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.

Biopharma 341
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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 134
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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Psilocybin-assisted therapy reduces depressive symptoms in cancer patients

European Pharmaceutical Review

Findings from a small Phase II clinical trial indicate that psilocybin, a hallucinogenic chemical found in certain mushrooms of the genus Psiloybe , may benefit individuals with cancer and major depression. The open-label trial involved 30 adults with cancer and major depression and was conducted by Sunstone Therapies in Rockville, Maryland. The participants each received a single 25mg dose of synthesised psilocybin, a one-to-one session with a therapist and group therapy support.

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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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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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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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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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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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 127
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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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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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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

Marketing 109
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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 124
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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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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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As ALS research booms, one treatment center finds itself in the spotlight

PharmaVoice

The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists. Still, the complexities of the disease and of drug development have brought hard-felt losses.

Doctors 105
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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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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.

Pharma 124
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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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Carbonated water makes chromatography more environmentally friendly

European Pharmaceutical Review

A study carried out by scientists from the University of Texas at Arlington (UTA) has found that using carbonated water in chromatography makes this relatively common chemical technique more environmentally benign. The research, led by Daniel W. Armstrong, the Welch Distinguished Professor of Chemistry and Biochemistry at UTA, was published in Green Chemistry.

Safety 105
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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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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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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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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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Otsuka to commercialise hereditary angioedema drug in Europe

European Pharmaceutical Review

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.

Medicine 105
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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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Why a Former ONC Chief Thinks TEFCA Is Inherently Flawed

MedCity News

Last week, the ONC announced that TEFCA had finally gone live. This followed years of the ONC heralding the project’s potential to boost interoperability and increase patients’ access to their healthcare data. However, former ONC Chief Don Rucker believes that TEFCA is built on an archaic data exchange protocol that will prevent the initiative from being useful.

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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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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.

Pharma 266
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European regulators prepare for AI in pharma

European Pharmaceutical Review

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 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time