Bio Pharma Dive
APRIL 15, 2024
Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.
Pharmaceutical Technology
APRIL 16, 2024
The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.
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AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 11, 2024
The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.
Rethinking Clinical Trials
APRIL 17, 2024
Dr. Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The Grand Rounds session will be held on Friday, April 19, 2024, at 1:00 pm eastern. The YODA Project promotes open science, research transparency, and the sharing of clinical research data to support healthcare research.
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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
BioSpace
APRIL 14, 2024
GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects.
Bio Pharma Dive
APRIL 15, 2024
Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 11, 2024
Using viruses that infect bacteria to detect proteins sprouted by a notorious parasite, scientists have honed in on possible vaccine targets for schistosomiasis, a neglected tropical disease that currently affects an estimated 600 million people worldwide, causing 280,000 deaths per year.
Fierce Pharma
APRIL 17, 2024
One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.
BioSpace
APRIL 16, 2024
As its lead oral targeted protein degrader moves through Phase III in partnership with Pfizer, Arvinas signs a licensing deal handing over all rights and responsibilities to Novartis.
Bio Pharma Dive
APRIL 15, 2024
Learn about why access to robust biomarkers such as cfHPV-DNA is pivotal in determining eligibility, assessing treatment response and detecting recurrence early to improve patient outcomes.
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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
APRIL 11, 2024
The oral drug, which gained UK approval in September 2023, is used for the prevention of both chronic and episodic migraines.
pharmaphorum
APRIL 17, 2024
Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.
Fierce Pharma
APRIL 15, 2024
After nearly two years of legal back and forth, Pfizer and its German partner BioNTech have won a brief reprieve in their patent fight against mRNA rival Moderna. | In a docket entry dated Friday, Massachusetts federal judge Richard G. Stearns granted a stay on Moderna's COVID-19 vaccine patent infringement lawsuit against Pfizer and BioNTech. The move will give the Patent Trial and Appeal Board more time to review challenges against two of the three relevant patents in the litigation.
BioSpace
APRIL 14, 2024
Metabolic dysfunction-associated steatohepatitis experts welcomed Madrigal’s Rezdiffra as an “important first," but there are more mid- to late-stage therapies showing promising results.
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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
APRIL 16, 2024
Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.
Pharmaceutical Technology
APRIL 15, 2024
Discover ImmunityBio Inc's groundbreaking patent for a cross-reactive SARS-CoV2 vaccine targeting multiple variants. Learn how this innovative method boosts immune response and memory cells for enhanced protection.
pharmaphorum
APRIL 16, 2024
A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.
Fierce Pharma
APRIL 11, 2024
As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.
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.
BioSpace
APRIL 16, 2024
With Wednesday’s readout showing symptom improvements in obstructive sleep apnea patients, Eli Lilly is preparing to file for a label expansion for its top-selling weight-loss drug Zepbound.
Bio Pharma Dive
APRIL 17, 2024
Following negative results, the company doesn’t plan to further test SAGE-718 in Parkinson’s. Other studies in Huntington’s and Alzheimer’s remain ongoing.
Pharmaceutical Technology
APRIL 17, 2024
Discover the innovative patent by WuXi AppTec Co Ltd for preparing a dichloroacetic acid composition with minimal glyoxylic acid. Learn about the process and benefits of accurate glyoxylic acid measurement.
pharmaphorum
APRIL 17, 2024
The FTC is seeking a $7 million fine on telehealth company Cerebral for violating patients' data privacy and making cancellation difficult.
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.
Pharma Times
APRIL 15, 2024
Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis
BioSpace
APRIL 12, 2024
This week’s American Association for Cancer Research annual meeting drove home the importance of antibody-drug conjugates as an emerging class of potential anti-cancer therapeutics.
Bio Pharma Dive
APRIL 16, 2024
Shares of the biotech rose 25% after a large trial found adding its drug Caplyta onto antidepressant therapy significantly helped people with major depression.
Pharmaceutical Technology
APRIL 17, 2024
Discover the groundbreaking patent by TCR2 Therapeutics Inc for T-cell receptor fusion proteins targeting tumor cell antigens. Revolutionizing disease treatment, including cancer, with engineered T cells expressing TFPs.
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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.
pharmaphorum
APRIL 15, 2024
Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.
BioPharma Reporter
APRIL 11, 2024
Specific doses of Eli Lillyâs GLP-1 blockbuster drugs Mounjaro and Zepbound are currently facing a supply shortage, and frustrated patients are urging the pharma giant to act â fast.
BioSpace
APRIL 16, 2024
On the heels of a Phase IIb win, Arrowhead Pharmaceuticals’ plozasiran could fulfill a critical unmet need in dyslipidemia treatment bringing in $707 million in sales by 2032, according to data analytics firm GlobalData.
Bio Pharma Dive
APRIL 17, 2024
Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.
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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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