Worldwide Clinical Trials

OCTOBER 14, 2024

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

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Bio Pharma Dive

OCTOBER 14, 2024

The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in supply.

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Medicine Drugs 167

Pharmaceutical Technology

OCTOBER 14, 2024

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

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Gene Therapy Manufacturing Gene 162

Bio Pharma Dive

OCTOBER 14, 2024

The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.

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Development Drugs Production 176

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Clinical Supply

Worldwide Clinical Trials

OCTOBER 14, 2024

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 130

Research Clinical Trials Clinical Trials Immune Response 130

Pharmaceutical Technology

OCTOBER 14, 2024

RHEACELL has been researching ABCB5-positive stem cell therapies for patients with severe immune and inflammation-related diseases for which there are currently no adequate treatment options. Positive feedback from the regulatory authorities on the study program now gives reason to hope that those affected will be able to benefit from this new approach to regenerative medicine in the near future.

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Pharmaceutical Technology

OCTOBER 14, 2024

Sanofi has announced negotiations with Clayton Dubilier & Rice (CD&R), regarding the potential sale of a 50% controlling stake in Opella.

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Sales 147

Bio Pharma Dive

OCTOBER 14, 2024

The company has set high expectations for depemokimab, which it is also advancing in three other inflammatory diseases, including asthma.

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Antibody Drugs 144

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 14, 2024

(Filipp Romanovski/Unsplash) If you look up at the sky on a clear day, you might notice little cobweb-like structures drifting across your field of vision.

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Clinical Trials Clinical Trials Trials 131

Bio Pharma Dive

OCTOBER 14, 2024

Choosing the right clinical outcome assessments (COAs) is an important part of successfully advancing drug development and securing regulatory approval.

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Development Drugs 130

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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

Pharmaceutical Technology

OCTOBER 14, 2024

Discover the leading Cybersecurity Companies for the Pharmaceutical Industry. Download the free Buyer's Guide today for full contact details.

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Bio Pharma Dive

OCTOBER 14, 2024

Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.

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Clinical Trials Clinical Trials Clinical Research Trials 130

Pharmaceutical Technology

OCTOBER 14, 2024

Pfizer has announced the approval of HYMPAVZI by the US Food and Drug Administration (FDA) for patients with haemophilia A and B.

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FDA Approval Drugs 130

Bio Pharma Dive

OCTOBER 14, 2024

An effective drug launch requires a hub partner with key capabilities, as outlined in the 2024 Patient Services Report by CareMetx.

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Drugs 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

Pharmaceutical Technology

OCTOBER 14, 2024

Daiichi Sankyo and AstraZeneca's ENHERTU has been conditionally approved by China's NMPA for a specific type of NSCLC.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 14, 2024

Concerned over the pathetic condition of the traditional medicine retailers in Tamil Nadu, the veteran pharma trader and former president of the Tamil Nadu Chemists and Druggists Association (TN CDA), Mannargudi Ramachandran, has commented that no new registered pharmacist in the state is coming forward to open individual pharmacy shops because of mushrooming of corporate […]

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Pharmacy Medicine Clinical Trials Clinical Trials 108

Pharmaceutical Technology

OCTOBER 14, 2024

Data from the Rainbowfish trial was presented at the World Muscle Society (WMS) Congress 2024 in Prague, Czech Republic.

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Trials 130

pharmaphorum

OCTOBER 14, 2024

Damage to a Baxter manufacturing facility caused by Hurricane Helene, which rolled across the east US a couple of weeks ago, has led to shortages in some critical medicines.The plant in North Cove, North Carolina, was severely affected by flooding and had to be shut down at the end of September. It is Baxter's biggest manufacturing site and is also the largest supplier of intravenous and peritoneal dialysis solutions to the US market.

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Medicine Manufacturing Marketing 103

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Pharmaceutical Technology

OCTOBER 14, 2024

Digital assessment technologies continue to hold the potential to revolutionise pro-cognitive trials in schizophrenia.

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Drug Trials Trials Drugs 130

pharmaphorum

OCTOBER 14, 2024

GSK's six-monthly IL-5 inhibitor depemokimab clears two phase 3 trials in chronic rhinosinusitis with nasal polyps (CRSwNP), its second indication

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Trials 98

Pharmaceutical Technology

OCTOBER 14, 2024

Inventiva will gain a new chairman following the deal as it presses ahead with a Phase III trial for its lead asset.

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Trials 130

Fierce Pharma

OCTOBER 14, 2024

Four days after a compounding industry group filed a lawsuit against the FDA | Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

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Regulation Production 90

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A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

Pharmaceutical Technology

OCTOBER 14, 2024

Capricor Therapeutics plans to apply for FDA approval for its DMD cell therapy, deramiocel, by the end of 2024.

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FDA Approval 130

pharmaphorum

OCTOBER 14, 2024

Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.

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Fierce Pharma

OCTOBER 14, 2024

On a mission to collect a key Crohn’s disease approval and build out its inflammatory bowel disease (IBD) profile, Eli Lilly has notched a trial win over a major rival in a head-to-head study.&nbsp | Eli Lilly's drug outperformed Johnson & Johnson's established Stelara in a phase 3 study that looked at histologic disease responses over 52 weeks.

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Marketing Trials Drugs 78

BioPharma Reporter

OCTOBER 14, 2024

From exploring the wonders of plants as a curious teen to leading global initiatives at SCIEX, Gitte Barknowitz has carved out an exciting and unconventional career in science.

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Clinical Development Development 72

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Fierce Pharma

OCTOBER 14, 2024

The FDA’s rejection of Vanda Pharmaceuticals’ stomach disease candidate has done little to dampen the enthusiasm of England’s Cycle Pharmaceuticals to acquire the Washington D.C.-based company. | The FDA’s rejection of Vanda Pharmaceuticals’ stomach disease candidate has done little to dampen the enthusiasm of England’s Cycle Pharmaceuticals to acquire the Washington, D.C.

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pharmaphorum

OCTOBER 14, 2024

For the first time, a vaccine candidate for Rift Valley fever, developed by Oxford University, has been advanced into a phase 2 trial backed by CEPI.

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Trials Vaccination Vaccine Development 71

Fierce Pharma

OCTOBER 14, 2024

Awaiting a potential acquisition by Novo Holdings, Catalent is giving its contract manufacturing compatriot a boost as Ardena plots its U.S. debut. | Catalent is selling its oral solids facility in Somerset, New Jersey, to Belgium’s Ardena for an undisclosed sum. The site also doubles as Catalent's current corporate headquarters.

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Manufacturing Contract Manufacturing 65

Drug Patent Watch

OCTOBER 14, 2024

Risk assessment plays a crucial role in the development of generic drugs, ensuring that these products meet the required standards of safety and efficacy. The Food and Drug Administration (FDA) and other regulatory bodies have implemented various measures to ensure that generic drugs are equivalent to their brand-name counterparts in terms of quality, safety, and efficacy.

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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