Bio Pharma Dive
AUGUST 27, 2024
The platform is similar in concept to a service launched this year by Eli Lilly, and aims to give consumers easier access to Pfizer’s migraine, COVID-19 and flu treatments.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 27, 2024
(Thirdman/Pexels) The proverbial “sugar high” that follows the ingestion of a sweet treat is a familiar example of the potentially positive effects of food on mood.
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Pharmaceutical Technology
AUGUST 27, 2024
Unlike its close neighbour Thailand, Singapore has not yet confirmed an mpox clade Ib case.
Bio Pharma Dive
AUGUST 27, 2024
New biotech Navigator is working on drugs for immune diseases. Meanwhile, UCB sold its neurology and allergy business in China, and J&J's Peter Fasolo will retire this year.
Pharmaceutical Technology
AUGUST 27, 2024
Eli Lilly and Novo Nordisk have announced that the supply of their GLP-1 weight loss drugs has improved with increased availability of Zepbound, Mounjaro, Wegovy, and Trulicity.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 27, 2024
In the ever-evolving pharmaceutical landscape, modified release (MR) dosage forms have emerged as a groundbreaking innovation, providing solutions that significantly improve patient compliance by simplifying complex drug regimens.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 27, 2024
The US FDA has granted fast track designation for BeiGene’s BGB-16673 to treat lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL).
Rethinking Clinical Trials
AUGUST 27, 2024
The Pain Management Collaboratory (PMC) will sponsor a series of presentations as part of the VA Spotlight on Pain Management (SoPM) Cyberseminar series, highlighting the accomplishments and future initiatives of the PMC. These webinars will feature early findings, lessons learned, and future directions for research based on the activities of PMC Pragmatic Clinical Trials.
Pharmaceutical Technology
AUGUST 27, 2024
SIFI has received the European Commission approval for AKANTIOR to treat acanthamoeba keratitis (AK), a rare and severe corneal infection.
Fierce Pharma
AUGUST 27, 2024
For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of federal agencies. | In June, when the Supreme Court voted 6-3 to overturn the Chevron doctrine, it brought significant impact for the healthcare industry and federal regulators like the FDA and the Centers for Medicare & Medicaid Services.
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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
AUGUST 27, 2024
The EC has granted approval to Roche’s PiaSky for the treatment of paroxysmal nocturnal haemoglobinuria in adult and adolescent patients.
Fierce Pharma
AUGUST 27, 2024
Eli Lilly has come up with a new way of supplying its popular weight-loss drug Zepbound that the company hopes could expand access while addressing other issues such as high prices and off-label co | Eli Lilly is offering its popular weight-loss drug Zepbound directly to consumers at a discount through its own online pharmacy. The company hopes the move could expand access while addressing other issues such as high prices and off-label cosmetic usage.
Pharmaceutical Technology
AUGUST 27, 2024
UCB has entered a divestment agreement in China to sell its mature neurology and allergy business to CBC Group and Mubadala for $680m.
BioPharma Reporter
AUGUST 27, 2024
Microbiotica has received the green light from EU and UK regulatory authorities to start phase 1b studies for its microbiome medicines in advanced melanoma and ulcerative colitis.
Pharmaceutical Technology
AUGUST 27, 2024
Rybrevant has been granted a Type II approval extension to treat NSCLC with EGFR mutations following the failure of TKI therapy.
pharmaphorum
AUGUST 27, 2024
Pfizer has become the latest big pharma group to launch a web-based platform that opens up a direct-to-consumer channel for medicines access.This morning, the company announced the launch in the US of PfizerForAll, a digital platform that it says provides access to same-day appointments with healthcare professionals – in-person or via a $35 telehealth visit – along with home delivery of medicines and diagnostics, vaccination appointments, and payment support.
Pharmaceutical Technology
AUGUST 27, 2024
OUD is a chronic neurological disorder described as the consequences associated with repeated, compulsive use of opioid drugs.
pharmaphorum
AUGUST 27, 2024
Roche's PiaSky is the first therapy for rare blood disorder PNH that can be given by monthly subcutaneous injection in the EU.
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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.
Pharmaceutical Technology
AUGUST 27, 2024
Declared a PHEIC by the WHO, an mpox outbreak in the DRC is posing a threat to human health.
pharmaphorum
AUGUST 27, 2024
Regeneron's Ordspono (odronextamab) for non-Hodgin lymphoma (NHL) is cleared in EU five months after being turned down by the FDA
Pharma Times
AUGUST 27, 2024
Over 135,000 people have signed a petition to prioritise a national screening programme
pharmaphorum
AUGUST 27, 2024
J&J's Balversa has been approved in the EU for advanced bladder cancer with FGFR3 genetic alterations after one line of prior therapy
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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
AUGUST 27, 2024
The agency provides an update surrounding the Act’s implementation efforts.
pharmaphorum
AUGUST 27, 2024
US biotech MBX Biosciences, files for an IPO, seeking around $100 million to take a hypoparathyroidism candidate into phase 3
Pharma Times
AUGUST 27, 2024
The spread of multiple bacteria could be tracked simultaneously through sequencing method
FDA Law Blog
AUGUST 27, 2024
The American Conference Institute (“ACI”) will hold (virtually) its 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA from October 8-24, 2024. This virtual three-week program is designed to give new lawyers and executives a solid foundation in the essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation.
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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
AUGUST 27, 2024
The pharmaceutical industry has witnessed significant advancements in recent years, particularly in the realm of advanced manufacturing technologies (AMTs). These innovations aim to enhance drug quality, efficiency, and customization. Despite their potential, the adoption of AMTs in generic drug manufacturing has been slow, mainly due to high upfront investment costs and regulatory barriers.
Drug Discovery World
AUGUST 27, 2024
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. It’s been a busy week for medical regulatory agencies, with a number of key decisions made on therapies for graft-versus-host-disease, neuroendocrine carcinoma, haemophilia B, lymphoma and non-small cell lung cancer.
Outsourcing Pharma
AUGUST 27, 2024
The INNA-051 formulation is designed to enhance the bodyâs natural immune response, targeting individuals aged 60 and over who are at increased risk for complications from respiratory viral infections.
Drug Discovery World
AUGUST 27, 2024
In the Global Biopharma Sustainability Review by Cytiva, more than 800 pharma and biopharma professionals articulated the benefits of meeting sustainability targets – and the risks of not clearly measuring progress on those targets. The research includes insights from executives in 18 countries. Sustainability is rising to the top of the global agenda as regulations are evolving and investors, customers, and talent demand more transparency from companies on the topic. 62% of respondents identifi
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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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