Fierce Pharma

SEPTEMBER 16, 2024

Following a meeting with the FDA’s Gastrointestinal Drug Advisory Committee Friday, the future of Intercept’s rare liver disease drug Ocaliva is under serious threat. | Looking to assess whether Ocaliva met its postmarketing requirements after a 2016 accelerated approval in the autoimmune disease primary biliary cholangitis, an FDA council of outside experts nearly unanimously rejected Intercept’s hopes for a full approval.

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FDA 259

Authentic Influence Group

SEPTEMBER 16, 2024

The Silent Edge: How Body Language and Communication Skills Shape Leadership Success October 9, 2024 | 8:00 AM | NYC Free Event | Limited to 30 Seats Enjoy a Breakfast Bagel | Take in the NYC Skyline | Master Leadership Through Body Language Harness the power of what’s not being said. Join Shelly O’Donovan to master body language that transforms your leadership presence, influences decisions, and builds stronger teams.

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Consulting Competition Training Leads 130

Fierce Pharma

SEPTEMBER 16, 2024

Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. | Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss, or lebrikizumab, to treat atopic dermatitis.

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FDA 241

MedCity News

SEPTEMBER 16, 2024

It’s important that we focus attention on the areas where AI is already having a significant impact. These are the practical applications that will allow the best and brightest researchers to focus on science rather than data munging. The post We’re Overcomplicating Healthcare AI — Here’s How We Achieve Impact Beyond The Hype appeared first on MedCity News.

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Healthcare Healthcare Electronics Medical 121

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Fierce Pharma

SEPTEMBER 16, 2024

The same set of clinical data on Cabometyx and Tecentriq in prostate cancer has led to two distinct regulatory plans between Exelixis and its partner Ipsen. | The same set of clinical data on Cabometyx and Tecentriq in prostate cancer has led to two distinct regulatory plans between Exelixis and its partner Ipsen.

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FDA 157

MedCity News

SEPTEMBER 16, 2024

Eli Lilly drug Ebglyss is now FDA-approved for atopic dermatitis, an inflammatory skin disorder also known as eczema. The biologic drug came from Lilly’s $1.1 billion acquisition of Dermira in 2020. The post New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds appeared first on MedCity News.

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Competition Pharma FDA Biopharma 117

Pharmaceutical Technology

SEPTEMBER 16, 2024

While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.

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FDA 116

pharmaphorum

SEPTEMBER 16, 2024

AstraZeneca reveals 'practice changing' data for Imfinzi as peri-operative therapy for bladder cancer, but will the FDA accept the study?

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FDA 106

MedCity News

SEPTEMBER 16, 2024

Pediatric innovation in mental health is the theme of the INVEST Digital Health Pitch Perfect contest at Pegasus Park in Dallas on September 18. The post Where is Pediatric Innovation Making an Impact? appeared first on MedCity News.

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pharmaphorum

SEPTEMBER 16, 2024

FDA raps AbbVie for 'misleading' ad for migraine drug Ubrelvy featuring tennis star Serena Williams

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FDA 109

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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.

Safety

MedCity News

SEPTEMBER 16, 2024

Providence Health Plan and the American Heart Association will create blood pressure programs in 20 community organizations and clinics over three years. The post Providence Health Plan, American Heart Association Launch Cardiovascular Health Initiative appeared first on MedCity News.

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pharmaphorum

SEPTEMBER 16, 2024

Pfizer's anti-GDF-15 antibody ponsegromab was able to achieve weight gain in cancer patients with cachexia in a phase 2 trial presented at ESMO

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Patients 82

Pharmaceutical Technology

SEPTEMBER 16, 2024

The Phase III trial evaluating nerandomilast as a treatment for idiopathic pulmonary fibrosis met its primary endpoint.

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pharmaphorum

SEPTEMBER 16, 2024

Rates of cancer among people aged 24 and below are rising fast, but health systems are often not catering well enough to the specific needs of this age group.A new partnership has been set up between the Ella Dawson Foundation, a UK-based charity for young people with cancer, and digital cancer care company Careology to try to tackle that deficit and improve their treatment and wellbeing.

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Patients 73

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MedCity News

SEPTEMBER 16, 2024

This test can be thought of as a crystal ball for cancer survivors and research has found it can predict with near certainty whether a patient’s cancer will recur. So why aren’t more patients getting the test? The post A Crystal Ball for Cancer Survivors appeared first on MedCity News.

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Patients 70

Pharmaceutical Technology

SEPTEMBER 16, 2024

Eli Lilly and Company has announced the FDA approval of EBGLYSS for treating atopic dermatitis in adults and children over 12.

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FDA Patients 80

MedCity News

SEPTEMBER 16, 2024

MIT spinout Bloomer Tech is developing a wearable electrocardiogram device designed to look and feel like a bra. The post Not Your Average Bra: How Bloomer Tech’s Wearable Is Addressing Heart Disease in Women appeared first on MedCity News.

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pharmaphorum

SEPTEMBER 16, 2024

Incyte's first attempt to get FDA approval for its PD-1 inhibitor Zynyz for squamous cell carcinoma of the anal canal (SCAC) was knocked back by the FDA, but new data could get the programme back on track.Zynyz (retifanlimab) is a late entrant to the PD-1/PD-L1 category but picked up its first approval in the rare tumour Merkel cell carcinoma last year.

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FDA 72

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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.

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PharmaTimes

SEPTEMBER 16, 2024

The decision is expected to facilitate timely access to Bavarian Nordic’s Imvanex

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pharmaphorum

SEPTEMBER 16, 2024

J&J plans phase 3 trials for Rybrevant in colorectal cancer, after reporting positive results for the METxEGFR bispecific antibody at ESMO

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PharmaVoice

SEPTEMBER 16, 2024

After the House of Representatives passed the Biosecure Act last week, U.S. biotechs could be forced to cut ties with five Chinese contract partners.

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Biopharma 65

PharmExec

SEPTEMBER 16, 2024

Results from the ADvocate 1, ADvocate 2, and ADhere clinical trials found that patients treated with Ebglyss 38% of patients with moderate-to-severe atopic dermatitis achieved clear or almost-clear skin after 16 weeks of treatment.

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FDA Patients 52

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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

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PharmaVoice

SEPTEMBER 16, 2024

Five ways to beat study timeline pressures and get medicines to patients faster.

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Medicine Patients 88

PharmExec

SEPTEMBER 16, 2024

The diversification of site-of-care delivery models is accelerating rapidly, creating new go-to-market implications for drug manufacturers—but also new opportunities to drive more fundamental innovation in engagement and access strategies.

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Manufacturing Marketing 52

Pharmaceutical Technology

SEPTEMBER 16, 2024

As clinical trials become more complex, the need for innovative solutions to capture patient data accurately and efficiently is more critical than ever.

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Patients 52

PharmExec

SEPTEMBER 16, 2024

Amid shifting operating dynamics in recent years, demands for external expertise have fluctuated—leaving those arrangements that mix innovation and agility likely to win out in pharma decision-making.

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Pharma 52

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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

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Pharmaceutical Technology

SEPTEMBER 16, 2024

Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.

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Food and Drug Administration Food FDA 52

PharmExec

SEPTEMBER 16, 2024

In this part of their Pharmaceutical Executive video interview, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, share their predictions for the future of telehealth and its role in providing access to essential medications like weight loss drugs

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Medical Pharmaceutical 52

Pharmaceutical Technology

SEPTEMBER 16, 2024

Having a specialty logistics partner that can act as lookout for pharmaceutical manufacturers is critical amid supply chain uncertainty.

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Pharmaceutical Pharmaceutical manufacturing Manufacturing 52

PharmExec

SEPTEMBER 16, 2024

Ocrevus Zunovo is the first and only twice-yearly, 10-minute subcutaneous injection for treating both relapsing multiple sclerosis and primary-progressive multiple sclerosis.

FDA 52

FDA 52

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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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