Bio Pharma Dive
OCTOBER 23, 2023
The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.
Pharmaceutical Technology
OCTOBER 23, 2023
At ESMO 2023, interim results from the Phase III LITESPARK-005 trial evaluating MSD’s Welireg (belzutifan) as a treatment for patients with previously treated advanced clear cell renal cell carcinoma (RCC) were presented.
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Bio Pharma Dive
OCTOBER 23, 2023
The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.
Pharmaceutical Technology
OCTOBER 23, 2023
What is quantum computing and what does it mean for business. Quantum computing has emerged from a hype cycle with continued investment.
Bio Pharma Dive
OCTOBER 23, 2023
A combination of Seagen and Astellas’ antibody-drug conjugate Padcev with Merck’s Keytruda dramatically improved survival in first-line bladder cancer.
Pharmaceutical Technology
OCTOBER 23, 2023
On 2 October, Eli Lilly announced that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the biologic license application (BLA) for its anti-interleukin (IL)-13 biologic lebrikizumab for the treatment of adults and adolescents (12 and older) with moderate-to-severe atopic dermatitis (AD).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 23, 2023
The combination’s ORR had a noticeable improvement over the data demonstrated by Keytruda in the first-line metastatic NSCLC setting.
Bio Pharma Dive
OCTOBER 23, 2023
Three essential components to create impactful real-world evidence with a 360-degree patient journey.
Pharmaceutical Technology
OCTOBER 23, 2023
Businesses are commonly unaware of the threats generative AI poses to cybersecurity and data privacy, new research has suggested.
Bio Pharma Dive
OCTOBER 23, 2023
Rare disease drug development is a unique and challenging field that demands strategic development expertise and uniting of the various stakeholders working toward the same goal.
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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
OCTOBER 23, 2023
BioMarin has seen the label for its achondroplasia drug expand following two clinical trials that saw positive growth in children living with the condition.
Bio Pharma Dive
OCTOBER 23, 2023
The Swiss pharmaceutical company has agreed to buy Televant, a company set up by Roivant and Pfizer to develop a promising inflammatory bowel disease treatment.
Pharmaceutical Technology
OCTOBER 23, 2023
Penbraya reduces the total number of doses needed for adolescents to be fully vaccinated against the leading serogroups that cause meningococcal disease.
Bio Pharma Dive
OCTOBER 23, 2023
McEvoy is leaving the company after 27 years to pursue other opportunities. Tim Schmid will now lead the MedTech business.
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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
Pharmaceutical Technology
OCTOBER 23, 2023
Hengst consolidates expertise in industrial air filtration bringing DELBAG and Nordic Air Filtration under the umbrella brand Hengst Filtration.
Pharma Times
OCTOBER 23, 2023
On 10 to 11 October 2023, the seventh FlyPharma Conference Europe successfully concluded in Vienna, Austria - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 23, 2023
H2O Therapeutics’s Parky app is a symptom tracker app designed to quantify the kinematics of movement disorder symptoms in PD patients.
Pharma Times
OCTOBER 23, 2023
STARMAP will accelerate the selection of AZ’s best molecule candidates - News - PharmaTimes
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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
OCTOBER 23, 2023
Less than a year after Roivant purchased the IBD drug from Pfizer, it is selling it on for massive profit.
Pharma Times
OCTOBER 23, 2023
STARMAP will accelerate the selection of AZ’s best molecule candidates - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 23, 2023
The Remicade biosimilar is forecasted to have sales of $2.3bn by 2029 as a subcutaneous form is approved for the US market.
Intouch Solutions
OCTOBER 23, 2023
EVERSANA INTOUCH recently introduced “Community Days” for our New York City and Chicago offices, in an effort to continue building our agency community and culture. One day a week, those local to either office or visiting, are invited to work, collaborate, meet, and network in the office with their peers. The first Community Days were filled with EVERSANA INTOUCHers.
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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.
Pharmaceutical Technology
OCTOBER 23, 2023
As it builds momentum towards a Phase IIa study for its NASH drug, Aligos aims to be a THR-β agonist market contender.
Drug Patent Watch
OCTOBER 23, 2023
Annual Drug Patent Expirations for FINACEA Finacea is a drug marketed by Leo Pharma As and is included in two NDAs. It is available from three suppliers. There are eight… The post New patent expiration for Leo Pharma drug FINACEA appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 23, 2023
The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.
BioPharma Reporter
OCTOBER 23, 2023
Scientists may have identified the biggest breakthrough in cervical cancer treatment in 20 years, giving patients existing drugs before standard radiotherapy treatment.
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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.
BioSpace
OCTOBER 23, 2023
Pluvicto improved radiographic progression-free survival in PSMA-positive patients with metastatic castration-resistant prostate cancer who had not been treated with taxane-based chemotherapy.
Fierce Pharma
OCTOBER 23, 2023
With a $385 million settlement, Suboxone maker Indivior is moving to wrap up years of antitrust litigation tied to its opioid addiction treatment. | The deal follows previous settlements worth $102 million and $30 million with two other claimant groups.
BioSpace
OCTOBER 23, 2023
The Swiss pharma reported a 12% sales increase and 21% core operating growth for the third quarter on Tuesday, while raising its full-year earnings forecast for the third time.
Fierce Pharma
OCTOBER 23, 2023
Regeneron and Sanofi are anxious to bring Dupixent as an answer for chronic spontaneous urticaria (CSU), a severe inflammatory condition that causes hives and deep swelling on or under the skin.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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