Bio Pharma Dive
MAY 15, 2024
The annual forecast, which comes as Eisai and Biogen have begun submitting a more convenient form of Leqembi for approval, looks “more realistic” than previous guidance, according to Jefferies analysts.
Pharmaceutical Technology
MAY 15, 2024
The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.
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Bio Pharma Dive
MAY 13, 2024
Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.
Worldwide Clinical Trials
MAY 10, 2024
By: Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions Patients with borderline personality disorder (BPD) face a heightened risk of substance abuse and suicide, as well as substantial delays in receiving treatment. Despite these risks, there are no medications specifically approved to target the core symptoms of BPD; current treatments are limited to managing underlying affective symptoms.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 14, 2024
A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 variant Covid-19 vaccine with local clinical trial waiver, for restricted use in emergency situation subject to conditions.
Rethinking Clinical Trials
MAY 13, 2024
May 9-10, 2024 | Bethesda, MD Main Purpose Day 1 : Hear from the newest NIH Collaboratory Trials; share challenges and lessons learned to promote successful trialconduct; discuss the evolution and current state of the NIH Collaboratory ecosystem; identify gaps and areas of opportunity for expanding the ecosystem of embedded pragmatic clinical trials (ePCTs).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Worldwide Clinical Trials
MAY 14, 2024
By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. The team’s ability to apply insights and proven strategies from their experience in rare disease research brings concepts to reality, getting medications to patients faster.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 9, 2024
Virus containing droplets were suspended in the CELEBS experimental device for different durations before infectivity was tested. (Allen Haddrell/University of Bristol) Keeping CO2 levels low reduces infectious airborne viral loads, new research suggests.
BioSpace
MAY 12, 2024
The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety.
Bio Pharma Dive
MAY 10, 2024
The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
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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
MAY 15, 2024
Nabla Bio has secured $26m in a Series A financing round led by Radical Ventures, for generative protein designing.
Worldwide Clinical Trials
MAY 14, 2024
By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. The team’s ability to apply insights and proven strategies from their experience in rare disease research brings concepts to reality, getting medications to patients faster.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 12, 2024
Running 10 hours a week for more than 120 km (75 miles) is extreme exercise, to be sure. Yet far from pushing the body beyond its limits, a new study suggests some professional athletes are adding years to their lives with such brutal routines.
Fierce Pharma
MAY 14, 2024
With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.
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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.
Bio Pharma Dive
MAY 10, 2024
Interim data surpassed expectations, iTeos said. Elsewhere, Acelyrin revealed chief executive officer Shao-Lee Lin is departing and Bluebird bio gave a fuller account of its gene therapy launches.
Pharmaceutical Technology
MAY 14, 2024
The two companies will develop neuroplastogens for psychiatric disorders as psychedelic market activity ramps up.
pharmaphorum
MAY 14, 2024
The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 13, 2024
The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
BioPharma Reporter
MAY 14, 2024
Anti-obesity jabs could reduce the risk of heart attacks, strokes or heart failure in obese people irrespective of the amount of weight they lose while using the medication, according to a new study.
Bio Pharma Dive
MAY 13, 2024
The deal — worth $100 million up front and potentially billions more later on — gives Takeda an exclusive option to license an Alzheimer’s vaccine and other “active immunotherapies.
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
pharmaphorum
MAY 14, 2024
Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
BioSpace
MAY 14, 2024
Following an initial rejection in 2023, Ascendis Pharma on Tuesday said it faces another regulatory bump in the road for TransCon PTH with a three-month delay in the ongoing FDA review.
Fierce Pharma
MAY 14, 2024
It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). | It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). And now, it’ll take another three months for the United States regulator to decide on the treatment for the endocrine disease hypoparathyroidism.
Bio Pharma Dive
MAY 14, 2024
The biotechs aim to marry FogPharma’s polypeptide science with Artbio’s lead-based radiopharmaceutical technology in one of the industry’s hottest fields.
Pharmaceutical Technology
MAY 10, 2024
Shionogi has concluded an exclusive global licence agreement for Maze Therapeutics’ MZE001 aimed at treating Pompe disease.
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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
pharmaphorum
MAY 15, 2024
The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer
BioSpace
MAY 13, 2024
Cytokinetics released data Monday on aficamten, an oral small molecule inhibitor of cardiac myosin, showing it significantly boosted exercise capacity in patients with obstructive hypertrophic cardiomyopathy.
Fierce Pharma
MAY 15, 2024
Though Galapagos has undergone plenty of staff shakeups and strategy revamps in recent years, the company is sticking strong to the CAR-T pivot first unveiled by CEO Paul Stoffels, M.D., following | Galapagos has teamed up with the largest blood supply network in the U.S. to help establish decentralized CAR-T production on a national scale.
Bio Pharma Dive
MAY 13, 2024
The deal gives the pharma partial rights to a medicine GSK once developed for heart disease but could soon become the first therapy for facioscapulohumeral muscular dystrophy.
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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.
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