Sat.Nov 09, 2024 - Fri.Nov 15, 2024

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BioNTech signs agreement to acquire Biotheus

Pharmaceutical Technology

BioNTech has signed a definitive agreement to acquire Biotheus to obtain complete worldwide rights to BNT327/PM8002, a programmed death-ligand 1 and vascular endothelial growth factor A-targeting bispecific antibody.

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PTC wins FDA approval for first brain-delivered gene therapy Kebilidi

Fierce Pharma

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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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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AI tool spots long COVID in electronic health records

pharmaphorum

Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records

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5 Ways You Can Win Faster with Gen AI in Sales

Incorporating generative AI (gen AI) into your sales process can speed up your wins through improved efficiency, personalized customer interactions, and better informed decision- making. Gen AI is a game changer for busy salespeople and can reduce time-consuming tasks, such as customer research, note-taking, and writing emails, and provide insightful data analysis and recommendations.

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How One Optum Exec Is Handling the Influx of Digital Mental Health Solutions

MedCity News

There has been a surge in digital mental health solutions, making it difficult to know which ones are effective. One Optum exec weighed in on how she’s managing this challenge. The post How One Optum Exec Is Handling the Influx of Digital Mental Health Solutions appeared first on MedCity News.

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In boost to GSK's £3B plan for Blenrep, myeloma ADC shows survival edge over J&J's Darzalex

Fierce Pharma

GSK’s 3 billion pounds sterling peak sales goal for its multiple myeloma drug Blenrep appears increasingly attainable thanks to a key patient survival win.

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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

FDA 105
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Centering Caregiver and Provider Feedback in Home-Based Care Innovation

MedCity News

The best healthcare technology emerges from collaborative efforts. Here’s why working alongside physicians, nurses, and home health caregivers builds a stronger foundation. The post Centering Caregiver and Provider Feedback in Home-Based Care Innovation appeared first on MedCity News.

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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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Gilead data lends insight into transforming HIV prevention landscape

European Pharmaceutical Review

New clinical trial findings show that twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP) had high efficacy and safety in a diverse group of participants. This data provides the first in-depth insight into full results of Gilead Sciences pivotal Phase III PURPOSE 2 trial. In the oral PrEP study group, adherence to the small molecule injectable HIV-1 capsid inhibitor and placebo injections was 91.0 percent with on-time injections at week 26, the results showed.

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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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FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine 

Pharmaceutical Technology

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

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How One Massachusetts Maternal Mental Health Program Scaled Across the Country

MedCity News

During a recent panel, experts discussed the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and how it achieved scale. The post How One Massachusetts Maternal Mental Health Program Scaled Across the Country appeared first on MedCity News.

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Lilly unwraps detailed data showing tirzepatide kept nearly 99% of prediabetic patients diabetes-free over 3 years

Fierce Pharma

Lilly unwraps detailed data showing tirzepatide kept nearly 99% of prediabetic patients diabetes-free over 3 years fkansteiner Wed, 11/13/2024 - 14:37

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Advantage BMS as AbbVie drug fails schizophrenia trials

pharmaphorum

AbbVie's $8.7bn play for Cerevel looks like a poor bet as its lead schizophrenia drug flunks two phase 2 trials, but which rival stands to benefit?

Leads 101
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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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Pharmaceutical Technology Excellence Awards 2024: BostonGene 

Pharmaceutical Technology

BostonGene is a winner in four categories in the 2024 Pharmaceutical Technology Excellence Awards.

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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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EMA changes tack, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population

Fierce Pharma

Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. But the recommendation for approval has a restriction.

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

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FDA grants accelerated approval for PTC’s AADC deficiency gene therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene therapy in the US that is directly delivered to the brain.

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Where Medicare Advantage Goes From Here

MedCity News

Now is the time for health plans to step up and embrace the tools and strategies that will not only meet regulatory demands, but also drive innovation in care delivery. The post Where Medicare Advantage Goes From Here appeared first on MedCity News.

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Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod

Fierce Pharma

Watch out, Gilead and Novartis: there's a new CAR-T in town. | Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.

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GSK hails survival data with revived myeloma drug Blenrep

pharmaphorum

GSK's multiple myeloma therapy Blenrep's increase in overall survival in the DREAMM-7 trial has achieved statistical significance

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10 Ways to Leverage Buyer Signals and Drive Revenue

In today’s ultra-competitive markets, it’s no longer enough to wait for buyers to show obvious signs of interest. Instead, sales teams must be proactive, identifying and acting on nuanced buyer behaviors — often before prospects are fully ready to make a purchase. In this eBook from ZoomInfo & Sell Better, learn 10 actionable ways to use these buyer signals to transform your sales strategy and close deals faster.

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Adaptimmune nears second sarcoma approval as Phase II trial hits endpoints 

Pharmaceutical Technology

Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.

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Merck Is Paying $588M for Potential Successor to Cancer Drug Juggernaut Keytruda

MedCity News

Merck is acquiring global rights to a bispecific antibody from LaNova Medicines that blocks two cancer targets, PD-1 and VEGF. The deal comes one day after BioNTech announced an $800 million acquisition that gives it full rights to a molecule in this hot class of cancer drug candidates. The post Merck Is Paying $588M for Potential Successor to Cancer Drug Juggernaut Keytruda appeared first on MedCity News.

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AstraZeneca CEO defends corporate oversight, $80B revenue target amid China probes

Fierce Pharma

Despite China’s investigations into insurance fraud, allegedly illegal importation of unapproved drugs and improper collection of patient data that have implicated senior executives, AstraZeneca CE | Despite China’s investigations that have implicated senior executives, AstraZeneca CEO Pascal Soriot argued that the company did not lose oversight and remains on track to achieve his ambitious $80 billion-by-2030 revenue goal.

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Daiichi and AZ pull Dato-DXd filing with FDA and try again

pharmaphorum

Daiichi Sankyo and AstraZeneca give up on their NSCLC application for Dato-DXd, and refile seeking a narrower label

FDA 96
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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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EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease

Pharmaceutical Technology

Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.

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NationsBenefits Acquires Good Measures to Advance Food-as-Medicine Offerings

MedCity News

To ramp up its food-as-medicine support, NationsBenefits has acquired Good Measures, a company that offers coaching and personalized food prescriptions. The post NationsBenefits Acquires Good Measures to Advance Food-as-Medicine Offerings appeared first on MedCity News.

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FDA nod for Azurity's Danziten will allow patients to take leukemia med without fasting

Fierce Pharma

Azurity Pharmaceuticals has earned an FDA approval for Danziten, a new formulation of Novartis’ chronic myeloid leukemia (CML) blockbuster Tasigna.

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MD Anderson Launches Cell Therapy Institute

PharmaTech

The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.

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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.