Bio Pharma Dive
MAY 23, 2024
After laying off staff late last year, Orna is expanding through the purchase of ReNAgade Therapeutics, which was built around technology designed to more effectively deliver RNA-based medicines.
Pharmaceutical Technology
MAY 23, 2024
AstraZeneca has entered into a worldwide licence and option agreement with Nona Biosciences for a preclinical monoclonal antibody.
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Bio Pharma Dive
MAY 23, 2024
Clinical trial abstracts posted by ASCO Thursday give a peek at anticipated datasets from Immunocore, Merck & Co., J&J and Arcus Biosciences.
Pharmaceutical Technology
MAY 23, 2024
Merck KGaA’s MilliporeSigma has entered a definitive agreement for the acquisition of Mirus Bio in a deal totaling $600m (€500m).
Bio Pharma Dive
MAY 23, 2024
The findings, from two trials involving tens of thousands of women, could influence guidelines around the use of hormonal treatment for menopausal symptoms.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 23, 2024
The medicine behind Ozempic and Wegovy, called semaglutide, could have significant benefits for heart health, reducing the risk of stroke or cardiac arrest even in those who don’t lose weight. The data comes from the largest and longest clinical trial on semaglutide use amongst those without diabetes, called the Semaglutide and Cardiovascular Outcomes (SELECT) trial.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 23, 2024
The Central Drugs Standard Control Organisation (CDSCO) has requested all stakeholders in the medical devices sector to deposit the requisite fee for retention of license or registration certificate under the Medical Devices Rules (MDR), 2017, well before the stipulated timeline in order to avoid cancellation of the approvals.
Bio Pharma Dive
MAY 23, 2024
The German drugmaker is bolstering its MilliporeSigma business with a unit of Gamma Biosciences that specializes in so-called transfection reagents.
Pharmaceutical Technology
MAY 23, 2024
In this issue: Lula's progress plan for Brazil, tracking opioid lawsuit settlements in the US, the cell & gene therapy landscape in the US, the latest on ESG in pharma, and more.
Pharma Times
MAY 23, 2024
High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours
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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
MAY 23, 2024
Experts at the OCT East Coast 2024 conference discussed the challenges and solutions for diverse recruitment, particularly as it pertains to rare disease.
Fierce Pharma
MAY 23, 2024
Over the last four years, with President Joe Biden milking a popular cause as an opponent of Big Pharma drug pricing, the industry has rarely seen good news coming from the White House. | Over the last four years, with President Joe Biden milking a popular cause as an opponent of Big Pharma's pricing, the industry has rarely seen good news coming from the White House.
Pharmaceutical Technology
MAY 23, 2024
The EC has granted marketing authorisation for Sandoz’s biosimilars, Wyost (denosumab) and Jubbonti (denosumab) for bone-related ailments.
Fierce Pharma
MAY 23, 2024
Over the years, melanoma has become a popular testing ground for researchers to explore new immuno-oncology approaches. | With prior approvals in melanoma, Bristol Myers Squibb and Iovance are now showcasing early clinical data for their novel combinations in small first-line melanoma trials.
Pharmaceutical Technology
MAY 23, 2024
Boehringer and OSE have also expanded two solid tumour programmes into cardiovascular-renal-metabolic (CRM) indications.
BioSpace
MAY 23, 2024
Phase I/II data for Regeneron Pharmaceuticals’ costimulatory bispecific antibody were disappointing, with only one complete response when used as a combination treatment with Libtayo for solid tumors.
Pharmaceutical Technology
MAY 23, 2024
Experts at OCT East Coast discuss the integral roles of patients and caregivers throughout a clinical trial’s lifecycle.
pharmaphorum
MAY 23, 2024
Cytokinetics has been a top biotech takeover candidate for some time, thanks to blockbuster speculation about its lead drug aficamten, but a $1 billion-plus set of financing deals shows it is prepared to go to market on its own.
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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
MAY 23, 2024
Biogen has signed a definitive agreement to acquire Human Immunology Biosciences (HI-Bio) in a deal worth $1.8bn.
Fierce Pharma
MAY 23, 2024
As Johnson & Johnson sorts through a mountain of litigation claiming its talcum-based powders caused users to develop cancers, the company has now been slapped with a related but different | Women represented by six law firms who previously filed lawsuits against J&J over talc claims have filed a proposed class action lawsuit in U.S. federal court in New Jersey.
Pharmaceutical Technology
MAY 23, 2024
The cost saving programme is expected run over multiple years and will save the company about $1.5bn by 2027.
pharmaphorum
MAY 23, 2024
Collaboration is the key to unlocking the potential of cell and gene therapies (CGTs) across geographical boundaries. Explore how autologous treatments are shaping the future of this cutting-edge medical field.
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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
MAY 23, 2024
After analysing data from a recent Phase III trial, Otsuka terminated its clinical program for AVP-786.
BioSpace
MAY 23, 2024
After selling off its oral TYK2 blocker to Takeda for $4 billion, Nimbus Therapeutics has posted strong early-stage data for its other clinical candidate, NDI-101150, in solid tumors.
pharmaphorum
MAY 23, 2024
Novo Nordisk’s second facility fire in a week is under control, although the office in Bagsvaerd affected by the latest blaze isn’t expected to be salvageable.
BioSpace
MAY 23, 2024
Amid shortages of its Mounjaro and Zepbound blockbuster drugs, Eli Lilly on Friday said it is investing an additional $5.3 billion in its production site in Lebanon, Indiana, to boost output of their active ingredient.
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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
MAY 23, 2024
Merck KGaA has agreed to a $600m deal to buy Mirus Bio, a specialist in transfection reagents used in the production of cell and gene therapies.
Pharmaceutical Commerce
MAY 23, 2024
The deal features felzartamab, an investigational anti-CD38 monoclonal antibody, whose clinical outcomes have shown potential to tackle various immune-mediated diseases.
pharmaphorum
MAY 23, 2024
Biogen has expanded its specialty immunology pipeline with an agreement to buy Human Immunology Biosciences (HI-Bio) and its lead drug felzartamab, in trials for a range of diseases including IgA nephropathy (IgAN).
BioSpace
MAY 23, 2024
Aiming to compete in the lucrative weight-loss drug market, Zealand Pharma on Thursday posted topline results showing its dapiglutide led to only a slight weight reduction in low doses.
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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.
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