Pharmaceutical Technology
JUNE 5, 2024
Belgian biotech, Bio-Sourcing, and Cape Town based company, Afrigen Biologics, have signed a partnership for a technology transfer pilot programme in South Africa of a biotherapeutic platform named BioMilk.
Bio Pharma Dive
JUNE 5, 2024
How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.
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Pharmaceutical Technology
JUNE 5, 2024
The US FDA has granted orphan drug designation to Be Biopharma’s (Be Bio) BE-101 for the treatment of haemophilia B.
Rethinking Clinical Trials
JUNE 5, 2024
Dr. Russell Rothman and Dr. Jason Block In this Friday’s PCT Grand Rounds, Russell Rothman of Vanderbilt University Medical Center and Jason Block of Harvard Medical School will present “The NIH COvid-19 and Diabetes Assessment (CODA) Study: Leveraging PCORnet for a Novel Cohort Study.” The Grand Rounds session will be held on Friday, June 7, 2024, at 1:00 pm eastern.
Bio Pharma Dive
JUNE 5, 2024
A study abstract shed more light on tirzepatide’s potential in MASH. Elsewhere, Cytokinetics CEO spoke on deal negotiations and AbbVie started a key multiple myeloma drug study.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 5, 2024
Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi has emphasised that the medical devices and in-vitro diagnostics (IVD) sold in the county should be tested for the standards prescribed by the Bureau of Indian Standards (BIS) for its quality and performance in the country.
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
JUNE 5, 2024
Scientists are learning about the pros and cons of Ozempic in real-time, as prescriptions of the appetite-suppressing drug explode into the millions worldwide.
Pharmaceutical Technology
JUNE 5, 2024
AbbVie's RINVOQ is now indicated for polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) in paediatric patients.
Bio Pharma Dive
JUNE 5, 2024
Anat Ashkenazi is switching industries after a 23-year career at the Indianapolis drugmaker.
Pharmaceutical Technology
JUNE 5, 2024
Johnson & Johnson has sought approval from the US FDA for the use of its HIV-1 therapy, PREZCOBIX, in children aged six years and above.
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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
Fierce Pharma
JUNE 5, 2024
The scope of Bristol Myers Squibb’s $1.5 billion savings drive is beginning to come into focus. | Starting this month, BMS will begin the process of laying off around 863 employees in Lawrenceville, New Jersey, according to a Worker Adjustment and Retraining Notification (WARN) alert from the state. The move forms part of BMS’ campaign to shave off $1.5 billion in costs by the end of 2025, a company spokesperson said over email.
Pharmaceutical Technology
JUNE 5, 2024
Having a competent and efficient partner by your side can elevate your mass production to new levels of efficiency and sustainable success.
BioSpace
JUNE 5, 2024
Moderna on Thursday said its investigational mRNA-based therapy for methylmalonic acidemia has been selected for the FDA’s accelerator program for rare diseases, dubbed START.
Pharmaceutical Technology
JUNE 5, 2024
AstraZeneca has announced the conclusion of its acquisition of clinical-stage biopharmaceutical company Fusion Pharmaceuticals.
BioSpace
JUNE 5, 2024
Structure Therapeutics is offering over nine million shares on the heels of mid-stage data for its oral GLP-1 receptor agonist, which showed weight loss of 6.2% in overweight or obese patients.
Pharmaceutical Technology
JUNE 5, 2024
An FDA advisory committee, whilst noting improvement in patient symptoms, was not convinced by Lykos’ trial design.
BioSpace
JUNE 5, 2024
Novo Nordisk will face strong generic competition from at least 15 companies in China for its blockbuster GLP-1 receptor agonist products Wegovy and Ozempic, according to Reuters.
Pharmaceutical Technology
JUNE 5, 2024
The biopharma shared preliminary Phase II data at EASL for its IgG1 monoclonal antibody, BJT-778
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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.
BioSpace
JUNE 5, 2024
Amgen’s CD19-directed antibody Uplizna in a late-stage study showed it can suppress the risk of flares by nearly 90% in patients with IgG4-related disease, the company announced Wednesday.
pharmaphorum
JUNE 5, 2024
An initiative set up by the FDA to accelerate the development of therapies for rare disease in the same way that Operation Warp Speed delivered COVID-19 vaccine has chosen its first pilot programme candidates.
BioSpace
JUNE 5, 2024
Telix Pharmaceuticals is looking to cash in on radiopharmaceuticals, which have emerged as one of the hottest spaces in oncology, with an initial public offering to help support its pipeline of targeted radiation products.
pharmaphorum
JUNE 5, 2024
KRAS inhibitors from Eli Lilly, Genfleet, and InxMed make their case for use in NSCLC at ASCO, as they case down Amgen and Bristol-Myers Squibb's market drugs
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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
BioSpace
JUNE 5, 2024
How do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology? Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement.
pharmaphorum
JUNE 5, 2024
Gilead Sciences is just a few weeks away from an FDA decision on seladelpar for rare liver disease primary biliary cholangitis (PBC) and will be buoyed by new data pointing to its long-term efficacy and safety.
Pharmaceutical Technology
JUNE 5, 2024
FDA officials outline what to expect at the upcoming hearing on AdComs, and elaborated how the right data can drive accelerated approvals.
pharmaphorum
JUNE 5, 2024
NHS hospitals in London have declared a critical incident caused by a ransomware attack on a pathology services provider, leading to cancelled procedures and patients having to be transferred to different care providers. The attack on Synnovis has had an impact on patient care at Guy’s and St Thomas’ and King’s College Hospital NHS Foundation Trusts, as well as GP services in southeast London, according to an NHS England statement.
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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.
BioPharma Reporter
JUNE 5, 2024
At the DIA 2024 Global Annual Meeting, Phastar iwill be proud to join a diverse group of stakeholders from industry, regulatory bodies, academia, and patient communities.
pharmaphorum
JUNE 5, 2024
PHTI's latest report finds that digital therapies for musculoskeletal conditions like low back pain can deliver clinically meaningful benefits
Fierce Pharma
JUNE 5, 2024
After 23 years at Eli Lilly, including the last three as its CFO, Anat Ashkenazi is leaving to take the same role at Google's parent company Alphabet.
BioPharma Reporter
JUNE 5, 2024
As the anticipation for the 60th DIA annual meeting reaches a fever pitch, eyes should be on Qinesca, the latest breakthrough in clinical research technology.
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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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