Worldwide Clinical Trials

JULY 26, 2024

At Worldwide Clinical Trials’ bioanalytical lab, we view challenges as opportunities to excel and set new standards. The path to drug approval is complex, with many variables and potential delays. That’s why our team is committed to continuous improvement through our initiative, WorldwideEdge, where we optimize everything from our processes to our teams’ performance for each drug development program.

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Clinical Trials Clinical Trials Trials Development 182

Bio Pharma Dive

JULY 26, 2024

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

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Regulation Sales Marketing Drugs 171

Pharmaceutical Technology

JULY 26, 2024

The European Commission has awarded conditional marketing authorisation for Pfizer's DURVEQTIX for haemophilia B treatment.

Gene Therapy 162

Gene Therapy Gene Marketing 162

Bio Pharma Dive

JULY 26, 2024

Glycomimetics and Cue Biopharma both revealed layoffs. Elsewhere, AbbVie’s earnings impressed Wall Street and an FDA panel recommended changing testing requirements for some lung cancer drugs.

Drugs 156

Drugs 156

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Clinical Supply

Pharmaceutical Technology

JULY 26, 2024

Mankind Pharma has announced a definitive agreement for the acquisition of Bharat Serums and Vaccines (BSV) for Rs136.3bn ($1.6bn).

Vaccination 147

Vaccination Vaccine 147

Bio Pharma Dive

JULY 26, 2024

All five large pharmaceutical companies to report earnings this week raised either their profit or revenue guidance for the year.

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pharmaphorum

JULY 26, 2024

Leading figures from industry and academia, including AstraZeneca, have urged UK PM Keir Starmer to turn the Oxford-Cambridge region into the "crown jewel" of his industrial growth plan

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Pharmaceutical Technology

JULY 26, 2024

Several patients are navigating ways to access innovative gene therapies with the help of enterprising research and nonprofit organisations.

Gene Therapy 130

Gene Therapy Gene Research 130

pharmaphorum

JULY 26, 2024

CHMP recommends against approval of Eisai, Biogen's Alzheimer's disease therapy Leqembi, saying side effects outweigh its benefits

Drugs 119

Drugs 119

Pharmaceutical Technology

JULY 26, 2024

The current approval, which is based on data from non-human primates and healthy individuals, will be updated with real-world observations.

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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

Fierce Pharma

JULY 26, 2024

Johnson & Johnson’s latest attempt to get a handle on its talc litigation using the controversial Texas two-step bankruptcy strategy has once again fallen flat after a federal appeals court rul | The ruling from the Third Circuit Court of Appeals came the night before claimants in the talc litigation were set to vote on a sweeping $6.48 billion settlement proposal from J&J.

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Pharmaceutical Technology

JULY 26, 2024

AbbVie has reported a 32.1% decrease in net earnings attributable to the company of $1.37bn in Q2 2024 from $2.02bn in Q2 last year.

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Fierce Pharma

JULY 26, 2024

Amid the sturm und drang over Inflation Reduction Act (IRA) drug price negotiations, Bristol Myers Squibb has been among the biopharma companies casting the most woe over the oncoming measures. | Bristol Myers Squibb CEO Chris Boerner said after seeing the final negotiated price for Eliquis that he is "increasingly confident" the company can navigate the impact of the IRA.

Drugs 98

Drugs 98

Pharmaceutical Technology

JULY 26, 2024

The ODAC highlighted that perioperative trials should separately evaluate the effectiveness of treatments pre- and post-operation.

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Trials 130

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Clinical Supply

pharmaphorum

JULY 26, 2024

Discover the innovative work of Steven Damon, the CEO of Micron Biomedical, a company specialising in microneedle technology for improved healthcare delivery. Learn about his cutting-edge innovations in the field.

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Pharmaceutical Technology

JULY 26, 2024

Roche has reported a net income of SFr6.6bn ($7.4bn) in H1 2024, a 4% decline compared to SFr7.5bn ($8.5bn) in H1 2023.

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Fierce Pharma

JULY 26, 2024

After Eli Lilly’s Olumiant won the distinction of becoming the first med approved by the FDA to treat the follicle-attacking autoimmune disease alopecia areata, Pfizer followed up with a green ligh | The FDA signed off on Sun’s oral JAK inhibitor deuruxolitinib to treat adults with severe alopecia areata. The drug is now approved in 8 mg tablets under the brand name Leqselvi.

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Branding Drugs 97

Pharmaceutical Technology

JULY 26, 2024

The company has fired 25% of its staff and plans to look for partnerships to further its oncology candidates.

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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

Outsourcing Pharma

JULY 26, 2024

Discover the groundbreaking work of Cure51, co-founded by Nicolas Wolikow and Simon Istolainen, revolutionizing cancer treatment through advanced AI and biotechnology.

Clinical Development 100

Clinical Development Development 100

Pharmaceutical Technology

JULY 26, 2024

The EMA recommended a label update that allows the drug to be used to reduce cardiovascular risk.

Drugs 130

Drugs 130

Pharma Times

JULY 26, 2024

Researchers predicted the onset of 67 diseases, out-performing current standard models

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Protein Development Research Biobanking 131

pharmaphorum

JULY 26, 2024

Discover the top 7 trends from the Cannes Lions Festival that pharma professionals should be aware of. Stay ahead of the game with these creative insights.

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101

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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

Pharma Times

JULY 26, 2024

The new Human Gut Microbiome Atlas could help treat conditions including IBS and AMR

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Bacteria 128

pharmaphorum

JULY 26, 2024

Discover 5 effective strategies for biopharma companies to optimize patient recruitment in clinical trials. Learn how to enhance recruitment processes and increase patient participation.

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Clinical Trials Clinical Trials Trials 92

XTalks

JULY 26, 2024

The FDA has issued a warning about dosing errors and subsequent adverse events related to compounded semaglutide injectable products. These errors have led to some patients being hospitalized due to overdoses. These issues primarily stem from patients and healthcare providers miscalculating or incorrectly administering the drug. Compounded semaglutide products, unlike the US Food and Drug Administration (FDA)-approved ones, can vary widely in strength and packaging, making it easy for mistakes t

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Drug Delivery Systems FDA Approval Drug Delivery Containment 91

Outsourcing Pharma

JULY 26, 2024

The approval of donanemab marks a significant breakthrough in Alzheimer's treatment, promising transformative changes in patient care and research.

Drugs 84

Drugs Research Clinical Development Development 84

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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

Fierce Pharma

JULY 26, 2024

Merely a month into an FDA approval for a broad first-line endometrial cancer population, Merck’s Keytruda has some company. | Merely a month into an FDA approval for a broad first-line endometrial cancer population, Merck’s Keytruda has some company in the form of a matching go-ahead by GSK's Jemperli.

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FDA Approval 67

pharmaphorum

JULY 26, 2024

Vaccination with GSK's recombinant shingles vaccine Shingrix could delay the onset of dementia, according to researchers in the UK.A study published in Nature Medicine suggests that people administered Shingrix have a lower risk of dementia compared to those given Zostavax - an older shingles shot based on a different technology – and builds on earlier research suggesting a benefit from this type of vaccination.

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Vaccination Vaccine Medicine Research 64

Fierce Pharma

JULY 26, 2024

While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions. | While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions.

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Medicine Regulation Drugs 62

pharmaphorum

JULY 26, 2024

Pfizer's haemophilia B gene therapy is approved in EU as Durveqtix, becoming the first alternative to CSL Behring's Hemgenix

Gene Therapy 81

Gene Therapy Gene 81

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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