disability Benefit Applications for Those with Serious Mental Illness appeared first on MedCity News.

Management 112

Management 112

Fierce Pharma

AUGUST 22, 2024

In a decision contrary to its European counterpart, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Eisai and Biogen's Alzheimer's disease drug Leqembi—though tha | For Eisai and Biogen's Leqembi, the health regulator in the U.K. has approved the drug for early-stage Alzheimer's disease although only in a patient subgroup, while England's drug cost watchdog figured the drug's “relatively small benefits” doesn't warrant co

Medicine 227

Medicine Healthcare Healthcare Patients 227

MedCity News

AUGUST 22, 2024

In this episode, we speak to a healthtech executive and a physician to see where AI tools can best be deployed in health systems The post MedCity Pivot Podcast: How Sentara Health is Applying Regard’s AI Platform appeared first on MedCity News.

Physicians 112

Physicians Healthcare Healthcare 112

Fierce Pharma

AUGUST 22, 2024

Breaking the Bottleneck: Streamlining Prior Authorizations and Unlocking Patient Access to Specialty Medications | Breaking the Bottleneck: Streamlining Prior Authorizations and Unlocking Patient Access to Specialty Medications

Medical 130

Medical Patients 130

Advertisement

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

Pharmaceutical Commerce

AUGUST 22, 2024

In the final part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, comments on the importance of mitigating security risks, along with ways to take action.

Pharma 105

Pharma 105

MedCity News

AUGUST 22, 2024

By integrating digitization and machine learning, there is an opportunity to deliver personalized care to all patients and scale precision dosing with minimal physician involvement, maximizing the effectiveness and accessibility of these drugs. The post Side Effects are Limiting GLP-1 Drug Efficacy: How Can Personalization Offer a Solution? appeared first on MedCity News.

Side effects 107

Side effects Physicians Patients Medicine 107

pharmaphorum

AUGUST 22, 2024

BioMarin names Amgen's Greg Friberg to lead its R&D and former Roche exec James Sabry as its chief dealmaker amid a strategy change

Leads 109

Leads 109

MedCity News

AUGUST 22, 2024

The eBook Femtech Revolution: How Entrepreneurs Are Championing Women’s Health Equity highlights femtech to help track menstruation, how femtech can support access to care, data privacy concerns, and more. The post In the Fight for Women’s Health Equity, Entrepreneurs Are Crucial appeared first on MedCity News.

98

98

Advertisement

Distribution

pharmaphorum

AUGUST 22, 2024

BMS looks ahead to April verdict from FDA on Opdivo/Yervoy combination as first-line treatment for unresectable hepatocellular carcinoma.

FDA 104

FDA 104

Pharmaceutical Technology

AUGUST 22, 2024

Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.

98

98

pharmaphorum

AUGUST 22, 2024

UK is first European country to approve Eisai and Biogen's Alzheimer's drug Leqembi, after EU advisors say safety concerns outweigh its benefits.

Safety 92

Safety 92

Pharmaceutical Commerce

AUGUST 22, 2024

The unveiling of the microbial fermentation manufacturing plant is headlined by a $131 million financial commitment.

Manufacturing 105

Manufacturing 105

Advertisement

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

pharmaphorum

AUGUST 22, 2024

Just a few months after buying Timber Pharma, LEO Pharma has revealed that the main drug it acquired as part of the deal has failed a phase 3 trial.Timber's lead candidate TMB-001 for rare skin disease congenital ichthyosis failed to meet its efficacy objectives across the board in the ASCEND trial and will not support a planned regulatory filing, said LEO in a statement.

Pharma 79

Pharma Leads 79

PharmaTech

AUGUST 22, 2024

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers.

64

64

PharmaTimes

AUGUST 22, 2024

200,000 people in the UK have what is considered a ‘hidden’ lung condition

Patients 96

Patients Networking 96

Clarivate

AUGUST 22, 2024

You’ve selected an IP management system (IPMS) that surpasses your current provider, but you’re uncertain about the migration process. While finding the best IPMS for your requirements is a crucial first step, it’s only the beginning. A smooth and successful implementation is often overlooked in the procurement process. In this blog, we explore key considerations to ensure a seamless transition.

Management 59

Management Engineering Marketing 59

Advertisement

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

pharmaphorum

AUGUST 22, 2024

US insomniacs have a new prescription DTx option Phil.

Prescription 103

Prescription 103

PharmaTimes

AUGUST 22, 2024

The grant will support clinical trials of rare disease therapy for leukodystrophy

84

84

Pharmaceutical Commerce

AUGUST 22, 2024

The latest news for pharma industry insiders.

Pharma 100

Pharma 100

PharmaTech

AUGUST 22, 2024

The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023.

FDA 59

FDA 59

Advertisement

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

Pharmaceutical Technology

AUGUST 22, 2024

Discover Zydus Lifesciences' patented liquid sildenafil citrate formulation for treating pulmonary hypertension and erectile dysfunction, ensuring stability and effectiveness.

Medical 52

Medical 52

PharmExec

AUGUST 22, 2024

Findings from a recent study demonstrated that high-dose psilocybin provided a superior reduction in depressive symptoms compared to both placebo and escitalopram in patients with major depressive disorder.

Patients 52

Patients 52

PharmaTech

AUGUST 22, 2024

Merck, known as MSD outside of the United States and Canada, will gain CN201, a next-generation bispecific antibody, from Curon Biopharmaceutical in a deal potentially worth up to $1.3 billion.

52

52

PharmExec

AUGUST 22, 2024

By integrating support directly into existing workflows and focusing on solutions that eliminate "shoulder time," manufacturers can significantly reduce delays and improve patient outcomes.

Manufacturing 52

Manufacturing Patients 52

Advertisement

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