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

article thumbnail

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.

98
article thumbnail

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.

FDA 358
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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.

FDA 125
article thumbnail

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

article thumbnail

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.

article thumbnail

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.

126
126
article thumbnail

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.

357
357

More Trending

article thumbnail

Accelerating Discovery and Development with Advances in High-Throughput Screening

PharmaTech

Automation, miniaturization, and new software algorithms are improving throughput and accuracy.

111
111
article thumbnail

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.

article thumbnail

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

Patients 317
article thumbnail

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.

article thumbnail

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

article thumbnail

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
article thumbnail

J&J bids to add smouldering myeloma to Darzalex label

pharmaphorum

Johnson & Johnson looks on course to make Darzalex the first approved drug therapy for smouldering multiple myeloma, after a phase 3 win

108
108
article thumbnail

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.

article thumbnail

‘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.

FDA 122
article thumbnail

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

article thumbnail

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.

FDA 104
article thumbnail

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

105
105
article thumbnail

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.

article thumbnail

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.

article thumbnail

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.

article thumbnail

Pharmaceutical Technology Excellence Awards 2024: BostonGene 

Pharmaceutical Technology

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

article thumbnail

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 105
article thumbnail

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.

Medicine 299
article thumbnail

CEO of Otsuka North America: Are We Getting better access with AI?

MedCity News

In an interview, Rabah talked about the promise of AI, where it can have the most impact, while also responding to the IRA and high drug prices in the United States. The post CEO of Otsuka North America: Are We Getting better access with AI? appeared first on MedCity News.

article thumbnail

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

article thumbnail

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.

article thumbnail

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 105
article thumbnail

AstraZeneca and Merck's Koselugo delivers phase 3 trial win in adults with NF1, teeing up filings

Fierce Pharma

Four years after winning an FDA approval for Koselugo to treat children with the rare disorder neurofibromatosis type 1 (NF1), AstraZeneca is touting a trial result that could allow the company and | Four years after scoring an FDA approval to treat children with NF1, AstraZeneca says its Merck-partnered Koselugo has shown promise in adults.

FDA 289
article thumbnail

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.

124
124
article thumbnail

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

article thumbnail

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.

article thumbnail

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.

Medicine 105
article thumbnail

Bayer's rising prostate cancer star Nubeqa crosses blockbuster barrier as Xarelto continues downward descent

Fierce Pharma

Despite generic headwinds to Xarelto and challenges across different sectors of the conglomerate suggesting “twists and turns” in the road ahead, Bayer is confident that the course it’s laid out th | As Xarelto generics continue to eat away at sales, Bayer's Nubeqa and Kerendia are picking up the slack while Regeneron-partnered Eylea makes for a solid base.

Sales 288
article thumbnail

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.

Medicine 122
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time