Sat.Dec 16, 2023 - Fri.Dec 22, 2023

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A Look Back: The Life Sciences Industry in 2023 and a View for 2024

PharmExec

In the coming year, efficiency and automation will take center stage to maximize constrained resources but balancing sensible financial management with strategic investments will be vital.

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2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue

Fierce Pharma

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. | Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise.

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How pharma’s sales and marketing teams are starting to use AI

Dominic Tyer

Traditionally R&D’s province, the meteoric rise of AI has turbo-charged discussions about how commercial organisations can make use of artificial intelligence.

Marketing 130
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A Step Too Far: Congress Must Act on Insurance Company Tactics that Delay Critical Care for Patients

MedCity News

This bipartisan legislation will help create a more transparent process that allows patients and physicians to seek exceptions to step therapy protocol. Although it only applies to employer-sponsored health plans, the bill represents an important step towards reining in this troubling practice.

Insurance 135
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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8 Tactics to Increase HCP Engagement in 2024

PM360

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.

Media 122
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Roche, Novartis move Xolair closer to FDA finish line for food allergies

Fierce Pharma

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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2023’s Wins and Losses in the Reproductive Health Space, Per 2 Advocates

MedCity News

Representatives from the Guttmacher Institute and NFPRHA shared their wins and losses for reproductive health in 2023. Their wins include states moving to protect contraception and the approval of Opill, while their losses include state enactments of abortion bans and the lack of funding for Title X.

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Defining Biotech Success in a Challenging Fundraising Environment

PM360

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.

Biopharma 111
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Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent

Fierce Pharma

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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Pharma breakthroughs: 10 novel drug approvals that made headlines in 2023 

Pharmaceutical Technology

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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How Machine Learning Drives Clinical Trial Efficiency

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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How WellSpan Health Is Using Artisight’s Virtual Nursing Tech to Reduce Burnout

MedCity News

WellSpan Health launched a virtual nursing pilot involving Artisight’s smart hospital platform. So far, WellSpan’s nurses “are loving it,” said Erin Langmead, the health system’s interim director of clinical informatics and physician informatics support.

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Audio Prime—Taking Audio Marketing to the Next Level

PM360

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.

Marketing 110
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After Amryt buyout, Chiesi scores with FDA nod for rare skin disease treatment Filsuvez

Fierce Pharma

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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Sanofi stops development of lung cancer drug

European Pharmaceutical Review

French pharmaceutical giant Sanofi announced that it is ending the development programme evaluating tusamitamab ravtansine as a monotherapy for certain patients with metastatic non-squamous, non-small cell lung cancer (NSCLC). The decision comes after interim analysis from a Phase III clinical trial , CARMEN-LC03, did not meet a primary end point. CARMEN-LC03, a randomised, open-label study was evaluating tusamitamab ravtansine as monotherapy compared to docetaxel in patients with metastatic non

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Gene Therapy and a New Medicine Delivery Approach Signal Progress for Cystic Fibrosis Patients

MedCity News

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.

Medicine 130
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4 Biotech Executives Share Strategies Behind Successful Fund Raises

PM360

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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J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk

Fierce Pharma

As the FDA investigates a safety signal for approved CAR-T therapies, the agency has upgraded a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carv | As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carvykti.

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The Transformative Potential of AI and Machine Learning in Biomedical Research and Healthcare

PharmExec

Oxford Academic report explores the positive improvements these technological capabilities could bring to the industry.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Illumina’s Antitrust Battles to End With Divestiture of Cancer Test Maker Grail

MedCity News

Illumina has decided against further appeals of U.S. and European antitrust litigation challenging its acquisition of liquid biopsy company Grail. Illumina expects to have terms of the divestiture set by the end of the second quarter of 2024.

Biopharma 125
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Content Supply Chain: From Craftsmanship to the Industrialization of Marketing

PM360

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.

Marketing 105
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Calliditas wins over FDA for full approval, broader label on kidney disease drug Tarpeyo

Fierce Pharma

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

FDA 292
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The imperative of fridge-free vaccines

European Pharmaceutical Review

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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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AI-Generated Drug Candidates Are Here, But Clinical Trial Wins Need More Time

MedCity News

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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Everything You Need to Know About Market Access in China

PM360

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.

Marketing 105
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2024 forecast: Big Pharma reworks China strategy, and job cuts are part of it

Fierce Pharma

Big Pharma companies have often talked about the major opportunities that await in China. | Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country.

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BioNTech wins round in CureVac mRNA patent dispute

pharmaphorum

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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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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How Are AI Companies Reacting to HHS’ New Transparency Requirements?

MedCity News

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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What Biden’s AI Executive Order Means for Healthcare and the Life Sciences

PM360

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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Charles River snags clearance to produce Vertex and CRISPR's Casgevy from Tennessee plant

Fierce Pharma

Following a string of approvals in the United States and beyond, Vertex Pharmaceuticals continues to build out its manufacturing network for the world’s first CRISPR-based gene therapy, Casgevy.

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Trends shaping the pharmaceutical industry in 2024

PharmaVoice

Advancements in cloud and AI technology will transform clinical trial efficiency and engagement.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.