Pharmaceutical Technology
SEPTEMBER 24, 2024
Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.
Bio Pharma Dive
SEPTEMBER 24, 2024
CEO Lars Fruergaard Jørgensen told lawmakers the company would consider new talks with insurers about the list prices of Wegovy and Ozempic if they pledge to keep the medicines on their formularies.
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Rethinking Clinical Trials
SEPTEMBER 24, 2024
In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system. The review was published online ahead of print in the Journal of Integrative and Complementary Medicine. Acupuncture is widely practiced in the United States and has been shown to be effective in multiple clinical applications for a variety of conditions.
Pharmaceutical Technology
SEPTEMBER 24, 2024
The EMA CHMP has recommended granting approval for AstraZeneca’s Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA).
Bio Pharma Dive
SEPTEMBER 24, 2024
Metsera revealed Phase 1 data it claims could support a weight-loss medicine that's administered monthly. Elsewhere, Sanofi invested in a struggling biotech and shares of two Duchenne drug developers climbed.
Pharmaceutical Technology
SEPTEMBER 24, 2024
The EC has granted marketing authorisation to LEO Pharma’s Anzupgo cream for treating adults with moderate to severe chronic hand eczema.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 24, 2024
Telix has paid an upfront cost of $230m to acquire 31 licenced radiopharmacies from RLS located across the US.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 24, 2024
(Wang et al., Small, 2024) Swarms of spherical nanobots barely larger than a virus could one day save hundreds of thousands of lives globally each year by staunching deadly bleeds in the brain.
Pharmaceutical Technology
SEPTEMBER 24, 2024
Discover the leading Pharmaceutical Packaging Companies, Suppliers & Solutions. Download the free Buyer's Guide today for full details.
Bio Pharma Dive
SEPTEMBER 24, 2024
In an interview with PharmaVoice, Alicia Zhou, the new head of the nonprofit Cancer Research Institute, expressed a desire to foster deeper partnerships between scientists and the pharmaceutical industry.
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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
SEPTEMBER 24, 2024
Iterum Therapeutics faces a mixed reception for its therapy for uncomplicated urinary tract infections (UTIs) as experts raise concerns about antibiotic resistance.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 24, 2024
India’s healthcare system has implemented a robust strategy to handle potential Mpox outbreaks. With 35 equipped laboratories nationwide, enhanced surveillance measures, and a comprehensive plan from the National Centre for Disease Control, the country is prepared for early detection and response. State-level authorities are actively raising awareness and establishing isolation facilities.
Pharmaceutical Technology
SEPTEMBER 24, 2024
Discover the leading Pharmaceutical Wastewater Treatment and Water Purification Systems, Suppliers & Solutions. Download for free today.
Rethinking Clinical Trials
SEPTEMBER 24, 2024
Speaker Fatima N. Mirza, MD, MPH Chief Resident Department of Dermatology Warren Alpert Medical School of Brown University Slides Keywords Artificial Intelligence; ChatGPT; Informed Consent Key Points Artificial Intelligence (AI), when implemented thoughtfully in clinical settings, can lead to meaningful results for patients.
Pharmaceutical Technology
SEPTEMBER 24, 2024
Takeda has secured the Japanese MHLW approval for its FRUZAQLA to treat unresectable advanced or recurrent colorectal cancer (CRC).
Fierce Pharma
SEPTEMBER 24, 2024
With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain. | Vertex has inked a long-term supply agreement with Swiss CDMO Lonza to crank out global commercial supply of Casgevy. Under the deal, Lonza will produce Casgevy from its cell therapy manufacturing facilities in Geleen in the Netherlands and, eventually, its plant in Portsmouth, New Hampshire.
Pharmaceutical Technology
SEPTEMBER 24, 2024
UCB has received US FDA approval for BIMZELX (bimekizumab-bkzx) to treat adults with three inflammatory conditions.
pharmaphorum
SEPTEMBER 24, 2024
After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagille syndrome (ALGS).Kayfanda (odevixibat) is labeled in the EU to treat cholestatic pruritus – itching caused by impaired bile formation or flow – in children aged six months and over with ALGS, a disease caused by a genetic mutation that leads to liver damage and jaundice.
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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
SEPTEMBER 24, 2024
After circling Novo Nordisk and its high GLP-1 drug prices for months, Sen. | Ahead of a hearing on Ozempic and Wegovy prices, prepared remarks from Novo CEO Lars Fruergaard Jørgensen shine a light on the larger U.S. healthcare system.
Outsourcing Pharma
SEPTEMBER 24, 2024
The small molecule drug arimoclomol (Miplyffa) has got the green light from the U.S. Food and Drug Administration (FDA) for the treatment of the rare disease Niemann-Pick disease type C (NPC), which until now has lacked FDA-approved therapies.
Fierce Pharma
SEPTEMBER 24, 2024
After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%. | After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%, or nearly 100 employees.
pharmaphorum
SEPTEMBER 24, 2024
Roche launches 12 in one test for respiratory virus, using its 'revolutionary' TAGS tech, that can be used in regular clinical labs
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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
Outsourcing Pharma
SEPTEMBER 24, 2024
The US biotechâs neurological drug candidate showed a reduction in disease progression of at least 50% and the company will now file with the FDA.
pharmaphorum
SEPTEMBER 24, 2024
Discover how the Within3 Insights Management Platform can support smart decision-making with its innovative features and capabilities. Learn more about this powerful solution spotlight.
Fierce Pharma
SEPTEMBER 24, 2024
Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for blockbuster eye disease drug Eylea, the same judge has rejected the c | Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for blockbuster eye disease drug Eylea, the same judge has rejected the company’s attempt to block Amgen’s Eylea biosimilar.
pharmaphorum
SEPTEMBER 24, 2024
UCB and Biogen say their first phase 3 trial of their systemic lupus erythematosus (SLE) candidate dapirolizumab pegol was a success, and a second is now expected to start before the end of the year.Data from the PHOENYCS GO study in moderate to severe SLE patients isn't available yet, but the partners say dapirolizumab pegol achieved a "clinical improvement" in the primary and secondary endpoints, including measures of disease activity and flares.
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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
SEPTEMBER 24, 2024
Flush with new business, Philadelphia-based CDMO PCI Pharma Services is blueprinting multiple manufacturing outlays on both sides of the Atlantic. | PCI has “heavily invested” in new drug delivery tech at its Philadelphia headquarters, laid plans for a 545,000-square-foot expansion in Rockford, Illinois, acquired a new packaging and device assembly plant near Dublin, Ireland, and broken ground on another at its CityNorth Dublin campus.
BioPharma Reporter
SEPTEMBER 24, 2024
UCB and Biogen revealed that their Phase 3 study testing dapirolizumab pegol in people with systemic lupus erythematosus met the primary and secondary endpoints.
Fierce Pharma
SEPTEMBER 24, 2024
The FDA is having second thoughts about the broad labels it has granted PD-1 inhibitors in newly diagnosed stomach cancer, questioning whether restrictions should be placed on products from Bristol | The FDA is having second thoughts about the broad labels it has granted PD-1 inhibitors in newly diagnosed stomach cancer, questioning whether restrictions should be placed on products from Bristol Myers Squibb, Merck & Co. and BeiGene.
pharmaphorum
SEPTEMBER 24, 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory pilot.
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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.
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