Bio Pharma Dive
AUGUST 15, 2023
More than a dozen startups have joined a few publicly traded biotechs and larger pharmaceutical firms in what’s become one of the most competitive areas in drug research.
Worldwide Clinical Trials
AUGUST 15, 2023
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.
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Bio Pharma Dive
AUGUST 15, 2023
San Diego-based Tentarix will receive $66 million in cash and equity from Gilead, which holds an option to acquire up to three of the company’s subsidiaries.
Pharmaceutical Technology
AUGUST 15, 2023
The biologic was able to halt disease progression in rheumatoid arthritis with the same effectiveness as gold-standard treatment Remicade.
Bio Pharma Dive
AUGUST 15, 2023
The agency had paused testing after a patient death, but is now permitting more types of bridging treatment to help keep participants’ disease at bay.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 15, 2023
By replacing fluorescent molecules in an existing imaging process with ones that instead scatter light, researchers have revealed a whole new level of dazzling details within our living cells. The innovative tweak will allow scientists to directly observe molecular behavior over a much longer period, opening a window onto pivotal biological processes like cell division.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 15, 2023
According to GlobalData’s recent von Willebrand Disease (vWD): Opportunity Analysis and Forecast report, the vWD market is expected to see significant growth during the 2022–32 forecast period
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 15, 2023
The National Institute of Mental Health and Neurosciences (NIMHANS) is accelerating its pace of human resources training to provide the much-needed convenient care. The institute sees the need to build a pool of clinical psychologists to widen the scope of therapy access. India a few years ago accounted for 1.
Pharmaceutical Technology
AUGUST 15, 2023
The $3.3bn deal is paused until 30 days after 'significant compliance' with DOJ's request, with concerns it may be blocked.
BioPharma Reporter
AUGUST 15, 2023
Vaxxinity has announced the publication of its phase 2 clinical trial data for UB-311, stating that the treatment was safe, well-tolerated and demonstrated a trend for slowing cognitive decline in mild Alzheimer's disease (AD).
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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
AUGUST 15, 2023
Sandoz is planning to file for regulatory approval in the US and EU for its Eylea (aflibercept) biosimilar in the next few months.
XTalks
AUGUST 15, 2023
In a nation where the majority of store-bought food contain incomprehensible ingredients and employ labeling tactics designed to confuse consumers, understanding the nature of our snacks and meals can often prove difficult. Evidently, other countries recognize that certain ingredients simply have no place within the food and beverage world. Preservatives and additives serve as routine ingredients for manufacturers, extending the shelf-life of food products.
Pharmaceutical Technology
AUGUST 15, 2023
The Hepzato Kit delivers melphalan chemotherapy directly to the liver and will launch in the last quarter of 2023.
Drug Patent Watch
AUGUST 15, 2023
A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs. Over the past three decades, biotherapeutics have revolutionized healthcare by providing effective treatments for complex diseases… The post Unsuccessful Regulatory Filings for Biosimilar Approval: A Comprehensive Review appeared first on DrugPatentWatch - Make Better Decisions.
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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
AUGUST 15, 2023
Thermo Fisher completes the acquisition of CorEvitas following a drop in Q2 2023 revenues compared to 2022.
Fierce Pharma
AUGUST 15, 2023
As the coronavirus surged and subsided, several biopharma companies experienced exaggerated revenue spikes and troughs. | Thanks to sales of their metabolism drugs, Novo Nordisk and Eli Lilly posted the biopharma industry’s largest revenue gains in the second quarter—by far. Meanwhile, only six of the industry’s top 20 firms experienced revenue decreases, with Pfizer's sales dropping a whopping 54%.
Pharmaceutical Technology
AUGUST 15, 2023
A deep understanding of regional differences in regulations and marketing is critical for global launches.
Outsourcing Pharma
AUGUST 15, 2023
Calliditas Therapeutics ABâs phase 3 study looking at a cure for a kidney disease called IgA nephropathy (IgAN) has met its primary endpoint and the full data has been published in The Lancet.
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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.
Fierce Pharma
AUGUST 15, 2023
Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. | Responding to recent acquisition rumors, Stada Arzneimittel's CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.
Outsourcing Pharma
AUGUST 15, 2023
The first patient has been dosed with an orally available small molecule cancer immunotherapy drug, Sosei Group Corporation and Cancer Research UK have announced.
Pharma Times
AUGUST 15, 2023
The study is specifically analysing the company’s new enteric coated tablet formation of the drug - News - PharmaTimes
Outsourcing Pharma
AUGUST 15, 2023
A partnership between technology company Fluree and Vitality TechNet is a âgroundbreaking effortâ to shorten timelines within the drug discovery process.
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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.
Drug Channels
AUGUST 15, 2023
Hi, Barbie! The likelihood of major national legislation over the pharmacy benefit management (PBM) industry has never been greater. A serious effort exists to require greater transparency into PBMs’ activities and mandate full pass-through of rebates to plan sponsors. Today, I review some surprising new data on a crucial aspect of the drug channel: how employer-sponsored health plans access the billions of dollars in manufacturer rebates that are negotiated by their PBMs.
BioSpace
AUGUST 15, 2023
Amid strong performance in the first half of 2023, Stada Arzneimittel’s private equity owners are considering a potential sale, though there are still no definite plans, according to CEO Peter Goldschmidt.
Fierce Pharma
AUGUST 15, 2023
Biogen’s $7.3 billion buyout of Skyclarys-maker Reata Pharmaceuticals surprised some industry watchers last month. | Biogen’s $7.3 billion buyout of Skyclarys-maker Reata Pharmaceuticals surprised some industry watchers last month. But it turns out Biogen wasn’t the only drugmaker jockeying for the Texas-based rare disease outfit, a new securities filing shows.
BioSpace
AUGUST 15, 2023
The clinical trial testing Seagen’s tyrosine kinase inhibitor Tukysa, in combination with Genentech’s Kadcyla, met the primary endpoint of progression-free survival in HER-2 breast cancer patients.
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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.
Pharmaceutical Commerce
AUGUST 15, 2023
Analysis requested by PhRMA indicates that these facilities charge anywhere from two to seven times what they originally paid.
Fierce Pharma
AUGUST 15, 2023
Almost a decade after Delcath suffered an FDA rejection for its drug/device combo, the company has crossed | Almost a decade after Delcath suffered an FDA rejection for its drug/device combo, the company has crossed the regulatory finish line in the U.S.
Pharma Times
AUGUST 15, 2023
The study concerns the use of Nefecon among adult patients with primary IgA nephropathy - News - PharmaTimes
BioSpace
AUGUST 15, 2023
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
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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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