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.
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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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.
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).
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.
Pharmaceutical Technology
JULY 26, 2024
The FDA approval is based on data gathered from two Phase III studies where over 30% of the patients gained 80% or more coverage of scalp hair.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 26, 2024
Several patients are navigating ways to access innovative gene therapies with the help of enterprising research and nonprofit organisations.
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.
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.
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.
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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
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.
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
Pharmaceutical Technology
JULY 26, 2024
The ODAC highlighted that perioperative trials should separately evaluate the effectiveness of treatments pre- and post-operation.
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.
Pharmaceutical Technology
JULY 26, 2024
The European Commission has awarded conditional marketing authorisation for Pfizer's DURVEQTIX for haemophilia B treatment.
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.
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.
pharmaphorum
JULY 26, 2024
CHMP recommends against approval of Eisai, Biogen's Alzheimer's disease therapy Leqembi, saying side effects outweigh its benefits
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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.
Pharmaceutical Technology
JULY 26, 2024
The company has fired 25% of its staff and plans to look for partnerships to further its oncology candidates.
Pharma Times
JULY 26, 2024
Researchers predicted the onset of 67 diseases, out-performing current standard models
Pharmaceutical Technology
JULY 26, 2024
The EMA recommended a label update that allows the drug to be used to reduce cardiovascular risk.
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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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
Pharma Times
JULY 26, 2024
The new Human Gut Microbiome Atlas could help treat conditions including IBS and AMR
Drug Patent Watch
JULY 26, 2024
Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.
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
Drug Patent Watch
JULY 26, 2024
Annual Drug Patent Expirations for OGSIVEO Ogsiveo is a drug marketed by Springworks and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug.
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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.
XTalks
JULY 26, 2024
The US Food and Drug Administration (FDA) has given the green light to Femlyv , a combination oral contraceptive containing norethindrone acetate and ethinyl estradiol. Femlyv is the first orally dissolvable tablet for preventing pregnancy. Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy.
Drug Discovery World
JULY 26, 2024
News round-up for 22-26 July by DDW Senior Digital Content Editor Diana Spencer. There have been some interesting developments in neuroscience this week. Perhaps most note-worthy, shingles vaccines Shingrix has been shown to reduce the risk of dementia by 17%, and TikoMed’s ALS drug caused a long-term slowing of ALS progression in a Phase II trial. The top stories: Oxford centre to address global epilepsy challenges The University of Oxford is launching The Centre for Global Epilepsy to address
XTalks
JULY 26, 2024
Orthopedic surgical robotics maker THINK Surgical has announced that its TMINI Miniature Robotic System (TMINI 1.1) has received 510(k) clearance from the US Food and Drug Administration (FDA). The system enables minimally invasive orthopedic procedures with enhanced precision and outcomes. The TMINI Miniature Robotic System is a robotic-assisted system designed to aid surgeons in performing complex orthopedic surgeries with greater accuracy and control.
BioPharma Reporter
JULY 26, 2024
In a candid interview at the DIA conference, James Bellamy, leader of the Solutions Consulting team at Qinecsa, shared his insights into the evolving landscape of pharmacovigilance (PV) technology.
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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.
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