Fierce Pharma

DECEMBER 20, 2023

Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit. | Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit.

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MedCity News

DECEMBER 20, 2023

Last week, HHS finalized a new rule that requires healthcare AI developers to provide more data about their products to customers, which could aid providers in determining AI tools’ risks and effectiveness. Some AI leaders believe the new guardrails are a step in the right direction, and others are skeptical about whether the new rules are necessary or will be effective.

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Healthcare Healthcare 122

Fierce Pharma

DECEMBER 20, 2023

Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has

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FDA 289

PM360

DECEMBER 20, 2023

A significant battle for the hearts and minds of healthcare professionals (HCPs) will play out in social media during 2024. A series of studies and surveys have documented the fact that substantial numbers of physicians, nurses, and allied health professionals are active on or prefer social media for professional purposes and to connect directly with peers.

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Fierce Pharma

DECEMBER 20, 2023

In 2020, Palatin Technologies paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. | In 2020, Palatin paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. Three years later, the New Jersey company has sold the treatment for the same up-front figure—$12 million—in a deal that indicates the medicine is unlikely to ever make a significant impact in the market.

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MedCity News

DECEMBER 20, 2023

Healthcare’s share of the global PE and VC deal count will likely continue decreasing in 2024, according to a new Pitchbook report. The report also predicted that generative AI and surgical robotics will continue to be hot areas of interest for investors, and that there will be at least three digital health IPOs next year.

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Healthcare Healthcare 116

PM360

DECEMBER 20, 2023

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. After a promising start to the year on the merger and acquisitions (M&A) front, the third quarter was a disappointment for those hoping that the challenging commercial situation was coming to an end.

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Biopharma Pharma Marketing Management 111

Fierce Pharma

DECEMBER 20, 2023

Last year, reports surfaced that Novartis—hot off the heels of a planned restructuring and spinoff of generics giant Sandoz—was further weighing a sale for its ophthalmology business. | In a deal worth around $116 million, Novartis is handing over a portfolio of “select ophthalmology brands” to Mumbai’s J.B. Chemicals & Pharmaceuticals. The sale is expected to go into effect in January 2027.

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Distribution Sales Pharma Medicine 195

MedCity News

DECEMBER 20, 2023

NourishedRx is joining ProHealth Connect’s network, meaning its nutrition offerings are accessible for members of 46 payers with food benefits through a ProHealth Connect OTC or flex card. These members will be able to receive NourishedRx’s food delivery services and its wraparound support.

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Food Networking Medicine 108

Fierce Pharma

DECEMBER 20, 2023

Less than one month after reporting a trial fail for Vyvgart Hytrulo in a rare bleeding disorder, argenx has swung and missed in a group of chronic blistering diseases. | After a swing and miss in a rare blood disorder last month, argenx's Vyvgart Hytrulo missed its primary and secondary endpoints in a phase 3 in patients with two types of pemphigus.

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Patients 191

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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

PM360

DECEMBER 20, 2023

I asked two friends of mine who know media and healthcare marketing and are wizzes when it comes to audio for input on this story. Alas, they were busy. Life, right? So, I asked Professor Scott Galloway’s AI for some words I could use in this story. Because if you can’t rely on an AI trained to think like a marketing prof you follow on LinkedIn, then, well, I have no idea how you can call yourself a modern marketer.

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Fierce Pharma

DECEMBER 20, 2023

In the dynamic realm of healthcare, ensuring drug safety stands as an absolute priority for life sciences companies. | Explore the 2023 PV Industry Survey and learn about the pivotal shifts in drug safety practices, from automation to the emergence of Gen AI. Read now.

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PM360

DECEMBER 20, 2023

How can biotech companies successfully raise funds in an environment where investment in the industry is headed for a third straight year of decline? At the close of Q3 2023, the SPDR S&P Biotech ETF (XBI), which tracks small and mid-size biotechs, was down 12% compared to the previous year while the S&P 500, an index tracking the stock performance of 500 of the largest companies in the U.S. listed on the stock exchanges, is up 13%, according to Leerink Partners’ “Navigating the Complex

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MedCity News

DECEMBER 20, 2023

In a new partnership, patients in need of weight loss support can receive primary care, mental health and chronic condition management through Hello Alpha. In between Hello Alpha visits, patients can access health coaching services from TrestleTree.

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Management Patients 106

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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

PM360

DECEMBER 20, 2023

For thousands of years, everything that people used was created and produced by craftsmen. The quality of the output highly relied on their skills and, as a result, varied greatly. The time to produce and costs associated with production were significant, too. The industrial revolution that started in the 18 th century changed it completely. The industrial production process reduced cost, time to market, and in most cases, improved quality.

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MedCity News

DECEMBER 20, 2023

Spending on prescription drugs for autoimmune diseases has increased by 459% over the past decade, even surpassing cancer drugs. Yet despite driving around 30% of employers’ entire prescription spend, autoimmune diseases have remained completely overlooked in employer health spend.

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Prescription Healthcare Healthcare 105

PM360

DECEMBER 20, 2023

Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceutical products. With its rapidly evolving healthcare system, limited transparency of public information, and language barriers, China has never proven to be an easy market for overseas pharmaceutical companies to enter.

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Marketing Insurance Medical Manufacturing 105

MedCity News

DECEMBER 20, 2023

GSK gains rights to a Hansoh Pharma antibody drug conjugate that targets a protein abundant on lung cancer cells and other types of solid tumors. The pharmaceutical giant plans to start its own slate of clinical trials with this ADC in 2024.

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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

PM360

DECEMBER 20, 2023

In the dynamic landscape of modern business, regulated industries—such as healthcare and the life sciences—stand at a critical juncture. Emerging technologies such as generative artificial intelligence (AI) present unprecedented opportunities to reimagine how companies work, innovate, and grow. President Biden’s recent Executive Order captures the need to take robust action to tackle some of the risks associated with AI technology.

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Healthcare Healthcare Ethics Media 105

pharmaphorum

DECEMBER 20, 2023

Shares in CureVac have plummeted after a German court ruled that a patent it holds on mRNA-based COVID-19 vaccines was invalid. The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot.

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MedCity News

DECEMBER 20, 2023

Effective communication in senior care is necessary for important interactions that happen within this complex healthcare environment. It’s not just about exchanging words; it’s about creating a nurturing, compassionate, and supportive environment for residents and the loved ones who visit them.

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Healthcare Healthcare Physicians 95

European Pharmaceutical Review

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The drug, a monoclonal antibody, could be used in adults and children over 1 year of age for reduction of allergic reactions, including anaphylaxis, that may occur following accidental exposure to one or more foods.

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Food Food and Drug Administration FDA Patients 96

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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 20, 2023

In a shifting market focused on targeted therapeutics, drugs that generate big profits are still a priority.

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Marketing 119

Integrity Solutions

DECEMBER 20, 2023

So often, we listen to respond. We’re waiting for the other person to finish talking so we can tell them what we know. Effective sales conversations, however, are rooted in a mindset of listening to understand. Let’s explore why that distinction is so fundamental in sales, and what you can learn about active listening in sales from the best sales coaches.

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Sales Consulting Training Leads 86

PharmaTimes

DECEMBER 20, 2023

The findings could lead to new treatments to target the mTOR and ease PD symptoms - News - PharmaTimes

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Leads 115

European Pharmaceutical Review

DECEMBER 20, 2023

In Q1 2023, the European Commission (EC) announced proposed changes to EU pharmaceutical legislation. 1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. The proposed changes to EU pharmaceutical legislation broadly aim to: Support innovation and boost attractiveness of EU market Ensure timely and equitable access to medicines for patients across the EU Address other ongoing issues, including antimicrobial resist

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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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pharmaphorum

DECEMBER 20, 2023

Aclaris will cut 46% of its workforce after stopping development of MK2 inhibitor zunsemetinib (ATI-450) for immuno-inflammatory diseases.

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Pharmaceutical Technology

DECEMBER 20, 2023

The FDA accepted the filing based on NIH-funded Phase III trial interim results, with an approval decision expected in Q1 2024

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Food FDA 97

PharmaTimes

DECEMBER 20, 2023

Researchers from Johns Hopkins University School of Medicine have revealed new findings about a key pathological protein associated with Parkinson’s disease (PD), which could lead to new treatments. Published in Science Translational Medicine , the study found that the pathological form of alpha-synuclein triggers cells to increase protein synthesis in the neurodegenerative condition.

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Medicine Engineering Leads 76

pharmaphorum

DECEMBER 20, 2023

GSK has turned to China’s Hansoh for another antibody-drug conjugate (ADC), licensing B7-H3-targeting HS-20093 for $185 million upfront.

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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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