Fierce Pharma

NOVEMBER 1, 2023

Cosentyx may soon share the hidradenitis suppurativa (HS) field with another inflammatory biologic—but, for now, the Novartis drug has a head start. | The FDA approved Cosentyx for the treatment of moderate to severe hidradenitis suppurativa in adults, Novartis said Tuesday. The green light makes Cosentyx the first new biologic to treat the lesser-known skin affliction in nearly a decade.

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FDA 252

MedCity News

NOVEMBER 1, 2023

While telemedicine seems to be the ideal solution to this ever-increasing shortage problem, it still has challenges and benefits that need to be considered before deciding to add a telemedicine program of your own.

Physicians 121

Physicians 121

Fierce Pharma

NOVEMBER 1, 2023

The FDA has signed off on Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. | The FDA has approved Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. But the new product will not launch until 2025 because of a settlement the companies made earlier this year, which delayed the launch in exchange for J&J dropping a patent infringement lawsuit.

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FDA 242

MedCity News

NOVEMBER 1, 2023

In a letter to Senate leadership, several organizations asked for the passing of legislation that would reform the patent system and improve competition in the prescription drug space.

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Prescription Competition Patients 118

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Fierce Pharma

NOVEMBER 1, 2023

After AstraZeneca’s Imfinzi last year claimed new territory the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. | The approval was based off of Merck's phase 3 KEYNOTE-966 trial and marks Keytruda's sixth in gastrointestinal cancers. Meanwhile, AZ's Imfinzi scored its first approval in the space last year.

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FDA 233

MedCity News

NOVEMBER 1, 2023

Medicare Advantage members have fewer readmissions, fewer preventable hospitalizations and lower rates of high-risk medication use than traditional Medicare, new research by Harvard Medical School and Inovalon shows.

Medical 114

Medical 114

MedCity News

NOVEMBER 1, 2023

AstraZeneca starts the Cellectis partnership with $105 million in upfront cash and an equity investment. The pharmaceutical giant will also cover research costs for up to 10 cell therapy programs in oncology, immunology, and rare diseases.

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Pharmaceutical Biopharma Pharma 111

Fierce Pharma

NOVEMBER 1, 2023

Besides Pfizer’s fast-declining COVID-19 sales, vaccine rival GSK is giving the New York drugmaker another reason to worry. | Aside from Pfizer's declining COVID-19 sales, GSK is giving the New York drugmaker another reason to worry. In the first round of their RSV vaccine showdown, GSK's Arexvy pulled down $860 million, more than doubling the haul from Pfizer's Abrysvo.

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Sales 223

MedCity News

NOVEMBER 1, 2023

Investing in comprehensive patient concierge services keeps trial administrators on track by removing the burden of logistical support and improving the overall participant experience, making dropouts and trial delays much less likely.

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Patients Biopharma 111

Fierce Pharma

NOVEMBER 1, 2023

As Argenx works to grow the reach of its up-and-coming rare disease med Vyvgart, the company is seeing significant early gains for its lone commercial product. | Sales of Argenx’s Vyvgart increased by 151% to $329 million in the third quarter as the momentum for the treatment continues with its recent approval to be administered subcutaneously. The company also announced that it will use a priority review voucher to speed an FDA decision on an application for Vyvgart to treat a second immunoglob

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FDA Sales 218

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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

Medgadget

NOVEMBER 1, 2023

Researchers at the Wyss Institute at Harvard University have developed a microfluidic chip that can recreate some of the features of radiation-induced lung injury. The lungs are very sensitive to radiation, and this can limit the application of radiotherapy to treat cancer. Accurately modeling radiation-induced lung injury could assist in developing new methods to prevent and treat the phenomenon, but it has been difficult to study this before the advent of advanced organ-on-a-chip models.

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Ethics Patients 106

Fierce Pharma

NOVEMBER 1, 2023

While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease | While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease progression before any Alzheimer’s symptoms are evident.

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Medicine Leads 177

MedCity News

NOVEMBER 1, 2023

MedCity News is inviting startups to apply for the INVEST 2024 Pitch Perfect Startup Contest on May 21-22 at the annual INVEST conference in the Ritz Carlton hotel in Chicago.

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Biopharma 98

Fierce Pharma

NOVEMBER 1, 2023

After wreaking havoc on a pandemic level for more than three years, COVID-19 has entered its first endemic season. | A few months ago, Fierce Pharma asked employees working in the biopharma industry to use photographs to tell their stories during the pandemic. Now, we’re showcasing those precious memories here.

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Biopharma Pharma 174

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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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European Pharmaceutical Review

NOVEMBER 1, 2023

In July 2022, the World Health Organization (WHO) released its inaugural report on the pipeline of vaccines currently in development to prevent infections caused by antimicrobial resistance (AMR) bacterial pathogens. 1 WHO’s analysis was stark. It asserted the need to accelerate trials for AMR-related vaccines in late‑stage development and maximise the use of those already on the market.

Safety 100

Safety Marketing Manufacturing Government 100

Integrity Solutions

NOVEMBER 1, 2023

We often talk about learning as a journey. We talk about success as never-ending. We acknowledge that habits require time to take hold and that progress, like a stock market chart, is never linear. So when it comes to maintaining sales motivation, do you have the discipline and perspective to maintain focus on progress? Do we actually have the patience for it?

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Sales Sales goal Prospecting Training 95

European Pharmaceutical Review

NOVEMBER 1, 2023

The European Commission has authorised the Nuvaxovid XBB.1.5-adapted COVID-19 vaccine, developed by Novavax for this autumn and winter season. The vaccine, known as Nuvaxovid XBB.1.5, is to be used for preventing COVID-19 in adults and children from 12 years of age. It was developed to target Omicron XBB in line with recommendations from the European Medicines Agency’s Emergency task force (ETF) as well as other international regulators and the World Health Organization.

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Side effects Medicine Safety Marketing 99

PharmaTech

NOVEMBER 1, 2023

Pharmaceutical Technology Europe® speaks with Dr. Rainer Schmidt from Galvita AG, an excipient manufacturer based in Switzerland, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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Manufacturing Pharmaceutical Marketing 94

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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.

Safety

Medgadget

NOVEMBER 1, 2023

Researchers at Rice University have developed a magnetoelectric material that converts a magnetic field into an electric field. The material can be formulated such that it can be injected into the body, near a neuron, and then an alternating magnetic field can be applied to the area from outside the body. Magnetic fields are very useful in this context, as they can easily penetrate tissue without causing any damage.

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Electronics Leads 92

Pharmaceutical Technology

NOVEMBER 1, 2023

The US FDA has granted approval for Novartis’ Cosentyx to treat adult patients with moderate to severe hidradenitis suppurativa (HS).

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FDA Patients 105

European Pharmaceutical Review

NOVEMBER 1, 2023

Washington State University researchers have developed a centrifugal bioreactor that is able to manufacture T cells, at 95 percent of the maximum growth rate — about 30 percent quicker than current technologies. The centrifugal bioreactor, which was developed using T cells from cattle, is expected to perform similarly on human cells, according to the research, which was published in the journal Biotechnology Progress.

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Manufacturing Engineering Competition Pharmaceutical 86

Pharmaceutical Commerce

NOVEMBER 1, 2023

SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas.

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FDA 104

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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.

Specialization

Pharmaceutical Technology

NOVEMBER 1, 2023

Pfizer has posted a net loss of $2.38bn in Q3 2023 compared to a net income of $8.61bn during the same period of 2022.

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PharmaVoice

NOVEMBER 1, 2023

From hallucinations to data privacy, pharma looks to iron out the kinks of generative AI.

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Pharma 115

PharmaTimes

NOVEMBER 1, 2023

The AI tools to be deployed will help NHS staff to analyse X-rays and CT scans - News - PharmaTimes

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103

PharmExec

NOVEMBER 1, 2023

Stark discusses pharma’s supply chain and the issues it is facing.

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Management 111

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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

Leads

PharmaTimes

NOVEMBER 1, 2023

All CDCs will be open by March 2024 to speed up lifesaving checks and tests - News - PharmaTimes

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Government 103

pharmaphorum

NOVEMBER 1, 2023

Bayer launches support tool for diabetic kidney disease Phil.

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107

PharmaTech

NOVEMBER 1, 2023

Pharmaceutical Technology Europe® spoke with Dr. Tom Kamperman from IamFluidics, a Dutch high-tech company that develops customized microencapsulation solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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Pharmaceutical Marketing 59

pharmaphorum

NOVEMBER 1, 2023

Imfinzi faces Keytruda competition in biliary tract cancer Phil.

Competition 101

Competition 101

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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.

Management