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.
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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.
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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.
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.
Bio Pharma Dive
SEPTEMBER 25, 2023
A holistic approach to R&D is key to support MS patients throughout their treatment journey.
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).
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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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors
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
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.
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.
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.
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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.
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.
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.
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
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.
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As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.
Pharma Times
SEPTEMBER 25, 2023
Therapy has been developed to treat adult patients with newly diagnosed multiple myeloma - News - PharmaTimes
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.
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.
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.
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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.
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.
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.
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).
BioSpace
SEPTEMBER 25, 2023
The Italian pharma company is acquiring what was once one of the hottest stocks in the biotech sector, just months after the FDA rejected Intercept’s non-alcoholic steatohepatitis candidate.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Pharma Times
SEPTEMBER 25, 2023
Trial involves the use of Padcev and Keytruda among patients with certain types of urothelial cancer - News - PharmaTimes
Fierce Pharma
SEPTEMBER 25, 2023
A who’s who of biopharma companies have backed a push to rai | A who’s who of biopharma companies have backed a push to raise awareness about lung cancer among Hispanic and Latino Americans, funding a project that has enlisted a Mission: Impossible star to educate the community about risk factors, early warning signs and screening.
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.
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
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
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