Bio Pharma Dive
SEPTEMBER 1, 2023
The Swiss pharma said, without details, that it observed “unprecedented” results that could make Alecensa the first treatment specifically available after surgery for ALK-positive lung tumors.
Pharmaceutical Technology
SEPTEMBER 1, 2023
Novo Nordisk's obesity drugs are driving Danish growth as well as record profits as the company becomes second-most valuable in Europe.
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Bio Pharma Dive
SEPTEMBER 1, 2023
The settlement between Amgen and the FTC may reassure those in the industry who feared a more activist regulator would gum up dealmaking.
Pharmaceutical Technology
SEPTEMBER 1, 2023
Otsuka Pharmaceutical has signed a definitive arrangement agreement to acquire Mindset Pharma, in an all-cash deal worth C$80m ($59.1m).
Bio Pharma Dive
SEPTEMBER 1, 2023
The newly posted documents show the agency had concerns about the side effects experienced by people with clinical depression who took Sage’s drug, Zurzuvae.
Pharmaceutical Technology
SEPTEMBER 1, 2023
As per GlobalData, AbbVie has remained the Crohn’s disease market leader over the last five years, with Humira sales of $2.7bn in 2022 in 8MM.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 1, 2023
Reset Pharma has entered a licensing agreement with Filament for psilocybin drug PEX010, designed for treating demoralisation syndrome.
Pharma Mirror
SEPTEMBER 1, 2023
The integration of artificial intelligence (AI) tools across medical communications is proving to be a transformative development, ushering in increased efficiencies and innovation across the healthcare industry. by Matt Lewis, Global Chief Artificial and Augmented Intelligence Officer at Inizio Medical, an Inizio company A subset of AI, augmented intelligence, refers to the synergy between AI, machine learning, and natural language processing (NLP) technologies to complement human intelligence
Pharmaceutical Technology
SEPTEMBER 1, 2023
Bayer adds three new Phase III heart failure studies to the Kidney and type 2 diabetes drug, Kerendia, clinical development programme.
Pharma Mirror
SEPTEMBER 1, 2023
North Charleston, SC: Pharmaceutical sterilization and cleaning equipment manufacturer Belimed Life Science, North Charleston, SC, has unveiled custom wash rack design and manufacturing services. A key option offered with the company’s automated cleaning and disinfecting wash systems, the custom wash rack services were developed to help pharmaceutical and nutritional product manufacturers ensure complete cleaning and disinfection of laboratory glassware, tableting tools, containers, valves
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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
Pharmaceutical Technology
SEPTEMBER 1, 2023
Twist and Ono will discover and develop novel antibodies to treat autoimmune diseases and generate comprehensive discovery campaigns.
Pharma Times
SEPTEMBER 1, 2023
The AI platform and expertise will be combined to discover novel targets for haematological cancers - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 1, 2023
NexImmune will reduce its workforce from 47 to just 22 full-time employees and has also paused enrolment for three of its trials.
Fierce Pharma
SEPTEMBER 1, 2023
After months of legal wrangling, Amgen is free to go forward with its $27.8 billion buyout of Horizon Therapeutics. | Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address “the potential competitive harm” that could result from the merger deal. Now, Amgen is free to go forward with its $28 billion buyout.
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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
Pharmaceutical Technology
SEPTEMBER 1, 2023
When expectant mothers are diagnosed with gestational diabetes mellitus (GDM) they often feel anxious and need extra support.
Pharma Times
SEPTEMBER 1, 2023
Partnership will discover and develop novel antibodies for a range of autoimmune diseases - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 1, 2023
The company announced a strategic shake-up that includes layoffs, leadership changes and halting of early-stage programs.
Fierce Pharma
SEPTEMBER 1, 2023
Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster. | Bayer plans three new trials to assess its potential blockbuster medicine Kerendia in heart failure. The drug was first approved 2 years ago in CKD associated with diabetes.
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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.
Pharmaceutical Technology
SEPTEMBER 1, 2023
Huadong has entered into an agreement to acquire licence rights for MC2 Therapeutics’ Wynzora cream in Greater China.
Fierce Pharma
SEPTEMBER 1, 2023
After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. | After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa.
Drug Patent Watch
SEPTEMBER 1, 2023
Annual Drug Patent Expirations for SPY+AGENT+GREEN+KIT Spy Agent Green Kit is a drug marketed by Novadaq Tech and is included in one NDA. It is available from one supplier. There… The post New patent for Novadaq Tech drug SPY AGENT GREEN KIT appeared first on DrugPatentWatch - Make Better Decisions.
XTalks
SEPTEMBER 1, 2023
Leading US plant-based food companies are reportedly considering the formation of a coalition to counteract successful marketing strategies like The Incredible, Edible Egg and Got Milk? , primarily propelled by Big Ag. This initiative, slated for a 2024 launch, comes as a reaction to the negative press and targeted ads by Big Ag. The plant-based sector has weathered turbulent times over recent years, facing hits from multiple directions.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Antidote
SEPTEMBER 1, 2023
As part of our efforts to better understand patients and their motivations to participate in clinical trials, Antidote and SCORR Marketing partnered on a survey to gain a deeper understanding of how patients think about the medical research process. Survey participants were recruited by eight of Antidote’s partners, including the American Kidney Fund, Allergy & Asthma Network, Healthline, JDRF, Lung Cancer Alliance, Lupus Research Alliance, Melanoma Research Alliance, and the Multiple Sclero
XTalks
SEPTEMBER 1, 2023
GlaxoSmithKline (GSK) has been pumping large sums of cash into expanding its vaccine manufacturing operations and today, it announced an investment of €250 ($272 million) into building a new unit for freeze-drying vaccines at its Wavre campus in Belgium. A company spokesperson revealed the new unit in Wavre, which is southeast of Brussels and is the world’s largest vaccine production site, will be operational by 2027.
pharmaphorum
SEPTEMBER 1, 2023
Or Shaval, CEO of Remepy and Shahar Shelly, the company’s chief medical officer, join Editor in Chief Jonah Comstock to talk about their unorthodox approach and the science that underpins it. They discuss how their in-development products are similar and different from traditional digital therapeutics.
Fierce Pharma
SEPTEMBER 1, 2023
When it comes to heart failure medication, a labeling mix-up can have dire consequences. | Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose, and vice versa.
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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.
pharmaphorum
SEPTEMBER 1, 2023
Harnessing CRM to drive innovation, strong customer experiences in life sciences Mike.
Drug Patent Watch
SEPTEMBER 1, 2023
Annual Drug Patent Expirations for NUMBRINO Numbrino is a drug marketed by Cody Labs Inc and is included in one NDA. It is available from one supplier. The generic ingredient… The post New patent for Cody Labs drug NUMBRINO appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
SEPTEMBER 1, 2023
News round-up for 28 August – 1 September by DDW Digital Content Editor Diana Spencer. This week’s headline news features a stem-cell derived Parkinson’s therapy, a monoclonal antibody for head and neck cancer, an estrogen receptor degrader for breast cancer, a mitochondrial activator for long Covid, and the world’s first AI-designed bispecific T cell engager – reflecting the breadth of innovative approaches to disease being employed by researchers across the globe.
Drug Patent Watch
SEPTEMBER 1, 2023
Annual Drug Patent Expirations for REZZAYO Rezzayo is a drug marketed by Cidara Theraps and is included in one NDA. It is available from one supplier. There are five patents… The post New patent for Cidara Theraps drug REZZAYO appeared first on DrugPatentWatch - Make Better Decisions.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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