Worldwide Clinical Trials

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. In a mental health disorder laden with patient enrollment barriers due to the indication’s symptoms, as well as many situational and social factors, how does a sponsor ensure their drug development program enrolls an adequate number of participants in a timely manner?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Bio Pharma Dive

JULY 8, 2024

The deal would hand Lilly an experimental pill that could one day rival Takeda's blockbuster medicine Entyvio as a treatment for inflammatory bowel disease.

Medicine 294

Medicine Drugs 294

Pharmaceutical Technology

JULY 8, 2024

Myricx Bio has secured £90m ($114m) in its Series A financing round to propel its NMTi-ADC therapeutics into the clinical development stage.

Development 264

Development Clinical Development 264

Bio Pharma Dive

JULY 8, 2024

Myricx Bio is developing a type of payload that it thinks could work in tumors resistant to the toxins contained in ADCs like Enhertu and Trodelvy.

Containment 285

Containment Development 285

Advertisement

Clinical Supply

Pharmaceutical Technology

JULY 8, 2024

Morphic’s lead asset MORF-057 is being investigated in three IBD clinical trials, with data in ulcerative colitis expected next year.

Clinical Trials 246

Clinical Trials Clinical Trials Trials 246

Bio Pharma Dive

JULY 8, 2024

Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.

Vaccination 269

Vaccination Vaccine Trials 269

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 8, 2024

The National Institutes of Pharmaceutical Education and Research (NIPERs) need to establish more comprehensive ecosystem that includes mentorship, support for incubation, funding methods, and industrial alliances to promote entrepreneurship in the pharmaceutical sector, which can also substantially help these institutes to foster self-reliance, according to a study.

Research 178

Research Clinical Trials Clinical Trials Clinical Research 178

Bio Pharma Dive

JULY 8, 2024

Acquiring Apeiron will hand Ligand rights to royalties on sales of the neuroblastoma drug Qarziba. Elsewhere, Aerovate said it’s considering strategic alternatives and CSL reported a notable milestone.

Sales 152

Sales Drugs 152

Worldwide Clinical Trials

JULY 8, 2024

By: Anna Chwalba, MD, Senior Medical Director, Oncology & Sue Batchelor, Executive Director, Oncology Project Management In oncology, the ability to pinpoint individual cancer cells can mean the difference between making an early life-saving diagnosis or missing it entirely. With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 8, 2024

Do you find that you daydream a lot? Are you often sluggish and tend to disengage easily when doing a task? You might have cognitive disengagement syndrome, or CDS.CDS was first described by psychologists in the 1960s and 1970s when they noticed that some people display these traits more persistently than others.

Clinical Trials 135

Clinical Trials Clinical Trials Clinical Research Trials 135

Advertisement

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

JULY 8, 2024

The Association of the British Pharmaceutical Industry (ABPI) also called out Novartis, Pfizer, and Otsuka for breaching its code.

147

147

Fierce Pharma

JULY 8, 2024

Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? | Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? While a head-to-head trial pitting the two treatments remains ongoing, new evidence shows that Lilly’s tirzepatide may be the superior weight loss product.

Production 135

Production Trials 135

Pharmaceutical Technology

JULY 8, 2024

China's NMPA approved Antengene’s new indication of XPOVIO for adults with relapsed or refractory diffuse large B-cell lymphoma.

130

130

Fierce Pharma

JULY 8, 2024

After a drawn-out litigation process, Merck & Co. seems to have finally washed its hands of more than a thousand lawsuits tied to its shingles vaccine Zostavax. | A U.S. appeals court has tossed a request to resurrect certain lawsuits claiming Merck’s popular shot Zostavax caused patients to develop shingles. The court made its decision after the plaintiffs filed a voluntary dismissal some two years after logging a loss in Pennsylvania.

Vaccination 116

Vaccination Vaccine Development 116

Advertisement

Clinical Supply

Pharmaceutical Technology

JULY 8, 2024

Ascentage Pharma has obtained approval for its new BCR-ABL1 TKI, olverembatinib, in Macau for haematological malignancy indications.

130

130

Fierce Pharma

JULY 8, 2024

As the process surrounding Medicare's drug price negotiations rolls on this summer—and as the pharmaceutical industry continues to loudly voice its complaints—another lawsuit contesting the legal v | Boehringer Ingelheim joins AstraZeneca, J&J and Bristol Myers Squibb in having a case challenging Medicare price negotiations fail to bear fruit.

Drugs 112

Drugs 112

pharmaphorum

JULY 8, 2024

A recent healthcare report conducted by Edelman reveals a concerning trend of declining public trust in healthcare institutions. Explore the key findings and implications in this comprehensive analysis.

110

110

Fierce Pharma

JULY 8, 2024

After announcing plans last year to expand manufacturing in its home country, Korean CDMO newcomer Lotte Biologics has kicked off work on a sprawling facility along Incheon’s waterfront near Seoul. | Late last week, Lotte Biologics broke ground on its flagship facility at the Songdo Bio Campus in Incheon International City, South Korea. The company is pitching the production effort as a key part of its quest to become one of the top 10 CDMOs in the world.

Production 109

Production Manufacturing 109

Advertisement

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

BioSpace

JULY 8, 2024

The blood plasma medicines manufacturer is considering a buyout offer from the founding family and asset manager Brookfield, which would delist the company from the Spanish and Nasdaq markets.

Manufacturing 108

Manufacturing Medicine Marketing 108

Fierce Pharma

JULY 8, 2024

Novo Nordisk’s massively successful GLP-1 analog semaglutide, the active ingredient in the popular diabetes and obesity meds Ozempic and Wegovy, may be linked to a vision loss disorder, a new | Novo Nordisk’s popular GLP-1 analog semaglutide may be linked to a vision loss disorder, a study suggests. But one team of analysts cautioned against reading too much into the analysis.

109

109

BioSpace

JULY 8, 2024

Eli Lilly on Monday announced a $3.2 billion all-cash deal to purchase Morphic and its pipeline of oral integrin therapies in a move to expand the pharma’s presence in the autoimmune diseases space.

108

108

Fierce Pharma

JULY 8, 2024

It took many years, but Johnson & Johnson’s tuberculosis med Sirturo can finally claim full approvals in the U.S. and Europe following initial conditional nods. | The traditional approvals follow initial accelerated approvals granted by the FDA in 2012 and the European Commission in 2014.

Marketing 106

Marketing 106

Advertisement

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

BioSpace

JULY 8, 2024

GLP-1 receptor agonists could reduce the risk of 10 obesity-associated cancers, such as meningioma, multiple myeloma and colorectal cancer, in type 2 diabetes patients, according to an analysis of electronic health records.

108

108

Fierce Pharma

JULY 8, 2024

Roche's launch of eye implant Susvimo was stopped short in 2022 after manufacturing concerns led to a market withdrawal. Now, with the FDA’s blessing to reintroduce the therapy, the | The company is reintroducing the therapy after receiving the FDA's blessing for updates made to the device, ending a two-year voluntary recall.

Manufacturing 104

Manufacturing Marketing 104

BioSpace

JULY 8, 2024

The U.K.-based biotech is the latest to cash in on the hot antibody-drug conjugate space, closing a $115.5 million Series A round co-led by Novo Holdings and with participation from Eli Lilly.

Antibody 104

Antibody Drugs 104

pharmaphorum

JULY 8, 2024

GLP-1 agonists like Novo Nordisk's Ozempic reduce the risk of 10 of 13 cancers associated with obesity in an observational study.

Drugs 114

Drugs 114

Advertisement

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

BioSpace

JULY 8, 2024

A federal judge ruled last week that the U.S. government can use its economic standing as a bulk drug purchaser to negotiate for better deals, handing Boehringer Ingelheim a loss in its legal challenge to the Inflation Reduction Act.

Drugs 100

Drugs 100

pharmaphorum

JULY 8, 2024

Myricx Bio taps into the red-hot interest in companies working on antibody-drug conjugates (ADCs) for cancer, raising £90m in its Series A

Antibody 111

Antibody Drugs 111

BioSpace

JULY 8, 2024

Roche’s tiragolumab, when combined with its PD-L1 blocker Tecentriq, did not significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with non-small cell lung cancer.

Drugs 98

Drugs 98

pharmaphorum

JULY 8, 2024

An observational study has suggested that Lilly’s tirzepatide is better at achieving weight loss than Novo Nordisk's semaglutide

111

111

Advertisement

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