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 147

Research Clinical Trials Clinical Trials Immune Response 147

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.

Development 299

Development Drugs Production 299

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.

Gene Therapy 279

Gene Therapy Manufacturing Gene 279

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.

Medicine 290

Medicine Drugs 290

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

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.

Sales 246

Sales 246

Bio Pharma Dive

OCTOBER 14, 2024

The approval of Hympavzi Friday was a dose of good news for Pfizer, which is dealing with research setbacks and a challenge from an activist investor.

Drugs 264

Drugs Research 264

Bio Pharma Dive

OCTOBER 14, 2024

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

Clinical Trials 242

Clinical Trials Clinical Trials Clinical Research Trials 242

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

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.

Antibody 147

Antibody Drugs 147

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.

145

145

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Clinical Supply

Pharmaceutical Technology

OCTOBER 14, 2024

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

Drug Trials 130

Drug Trials Trials 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.

Drugs 130

Drugs 130

Pharmaceutical Technology

OCTOBER 14, 2024

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

Trials 130

Trials 130

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.

Development 130

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

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

FDA Approval 130

FDA Approval 130

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.

Marketing 128

Marketing Trials Drugs 128

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.

Trials 130

Trials 130

Pharma Times

OCTOBER 14, 2024

Phase 2 study of TG4001 shows promise in cervical cancer patients

Vaccine 125

Vaccine Vaccination Trials 125

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Clinical Supply

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.

130

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.

Regulation 122

Regulation Production 122

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.

130

130

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.

Manufacturing 119

Manufacturing Contract Manufacturing 119

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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

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.

FDA Approval 130

FDA Approval Drugs 130

Pharma Times

OCTOBER 14, 2024

Acquisition to enhance Lundbeck’s neuroscience pipeline

116

116

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

Trials 111

Trials 111

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.

111

111

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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

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.

Trials 111

Trials Vaccine Vaccination Development 111

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.

Generic Drugs 111

Generic Drugs Development Drugs Branding 111

pharmaphorum

OCTOBER 14, 2024

Faced with lawsuit, FDA rethinks block on compounding pharmacies making Eli Lilly's diabetes and obesity drug tirzepatide

Pharmacy 110

Pharmacy Drugs 110

Fierce Pharma

OCTOBER 14, 2024

By Lalit Saxena, Senior Director of MSAT, and Sungkeum Seo, Director of MSAT Labs Upstream Processing at Samsung BiologicsIntroduction | The biopharmaceutical industry is expanding rapidly, driven by an increasing demand for complex biomedicines. Today, manufacturing biomolecules presents unique challenges, like cost pressure and market uncertainty.

Manufacturing 93

Manufacturing Production Marketing Development 93

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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