Pfizer and Astellas & #039; XTANDI ® approved by U.S. FDA in earlier prostate cancer treatment setting
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. (Source: World Pharma News)
Source: World Pharma News - November 21, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
Potential therapeutic target found to combat tuberculosis, a disrupted NAD(H) homeostasis
It has been uncertain how Mycobacterium tuberculosis deflects the immune response in humans, though evidence has pointed to host immunometabolism - the intrinsic link between metabolism in immune cells and their immune function. The pathogen M. tuberculosis is known to disrupt a metabolic pathway called glycolysis in infected myeloid cells, which include macrophages, through an unclear mechanism. (Source: World Pharma News)
Source: World Pharma News - November 20, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
First electronic product information (ePI) published for selected human medicines
The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU).
The product information of a medicine includes its summary of product characteristics, labelling and package leaflet. (Source: World Pharma News)
Source: World Pharma News - November 17, 2023 Category: Pharmaceuticals Tags: Featured EMA Regulatory Affairs Source Type: news
Vitamin B12: a key player in cellular reprogramming and tissue regeneration
Vitamin B12 is a well-known micronutrient that has long been acknowledged for its essential role in maintaining nerve function, supporting red blood cell production, and facilitating DNA synthesis, all vital processes for overall health. Researchers led by Dr. Manuel Serrano at IRB Barcelona have now revealed that vitamin B12 also plays a pivotal role in cellular reprogramming and tissue regeneration. (Source: World Pharma News)
Source: World Pharma News - November 16, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
UK diabetes prevention program may have global impact
A nationwide programme to reduce the risk of developing diabetes in the UK is proven beyond reasonable doubt to work, a new study reveals.
The positive effects observed in the NHS Diabetes Prevention Programme - the largest such project in the world helping people across the UK to lose weight and control their blood sugar levels - may have relevance globally for tackling the diabetes epidemic. (Source: World Pharma News)
Source: World Pharma News - November 15, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Roche & #039;s subcutaneous injection of Tecentriq recommended by the EU & #039;s CHMP for multiple cancer types
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin) Tecentriq® (atezolizumab). Tecentriq SC can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for intravenous (IV) infusion, which can free up time for patients, healthcare teams and caregivers. (Source: World Pharma News)
Source: World Pharma News - November 14, 2023 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news
Artificial intelligence: Unexpected results
Artificial intelligence (AI) is on the rise. Until now, AI applications generally have "black box" character: How AI arrives at its results remains hidden. Prof. Dr. Jürgen Bajorath, a cheminformatics scientist at the University of Bonn, and his team have developed a method that reveals how certain AI applications work in pharmaceutical research. (Source: World Pharma News)
Source: World Pharma News - November 13, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Bayer and Recursion focus research collaboration on oncology
Bayer and US-based Recursion Pharmaceuticals, Inc., a clinical stage TechBio company decoding biology to industrialize drug discovery, announced that they have updated the focus of their research collaboration to precision oncology.
The oncology-focused collaboration will leverage Bayer's small molecule compound library and expertise in biology and medicinal chemistry as well as Recursion’s purpose-built artificial intelligence-guided drug discovery platform. (Source: World Pharma News)
Source: World Pharma News - November 10, 2023 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news
FDA approves first treatment for patients with rare inherited blood clotting disorder
Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder. (Source: World Pharma News)
Source: World Pharma News - November 9, 2023 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news
Immunotherapy plus an investigational cancer drug improves anti-tumor effects
An investigational therapy for solid tumors could be especially effective when combined with immunotherapy to target a specific kind of cancer cell, a research team at Duke and Harvard have found.
Led by Lee Zou, Ph.D., chair of Duke’s Department of Pharmacology & Cancer Biology, the researchers focused on the way some cancer cells impede normal DNA repair to fuel tumor formation. This phenomenon is known as defective DNA mismatch repair. (Source: World Pharma News)
Source: World Pharma News - November 8, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Bayer expands global life science incubator network
Bayer AG today announced the global expansion of its life science incubator network, Bayer Co.Lab, to Shanghai, China, and Kobe, Japan.
This move establishes new sites for the Bayer Co.Lab program at the hotspots of innovation in China as well as in Japan. (Source: World Pharma News)
Source: World Pharma News - November 7, 2023 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news
First in human trial of new drug raises hopes for patients with relapsed blood cancer
A new targeted drug, studied by researchers at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James), may offer a new treatment option for patients with blood cancers, including chronic lymphocytic leukemia (CLL) and Non-Hodgkin lymphoma (NHL) whose disease has stopped responding to standard treatments. (Source: World Pharma News)
Source: World Pharma News - November 6, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Metabolite tells cells whether to repair DNA
Metabolites called nucleotides are the building blocks of DNA and can impact cancer's sensitivity or resistance to chemotherapy and radiation in brain cancer.
Findings from researchers at the University of Michigan Health Rogel Cancer Center, published in Cancer Discovery, show how a specific nucleotide metabolite, called GTP, controls responses to radiation and chemotherapy in an unexpected way. (Source: World Pharma News)
Source: World Pharma News - November 3, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
Bayer and Broad Institute of MIT and Harvard extend research collaboration to develop new cancer therapies
Bayer and the Broad Institute of MIT and Harvard today announced that they have extended their research collaboration of 10 years by an additional five years, to develop and advance innovative cancer treatments. The expanded agreement will focus on joint cancer target identification and discovery of new therapeutic approaches in oncology. (Source: World Pharma News)
Source: World Pharma News - November 2, 2023 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news
AstraZeneca announces collaboration and investment agreement with Cellectis to accelerate cell therapy and genomic medicine ambitions
AstraZeneca today announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases. (Source: World Pharma News)
Source: World Pharma News - November 1, 2023 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news
