Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study
Bio Pharma Dive
APRIL 18, 2024
Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.
Sat.Apr 13, 2024 - Fri.Apr 19, 2024
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4 Investigational Weight Loss Drugs That Could Change the Market
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.
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Clearmind licenses psychedelic compounds for mental disorders
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.
April 17, 2024: In This Week’s PCT Grand Rounds, 10 Years of the YODA Project
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.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Metsera, a well-funded obesity drug startup, sees chance to challenge Lilly, Novo
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.
Francis Crick researchers reveal pathways linking intestinal inflammation and colitis
Pharma Times
APRIL 15, 2024
Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis
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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir
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.
Ultragenyx says Angelman therapy is working, but safety questions remain
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.
Bio-Rad and Oncocyte partner to develop and commercialise transplant monitoring products
Pharma Times
APRIL 16, 2024
Solid organ transplantation is used to treat end-stage organ failure, including the kidneys
Norgine seeks approval for high-risk neuroblastoma treatment
Pharmaceutical Technology
APRIL 16, 2024
Norgine has sought approval for eflornithine (DFMO) for the treatment of patients with high-risk neuroblastoma (HRNB).
Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus
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.
Vertex begins bid for US approval of non-opioid painkiller
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.
Researchers introduce new AI tool to help clinicians capture uncertainty in medical images
Pharma Times
APRIL 18, 2024
The Tyche model could help clinicians and researchers capture crucial information in images
India sees insignificant revision to price ceiling in 2024
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.
The New Age of Decentralized Clinical Trials
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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
Smart sensor cleared for use with AZ asthma, COPD inhalers
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.
Stelara biosimilar from Alvotech, Teva approved by FDA
Bio Pharma Dive
APRIL 17, 2024
The companies plan to launch their copycat version of the blockbuster immune disease drug early next year, per a legal settlement with J&J.
TAE Life Sciences Welcomes Dr. Deepak “Dee” Khuntia to Its Board of Directors
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.
Inflammation among current dementia research focus, says Alchemab CSO
Pharmaceutical Technology
APRIL 18, 2024
Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations
Worldwide Clinical Trials
APRIL 15, 2024
As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. In fact, recent industry dynamics indicate a considerable shift in preference towards midsize CROs, driven by the need for more personalized, agile, and cost-effective partnerships.
Roche wins FDA OK for targeted drug in early lung cancer
Bio Pharma Dive
APRIL 19, 2024
The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.
Pfizer, BioNTech win pause in patent infringement case from rival Moderna
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.
Lexeo wins fast track designation for Friedreich’s ataxia gene therapy
Pharmaceutical Technology
APRIL 17, 2024
LX2006 consists of adeno-associated virus (AAV) vector carrying the frataxin gene, responsible for causing Friedreich’s ataxia.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
UCL study reveals carbon beads could help reduce progression of liver disease
Pharma Times
APRIL 16, 2024
Liver cirrhosis, caused by long-term liver damage, is estimated to affect around 100 million people worldwide
Roche reports survival data for new dual-acting lymphoma drug
Bio Pharma Dive
APRIL 15, 2024
The results could give Roche’s Columvi an edge over a rival medicine from AbbVie and Genmab, while Regeneron awaits an approval of its own therapy.
Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder
Fierce Pharma
APRIL 16, 2024
Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.
AskBio’s AB-1002 gene therapy receives FDA fast-track status
Pharmaceutical Technology
APRIL 19, 2024
The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).
‘Stiffness’ of cells could give early warning of cancer
pharmaphorum
APRIL 16, 2024
Researchers from the UK have developed an endoscopic device that uses 3D imaging to look at the stiffness of cells and could diagnose cancer earlier.
Keeping cleanrooms clean: Choosing the right laboratory equipment is key
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.
Roche snags postsurgery FDA nod for Alecensa, eyes even broader lung cancer use
Fierce Pharma
APRIL 19, 2024
Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. | Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations.
Q&A: Cell and gene therapy value assessments need a rework to allow access
Pharmaceutical Technology
APRIL 19, 2024
Paolo Morgese, vice president of European public affairs at the Alliance for Regenerative Medicine, discusses the barriers affecting access to gene therapies.
The New Age of Decentralized Clinical Trials
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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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