Bio Pharma Dive
FEBRUARY 27, 2024
The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.
Pharmaceutical Technology
FEBRUARY 27, 2024
Bristol Myers Squibb (BMS) has announced the conclusion of its acquisition of RayzeBio, a radiopharmaceutical company, for $4.1bn.
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AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 27, 2024
On the list of illnesses that nobody wants, cancer and HIV both rank pretty high, and Californian man Paul Edmonds had both. But ever since one particular treatment five years ago, he’s been free of both cancer and HIV.
Pharmaceutical Technology
FEBRUARY 27, 2024
Novo Nordisk has partnered with US startup Neomorph to develop multiple molecular glue degraders for cardiometabolic and rare diseases.
Bio Pharma Dive
FEBRUARY 27, 2024
Analysts viewed results for one of Janux’s drug, a T cell engager aimed at metastatic prostate cancer, as potentially best-in-class in a field that’s crowded with competitors.
Pharmaceutical Technology
FEBRUARY 27, 2024
Making therapies feasible from biological, regulatory, and commercial standpoints drives scalable genetic medicine.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
FEBRUARY 27, 2024
The agency’s complete response letter knocks back Minerva’s attempt to secure approval of the drug over agency reviewers’ objections.
Pharmaceutical Technology
FEBRUARY 27, 2024
The industry must utilise AI with the mindset to innovate over the desire to slash drug costs and reduce time to commercialisation.
Rethinking Clinical Trials
FEBRUARY 27, 2024
The Health Care Systems Research Network (HCSRN) extended early-bird registration for its 2024 Annual Conference to February 29. The conference will be held from April 9 to 11 in Milwaukee, Wisconsin. New this year, a preconference grant writing workshop will take place on Monday, April 8. The workshop will bring together experts throughout HCSRN to assist early investigators with NIH R series applications.
Pharmaceutical Technology
FEBRUARY 27, 2024
Gilead Sciences has received FDA approval for an expanded indication for Biktarvy to treat HIV patients with M184V/I resistance mutations.
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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
FEBRUARY 27, 2024
The infusion from unnamed private investors will bolster the company’s balance sheet days after a Sanofi-partnered ALS drug stumbled in a clinical trial.
Pharmaceutical Technology
FEBRUARY 27, 2024
The EMA CHMP has recommended AstraZeneca's Voydeya for marketing authorisation to treat paroxysmal nocturnal haemoglobinuria (PNH).
Fierce Pharma
FEBRUARY 27, 2024
Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.
Pharmaceutical Technology
FEBRUARY 27, 2024
The Phase II trial met its primary endpoint where 83% of patients saw an improvement in MASH compared to 18.2% on placebo.
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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
pharmaphorum
FEBRUARY 27, 2024
Pharmaceutical companies are increasingly focusing on radiopharmaceuticals due to their potential in oncology and therapeutic applications. Learn more about why the industry is excited about radioisotopes in this article.
Pharmaceutical Technology
FEBRUARY 27, 2024
Telix Pharmaceuticals has signed an agreement for the acquisition of radiopharmaceutical company IsoTherapeutics.
Fierce Pharma
FEBRUARY 27, 2024
AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.
pharmaphorum
FEBRUARY 27, 2024
Next-generation technology is enabling drug discovery at an entirely new scale, accelerating the process, transforming therapies and advancing precision medicine, and resulting in better patient outcomes. In this podcast, Dr Mohit Jain, founder and CEO of Sapient, discusses personalised disease prediction, diagnostics, and therapies.
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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.
Antidote
FEBRUARY 27, 2024
We’re here with Antidote’s tenth installment of Talk of the Towne, and it’s a very special one! We recently attended SCOPE 2024, where we met up with our partners at Rare Patient Voice and recorded our first Talk of the Towne episode live and in person.
Drug Discovery World
FEBRUARY 27, 2024
New studies have demonstrated that Vaxxinity’s vaccine VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in non-human primates. The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease. VXX-401 is a synthetic peptide vaccine designed to stimulate the immune system to produce antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), whi
Outsourcing Pharma
FEBRUARY 27, 2024
Biogen Inc. has announced a significant advancement in the treatment of amyotrophic lateral sclerosis (ALS), commonly known as motor neuron disease (MND).
pharmaphorum
FEBRUARY 27, 2024
The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.
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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
FEBRUARY 27, 2024
Biogen Inc. has announced a significant advancement in the treatment of amyotrophic lateral sclerosis (ALS), commonly known as motor neuron disease (MND).
pharmaphorum
FEBRUARY 27, 2024
Looking to the future of clinical trials: Gene therapy, precision medicine, and the ongoing quest for rare disease solutions Mike.
Pharma Times
FEBRUARY 27, 2024
Eight out of ten patients who took the test were discharged without needing further testing
pharmaphorum
FEBRUARY 27, 2024
Europe's commercial leaders are gearing up for a faster trial-to-treatment pathway, leveraging CRM technology to empower HCPs and sales teams.
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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
FEBRUARY 27, 2024
Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. | Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. The U.S. regulator has signed off on Allecra Therapeutics’ Exblifep as a treatment for cUTIs, including the severe kidney condition pyelonephritis.
pharmaphorum
FEBRUARY 27, 2024
UK cancer survival is lagging 10-15 years behind other countries due to lower rates of chemotherapy and radiotherapy, says UCL study backed by CRUK.
Pharma Times
FEBRUARY 27, 2024
The white paper outlines three strategic recommendations to support further research
pharmaphorum
FEBRUARY 27, 2024
UK biotech Curve Therapeutics raises $51 million in a Pfizer-led Series A that will support its platform for screening drugs within cells.
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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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