Pharmaceutical Technology

MAY 9, 2023

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f

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Bio Pharma Dive

MAY 9, 2023

The buyout of privately held XinThera continues a string of recent acquisitions of smaller biotechs by Gilead and hands it a group of drug prospects that could begin clinical testing later this year.

Drugs 265

Drugs 265

Pharmaceutical Technology

MAY 9, 2023

Ginkgo Bioworks and Boehringer Ingelheim have collaborated to develop breakthrough therapies for hard-to-treat diseases. The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs. They will also use the metagenomic sequence database of Ginkgo Bioworks which comprises more than three terabases of sequence data and over two billion protein sequences fr

Development 261

Development Protein Sales Production 261

Bio Pharma Dive

MAY 9, 2023

The deal, which gives FibroGen four years to acquire Fortis at a pre-negotiated price, allows the startup to earn returns for its investors without relying on an IPO in a tough market.

Drugs 245

Drugs Marketing 245

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Clinical Supply

Pharmaceutical Technology

MAY 9, 2023

Baxter International has signed a definitive agreement to sell its BioPharma Solutions (BPS) business to private equity investor Advent International and growth investor Warburg Pincus, in a deal valued at $4.25bn in cash. BPS offers parenteral delivery systems, sterile contract manufacturing solutions and customised support services to the pharma and biotech industries.

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Contract Manufacturing Manufacturing Clinical Research Development 243

Bio Pharma Dive

MAY 9, 2023

The layoffs, which will affect hundreds of employees, are part of a major restructuring designed to reduce operational and research spending by as much as half.

Sales 171

Sales Vaccination Vaccine Research 171

Bio Pharma Dive

MAY 9, 2023

The drug, currently in Phase 1, is an oral medicine designed to cross the blood-brain barrier and better treat HER2 tumors that have spread to the brain.

Drugs 156

Drugs Medicine 156

Pharmaceutical Technology

MAY 9, 2023

The global pharmaceutical industry experienced a 113% rise in company filings mentions of cybersecurity in Q1 2023 compared with the previous quarter, with the highest share accounted for by Alnylam Pharmaceuticals with 114% year-on-year increase, according to GlobalData’s analysis of over 667 pharmaceutical company filings. GlobalData’s Cybersecurity in Healthcare – Thematic Research market report helps get a detailed understanding on how Cybersecurity impacts the value chain in the

Marketing 188

Marketing Research 188

Bio Pharma Dive

MAY 9, 2023

The lawsuit seeks to remove safety restrictions on mifepristone or, alternatively, prevent further altering of access to the drug.

Drugs 130

Drugs 130

Pharmaceutical Technology

MAY 9, 2023

The global pharmaceutical industry experienced a 190% rise in company filings mentions of artificial intelligence in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novartis with 59% year-on-year increase, according to GlobalData’s analysis of over 220 pharmaceutical company filings. Artificial Intelligence is among the top emerging technologies being employed for drug discovery and development and has demonstrated strong potential in the Pharmaceutical sector

Marketing 147

Marketing Drugs Research Development 147

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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

Clinical Trials

Medical Xpress

MAY 9, 2023

Maynooth University's Kathleen Londsdale Institute for Human Health Research has just published research into the benefits of the popular obesity treatment drug, GLP-1.

Research 143

Research Drugs 143

Pharmaceutical Technology

MAY 9, 2023

Revenue prospects for Novo Nordisk’s blockbuster diabetes and weight-loss drug semaglutide in Brazil have been dealt a major blow after a federal court denied a request by the Danish firm for two patent extensions. The 5th Panel of the Federal Court of the 1st Region (Tribunal Regional Federal da 1ª Região, TRF-1) upheld the existing expiry dates of two patents—one for semaglutide itself (2026), and the other for the delivery mechanism for the oral formulation of the drug, Rybelsus (2031).

Marketing 147

Marketing Trials Manufacturing Drugs 147

Medical Xpress

MAY 9, 2023

Researchers from Karolinska Institutet and Sachs' Children and Youth Hospital have mapped the immune system in the gut of children with inflammatory bowel disease (IBD). The results, which were published in Cell Reports Medicine, can be used to design more targeted therapies.

Research 128

Research Medicine 128

Pharmaceutical Technology

MAY 9, 2023

The global pharmaceutical industry experienced a 114% rise in company filings mentions of environmental sustainability in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novozymes with 27% year-on-year increase, according to GlobalData’s analysis of over 757 pharmaceutical company filings. With an increasing focus on ESG, Pharmaceutical companies are under pressure to incorporate sustainability with suppliers playing a crucial role in the process.

Manufacturing 130

Manufacturing 130

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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

Clinical Research

Medical Xpress

MAY 9, 2023

Your brain is responsible for controlling most of your body's activities. Its information processing capabilities are what allow you to learn, and it is the central repository of your memories. But how is memory formed, and where is it located in the brain?

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Pharmaceutical Technology

MAY 9, 2023

The global pharmaceutical industry experienced a 190% rise in company filings mentions of artificial intelligence in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novartis with 59% year-on-year increase, according to GlobalData’s analysis of over 220 pharmaceutical company filings. Artificial Intelligence is among the top emerging technologies being employed for drug discovery and development and has demonstrated strong potential in the Pharmaceutical sector

Marketing 130

Marketing Drugs Research Development 130

Medical Xpress

MAY 9, 2023

Having a latex allergy is no fun, but it can be a real challenge for health professionals who have to work with a wide variety of medical equipment that can contain the allergen.

Allergies 105

Allergies Containment 105

Pharmaceutical Technology

MAY 9, 2023

Biotechnology company Neuro3 Therapeutics has signed an exclusive worldwide licence and option agreement with pharmaceutical firm Lundbeck to develop and commercialise clinical stage KCNQ2 activators. Neuro3 Therapeutics will receive global licences for intellectual property that cover two clinical stage and one pre-clinical stage KCNQ2 activator programmes.

Development 130

Development Licensing Licensing Research 130

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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.

Clinical Trials

Medical Xpress

MAY 9, 2023

A team of biochemists at the University of Notre Dame has found a possible new way to treat patients infected with Clostridioides difficile, a type of bacteria that causes serious gastrointestinal problems. In their study, reported in Proceedings of the National Academy of Sciences, the group searched medical databases for antibacterial molecules that might work better for patients with C. difficile infections.

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Bacteria 105

Pharmaceutical Technology

MAY 9, 2023

The US Food and Drug Administration (FDA) has granted Vedanta Biosciences’ oral microbiome treatment VE303 a fast track designation for the treatment of recurrent Clostridioides difficile (C.diff) infection, as the company plans to start a Phase III trial later this year, based on a May 8 announcement. In late April, the Cambridge, Massachusetts-headquartered company announced a $106.5 million financing round that will fuel the upcoming Phase III trial, which is set to begin by Q3 2023.

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FDA Approval Drugs Trials Development 130

Medical Xpress

MAY 9, 2023

Researchers at the Neural Computation Institute of Ruhr University Bochum, Germany, have constructed a computer model that learns spatial information in a pattern similar to that of rodents.

Research 105

Research 105

Pharmaceutical Technology

MAY 9, 2023

Recursion Pharmaceuticals announced it has entered into agreements to acquire two drug chemistry-focused preclinical startups, Cyclica and Valance, for a total of $87.5 million. The deals will add digital chemistry predictive models and further deep learning capabilities to Recursion’s artificial intelligence (AI)-enabled drug discovery platform. The agreed purchase prices are $40m and $47.5m for Cyclica and Valence respectively.

Drugs 130

Drugs Production Research 130

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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.

Clinical Supply

Medical Xpress

MAY 9, 2023

The amount of environmental exposure to polycyclic aromatic hydrocarbons, or PAH for short, is strongly linked to a person's risk of developing rheumatoid arthritis, suggests research published in the open access journal BMJ Open.

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Development Research 105

Pharmaceutical Technology

MAY 9, 2023

AstraZeneca has announced that the National Medical Products Administration (NMPA) in China has granted approval for Koselugo (selumetinib) to treat symptomatic inoperable plexiform neurofibromas (PN) and neurofibromatosis type 1 (NF1) in paediatric patients aged three years and over. Koselugo is a mitogen-activated protein kinase (MEK) inhibitor that works by blocking the enzymes MEK1 and MEK2 that are involved in stimulating cell growth.

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Genetics Trials Protein Production 130

Medical Xpress

MAY 9, 2023

We all know this scenario. You've been sticking to a healthy diet, then the weekend rolls around. Pub meals, greasy fry-ups, takeaway dinners… None of that matters as long as you ate healthily during the week, right?

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Pharmaceutical Technology

MAY 9, 2023

Biopharmaceutical company Trevena announced that its partner, Jiangsu Nhwa, has received approval from China’s National Medical Products Administration (NMPA) for Olinvyk (oliceridine). Olinvyk is an opioid agonist indicated to manage pain severe enough to require an intravenous opioid analgesic in adult patients whose alternative treatments are inadequate.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Sales 130

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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.

Clinical Trials

Medical Xpress

MAY 9, 2023

Researchers at the CNIO (Spanish National Cancer Research Center) have discovered that one of the causes for the rare tumor pheochromocytoma-paraganglioma is the interruption of a very specific step in the production of some proteins, called succinylation. This is a relatively poorly studied mechanism that may be involved in more diseases than previously thought, according to the new results, which are published in the journal Cancer Communications.

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Research Protein Production 105

Pharmaceutical Technology

MAY 9, 2023

At the annual European Heart Rhythm Association Congress, new real-world data was presented by researchers from Hong Kong, demonstrating that the risk of strokes was lower in atrial fibrillation (AF) patients who had been using statins within a year of their diagnosis. While statin therapy is widely prescribed to lower blood cholesterol and reduce the likelihood of heart attack and stroke, the benefit of statins for stroke prevention in patients with AF has remained largely unclear.

Research 130

Research 130

Medical Xpress

MAY 9, 2023

A new paper in the European Journal of Endocrinology, indicates that overweight boys tend to have lower testicular volume, putting them at risk for infertility in adulthood.

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Pharmaceutical Technology

MAY 9, 2023

Health Canada has approved Rhythm Pharmaceuticals’ IMCIVREE setmelanotide subcutaneous injection for use in weight management in adult and paediatric patients aged six years and above with Bardet-Biedl syndrome (BBS). The drug will also be used to treat those with genetically-confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency driven by variants interpreted as pathogenic, likely pathogenic or of uncertain imp

Genetics 130

Genetics Trials Medicine Drugs 130

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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.

Clinical Supply