NICE, NHS England unveil new pathway for medtech
pharmaphorum
MAY 24, 2024
NICE and NHS England are seeking feedback on proposed new rules and commissioning principles for medtech products.
Fri.May 24, 2024
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Lilly to pour $5B more into expanding Zepbound, Mounjaro production
Bio Pharma Dive
MAY 24, 2024
The planned spending on new facilities in Lebanon, Indiana, brings its total commitment to the site to $9 billion, the largest single manufactuing investment in company history.
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FDA advisory committee reviews Novo Nordisk insulin icodec for T1D
Pharmaceutical Technology
MAY 24, 2024
The US FDA's EMDAC is set to hold a meeting to assess the benefit-risk profile of Novo Nordisk's insulin icodec, to treat type 1 diabetes.
With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals
Bio Pharma Dive
MAY 24, 2024
But the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening use of Sarepta’s Duchenne gene therapy Elevidys.
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
ASCO 2024: Merus touts positive Phase II data for head and neck cancer antibody
Pharmaceutical Technology
MAY 24, 2024
Shares in Merus rose by 15% in premarket trading, following the announcement of positive Phase II data to be presented at ASCO.
King’s Doctoral Training Centre to investigate MS symptom management
Pharma Times
MAY 24, 2024
The lifelong autoimmune disease affects more than 150,000 people living in the UK
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Agenda announced for FlyPharma Vienna 2024
Pharma Times
MAY 24, 2024
The conference will take place on 23 to 24 October at Vienna AirportCity
EC approves Celltrion’s Omlyclo for allergic conditions
Pharmaceutical Technology
MAY 24, 2024
The EC has approved Celltrion’s Omlyclo, an omalizumab biosimilar for reference product Xolair to treat allergic conditions.
Latest Ozempic results 'move the needle' for treating patients with diabetes, chronic kidney disease: Novo exec
Fierce Pharma
MAY 24, 2024
While it’s hard to overstate the success Novo Nordisk’s GLP-1 franchise has already achieved, the company’s latest deep dive into semaglutide data in chronic kidney disease (CKD) could help set a n | Early Friday, Novo shared full, positive results from the FLOW trial assessing the ability of once-weekly semaglutide 1.0 mg to help combat major kidney outcomes such as kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and chronic
ASCO 2024: MSD’s ADC shows efficacy in lung and breast tumours
Pharmaceutical Technology
MAY 24, 2024
MSD licenced the antibody-drug conjugate (ADC) therapy, sacituzumab tirumotecan, from China-based Sichuan Kelun-Biotech in 2022.
Even after sharp sales drop, Pfizer sees bright side with priority review voucher from Paxlovid approval
Fierce Pharma
MAY 24, 2024
In a change of pace from the recent COVID-related business struggles for Pfizer, the drugmaker has picked up a valuable reward from the FDA in the form of a priority review voucher (PRV). | The FDA awarded the voucher based on Paxlovid's status as a countermeasure to a material medical threat, according to a notice in the Federal Register.
Grey Wolf gains $50m boost for antigen modulation tech
Pharmaceutical Technology
MAY 24, 2024
Grey Wolf Therapeutics has concluded an oversubscribed $50m in Series B financing expansion to advance its antigen modulation technology.
This week in clinical trials: 20th to 24th May
pharmaphorum
MAY 24, 2024
Exciting advancements in the world of clinical trials - Arecor Therapeutics, Faron, AstraZeneca, Volta Medical, J&J, Pneumagen, and Nimbus Therapeutics make headlines. Dive into this week's top stories impacting the future of medicine.
ASCO 2024: Verastem’s combo therapy for pancreatic cancer hits early trial success
Pharmaceutical Technology
MAY 24, 2024
Shares in the pharma company rose 40% in premarket trading.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
ASCO: AffyImmune claims a first with CAR-T for solid tumours
pharmaphorum
MAY 24, 2024
AffyImmune Therapeutics has recorded what it says is the first documented complete response in a patient with a solid tumour treated with CAR-T therapy. The case comes from a phase 1 study of its ICAM-1 targeting CAR-T autologous candidate AIC100 in patients with relapsed/refractory poorly differentiated thyroid cancer (PDTC) and anaplastic thyroid cancer (ATC), which will be reported at the ASCO congress next week.
Biocon and Handok link to commercialise Liraglutide in South Korea
Pharmaceutical Technology
MAY 24, 2024
Biocon has entered an exclusive licence and supply agreement with Handok to commercialise synthetic Liraglutide in South Korea.
Therapy reprogrammes immune cells to shrink prostate and bladder cancers
Pharma Times
MAY 24, 2024
JHU083 reduced tumour growth and triggered tumour cell death in mice
Cystic fibrosis: global clinical trials landscape and treatments
Pharmaceutical Technology
MAY 24, 2024
Affecting more than 162,000 patients worldwide, global clinical trials are researching innovative new treatments for cystic fibrosis.
ASCO: Merus bispecific garners attention after abstract drop
pharmaphorum
MAY 24, 2024
Shares in Merus spike on ASCO abstract on phase 2 trial of EGFRxLGR5 bispecific petosemtamab in head and neck cancer.
Fierce Pharma Asia—AstraZeneca eyes China's innovation, plots Singapore ADC plant; FDA rejects Hengrui's PD-1 drug
Fierce Pharma
MAY 24, 2024
AstraZeneca's CEO wants to tap into China's innovation explosion. The company inked an oncology antibody deal with Harbour BioMed, and it plans to build a $1.5 billion ADC plant in Singapore. | AstraZeneca's CEO wants to tap into China's innovation explosion. The company inked an oncology antibody deal with Harbour BioMed, and it plans to build a $1.5 billion ADC plant in Singapore.
ADC developer Pheon raises $120m, and other bio financings
pharmaphorum
MAY 24, 2024
This week’s round-up of biotech financings is led by a $120 million round for UK-based antibody-drug conjugate (ADC) developer Pheon, with SixPeaks also pulling in nine figures and smaller rounds for Progentos, LabGenius, and Grey Wolf, and Imvax.
Buyer’s Checklist for selecting the right EDC vendor
Cloudbyz
MAY 24, 2024
Selecting the right Electronic Data Capture (EDC) system is vital for the success of clinical trials. An effective EDC system streamlines operations, ensures data quality, and enhances regulatory compliance while prioritizing patient engagement. To help you make an informed decision, we’ve created a comprehensive buyer’s checklist. This checklist covers essential features such as product/ user administration, data management, regulatory compliance, and user support.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Which pharmaceutical drugs have the most drug patents in Ireland?
Drug Patent Watch
MAY 24, 2024
This chart shows the drugs with the most patents in Ireland. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.
Pharma Pulse 5/24/24: Pre-Approval Information Exchange to Accelerate Product Success, Walgreens Boots Alliance Sells Shares of Cencora & more
Pharmaceutical Commerce
MAY 24, 2024
The latest news for pharma industry insiders.
New patent expiration for Galderma Labs drug MIRVASO
Drug Patent Watch
MAY 24, 2024
Annual Drug Patent Expirations for MIRVASO Mirvaso is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier.
Orna Therapeutics Enhances Circular RNA Capabilities, Acquires ReNAgade Therapeutics
Pharmaceutical Commerce
MAY 24, 2024
The deal grows it pipeline, powered by panCAR programs in autoimmune disease and oncology.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
New patent expiration for Abbvie drug LATISSE
Drug Patent Watch
MAY 24, 2024
Annual Drug Patent Expirations for LATISSE Latisse is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier.
The biosimilars dance: How drugmakers game the US patent system
pharmaphorum
MAY 24, 2024
The biosimilars dance has big pharma and regulators tangled in a complex patent battle. At stake: billions in profits and affordable access to vital meds.
New patent expiration for Haleon Us drug CHILDREN’S ADVIL ALLERGY SINUS
Drug Patent Watch
MAY 24, 2024
Annual Drug Patent Expirations for CHILDREN%27S+ADVIL+ALLERGY+SINUS For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.
World Hunger Day 2024: How the Food Industry Can Get Involved
XTalks
MAY 24, 2024
World Hunger Day 2024 is fast approaching, offering an opportunity to address global food insecurity. This day, observed annually on May 28, brings together organizations, communities and individuals to fight hunger worldwide. World Hunger Day was founded by The Hunger Project in 2011. This global initiative aims to raise awareness about the hundreds of millions of people who suffer from chronic hunger.
How Machine Learning Drives Clinical Trial Efficiency
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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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