Drug Patent Watch
NOVEMBER 18, 2024
The pharmaceutical industry is undergoing a significant shift, with emerging markets offering the next growth opportunity. This growth is driven by several factors, including the increasing prevalence of chronic diseases, cost-effectiveness, and patent expirations of branded drugs.
Bio Pharma Dive
NOVEMBER 18, 2024
The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.
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Pharmaceutical Technology
NOVEMBER 18, 2024
The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.
Bio Pharma Dive
NOVEMBER 18, 2024
Phase 1 data indicate Intellia’s medicine could be a powerful treatment for a cardiac form of ATTR amyloidosis. But rival drugs are further ahead.
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Pharmaceutical Technology
NOVEMBER 18, 2024
During AHA 2024, data were presented from the Phase III trial of plozasiran targeting adults with genetically or clinically diagnosed FCS,
Bio Pharma Dive
NOVEMBER 18, 2024
Explore solutions to reduce variability in gene expression during cell line development.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 18, 2024
In a move to streamline its growing intellectual property (IP) management needs, the Indian Council of Medical Research (ICMR) has issued an Expression of Interest (EOI) for the procurement of an online intellectual property management software. Technical proposals must be submitted by November 22, 2024, by 9:00 am.
Pharmaceutical Technology
NOVEMBER 18, 2024
The US FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for treating acute leukaemia with KMT2A translocation.
Bio Pharma Dive
NOVEMBER 18, 2024
Revuforj is the first so-called menin inhibitor cleared in the U.S., securing FDA approval for use in adults and certain pediatric patients with an aggressive form of acute leukemia.
Pharmaceutical Technology
NOVEMBER 18, 2024
Intellia presented data from its Phase I study of NTLA-2001 at the 2024 American Heart Association scientific meeting in Chicago.
Bio Pharma Dive
NOVEMBER 18, 2024
Learn how the optimal NGS solution can help you hit your milestones during clinical trials, throughout CDx development and into global commercialization.
Pharmaceutical Technology
NOVEMBER 18, 2024
AstraZeneca will advance preclinical and clinical development of the Type 1 Diabetes cell therapy candidate.
Fierce Pharma
NOVEMBER 18, 2024
Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr. may not rock the boat as much as feared for the biopharma industry.
Pharmaceutical Technology
NOVEMBER 18, 2024
At AHA 2024, clinical trial results were presented from the ongoing open-label extension trial, LIBERATE-OLE, involving lerodalciep.
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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
Fierce Pharma
NOVEMBER 18, 2024
The scope of Gilead Sciences' recent round of layoffs is coming into clearer view with the revelation that the company is planning more than 100 cuts at its corporate headquarters. | The scope of Gilead Sciences' recent round of layoffs is coming into clearer view with the revelation that the company is planning more than 100 cuts at its corporate headquarters.
Pharmaceutical Technology
NOVEMBER 18, 2024
The EMA's CHMP has recommended approval of a combination therapy of BMS's Opdivo and Yervoy for the treatment of colorectal cancer.
pharmaphorum
NOVEMBER 18, 2024
Using AI-powered PanEcho software for screening ECGs could deliver results more quickly and allow treatment to be started earlier.
Pharma Times
NOVEMBER 18, 2024
The companies will focus on mechanisms of action, dose selection and biomarker analyses
pharmaphorum
NOVEMBER 18, 2024
Private equity company Brookfield has reportedly moved closer to taking control of Grifols, after months of disruption at the Spanish pharma company.A report in Spanish newspaper El Confidencial suggests that Brookfield is preparing to make a bid to take a 65% controlling stake in the drugmaker for €10.50 per share, worth around €7 billion ($7.4 billion).
Fierce Pharma
NOVEMBER 18, 2024
With several high-profile manufacturing outlays already in the books in Europe this year, Sanofi is returning to the bloc in a bid to boost production for a long-approved transplant treatment and a | Sanofi has unveiled a 40 million euro investment at its Lyon Gerland biomanufacturing site in France. The cash infusion will help bolster local production of the company’s polyclonal antibody Thymoglubulin for kidney transplant rejection, as well as expected future capacity needs for the type 1 diab
pharmaphorum
NOVEMBER 18, 2024
Neurogene has halted patient enrolment in the high-dose arm of its trial of Rett syndrome gene therapy, sparking another run on its shares
Fierce Pharma
NOVEMBER 18, 2024
In the wake of a market pull in obesity nearly five years ago, the other shoe has dropped for Eisai’s serotonin 2C receptor agonist lorcaserin. | Eisai has terminated a phase 3 study of lorcaserin as a potential adjunct treatment for patients with Dravet syndrome, a rare form of epilepsy that starts in infancy. The company is also shutting down an extended access program in which patients were able to access the medication off-label.
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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
NOVEMBER 18, 2024
Shortly after a disappointing trial readout for Syndax's menin inhibitor Revuforj in one form of leukaemia, the company has claimed FDA approval in another
Outsourcing Pharma
NOVEMBER 18, 2024
Genesis also announced a further investment from NVentures, NVIDIA’s venture capital arm.
pharmaphorum
NOVEMBER 18, 2024
Eli Lilly's tirzepatide has been shown to significantly cut cardiovascular risks in patients with obesity and a form of heart failure with few treatment options, in another big win for the GLP-1 receptor agonist class.The results from the SUMMIT trial of tirzepatide in obese patients with heart failure with preserved ejection fraction (HFpEF) showed that Lilly's drug cut the risk of cardiovascular mortality and worsening heart failure events by 38% over a median follow-up of roughly two years.
Fierce Pharma
NOVEMBER 18, 2024
Months after filing for bankruptcy, VBI Vaccines is taking the next step in shuttering operations with the voluntarily withdrawal of its hepatitis B vaccine, PreHevbrio. | The company initiated a voluntary recall of its sole commercial product, 2021-approved PreHevbrio, after filing for Chapter 15 bankruptcy earlier this year.
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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
pharmaphorum
NOVEMBER 18, 2024
AbbVie's Elahere is approved in EU, ending a 10-year wait for a new therapy for platinum-resistant ovarian cancer.
Drug Patent Watch
NOVEMBER 18, 2024
EVZIO (naloxone hydrochloride) Kaleo inc Patent: 9,737,669 Expiration: Nov 23, 2024 See More … Source
Crucial Data Soutions
NOVEMBER 18, 2024
Let’s be real: managing clinical trials is tough enough without juggling multiple disconnected systems. Yet for many research teams, that’s. The post Maximizing Site Performance: The Hidden Benefits of Unified eConsent and EDC appeared first on Crucial Data Solutions.
Pharmaceutical Commerce
NOVEMBER 18, 2024
The latest news for pharma industry insiders.
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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.
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