November, 2024

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Airways unbound: The biologic revolution in asthma treatment  

Pharmaceutical Technology

In recent years, the evolution of biologic therapies for severe asthma has paralleled advancements in other chronic conditions such as rheumatoid arthritis and psoriasis, where biologics have also transformed treatment paradigms.

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PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain

MedCity News

The PTC Therapeutics gene therapy, Kebilidi, treats an enzyme deficiency that affects the body’s ability to produce dopamine, a neurotransmitter important for motor control. FDA approval for the product comes two years after it won its first regulatory approvals in Europe. The post PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain appeared first on MedCity News.

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'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

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Spravato is just the beginning in a new wave of depression meds

PharmaVoice

Psychiatry is getting more targeted as drugmakers develop a new range of treatments for depression.

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State of AI in Sales & Marketing 2025

AI adoption is reshaping sales and marketing. But is it delivering real results? We surveyed 1,000+ GTM professionals to find out. The data is clear: AI users report 47% higher productivity and an average of 12 hours saved per week. But leaders say mainstream AI tools still fall short on accuracy and business impact. Download the full report today to see how AI is being used — and where go-to-market professionals think there are gaps and opportunities.

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The EU AI Act: will regulation drive life science innovation away from Europe?

European Pharmaceutical Review

When the General Data Protection Regulation (GDPR) 1 came into effect in 2018, this appeared to accelerate the migration out of Europe for pharmaceutical clinical trials. This was not so much due to non-compliance but stemmed from regulatory ambiguity. As the EU now sets its sights on the regulation of artificial intelligence (AI) through the EU Artificial Intelligence Act (EU AI Act), 2 similar questions arise regarding the implementation and enforcement of the regulation.

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Top-10 Best Practices for Virtual Publication Planning and Development

Impetus Digital

A version of this article was previously published in the Journal of mHealth. The landscape of publication planning is constantly evolving with the rise of novel digital tools, artificial intelligence, and virtual collaboration platforms. As a result, traditional barriers to effective and efficient publication planning and development are being broken down, while new challenges related to compliance, data security, and global collaboration in the virtual setting have emerged.

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FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

MedCity News

BridgeBio Pharma claims its drug, Attruby, has an edge over a Pfizer drug as a treatment for cardiomyopathy caused by transthyretin-mediated amyloidosis. But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March. The post FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug appeared first on MedCity News.

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Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings

Fierce Pharma

With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.

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CEO with type 1 diabetes works to deliver ‘world’s first’ functional cure

PharmaVoice

Sernova’s technology helped type 1 diabetes patients achieve insulin independence in early- and mid-stage trials.

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The Intersection of AI and Sales: Personalization Without Compromise

Speaker: Jesse Hunter and Brynn Chadwick

Today’s buyers expect more than generic outreach–they want relevant, personalized interactions that address their specific needs. For sales teams managing hundreds or thousands of prospects, however, delivering this level of personalization without automation is nearly impossible. The key is integrating AI in a way that enhances customer engagement rather than making it feel robotic.

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ReferralMD Named to AVIA Marketplace’s 2024 Top Conversational AI Companies

Referral MD

MT. PLEASANT, S.C. , Nov. 1, 2024 /PRNewswire-PRWeb/ — ReferralMD, a leader in healthcare technology solutions, announced today that it was recognized as a 2024 Top Company in Conversational AI upon the conclusion of extensive research and company outreach by AVIA Marketplace, the leading digital health marketplace. ReferralMD offers a comprehensive platform that seamlessly integrates with Electronic Health Records (EHR), Practice Management, and Scheduling systems, automating time-consu

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Journey slips on FDA approval of rosacea therapy

pharmaphorum

Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.

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European Pharmaceutical Review Issue 5 2024

European Pharmaceutical Review

Articles in Issue 5 of European Pharmaceutical Review include: FOREWORD ICH Q6(R1): test criteria and specifications Dave Elder David P Elder Consultancy CELL & GENE THERAPY How automation and digital technologies will unlock the full potential of advanced therapies Dr Stephen Ward CGT Catapult Hydrogel encapsulation: unlocking the potential of cell therapies for targeted treatments Dr Stephen Harrington and Francis Karanu Likarda SUSTAINABILITY Transitioning to digital product information t

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Roche Expands Its Scope in Allogeneic Cell Therapy With $1B Poseida Therapeutics Acquisition

MedCity News

Roche is acquiring Poseida Therapeutics, a biotech developing allogeneic cell therapies for cancers and immunological indications. The two companies have been partners in hematological malignancies since 2022. The post Roche Expands Its Scope in Allogeneic Cell Therapy With $1B Poseida Therapeutics Acquisition appeared first on MedCity News.

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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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Incyte wins injunction to block launch of Sun Pharma's JAK inhibitor Leqselvi

Fierce Pharma

Despite winning an alopecia areata approval for its drug Leqselvi in July, Sun Pharma will have to wait a while longer to launch its JAK inhibitor competitor to Eli Lilly and Incyte’s Olumiant and | Sun Pharma, which had been plotting a mid-October launch for its JAK inhibitor Leqselvi, has been slapped with in an injunction blocking the rollout of the alopecia areata drug.

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Keytruda represents almost half of Merck’s sales, and a new formulation could fend off rivals

PharmaVoice

A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.

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What Matters Most: The Three Trends That Will Change Pharma Marketing in 2025

Eversana Intouch

Download the Report This year’s EVERSANA INTOUCH annual trends forecast – our ninth! – is both smaller and bigger than those that have come before it. It’s smaller because while in previous years we looked at five to seven trends affecting marketers, this year we’re spotlighting only three. It’s bigger because the impact of these issues is almost impossible to overstate.

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Chasing $80bn sales target, AZ unveils $3.5bn US investment

pharmaphorum

AstraZeneca plans to invest a whopping $3.5 billion to expand its R&D and manufacturing operations in the US by 2026 as part of a drive to raise its revenues to $80 billion by the end of the decade.The programme – part of the pharma group's Ambition 2030 effort – will include the construction of a new R&D centre at Kendall Square in the heart of the biopharma hub in Cambridge, Massachusetts, and a biologics manufacturing facility in Maryland.

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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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How Counterfeit Medicines Challenge Pharma Sales in Malaysia

Contrarian Sales Techniques

Imagine spending weeks building trust with a doctor or pharmacist, only to find out that counterfeit versions of your product are circulating in the market. It’s a reality for many of us in pharma sales in Malaysia. Counterfeit medicines aren’t just a risk to patients’ health – they’re a blow to the industry’s reputation and our efforts to promote genuine, high-quality treatments.

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‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

MedCity News

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability. The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

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Fierce Pharma Asia—AstraZeneca's China fallout; Pfizer's $1B plan in China; Incyte-Sun JAK dispute

Fierce Pharma

AstraZeneca's China president has been detained by Chinese authorities amid investigation into illegal importation and improper collection of patient data. | AstraZeneca confirmed its China president has been detained by Chinese authorities. Pfizer plans to invest $1 billion in China in the next five years. Sun Pharma's JAK inhibitor Leqselvi was slapped with an injunction in a lawsuit with Incyte.

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An RNA biotech draws the blueprint for a late-stage Dravet syndrome trial and beyond

PharmaVoice

Stoke Therapeutics is entering phase 3 with its RNA medicine designed to treat a rare epileptic condition.

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

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Pay Per Click Essentials for Pharma Marketing Executives: A Beginner’s Guide

Pharma Marketing Network

In today’s digital-first world, Pay Per Click (PPC) advertising has become an essential strategy for pharma marketing executives. Imagine having a tool that allows you to target specific audiences actively searching for healthcare solutions, like branded medications or treatment options. PPC does just that. But how does it work, and how can you make the most of it in the competitive pharmaceutical industry?

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MSD joins PD-1/VEGF push in cancer with LaNova deal

pharmaphorum

There has been a lot of talk about drugs targeting both PD-1 and VEGF stealing the crown held by MSD's Keytruda in cancer immunotherapy. Now, the company has made a move to try to make sure it isn't left behind. Its solution is a licensing deal with Chinese biotech LaNova Medicines for LM-299, which consists of an anti-VEGF antibody joined to the functional parts of a pair of anti-PD-1 antibodies.

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New $3.5b AstraZeneca investment to accelerate US R&D and manufacturing

European Pharmaceutical Review

To boost AstraZeneca’s research and manufacturing footprint by the end of 2026, it is dedicating $3.5 billion of capital investment in the US. Of this amount, $2 billion will generate over 1,000 new jobs, the company added. AstraZeneca highlighted its US footprint is expanding in multiple areas such as: • a state-of-the-art R&D centre in Kendall Square, Cambridge, Massachusetts • next generation biologics manufacturing facility based in Maryland • cell therapy manufacturing capacity on the W

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FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

MedCity News

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters. The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

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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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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

Fierce Pharma

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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What RFK Jr.’s influence could mean for pharma

PharmaVoice

Past comments hint at the changes Robert F. Kennedy Jr. could make across the various sectors of healthcare.

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Healthcare Email Marketing Strategies: A Guide for Pharma Executives

Pharma Marketing Network

In today’s digital world, healthcare email marketing is more than just sending out newsletters. It’s a strategic tool that, when done right, can boost engagement, nurture relationships with healthcare professionals (HCPs), and increase brand awareness. But how can pharma companies truly maximize the potential of email marketing? Let’s dive in and explore some proven strategies.