Pharmaceutical Technology
MAY 29, 2023
Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). It is intended to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure.
JAMA Internal Medicine
MAY 29, 2023
This cohort study examines the association of intensive treatment of elevated blood pressure in hospitalized older adults with in-hospital clinical outcomes.
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Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 13% drop in company filings mentions of big data in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novartis with 185% year-on-year increase, according to GlobalData’s analysis of over 603 pharmaceutical company filings. The big data landscape is rapidly evolving and pharma companies are increasingly integrating big data analytics into their value chains.
XTalks
MAY 29, 2023
A recent milk commercial starring actress Aubrey Plaza has rapidly emerged as a symbol of the ongoing clash between dairy and plant-based milk producers. The ad has caused such a stir that a faction is demanding its withdrawal, suggesting that its distribution might have been unlawful. The Physicians Committee for Responsible Medicine, a non-profit organization focusing on public health advocacy, has taken their concerns to the US Department of Agriculture’s (USDA) Office of Inspector General.
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 17% rise in company filings mentions of blockchain in Q1 2023 compared with the previous quarter, with the highest share accounted for by Bayer, according to GlobalData’s analysis of over 60 pharmaceutical company filings. GlobalData’s Blockchain Market Size, Share, Trends, and Segment Forecast to 2030 report offers insights on application of blockchain in healthcare and other key sectors.
Pharma Tutor
MAY 29, 2023
A REVIEW OF MAGNETIC NANOPARTICLES IN TARGETED DRUG DELIVERY admin Mon, 05/29/2023 - 15:04 About Authors CHETNA MODI 1 *, VINIT MODI 2 , SHWETA RAY 2 , PIYUSH NARIYA 2 , VARSHA GADHVI 2 1 Professor, Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, India. 2 Research Scholar, Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, India. * chetnamodi306@gmail.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
MAY 29, 2023
Eli Lilly and Novo Nordisk Face Off in Lucrative Obesity Market 5/30/2023
Pharmaceutical Technology
MAY 29, 2023
The US Food and Drug Administration (FDA) has accepted Iovance Biotherapeutics’ biologics license application (BLA) for lifileucel to treat advanced melanoma. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy developed to treat advanced melanoma patients who advanced on or after prior anti-PD-1/L1 therapy and targeted therapy. It has been granted priority review by the FDA, with a target action date of 25 November this year, under the Prescription Drug User Fee Act (PDUFA).
Pharma in Brief
MAY 29, 2023
On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection ( CSP Guidance ). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices.
Pharmaceutical Technology
MAY 29, 2023
Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). A protein-based vaccine, Nuvaxovid has been recommended for MA for use as a primary series in individuals of the age 12 years and above and as a booster in those aged 18 years and older to prevent Covid-19.
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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
BioSpace
MAY 29, 2023
AstraZeneca Touts Positive Phase III Endometrial Cancer Data for Imfinzi, Lynparza 5/30/2023
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 38% drop in company filings mentions of virtual care in Q1 2023 compared with the previous quarter, with the highest share accounted for by ICON with 25% year-on-year decrease, according to GlobalData’s analysis of over 88 pharmaceutical company filings. GlobalData’s Telehealth Market Size by Segments, Share, Trends, and Forecast, 2022-2030 report provides key insights into business strategies, trends driving the telehealth market and granul
Drug Patent Watch
MAY 29, 2023
NUZYRA (omadacycline tosylate) Paratek pharms inc Patent: 7,553,828 Expiration: Jun 2, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact… The post Drug Patent Expirations for the Week of May 28, 2023 appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 24% drop in company filings mentions of regenerative medicine in Q1 2023 compared with the previous quarter, with the highest share accounted for by Sarepta Therapeutics with 20% year-on-year decrease, according to GlobalData’s analysis of over 578 pharmaceutical company filings. GlobalData’s Regenerative Medicine in Medical thematic intelligence report provides an overview of the current landscape, including healthcare, technology, regulato
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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
Drug Discovery World
MAY 29, 2023
Scientists are calling for tighter regulation of stem cell treatments, claiming clinics worldwide are offering unproven ‘therapies’ for conditions as varied as hair loss and Parkinson’s. Researchers at the University of Reading and the Universiti Sains Malaysia have identified 114 companies in over 20 countries offering unproven, unregulated, stem-cell derived products to consumers.
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced an 18% drop in company filings mentions of orphan designated drugs in Q1 2023 compared with the previous quarter, with the highest share accounted for by Horizon Therapeutics with 50% year-on-year increase, according to GlobalData’s analysis of over 182 pharmaceutical company filings. GlobalData’s New Drug Approvals and Their Contract Manufacture report provides critical insight into the contract manufacturing organization (CMO) industry by an
Drug Discovery World
MAY 29, 2023
Gene delivery technologies company VectorBuilder has opened a new office in Edinburgh, hoping to bolster its presence in the United Kingdom. The new location is part of Edinburgh Technopole, a Pioneer Group in Midlothian Science Zone. “When it comes to published scientific research, the UK is ranked third in the world with nearly 200,000 citable publications in 2020.
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 30% drop in company filings mentions of microbiome in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novozymes with 9% year-on-year decrease, according to GlobalData’s analysis of over 50 pharmaceutical company filings. GlobalData’s Microbiome-Targeting Therapeutics in Infectious Diseases – Thematic Research report provides information on market classification by therapy and technologies, regulatory and m
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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.
Drug Discovery World
MAY 29, 2023
The US Food and Drug Administration has approved Krystal Biotech’s Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of dystrophic epidermolysis bullosa (DEB). It is approved for treating wounds in patients six months of age and older with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. “Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, Director of the FDA’s Ce
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 27% drop in company filings mentions of future of work in Q1 2023 compared with the previous quarter, with the highest share accounted for by Moderna with 13% year-on-year decrease, according to GlobalData’s analysis of over 419 pharmaceutical company filings. GlobalData’s Future of Work – Thematic Research report explains how the theme future of work is impacting the workforce across different sectors, it presents key technology, macroecono
BioSpace
MAY 29, 2023
Lexicon Breaks Sotagliflozin Losing Streak with FDA Nod in Heart Failure 5/30/2023
pharmaphorum
MAY 29, 2023
EU approval for Novartis’ sickle cell drug set to be pulled Phil.
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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.
BioSpace
MAY 29, 2023
Opinion: What to Expect From an Experimental Anti-Abuse Opioid Drug 5/30/2023
JAMA Internal Medicine
MAY 29, 2023
This data analytic study uses a microsimulation model to estimate costs of implementing interventions to address social needs identified in patients in primary care practice.
BioSpace
MAY 29, 2023
Pfizer’s Weekly Injection Reduced Bleeding in Phase III Hemophilia Trial 5/30/2023
pharmaphorum
MAY 29, 2023
SGLT latecomer Lexicon gets heart failure okay Phil.
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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.
BioSpace
MAY 29, 2023
European Regulator Leaning Toward Rejecting Amylyx’s ALS Drug 5/30/2023
Drug Patent Watch
MAY 29, 2023
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Spain. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Spain? appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
MAY 29, 2023
FDA Gives Akebia Glimmer of Hope for Rejected CKD-Related Anemia Drug 5/30/2023
BioSpace
MAY 29, 2023
The Top Biotech Companies in Boston Hiring Now 5/30/2023
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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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