Bio Pharma Dive
APRIL 18, 2024
The start of a so-called rolling review formally begins an FDA evaluation of a closely watched drug that’s important to the biotech’s future, but faces questions about its sales potential.
Pharmaceutical Technology
APRIL 18, 2024
Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.
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Pharmaceutical Technology
APRIL 17, 2024
Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).
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
Pharma Mirror
APRIL 17, 2024
As an authority in radiation oncology, Dr. Khuntia joining the board of directors validates BNCT and the work TAE Life Sciences is doing to make it a mainstay of modern cancer care IRVINE, Calif.- TAE Life Sciences, a pioneer in advancing Boron Neutron Capture Therapy (BNCT) for cancer treatment, proudly announces the appointment of Dr. Deepak “Dee” Khuntia, M.D., FASTRO, to its esteemed Board of Directors.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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.
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 17, 2024
In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).
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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
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.
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.
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 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.
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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 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.
Pharmaceutical Technology
APRIL 18, 2024
Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0 psychedelic compounds for mental disorders.
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.
pharmaphorum
APRIL 18, 2024
Embark on an omnichannel marketing odyssey by exploring the top trends reshaping the industry in 2024. Discover how chatbots, video content, and interactivity are transforming marketing strategies.
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.
Fierce Pharma
APRIL 18, 2024
Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.
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.
Pharmaceutical Technology
APRIL 17, 2024
LX2006 consists of adeno-associated virus (AAV) vector carrying the frataxin gene, responsible for causing Friedreich’s ataxia.
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.
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.
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.
Pharma Times
APRIL 15, 2024
Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis
Bio Pharma Dive
APRIL 18, 2024
It’s “early innings” in the obesity drug race, said Metsera CEO Clive Meanwell, whose company has acquired a portfolio of medicines it aims to test in combination.
Pharmaceutical Technology
APRIL 12, 2024
Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya.
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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.
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.
pharmaphorum
APRIL 18, 2024
UK researchers describe an algorithm that is more accurate than current tools at predicting an individual’s risk of developing cardiovascular disease in the next 10 years.
Fierce Pharma
APRIL 17, 2024
After proving the merits of its drug delivery platform last year with the approval of Teva’s long-acting schizophrenia drug Uzedy, France’s Medincell has hooked another big-name partner. | Medincell and AbbVie inked a development and licensing pact to create up to six long-acting injectables, Medincell said Wednesday. Under the deal, Medincell is line to receive an upfront payment of $35 million plus much more in potential development and commercial milestones.
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.
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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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