FDA authorizes Florida to import drugs from Canada
Bio Pharma Dive
JANUARY 5, 2024
The clearance is a major shift for the agency, which described its decision as a “first step” in allowing Florida to bulk purchase lower-cost Canadian medicines.
Bio Pharma Dive
JANUARY 5, 2024
The clearance is a major shift for the agency, which described its decision as a “first step” in allowing Florida to bulk purchase lower-cost Canadian medicines.
Pharmaceutical Technology
JANUARY 5, 2024
AbbVie and Umoja Biopharma partnered for the development of in-situ CAR-T cell therapy candidates for oncology targets.
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Bio Pharma Dive
JANUARY 5, 2024
Lykos Therapeutics, formerly known as MAPS Public Benefit Corp., recently submitted its MDMA capsules for FDA approval, following two positive studies.
Pharma Mirror
JANUARY 5, 2024
New Delhi, India – FD-AID, LLC, a distinguished leader in pharmaceutical quality and compliance solutions, proudly announces its entry into the Indian pharmaceutical market. Spearheaded by a former US FDA Investigator and seasoned pharmaceutical executive, FD-AID is uniquely positioned to bring a wealth of expertise and insight to India’s rapidly growing pharmaceutical industry.
Pharmaceutical Technology
JANUARY 5, 2024
Intellia Therapeutics announced its clinical goals for the next few years, pushing development for its late-stage ATTR asset.
Fierce Pharma
JANUARY 5, 2024
Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medi | Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medical records of patients shows no link between use of the GLP-1 drugs and an increase in suicidal though
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Discovery World
JANUARY 5, 2024
Kyverna Therapeutics has revealed plans to progress to Phase II trials of KYV-101 for multiple sclerosis (MS) following a green light from the US Food and Drug Administration (FDA). KYV-101 is an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate for use in B cell-driven autoimmune diseases. “This approval is a critically necessary step that paves the way to enrol patients with treatment-refractory progressive MS for whom there are no currently available
Pharmaceutical Technology
JANUARY 5, 2024
KAI, a technology company based in the UK, is a Category Award Winner for Innovation in the 2023 Pharmaceutical Technology Excellence Awards
Antidote
JANUARY 5, 2024
Though clinical trial patient recruitment is an integral part of the medical research process, it is often one of the most difficult aspects of conducting a study. There are various reasons for this challenge, and among them is the widespread existence of misconceptions about participating in research that many patients may see as a barrier to entry.
Pharmaceutical Technology
JANUARY 5, 2024
Avistone has closed its Series B financing round, raising 1bn yuan ($140m), to support clinical research and development of its drug pipeline.
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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
pharmaphorum
JANUARY 5, 2024
Explore the highlights of the 2023 Benchling biotech press roundtable before Benchtalk London, showcasing cutting-edge software and innovations in the field of biotechnology.
Pharmaceutical Technology
JANUARY 5, 2024
Menarini subsidiary Stemline will receive upfront and milestone payments, potentially worth more than $500m, along with royalties from sales.
pharmaphorum
JANUARY 5, 2024
Gain insights from sustainability leaders in the life sciences industry on navigating the path to sustainable pharma. Learn about their efforts in addressing environmental issues, social impact, governance practices, and enhancing patient outcomes.
Pharmaceutical Technology
JANUARY 5, 2024
Boehringer Ingelheim has signed a deal with 3T Biosciences for the discovery and development of next-generation cancer immunotherapies.
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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
Pharmaceutical Commerce
JANUARY 5, 2024
LillyDirect will facilitate access to medications by connecting patients with independent telehealth providers, bypassing the need to obtain a prescription from a physician and then going to a pharmacy to fill it.
Pharmaceutical Technology
JANUARY 5, 2024
MOMA Therapeutics and Roche have signed a strategic partnership and licensing agreement for discovering drug targets for cancer.
Fierce Pharma
JANUARY 5, 2024
When Theravance called it quits on a phase 2 JAK inhibitor program last February, the South San Francisco and Dublin-based biopharma company put the majority of its chips on a head-to-head trial pi | In the phase 4 study, Theravance and Viatris’ Yupelri failed to demonstrate greater lung function improvement in adults with COPD versus Spiriva delivered by a dry powder inhaler, Theravance said Friday.
Pharmaceutical Technology
JANUARY 5, 2024
Rhythm to acquire global rights for South Korean LG Chem’s oral obesity drug LB54640 for $100m in cash and equity.
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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.
pharmaphorum
JANUARY 5, 2024
Beckley Psytech has announced that is has received substantial strategic investment from atai Life Sciences, totalling $50 million, to accelerate the clinical development of short-duration psychedelics.
Pharmaceutical Technology
JANUARY 5, 2024
The company aims to drive a small molecule resurgence with its lead Alzheimer’s symptom relief agent AD-101.
Fierce Pharma
JANUARY 5, 2024
The last few days of 2023 and the beginning of 2024 featured a flurry of dealmaking by the likes of AstraZeneca, Johnson & Johnson, Roche and Boehringer Ingelheim with Asian companies | A flurry of deals were inked by the likes of AstraZeneca, Johnson & Johnson, Roche and Boehringer Ingelheim with Asian companies. Big Pharma companies are also increasingly entrusting commercialization of some products in China to domestic firms.
Pharma Times
JANUARY 5, 2024
The companies will aim to select targets, discover and develop new therapeutics
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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.
XTalks
JANUARY 5, 2024
OAKBERRY, a leading Brazilian global açaí brand, has successfully raised $67 million in Series C funding. This significant financial milestone was led by the Brazilian investment bank, BTG Pactual. The capital raised will be set aside to accelerate OAKBERRY’s global expansion strategy, with a keen focus on the US market. The funds are strategically intended to bolster OAKBERRY’s revenue to an impressive $200 million.
Pharma Times
JANUARY 5, 2024
Vd1-gd T cells were effective in predicting positive responses to ICI therapy
Fierce Pharma
JANUARY 5, 2024
UCB is heading into 2024 with several new approvals under its belt, but it’s leaving its membership in the Biotechnology Innovation Organization (BIO) behind. | Both companies opted not to renew their 2024 memberships with the Biotechnology Innovation Organization (BIO). UCB will still retain its membership in other top trade groups, including the Pharmaceutical Research and Manufacturers Association of America (PhRMA).
Drug Discovery World
JANUARY 5, 2024
Massachusetts Institute of Technology (MIT) researchers have used deep learning to identify a new class of antibiotic candidates that can kill methicillin-resistant Staphylococcus aureus (MRSA). The study represents more good news in the battle against antimicrobial resistance, as researchers from Harvard University and Roche also recently announced the discovery of a novel class of antibiotics.
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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.
Drug Patent Watch
JANUARY 5, 2024
Annual Drug Patent Expirations for BRYHALI Bryhali is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are two patents protecting… The post New patent for Bausch drug BRYHALI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
JANUARY 5, 2024
Techbio SimBioSys and the Mayo Clinic have entered into a strategic collaboration to develop novel digital precision medicine solutions for breast cancer. The aim of the collaboration is to develop cloud-based clinical software tools that will support the end-to-end decision-making process for early-stage breast cancer patients, including drug selection and risk stratification.
XTalks
JANUARY 5, 2024
Eli Lilly launched LillyDirect this week, an online service that provides access to the company’s medicines, including its newly approved weight loss drug Zepbound (tirzepatide). The website, according to the announcement from Lilly , offers an end-to-end digital healthcare experience and will provide patients access to its diabetes, weight loss and migraine medications, among others.
Pharmaceutical Commerce
JANUARY 5, 2024
Trials will evaluate four novel agents for cancers that include essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer.
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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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