Fierce Pharma

DECEMBER 19, 2023

On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. | On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. The agency granted a priority review to Roche's filing and plans to make a decision during the first quarter of next year.

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Food FDA Marketing 294

MedCity News

DECEMBER 19, 2023

It’s time to build the infrastructure needed to scale up inhaled gene therapies targeting cystic fibrosis, and to bolster investment that supports several key program components.

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Medicine Patients Biopharma 130

Fierce Pharma

DECEMBER 19, 2023

A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. | A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech.

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MedCity News

DECEMBER 19, 2023

Despite artificial intelligence’s growing role in drug research, a fully AI-generated molecule has yet to advance from discovery all the way through clinical development. A novel molecule may eventually meet that goal, but some industry observers say it’s too early to focus on winning a race that has many twists and turns yet to come.

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Biopharma Pharma 125

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Fierce Pharma

DECEMBER 19, 2023

Following a significant loss at the U.S. Supreme Court last October, Biogen’s Tecfidera patent odyssey continues to spin in the company’s favor overseas. | The European Commission has revoked marketing authorizations for generic versions of Biogen's multiple sclerosis med Tecfidera, also known as dimethyl fumarate, that are owned by Accord, Mylan, Neuraxpharm, Polpharma and Teva.

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Marketing 244

MedCity News

DECEMBER 19, 2023

Butterfly Network announced a product co-development deal with surgical robotics startup Mendaera, in which the startup will build custom robotics around Butterfly’s ultrasound-on-a-chip technology to create a new system designed for better surgical precision and consistency. Both partners expect to complete the product’s FDA submission by 2025.

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Networking FDA 118

MedCity News

DECEMBER 19, 2023

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition.

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FDA Pharma Biopharma 112

Fierce Pharma

DECEMBER 19, 2023

As the biopharma world readies for the turn of the calendar, the all-too-familiar topic of drug pricing once again presents an industry-wide overhang. | Based on the series of measures centered on U.S. drug prices coming out of Washington, the Biden administration is clearly emboldened on the topic.

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Biopharma Pharma 183

MedCity News

DECEMBER 19, 2023

A recent peer-reviewed study from Maven Clinic found that virtual doulas significantly reduced the chances of a C-section, especially among Black mothers.

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Fierce Pharma

DECEMBER 19, 2023

Partnerships in healthcare have never been more important. | Agilent Technologies discusses the importance of working with pharmaceutical companies to drive medical innovation and improve patient outcomes, helping to speed up the process of bringing the right treatments to the right patients at the right time.

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Pharma Healthcare Healthcare Medical 180

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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.

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MedCity News

DECEMBER 19, 2023

Molina Healthcare’s purchase price of Bright Health Group’s Medicare Advantage business has dropped from $600 million to $500 million. This will make it increasingly difficult for Bright Health to pay off its debts, one expert said.

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Healthcare Healthcare 108

Pharmaceutical Technology

DECEMBER 19, 2023

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

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Food and Drug Administration Food Pharma FDA 105

European Pharmaceutical Review

DECEMBER 19, 2023

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. Since only about 20 percent of the world’s population is lucky enough to live in areas where reliable refrigeration is available, 1 the remaining majority live with

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Distribution Manufacturing Food Specialization 101

Pharmaceutical Commerce

DECEMBER 19, 2023

FDA expands indication for LEO Pharma’s Adbry (tralokinumab-ldrm) to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis.

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FDA Patients 105

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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

Distribution

European Pharmaceutical Review

DECEMBER 19, 2023

Otsuka Pharmaceutical has agreed to acquire exclusive marketing rights to Ionis’ hereditary angioedema (HAE) drug candidate, donidalorsen, in Europe. Under the terms of the agreement, Otsuka will pay California-based Ionis $65 million upfront, along with additional milestone-related payments. Ionis is also eligible to earn tiered royalties ranging from 20 to 30 percent based on aggregate annual net sales.

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Medicine Pharmaceutical Patients Marketing 94

Copyright Clearance Center

DECEMBER 19, 2023

We must not take for granted how critical these media activities are to the joy of celebrating our humanity and to the responsibility of sustaining our freedom.

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Media 98

European Pharmaceutical Review

DECEMBER 19, 2023

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have published a plan, which sets out a “collaborative and coordinated strategy” to maximise the benefits of artificial intelligence in regulation. The workplan, which runs until 2028, will help the European medicines regulatory network (EMRN) embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit

Pharma 92

Pharma Networking Medicine Ethics 92

Pharmaceutical Technology

DECEMBER 19, 2023

Sanofi and Innate’s cancer collaboration agreement stretches back to 2016, with two of Sanofi’s NK cell engagers in clinical studies.

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Pharma 98

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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

European Pharmaceutical Review

DECEMBER 19, 2023

Gene therapy manufacturing processes produce low yields, particularly in early product development stages. Yet the products are subject to the same regulatory release criteria and expectations as those used for traditional microbiology testing on biologics/pharma products producing significantly higher yields. Often, if gene therapy manufacturers were to adhere to current release requirements, the outcome would be little, if any, remaining product for the clinic or patients who often have no oth

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Manufacturing Safety Pharma Pharmaceutical 80

Pharmaceutical Technology

DECEMBER 19, 2023

Kronos Bio is prioritising its multiple myeloma therapy after reviewing negative Phase Ib AML data for lanraplenib.

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PharmaTimes

DECEMBER 19, 2023

The BioMed X Institute and Ono Pharmaceutical have announced a new joint research collaboration for cancer research. The project, ‘New Strategies to Engage Neutrophils in Solid Tumors’, will help to design next-generation immunotherapies by advancing the antitumour effects of neutrophils. Neutrophils are a type of white blood cell that helps the immune system fight infections and heal injuries.

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Pharmaceutical Management Leads Patients 74

pharmaphorum

DECEMBER 19, 2023

Checkpoint Therapeutics’ PD-L1 inhibitor cosibelimab has been turned down by the FDA as a treatment for skin cancer cSCC

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FDA 92

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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

PharmaVoice

DECEMBER 19, 2023

The last year showed how some of the world’s biggest pharma companies are leveraging AI tech.

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Pharma 99

PharmaTimes

DECEMBER 19, 2023

In the UK, heart rhythms affect around two million people and can cause sudden death - News - PharmaTimes

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Copyright Clearance Center

DECEMBER 19, 2023

The post Amazon Urges Judge To Dismiss Antitrust Case appeared first on Copyright Clearance Center.

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pharmaphorum

DECEMBER 19, 2023

Novo Nordisk Foundation is providing $260m in funding for an R&D initiative to find vaccines for respiratory infectious diseases like TB and flu

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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

DECEMBER 19, 2023

In 2020, there were over ten million deaths worldwide associated with cancer - News - PharmaTimes

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Pharmaceutical 90

pharmaphorum

DECEMBER 19, 2023

Pharma has embraced digital and omnichannel to transform sales engagement, but has little to show for the effort.

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Sales Pharma 82

PharmaVoice

DECEMBER 19, 2023

Arbor Biotechnologies is looking past CRISPR’s recent regulatory wins and into the next stage of gene editing.

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pharmaphorum

DECEMBER 19, 2023

Owkin and MSD join forces on AI-powered digital pathology Phil.

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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