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 25, 2023
Eisai and BioArctic’s Leqembi is the only approved treatment that slows cognitive and functional decline in adults with Alzheimer’s.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
SEPTEMBER 25, 2023
Eisai and Biogen’s anti-amyloid drug is still undergoing regulatory reviews in the EU, U.K. and elsewhere.
Pharmaceutical Technology
SEPTEMBER 25, 2023
Valneva has received a contract from the US Department of Defense (DoD) for the delivery of its Japanese encephalitis (JE) vaccine, IXIARO.
Bio Pharma Dive
SEPTEMBER 25, 2023
Novartis has made a large investment in targeted radiotherapies, sparking competition from fellow pharma companies and young biotechs.
Pharmaceutical Technology
SEPTEMBER 25, 2023
Pierre Fabre will fund the discovery and development of multiple small-molecule cancer therapies developed in partnership with Vernalis.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 25, 2023
Merck KGaA and the ICR have entered into a renewed strategic collaboration to discover and develop new therapeutics for treating cancer.
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.
Pharmaceutical Technology
SEPTEMBER 25, 2023
Boehringer and Eli Lilly have received approval from the US FDA for Jardiance to treat adults with chronic kidney disease (CKD).
Pharma Times
SEPTEMBER 25, 2023
Therapy has been developed to treat adult patients with newly diagnosed multiple myeloma - News - PharmaTimes
Advertisement
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
SEPTEMBER 25, 2023
China has granted approval for Henlius Biotech’s Hansizhuang for patients with oesophageal squamous cell carcinoma (ESCC).
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.
Pharmaceutical Technology
SEPTEMBER 25, 2023
The Phase III trial of Luthathera as a first-line therapy showed improved progression-free survival in treating GEP-NETs.
Drug Patent Watch
SEPTEMBER 25, 2023
“Measuring Patent Value Indicators with Patent Renewal Information” aims to address the research gap by constructing a dynamic model that incorporates both ex ante and ex post patent value indicators.… The post Measuring Patent Value Indicators appeared first on DrugPatentWatch - Make Better Decisions.
Advertisement
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
SEPTEMBER 25, 2023
The biopharma giant's decision to end its partnership with I-Mab follows it ending a trial for the drug early.
Pharma Times
SEPTEMBER 25, 2023
Trial involves the use of Padcev and Keytruda among patients with certain types of urothelial cancer - News - PharmaTimes
BioPharma Reporter
SEPTEMBER 25, 2023
A new treatment for esophageal squamous cell carcinoma (ESCC) from Shanghai-based Henlius Biotech has been approved by the National Medical Products Administration (NMPA).
Fierce Pharma
SEPTEMBER 25, 2023
After several diabetic patients received a sham version of Roche's Avastin and lost their sight, the Drug Regulatory Authority of Pakistan (DRAP) is halting the sale or distribution of the drug unt | Authorities in Pakistan are investigating the use of altered versions of Roche's Avastin after several diabetic patients who received a sham version of the drug lost their sight.
Advertisement
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 25, 2023
The Swiss pharma is one step closer to bringing Lutathera into the front-line setting, with data from the Phase III NETTER-2 study showing that the radiotherapy met its primary endpoint.
Outsourcing Pharma
SEPTEMBER 25, 2023
Mural Health Technologies, Inc. has raised $8 million in seed funding for the growth of its Mural link platform it says is aimed at âmodernizing the clinical trial experience for both patients and caregiversâ.
BioSpace
SEPTEMBER 25, 2023
The Japanese multinational pharma is pledging up to $580 million in a development and commercialization deal with AcuraStem for the latter’s PIKFYVE program for amyotrophic lateral sclerosis.
Outsourcing Pharma
SEPTEMBER 25, 2023
Exscientia plc will receive an upfront cash payment of $20 million from Merck KGaA, Darmstadt, Germany, as the companies collaborate plus potential payments of up to $674 million in aggregate.
Advertisement
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.
BioSpace
SEPTEMBER 25, 2023
The FDA on Monday approved the Canadian biopharma’s liquid antibiotic metronidazole, an alternative for patients who are unable to use pills or injections.
Fierce Pharma
SEPTEMBER 25, 2023
While GSK’s Arexvy was first out the gate in this summer’s respiratory syncytial virus (RSV) vaccine race, Pfizer has kept the pressure up with its rival shot Abrysvo. | While GSK’s Arexvy was first out the gate in this summer’s respiratory syncytial virus (RSV) vaccine race, Pfizer has kept the pressure up with its rival shot Abrysvo. Now, as the RSV season creeps up, Pfizer’s vaccine has received a formal endorsement from the CDC to be used during pregnancy to protect infants.
BioSpace
SEPTEMBER 25, 2023
The company’s olezarsen cleared a late-stage study, eliciting a sharp reduction in triglyceride levels in patients with familial chylomicronemia syndrome. Ionis plans to submit a New Drug Application to the FDA.
Fierce Pharma
SEPTEMBER 25, 2023
Drugs tainted with impurities ranging from bacteria and particulates to likely cancer agents have triggered multiple FDA recalls in recent years. | Drugs tainted with impurities ranging from bacteria and particulates to likely cancer agents have triggered multiple FDA recalls in recent years. Now, Florida’s VistaPharm is pulling a popular ulcer treatment from U.S. shelves thanks to its own contamination scare.
Advertisement
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 25, 2023
Shares were up over 60% in premarket trading on news that the company’s anti-FcRn antibody exhibited dose-dependent reductions in IgG levels, drivers of inflammation in many autoimmune diseases.
Fierce Pharma
SEPTEMBER 25, 2023
In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing has largely resumed. | In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing is starting back up. Still, the company expects supply shortfalls for some drugs produced at the plant to stretch into next year.
Outsourcing Pharma
SEPTEMBER 25, 2023
Relmada Therapeutics, Inc. has announced rapid and sustained effects of an anti-depressant in patients with major depressive disorders (MDD).
Fierce Pharma
SEPTEMBER 25, 2023
GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns esagonowsky Mon, 09/25/2023 - 12:26
Advertisement
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.
Expert insights. Personalized for you.
294 
Let's personalize your content