Pharmaceutical Technology
MAY 30, 2023
SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.
Bio Pharma Dive
MAY 30, 2023
The biotech said a committee advising the European Medicines Agency is “trending” toward issuing a negative opinion of its drug Relyvrio, which was approved in the U.S. last year.
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Pharmaceutical Technology
MAY 30, 2023
According to GlobalData’s Looking Ahead to 2023 – the Future of Pharma report, five drugs set for approval in 2023 are projected to attain blockbuster status or near-blockbuster status by 2028 with US company dominance. Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut.
Bio Pharma Dive
MAY 30, 2023
The drug, called marstacimab, outperformed factor treatment in the study, and wasn’t associated with the kind of safety signals that have dogged other medicines in its class.
Pharmaceutical Technology
MAY 30, 2023
Amplo Biotechnology has received a fast track phase I/II STTR grant from the NIH-NIAMS [National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases] for its gene therapy AMP-201. The company will receive substantial funding to advance AAV-ColQ gene therapy. AMP-201 addresses the severe congenital myasthenic syndrome (CMS) caused by collagen Q (ColQ) deficiency.
Bio Pharma Dive
MAY 30, 2023
The regulator denied an appeal of its decision to turn back vadadustat, but outlined a path forward for the company to resubmit an application without running another clinical trial.
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Bio Pharma Dive
MAY 30, 2023
See how ddPCR technology can take your lentiviral cell and gene therapies to the next level.
Pharmaceutical Technology
MAY 30, 2023
Catalent’s (Somerset, NJ, US) CEO has admitted to the company’s “disappointing” and “poor performance” over the past quarter, and dropped expected annual revenue for FY2023 by $450m. The company plans to slash CapEx and other costs to recover and has replaced many of its executives. In an investor call on 19 May, Catalent reduced its annual net revenue forecast by approximately 10% compared to its February predictions.
Bio Pharma Dive
MAY 30, 2023
The biotech, which went public in 2021 to develop a cancer drug licensed from Daiichi Sankyo, may try to acquire a different tumor-targeting medicine to grow its pipeline.
Pharmaceutical Technology
MAY 30, 2023
Biotechnology company BioSenic’s affiliate Medsenic has amended its licence agreement with Australia-based pharmaceutical company Phebra for the oral formulation of arsenic trioxide (OATO). Medsenic reached licensing, marketing and supply agreements with Phebra for OATO in May 2021. The formulation is intended for indications, including systemic sclerosis, graft versus host disease, systemic lupus erythematosus 151, central nervous system inflammatory diseases associated with multiple sclerosis
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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
Bio Pharma Dive
MAY 30, 2023
The COVID-19 drug developer said the offer from the firm that recently took over Jounce Therapeutics “fundamentally undervalues the company.
Pharmaceutical Technology
MAY 30, 2023
Sun Pharmaceutical Industries has reached a licence agreement with Philogen for the commercialisation of Philogen’s Nidlegy (Daromun) in Australia, New Zealand and Europe. Nidlegy is a new anti-cancer biopharmaceutical being developed to treat patients with melanoma and non-melanoma skin cancers. It is currently undergoing Phase III clinical studies.
Bio Pharma Dive
MAY 30, 2023
Boost campaign effectiveness by 23% by synchronizing sales and marketing.
Pharmaceutical Technology
MAY 30, 2023
Roche Canada has successfully concluded talks with the pan-Canadian Pharmaceutical Alliance (pCPA) for Vabysmo (faricimab injection). Vabysmo is administered into the eye to treat patients with neovascular (wet) age-related macular degeneration (AMD) and diabetic macular oedema (DME). Canada’s health technology assessment bodies, including the Canadian agency for drugs and technologies in health (CADTH) and the institut national d’excellence en santé et en services sociaux (INESSS) have bo
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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
XTalks
MAY 30, 2023
World Multiple Sclerosis (MS) Day is a global event dedicated to raising awareness about MS, a chronic and debilitating neurological disease that currently affects millions of individuals worldwide. Celebrated annually on May 30 every year, the day puts a spotlight on the strength, resilience and unity of the global MS community, along with driving international collaboration in the fight against this disease.
Fierce Pharma
MAY 30, 2023
Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit zbecker Tue, 05/30/2023 - 10:24
XTalks
MAY 30, 2023
The electrocardiogram (ECG) is an invaluable tool for monitoring heart conditions, as it records the heart’s electrical signals. Personal health monitoring devices, such as ECG patches and holter monitors, have become increasingly popular for medical applications due to their ease of use and relatively low cost; however, these devices are commonly made from fossil fuel-based sources that are difficult to recycle, creating a demand for sustainable materials to decrease the waste generated b
Antidote
MAY 30, 2023
To successfully advertise a clinical trial , it is important to create materials that engage patients and adhere to the strict guidelines of the Food and Drug Administration (FDA) in equal measure. It can be challenging to come up with creative and captivating material within these confines, but by developing a strategic advertising plan , it’s possible to find the appropriate balance.
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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.
Pharma Times
MAY 30, 2023
The drug has already been approved for this indication in the EU, with regulatory reviews continuing elsewhere including in the US
BioSpace
MAY 30, 2023
The company’s blockbuster JAK inhibitor, alone or as a combination therapy, showed durable improvements in systemic lupus erythematosus disease activity at 48 weeks.
Pharma Times
MAY 30, 2023
The EMA's human medicines committee concluded that the benefits of Adakveo did not outweigh its risks
pharmaphorum
MAY 30, 2023
The benefits of adopting a truly digital mindset for pharmaceuticals Mike.
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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.
Fierce Pharma
MAY 30, 2023
Lexicon finally scores FDA nod for heart failure drug Inpefa kdunleavy Tue, 05/30/2023 - 05:46
pharmaphorum
MAY 30, 2023
Parkinson’s wearable matches experts in clinical trial Phil.
Fierce Pharma
MAY 30, 2023
Persistent Sun Pharma ready to complete Taro buyout—16 years after initial offer kdunleavy Tue, 05/30/2023 - 09:57
Drug Channels
MAY 30, 2023
Summer unofficially began over the weekend. Check out these noteworthy delicacies, seared to perfection on the Drug Channels grill: Fresh evidence of 340B abuses by hospitals and contract pharmacies OptumRx rewrites its biosimilar Humira strategy ICER discovers channel markups Tax-exempt hospitals are not holding up their end of the bargain Plus, Dr.
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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.
Fierce Pharma
MAY 30, 2023
With court's blessing, billionaire Sackler family awarded legal protections in Purdue's $6B settlement zbecker Tue, 05/30/2023 - 15:41
BioSpace
MAY 30, 2023
Accelerated Approval of Gene Therapies Intensifies Reimbursement Questions 5/31/2023
Fierce Pharma
MAY 30, 2023
After price cuts, Eli Lilly inks $13.
Imperical Blog
MAY 30, 2023
Clinical research supply chains ensure trial sites have the supplies needed throughout the study. This allows patient visits to occur without delays due to missing drugs, supplies, or equipment. This is an update to a blog post from last year: Clinical Trial Supply Chains: The Key… The post Clinical Research Supply Chains: Disruptions Easing, But New Problems Emerge appeared first on Imperial Clinical Research Services Blog.
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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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