Bio Pharma Dive
SEPTEMBER 27, 2023
John Tsai, previously Novartis’ chief medical officer, has been named CEO of Forcefield Therapeutics, an 18-month-old biotech working on a treatment for heart attacks.
Pharmaceutical Technology
SEPTEMBER 28, 2023
The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.
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Rethinking Clinical Trials
SEPTEMBER 28, 2023
Speaker Tumaini Rucker Coker, MD, MBA Professor of Pediatrics Division Head for General Pediatrics University of Washington Department of Pediatrics Seattle Children’s Hospital Slides Keywords Pediatrics, Preventive Medicine, Community Health, Well Child Care Key Points There are 10 preventive care visits from ages 0-3, usually scheduled as 15-20 minute visits with a pediatrician.
Fierce Pharma
SEPTEMBER 25, 2023
More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-fo | More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.
Bio Pharma Dive
SEPTEMBER 25, 2023
Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.
Pharmaceutical Technology
SEPTEMBER 29, 2023
Karuna Therapeutics has announced the submission of a NDA to the FDA for KarXT (xanomeline-trospium) for the treatment of schizophrenia.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 28, 2023
Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here's a closer look.
Bio Pharma Dive
SEPTEMBER 29, 2023
The biotech is expanding cuts it announced a few months ago after the EMA decided against renewing a conditional clearance for its drug Translarna.
Pharmaceutical Technology
SEPTEMBER 27, 2023
The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.
Fierce Pharma
SEPTEMBER 28, 2023
Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. | Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.
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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
BioSpace
SEPTEMBER 26, 2023
The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturing vaccines in Africa.
Bio Pharma Dive
SEPTEMBER 26, 2023
Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.
Pharmaceutical Technology
SEPTEMBER 27, 2023
The popular acne treatment will soon be available in 15 EU countries in addition to UK and South Africa.
Antidote
SEPTEMBER 25, 2023
Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed. Before any new treatment becomes available on the market, it must go through this process, as required by the FDA.
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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.
BioSpace
SEPTEMBER 26, 2023
After picking up magrolimab in a $4.9 billion purchase of Forty Seven, a second Phase III study is being discontinued for the anti-CD47 antibody, this time in acute myeloid leukemia.
Bio Pharma Dive
SEPTEMBER 27, 2023
Laboratoires Théa terminated its planned purchase of ProQR’s sepofarsen after certain ProQR personnel opted against working for the French company.
Pharmaceutical Technology
SEPTEMBER 25, 2023
Eisai and BioArctic’s Leqembi is the only approved treatment that slows cognitive and functional decline in adults with Alzheimer’s.
Pharma Times
SEPTEMBER 28, 2023
Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes
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
SEPTEMBER 24, 2023
Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.
Bio Pharma Dive
SEPTEMBER 27, 2023
Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.
Pharmaceutical Technology
SEPTEMBER 29, 2023
At the industry crossroads of healthcare and pharmaceuticals at the Life Sciences Baltics 2023 conference, all signs pointed towards an AI-based future.
Fierce Pharma
SEPTEMBER 29, 2023
After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlem | After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlement talks.
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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
SEPTEMBER 28, 2023
An FDA advisory committee this week voted overwhelmingly against BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis treatment. However, other potential therapies offer hope for ALS patients.
Bio Pharma Dive
SEPTEMBER 29, 2023
Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug Structure is developing, reflecting investor enthusiasm for the weight loss medicines.
Pharmaceutical Technology
SEPTEMBER 29, 2023
India is known as the 'pharmacy of the world', producing a substantial quantity of generic drugs globally. However, its lax regulatory oversight has resulted in persistent drug recalls and scandals that have stained the country’s manufacturing reputation.
BioPharma Reporter
SEPTEMBER 26, 2023
Psychedelics have re-emerged in the world of medicine as promising treatments for various mental health conditions, particularly post-traumatic stress disorder (PTSD).
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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.
BioSpace
SEPTEMBER 27, 2023
The New England Journal of Medicine study suggests that the 2022 death of a Duchenne muscular dystrophy patient was due to an adverse effect of recombinant AAV used to deliver the gene therapy.
Bio Pharma Dive
SEPTEMBER 28, 2023
In a note to clients, Evercore ISI analyst Jonathan Miller described the Project NextGen contract for Gritstone as “certainly a nice signal of continued government support for COVID research.
Pharmaceutical Technology
SEPTEMBER 27, 2023
Arcturus Therapeutics has extended an existing agreement in place with the Cystic Fibrosis Foundation (CF Foundation) for advancing ARCT-032.
Outsourcing Pharma
SEPTEMBER 28, 2023
A study to evaluate the effect of seladelparm, a small molecule treatment by CymaBay Therapeutics, Inc. on patients with cirrhosis was announced this month (September 21).
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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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