Pharmaceutical Technology
MARCH 18, 2024
Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.
Bio Pharma Dive
MARCH 18, 2024
Balancing automated patient support with human touch is key in healthcare. Hybrid models offer a pragmatic path forward, prioritizing patient-centricity.
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Pharmaceutical Technology
MARCH 18, 2024
The US FDA's ODAC has recommended Johnson & Johnson’s CARVYKTI to treat relapsed or refractory multiple myeloma (R/R MM).
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 18, 2024
The hair rising on the back of your neck, the gelid pool in the pit of your stomach, the flutter in your heart when a shadow shifts. Fear can be devastating, sickening, and, strangely, a lot of fun.
Bio Pharma Dive
MARCH 18, 2024
HCPs today want inbound channels for help when they need it. See how you can meet their preferences.
Pharmaceutical Technology
MARCH 18, 2024
In the realm of clinical trials, participant retention is a cornerstone for success, offering robustness to the data collected and ensuring the validity of the trial outcomes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 18, 2024
Using GlobalData’s POLI & HTA database, analysis has been conducted that will provide insight into how the HTA landscape adapted between 2019 and 2023.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 18, 2024
In a move aimed at enhancing compliance and facilitating smoother trade operations, the Directorate General of Foreign Trade (DGFT) has introduced stringent policy conditions for the export of chitin and chitosan derivatives.
Pharmaceutical Technology
MARCH 18, 2024
AdCom voted eight to three in favour of BMS and 2seventy bio’s CAR-T cell therapy, Abecma in triple-class exposed multiple myeloma patients.
Fierce Pharma
MARCH 18, 2024
Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is | Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is prepared to do the same with a larger selloff, according to the consumer healthcare company. Pfizer is set to reduce its stake in Haleon from 32% to 24% by selling 630 million shares in a public offering.
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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
Pharmaceutical Technology
MARCH 18, 2024
The US FDA has granted approval for Optinose’s XHANCE nasal spray for chronic rhinosinusitis without nasal polyps in adult patients.
BioSpace
MARCH 18, 2024
Following in the footsteps of Bristol Myers Squibb and Eli Lilly, AstraZeneca on Tuesday jumped into the radiopharmaceuticals space by acquiring Fusion Pharmaceuticals in a deal worth $2.4 billion.
Pharmaceutical Technology
MARCH 18, 2024
Fennec’s Pedmarqsi/Pedmark is the only approved therapy to treat cisplatin-induced hearing loss in paediatric cancer patients.
BioSpace
MARCH 18, 2024
To help support the launch of Lyfgenia, bluebird bio on Monday entered into a five-year term loan deal with Hercules Capital that will extend the biotech’s cash runway through the first quarter of 2026.
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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 Technology
MARCH 18, 2024
Novartis has broken ground on the expansion of its $256m biopharmaceutical manufacturing facility in Singapore.
BioSpace
MARCH 18, 2024
An appellate court sided with Regeneron versus Novartis on Monday, agreeing that anti-VEGF pre-filled syringes constitute a distinct market than those sold in vials. The case involves Regeneron’s Eylea and Novartis’ Lucentis eye treatments.
Pharmaceutical Technology
MARCH 18, 2024
Tempol is under clinical development by DMK Pharmaceuticals and currently in Phase II for Radiodermatitis.
BioSpace
MARCH 18, 2024
Engrail Therapeutics’ latest financing round will give it enough funds to advance its candidates for neuropsychiatric and neurodevelopmental disorders through clinical development.
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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.
Fierce Pharma
MARCH 18, 2024
Kyowa Kirin’s bet on Orchard Therapeutics has paid off, furnishing the Japanese drugmaker with a newly approved gene therapy in the U.S. | The FDA on Monday gave a thumbs up to Lenmeldy as the first gene therapy in the U.S. for kids with certain types of metachromatic leukodystrophy (MLD).
BioSpace
MARCH 18, 2024
Orchard Therapeutics on Monday secured the FDA’s first approval for an autologous gene therapy to treat the rare metabolic disease metachromatic leukodystrophy in children.
pharmaphorum
MARCH 18, 2024
Discover the top 7 challenges faced by pharmaceutical and life sciences companies in achieving patient-centricity and engaging healthcare professionals (HCPs). Explore strategies to overcome these obstacles for successful outreach efforts.
BioSpace
MARCH 18, 2024
Bayer bagged another late-stage victory for its menopause drug candidate Tuesday, setting up a potential showdown with Astellas’ Veozah which was approved last year by the FDA for the treatment of hot flashes.
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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.
pharmaphorum
MARCH 18, 2024
FDA advisors have said that two BCMA-targeted CAR-T therapies can be used earlier in the treatment pathway for multiple myeloma, setting up FDA approvals for use in a broader patient population.
Pharmaceutical Technology
MARCH 18, 2024
Ulotaront hydrochloride is under clinical development by Sumitomo Pharma America and currently in Phase III for Generalized Anxiety Disorder (GAD).
Fierce Pharma
MARCH 18, 2024
After a quick FDA approval in a subset of endometrial cancer, GSK is back with more data for two Jemperli regimens in hopes of reaching a broader patient population. | After a quick FDA approval in a subset of endometrial cancer, GSK is back with more data for two Jemperli regimens—including one with a PARP drug—in hopes of reaching a broader patient population.
Pharmaceutical Technology
MARCH 18, 2024
Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Humoral Hypercalcemia of Malignancy.
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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.
Fierce Pharma
MARCH 18, 2024
As bluebird bio works to make the most of three gene therapy launches, cash-flow concerns have been looming over the drugmaker. | The funding should extend bluebird bio's cash runway through the first quarter of 2026 as it advances three gene therapy launches. Previously, the company expected its cash to run out by this year's second quarter.
BioSpace
MARCH 18, 2024
The biotech Tuesday reported that 56% of patients taking paltusotine in a late-stage trial achieved the primary endpoint of IGF-1 levels for their rare hormonal disorder. An NDA submission is slated for later this year with a launch anticipated in 2025.
Pharmaceutical Technology
MARCH 18, 2024
Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Post Menopausal Osteoporosis.
BioPharma Reporter
MARCH 18, 2024
Eli Lilly is partnering with ecommerce titan Amazon to deliver its weight loss drug Zepbound straight to patientâs doors, in a bid to address ongoing shortages.
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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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