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.
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.
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.
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AI in Medical Communications: Revolutionising the present, redefining the future
pharmaphorum
APRIL 17, 2024
Discover how AI is transforming medical communications and reshaping the future of healthcare. Learn about the latest trends, technologies, and advancements in this rapidly evolving field.
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.
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.
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
Predictions for AI in mental health in the coming year
pharmaphorum
APRIL 18, 2024
In a new episode of the pharmaphorum podcast, web editor Nicole Raleigh welcomes Dr Carl Marci, chief psychiatrist and managing director of mental health and neuroscience at OM1 to discuss predictions for AI in mental health in the coming year, as well as what might truly make a difference in the field and lessen the mental health crisis.
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.
Genentech Wins FDA Approval for First Adjuvant Therapy for ALK-Positive, Early NSCLC
BioSpace
APRIL 18, 2024
Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.
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).
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.
Psychedelic treatments on cusp of approval, but questions remain
pharmaphorum
APRIL 15, 2024
Psychedelic treatments for conditions like PTSD using substances like MDMA are on the brink of approval, but there are still unanswered questions surrounding their effectiveness and potential risks. Learn more here.
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.
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.
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.
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.
Reuters Pharma USA 2024 – Serena Goodwin
pharmaphorum
APRIL 19, 2024
Stay updated on the latest STEM Healthcare news from Reuters Pharma USA 2024, featuring insights from global account lead at STEM, Serena Goodwin on the impact of AI in healthcare.
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.
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.
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).
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical 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
Reshoring the UK pharmaceutical supply chain for future resilience
pharmaphorum
APRIL 17, 2024
Learn about the importance of reshoring the UK pharmaceutical supply chain for future resilience. Discover how this strategic move can enhance local production and secure the availability of critical medications.
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.
FDA Requires Boxed Warning for Secondary Cancers on CAR-T Therapies
BioSpace
APRIL 18, 2024
Following a months-long safety review, the regulator on Thursday said it is now requiring black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
Estetrol by Mithra Pharmaceuticals for Genitourinary Syndrome of Menopause (GSM): Likelihood of Approval
Pharmaceutical Technology
APRIL 17, 2024
Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).
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.
Omnichannel odyssey: Trends redefining marketing in 2024
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.
The growing role for cfHPV-DNA testing in OPSCC therapeutic development
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.
Treg Cell Therapy for Neurodegenerative Diseases – Interview with Dr. Howard Berman, CEO, Coya Therapeutics – Xtalks Life Science Podcast Ep. 155
XTalks
APRIL 17, 2024
In this episode, Ayesha spoke with Howard Berman, PhD, Founder and CEO of Coya Therapeutics , a clinical-stage biotech company developing regulatory T cell (Treg) therapies targeting neurodegenerative, autoimmune and metabolic diseases. Dr. Berman founded Coya Therapeutics in 2021. Howard Berman, PhD Founder and CEO Coya Therapeutics Dr. Berman has over 18 years of entrepreneurial and industry experience working at the interplay of science and business.
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.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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