Bio Pharma Dive
JANUARY 17, 2024
The offering is the fifth outlined by a biotech startup this month, suggesting companies are becoming more willing to gauge investors’ appetite for new stock offerings.
Pharmaceutical Technology
JANUARY 17, 2024
Coya plans to file investigational new drug applications for COYA 302 in amyotrophic lateral sclerosis and frontotemporal dementia later this year.
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Bio Pharma Dive
JANUARY 17, 2024
The startup is focusing on immune cells called Tr1 cells, which it claims could be important in treating autoimmune conditions like graft-versus-host disease.
Pharmaceutical Technology
JANUARY 17, 2024
Takeda has gained approval from the US Food and Drug Administration for HYQVIA to treat chronic inflammatory demyelinating polyneuropathy.
Bio Pharma Dive
JANUARY 17, 2024
The biotech is developing an RNA-based therapy for what it describes as a root cause of the pregnancy-related complication, which affects millions of women.
Pharmaceutical Technology
JANUARY 17, 2024
The US FDA has approved Vertex's CASGEVY, a gene-edited cell therapy, to treat transfusion-dependent beta thalassemia.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 17, 2024
AI in telemedicine for behavioural health can revolutionise patient access to treatment, lower costs and identify urgent concerns.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 17, 2024
The Union Ministry of Ayush (MoA) is taking steps to amend the Drugs and Cosmetics Act, 1940 to add the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country.
Pharmaceutical Technology
JANUARY 17, 2024
Speaking at Davos, WHO chief Dr. Ghebreyesus said learning lessons from the Covid-19 pandemic is a priority in fighting Disease X.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 17, 2024
A new drug called kush is wreaking havoc in west Africa, particularly in Sierra Leone where it is estimated to kill around a dozen people each week and hospitalise thousands.
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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
JANUARY 17, 2024
The British health insurance and coverage provider is well-placed to invest in new technology due to its payment structure.
Rethinking Clinical Trials
JANUARY 17, 2024
Speaker Erin K. McCreary, PharmD, BCIDP Director of Infectious Diseases Improvement and Clinical Research Innovation, UPMC Clinical Assistant Professor of Medicine, University of Pittsburgh President-Elect, Society of Infectious Diseases Pharmacists (SIDP) Slides Keywords COVID-19, therapeutics, health equity, pragmatic clinical trial Key Points In April 2020, UPMC established a COVID Therapeutics Committee to determine a process for allocating experimental COVID-19 therapies.
Pharmaceutical Technology
JANUARY 17, 2024
The decision invalidates all claims of patent infringement, which has been central in litigation of breast cancer drug Enhertu.
XTalks
JANUARY 17, 2024
Oncology is recognized as having the largest drug pipeline of any therapeutic area. Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their
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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
Pharmaceutical Technology
JANUARY 17, 2024
KBI Biopharma and Argonaut have entered into a strategic partnership to provide biopharmaceutical clients with drug manufacturing solutions.
XTalks
JANUARY 17, 2024
This episode features an interview with Ben Sexson, CFA, Co-Founder, CEO, Monogram Orthopedics at Monogram Orthopedics , a company dedicated to revolutionizing orthopedic joint replacement through surgical robotics. Monogram is focused on developing patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging.
Pharmaceutical Technology
JANUARY 17, 2024
The EC has granted orphan drug designation (ODD) for Precigen's PRGN-2012 aimed at treating recurrent respiratory papillomatosis (RRP).
Fierce Pharma
JANUARY 17, 2024
Bayer is launching a sweeping business overhaul as the German conglomerate sees “no viable alternative.” | Bayer is launching a sweeping business overhaul that will “come at the expense of many managerial employees,” as the German conglomerate sees “no viable alternative.
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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.
Pharmaceutical Technology
JANUARY 17, 2024
In a report, findings suggested that cancer patients in the Netherlands will face longer waits to access new oncology medicines.
pharmaphorum
JANUARY 17, 2024
The disparity in access to healthcare between women and men around the world is often talked about but has never been given a dollar value – until now.
Pharmaceutical Technology
JANUARY 17, 2024
The Switzerland based company plans to use the Series B money to fund clinical trials for its three pipeline candidates.
pharmaphorum
JANUARY 17, 2024
Scotland's expertise in advanced therapies, combined with its robust healthcare system and strong research infrastructure, positions it as a leader in tackling complex diseases such as lung, liver, and vascular disorders. Discover why Scotland is at the forefront of innovation and advancements in this field.
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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.
Outsourcing Pharma
JANUARY 17, 2024
After visiting Biofourmis in Boston last year, OSP was impressed with the remote care the company could offer people from the comfort of their own homes.
pharmaphorum
JANUARY 17, 2024
Oral cytisine therapy for smoking cessation from Consilient Health will launch in the UK next week, helping to alleviate a shortage of prescription drugs to help people quit
Pharma Times
JANUARY 17, 2024
License agreement concerns development of cell therapies for corneal blindness
pharmaphorum
JANUARY 17, 2024
Stay up to date on the latest clinical trials happening in the week of 8th-12th January. Get information on trials for Lytix Biopharma's Verrica, Celletcar, Ariceum, Dermavant, BI, and more.
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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.
Fierce Pharma
JANUARY 17, 2024
GSK is sticking to its plan to gradually monetize its stake in Haleon, the consumer health business the British pharma giant spun off in 2022. | GSK is sticking to its plan to gradually monetize its stake in Haleon, the consumer health business the British pharma giant spun off in 2022.
pharmaphorum
JANUARY 17, 2024
FDA has approved Vertex and CRISPR Therapeutics' Casgevy as first CRISPR based therapy for transfusion-dependent thalassaemia.
Fierce Pharma
JANUARY 17, 2024
After years of patent litigation between cancer drug developers Daiichi Sankyo and Seagen, the U.S. Patent and Trademark office (U.S. PTO) has handed Daiichi the latest win in the saga. | After a Texas jury sided with Seagen a patent spat, the U.S. Patent and Trademark Office has invalidated the patent in question.
pharmaphorum
JANUARY 17, 2024
The US patent office has invalidated the only Seagen patent cited in a lawsuit claiming infringement by Daiichi Sankyo’s breast cancer therapy Enhertu.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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