February 2, 2024
Via: Biopharma DiveAnother biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in an uptick of IPO activity that suggests rebounding investor interest in life sciences stocks. Alto Neuroscience raised about $129 million […]
January 25, 2024
Via: Biopharma DiveThe Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments. At the two-day workshop led […]
January 19, 2024
Via: PharmaphorumThe drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without […]
January 18, 2024
Via: Biopharm InternationalFDA’s Center for Drug Evaluation and Research (CDER) published its New Drug Therapy Approvals 2023 report on Jan. 16, 2024 highlighting new drugs approved in 2023. CDER approved 55 novel drugs during the year and expanded indications or patient populations […]
January 16, 2024
Via: PharmaphorumTheir novel approach to high-throughput experimentation (HTE) could do away with the current need to run trial-and-error experiments to see how chemicals used to make medicines react with one another, predicting their behaviour virtually, and has been described in a […]
January 10, 2024
Via: Biopharma DiveThe arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into the sector’s most valuable companies and sending others scrambling to catch up. Analysts predict that so-called GLP-1 drugs like Lilly’s […]
December 18, 2023
Via: Biopharma DiveAn experimental obesity pill being developed by Structure Therapeutics helped lower the blood sugar levels of people with Type 2 diabetes in a clinical trial, but didn’t match the degree of weight loss observed in testing of a rival medicine. […]
December 11, 2023
Via: Biopharma DiveAt the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s new logos are splashed across the side of phone charging stations. Sanofi, among others, let attendees know via hand sanitizer stands that it […]
October 17, 2023
Via: PharmaphorumZilbrysq (zilucoplan), billed as the first once-daily subcutaneously-administered complement C5 inhibitor, will launch onto the US market in competition with AstraZeneca’s Soliris (eculizumab) and follow-up Ultomiris (ravulizumab) – both given as intravenous infusions – which were approved for gMG in […]
September 13, 2023
Via: Biopharm InternationalDrug development is inherently costly and time-intensive, with potential attrition a persistent burden on companies’ finances (1). As companies gain a deeper understanding of cell and molecular biology and seek to develop more complex therapeutics for patient populations, they will […]
Clinical Trials, Industry, Pharma, Research and Development
September 1, 2023
Via: Biopharm InternationalClinical trials are essential for establishing the efficacy of new drugs, observing patients’ reactions to treatments, and representing populations of people that may not always be discussed in everyday conversation. Although there are many diseases and disorders that are waiting […]
August 17, 2023
Via: Drugs.comThe U.S. Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer. The approval makes Akeega the first and only dual action tablet combining a poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor […]
August 1, 2023
Via: Biopharm InternationalThe M7 (R2) guidance emphasizes the importance of safety and risk management in creating levels of mutagenic impurities that are anticipated to not pose significant carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that live in […]
July 25, 2023
Via: Contract PharmaTeva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech, a global biotech company specializing in the development and manufacture of biosimilars, expanded their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be […]
July 17, 2023
Via: Biopharma DiveNovartis said it was drawn to DTx for multiple reasons, interested in both the biotech’s lead treatment for Charcot-Marie-Tooth as well as its capabilities with small, interfering RNA — a technology with which the pharma is already familiar. Small, interfering […]
July 10, 2023
Via: World Pharma NewsBayer and Peking University (PKU) will collaborate to foster the translation of basic pharmaceutical research into drug discovery and development, while accelerating scientific research on cutting-edge technologies across the pharmaceutical value chain. The collaboration will focus on selected key areas […]
June 28, 2023
Via: World Pharma NewsThis afternoon at 2 pm CET (8 am EDT), Bayer AG will host its Pharmaceuticals R&D Event 2023 for Investors. The company will present a deep dive on the innovation strategy in its four therapeutic core areas Oncology, Cardiovascular Diseases, […]
May 26, 2023
Via: PMLiVEThe designations for the investigational oral factor XIa inhibitor cover all three indication-seeking studies within the phase 3 Librexia development programme: ischaemic stroke, acute coronary syndrome and atrial fibrillation. According to the companies, the programme aims to evaluate whether milvexian […]
May 24, 2023
Via: Biopharma DiveAcinetobacter baumannii are a common cause of pneumonia in hospitals, and infections can be life-threatening. Innoviva’s treatment consists of a drug, sulbactam, that’s similarly structured as the antibiotic penicillin, along with another compound, durlobactam, that helps protect it from degradation. […]
May 12, 2023
Via: Drugs.comOutside advisors for the U.S. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions. Although most of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) […]