Tue.Dec 19, 2023

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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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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 129
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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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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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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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Biogen notches another Tecfidera patent win in Europe as officials revoke generic approvals

Fierce Pharma

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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Butterfly Network Partners with Mendaera to Co-Develop a ‘New Category of Robotics’

MedCity News

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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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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Addressing the evolving needs of pharma for CDx development

Fierce Pharma

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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Study: Virtual Doula Care Improves Maternal Health Outcomes

MedCity News

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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2024 forecast: Biden admin efforts show there's no pricing relief on the horizon for pharma

Fierce Pharma

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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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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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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Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

MedCity News

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.

FDA 114
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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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‘We’re Getting Closer and Closer To Bright Going Dark’: Molina Lowers Purchase Price for Bright Health Group’s MA Business

MedCity News

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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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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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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FDA Approves Expanded Indication for Adbry in Atopic Dermatitis

Pharmaceutical Commerce

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.

FDA 105
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Bioburden and sterility testing: how to conserve gene therapy product

European Pharmaceutical Review

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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In 2023, Voices Carry

Copyright Clearance Center

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.

Media 98
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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The nitty gritty of biotherapeutics production

European Pharmaceutical Review

Can you reflect a little on what’s happening from a technology standpoint in the bioproduction space? Mahesh Bhalgat (MB): We are seeing continued emphasis on use of technology, as we’ve seen historically, but even more so now on titer and productivity. And that is now translating into evaluating productivity of the overall process. As a result, you’re starting to see a trend of not only looking at titer at the expression stage, but also combining titer with downstream purifica

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Sanofi licenses fourth NK cell engager from Innate Pharma

Pharmaceutical Technology

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

Pharma 98
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FDA says no to Checkpoint’s skin cancer drug cosibelimab

pharmaphorum

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

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Kronos Bio swivels focus towards multiple myeloma after AML failure

Pharmaceutical Technology

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

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Novo Nordisk Foundation puts $260m into vaccine drive

pharmaphorum

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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BioMed X and Ono Pharmaceutical enter joint cancer research project

PharmaTimes

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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5 noteworthy pharma AI investments in 2023

PharmaVoice

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

Pharma 99
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Book explores why pharma’s digital sales shot has missed

pharmaphorum

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

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Amazon Urges Judge To Dismiss Antitrust Case

Copyright Clearance Center

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

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Heart vests to identify those at high risk of sudden cardiac death

PharmaTimes

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

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Owkin and MSD join forces on AI-powered digital pathology

pharmaphorum

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

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BioMed X and Ono Pharmaceutical enter joint cancer research project

PharmaTimes

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

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A