Bio Pharma Dive
JULY 11, 2024
Far behind companies like Novo and Eli Lilly, Pfizer hopes the version of the drug, danuglipron, that it’s chosen to advance can break into the ultra-lucrative market for weight-loss medicines.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 11, 2024
White could be the new beige when it comes to fat cells, following the discovery of a switch that maintains the functions of adipose tissue in mice, transforming it from a lipid-locker into a calorie-burner.
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Bio Pharma Dive
JULY 11, 2024
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 11, 2024
The Central Drugs Standard Control Organisation (CDSCO) has released guidance for the companies to attain export No Objection Certificate (NOC) for manufacture of unapproved, banned or new drugs, a process which was centralised recently.
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Bio Pharma Dive
JULY 11, 2024
The FDA’s decision to turn back the drugmaker’s new insulin product narrows Novo’s lead in the U.S. over Eli Lilly, which has a similar diabetes treatment in late-stage testing.
Pharmaceutical Technology
JULY 11, 2024
PharmassêtX has received FDA orphan drug designation for epigallocatechin gallate (EGCG), to treat a rare form of IBD.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 11, 2024
Rgenta has secured approval for its IND application for RGT-61159, an oral small molecule RNA modulator, to treat cancers.
Pharma Times
JULY 11, 2024
Macmillan Cancer Support estimates that cancer affects over three million people in the UK
Pharmaceutical Technology
JULY 11, 2024
J&J gains Phase II ready NM26, a bispecific antibody in development for the treatment of atopic dermatitis.
Fierce Pharma
JULY 11, 2024
Following this month's FDA approval of Eli Lilly’s amyloid-busting antibody Kisunla (donanemab), the Alzheimer’s disease market is set to grow in earnest—and Lilly is already eyeing a spot at the t | On top of Eisai and Biogen's Leqembi, Kisunla’s approval likely marks the “end of the beginning in treating this disease,” Andrew Lechleiter, VP of U.S.
Pharmaceutical Technology
JULY 11, 2024
Boehringer Ingelheim’s For Generations framework is all in on sustainability for the long term across the ESG spectrum.
pharmaphorum
JULY 11, 2024
The FTC is said to be gearing up to file lawsuits against the top three pharmacy benefit managers in the wake of its damning report on the sector.
Pharmaceutical Technology
JULY 11, 2024
The company did not expect to resolve concerns related to manufacturing and the safety profile for type 1 diabetes by the end of the year.
pharmaphorum
JULY 11, 2024
The US Senate has come together to pass a bill that aims to prevent pharma companies from filing multiple patents around biologic drugs as a way to delay biosimilar competitors.Lawmakers unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150), which is part of a lengthening list of measures being taken by Congress to curb the prices of medicines in the US.
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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
JULY 11, 2024
Novo Nordisk-partnered Aspect develops bioprinted tissue therapeutics designed to replace or support specific biological functions.
pharmaphorum
JULY 11, 2024
SK Life Science Leverages Smart, Efficient Solutions Across its Engaged Industry-Leading Sales Team Mike.
Pharmaceutical Technology
JULY 11, 2024
The deal strengthens Merz’s market position in Parkinson’s disease whilst expanding into the multiple sclerosis sector.
Pharma Times
JULY 11, 2024
The ESRC EquaDem Network Plus aims to improve disparities in diagnosis and care
Pharmaceutical Technology
JULY 11, 2024
Research suggests biomanufacturing specialists remain nervy about global supply chain resilience.
pharmaphorum
JULY 11, 2024
The rise of GenAI is revolutionising the field of pharma medical writing in biopharma. Explore how this innovative technology is transforming the industry and its impact on medical writing practices.
Pharmaceutical Technology
JULY 11, 2024
AusperBio Therapeutics and Ausper Biopharma have received breakthrough therapy designation in China for AHB-137 for CHB.
pharmaphorum
JULY 11, 2024
Tune in to Caroline Redecker and Jason Casarella as they discuss clinical trial trends and the rise of site networks in this insightful podcast episode brought to you by Advanced Clinical.
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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
JULY 11, 2024
BioArctic has announced that its partner, Eisai has approval from Hong Kong's Department of Health for Leqembi for the treatment of AD.
Fierce Pharma
JULY 11, 2024
In surging to the top spot in the market cap rankings in Europe, Novo Nordisk has been on an extended winning streak. | The FDA has slowed the roll for Novo Nordisk, rejecting its once-a-week insulin icodec for patients with Type 1 and Type 2 diabetes. In a complete response letter, the U.S. regulator made "requests related to the manufacturing process and the type 1 diabetes indication," which the company said it does not expect to remedy by the end of this year.
Antidote
JULY 11, 2024
When determining which clinical trial is the right fit , many factors must be considered. The site location, the number of required visits, and the length of the study are all important considerations, but before any of this, it is vital to consider the study's inclusion and exclusion criteria.
Fierce Pharma
JULY 11, 2024
After a rocky road to approval and two amendments to the original pact, Akebia Therapeutics and CSL Vifor have terminated their collaboration around the oral chronic kidney disease (CKD) anemia dru | As it ends a licensing agreement with CSL Vifor, Akebia has priced its chronic kidney disease anemia drug Vafseo by incorporating an uncertain future label expansion that it plans to discuss with the FDA later this year.
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pharmaphorum
JULY 11, 2024
FDA rejects Novo Nordisk’s once-weekly basal insulin for people with diabetes, which would reduce the number of injections needed
Fierce Pharma
JULY 11, 2024
Freshly equipped with two approved meds from Acorda Therapeutics, Frankfurt, Germany’s Merz Therapeutics is kicking its specialty neurology ambitions into high gear. | Equipped with two approved meds from Acorda Therapeutics, Germany’s Merz Therapeutics is kicking its specialty neurology ambitions into high gear.
Drug Patent Watch
JULY 11, 2024
The value proposition of Contract Development and Manufacturing Organizations (CDMOs) has become increasingly crucial in the pharmaceutical industry.
Fierce Pharma
JULY 11, 2024
AbbVie is asking the U.S. | AbbVie is asking the U.S. Supreme Court to overrule a lower court's ruling that the company must turn over records of communications with its lawyers regarding a patent lawsuit it filed against a generic drug maker more than a decade ago.
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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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