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
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 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
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.
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
Rgenta has secured approval for its IND application for RGT-61159, an oral small molecule RNA modulator, to treat cancers.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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.
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 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.
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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.
BioSpace
JULY 11, 2024
In its second antibody-drug conjugate licensing agreement this year, Ipsen has secured exclusive rights to Foreseen Biotechnology’s FS001, which targets a novel antigen expressed across a range of solid tumors.
Pharmaceutical Technology
JULY 11, 2024
AusperBio Therapeutics and Ausper Biopharma have received breakthrough therapy designation in China for AHB-137 for CHB.
XTalks
JULY 11, 2024
The electrolyte beverage market is rapidly growing in 2024, driven by consumer demand for functional drinks. Electrolytes are minerals like sodium, potassium and magnesium that are essential for various bodily functions, including hydration, muscle function and nerve signaling. As more people recognize the benefits of these nutrients, the popularity of electrolyte beverages has surged.
Pharmaceutical Technology
JULY 11, 2024
Boehringer Ingelheim’s For Generations framework is all in on sustainability for the long term across the ESG spectrum.
Drug Discovery World
JULY 11, 2024
Evotec and Pfizer have entered into a multi-year research collaboration, initially focused on early discovery research for metabolic and infectious diseases. The research will be carried out at Evotec’s sites in France, including Campus Curie in Toulouse with capabilities spanning high throughput screening, in vitro and in vivo biology, proteomics and metabolomics.
Pharmaceutical Technology
JULY 11, 2024
The deal strengthens Merz’s market position in Parkinson’s disease whilst expanding into the multiple sclerosis sector.
Outsourcing Pharma
JULY 11, 2024
Ketaki Patwardhan, a global technical developer at Roquette, has built a remarkable career in the pharmaceutical industry by leveraging her curiosity and passion for science.
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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
Boehringer Ingelheim’s For Generations framework is all in on sustainability for the long term across the ESG spectrum.
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.
Pharmaceutical Technology
JULY 11, 2024
PharmassêtX has received FDA orphan drug designation for epigallocatechin gallate (EGCG), to treat a rare form of IBD.
Drug Patent Watch
JULY 11, 2024
The value proposition of Contract Development and Manufacturing Organizations (CDMOs) has become increasingly crucial in the pharmaceutical industry.
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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
JULY 11, 2024
J&J gains Phase II ready NM26, a bispecific antibody in development for the treatment of atopic dermatitis.
BioSpace
JULY 11, 2024
Kazia Therapeutics is eyeing an FDA accelerated approval pathway for its investigational glioblastoma drug paxalisib, with Wednesday’s release of secondary overall survival data from a Phase II/III trial.
Pharmaceutical Technology
JULY 11, 2024
Research suggests biomanufacturing specialists remain nervy about global supply chain resilience.
BioPharma Reporter
JULY 11, 2024
Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.
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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.
Outsourcing Pharma
JULY 11, 2024
In an exclusive interview, Akash Bakshi, CEO of YourChoice Therapeutics, delves into the inspiration and journey behind developing a hormone-free birth control pill for men.
Pharma Times
JULY 11, 2024
Macmillan Cancer Support estimates that cancer affects over three million people in the UK
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.
Drug Patent Watch
JULY 11, 2024
In the high-stakes world of biosimilar development, manufacturers are increasingly turning to an unexpected partner: the Patent Trial and Appeal […] Source
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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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