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 14, 2024
A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection. The trial tested whether the six-month injection of lenacapavir would provide better protection against HIV infection than two other drugs, both daily pills.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 10, 2024
A class of diabetes medications, which include the best-selling drug Ozempic, are associated with a reduced risk of certain obesity-related cancers, according to a study released Friday.
Pharmaceutical Technology
JULY 12, 2024
The subcutaneous formulation of Roche’s blockbuster Ocrevus will cut hospital treatment time for patients.
Rethinking Clinical Trials
JULY 10, 2024
Dr. Miguel Hernán In this Friday’s PCT Grand Rounds, Miguel Hernán of Harvard University will present “Causal Estimands: Should We Ask Different Causal Questions in Randomized Trials and in the Observational Studies That Emulate Them?” The Grand Rounds session will be held on Friday, July 12, 2024, at 1:00 pm eastern. Hernán is the Kolokotrones Professor of Biostatistics and Epidemiology and the director of the CAUSALab at Harvard T.H.
BioSpace
JULY 10, 2024
Investment in the development of new antimicrobials is falling rapidly, even as the global public health threat of antimicrobial resistance is growing increasingly severe worldwide.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 8, 2024
Myricx Bio has secured £90m ($114m) in its Series A financing round to propel its NMTi-ADC therapeutics into the clinical development stage.
Fierce Pharma
JULY 12, 2024
Trials have already shown that Novo Nordisk’s semaglutide | Trials have already shown that Novo Nordisk’s semaglutide can cut the risk of cardiovascular events and kidney disease. Now a study from the University of Oxford indicates that the company’s semaglutide type 2 diabetes drug Ozempic can reduce the risk of dementia compared with another popular diabetes medicine.
BioSpace
JULY 12, 2024
The Senate on Thursday unanimously passed a bill aimed at limiting the number of patents drugmakers can introduce and making it easier for generic and biosimilar competitors to enter the market.
Bio Pharma Dive
JULY 8, 2024
The deal would hand Lilly an experimental pill that could one day rival Takeda's blockbuster medicine Entyvio as a treatment for inflammatory bowel disease.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 9, 2024
The World Health Organization‘s cancer agency on Friday classified talc as “probably carcinogenic” for humans, however an outside expert warned against misinterpreting the announcement as a “smoking gun” The decision was based on “limited evidence” talc could cause ovarian cancer in humans, “sufficient evidence” it was linked to cancer in rats and “strong mechanistic evidence” […]
Pharmaceutical Technology
JULY 12, 2024
Ipsen has entered an exclusive global licensing agreement with Foreseen Biotech for FS001, a potentially first-in-class ADC.
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.
Fierce Pharma
JULY 8, 2024
Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? | Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? While a head-to-head trial pitting the two treatments remains ongoing, new evidence shows that Lilly’s tirzepatide may be the superior weight loss product.
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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.
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.
Pharmaceutical Technology
JULY 10, 2024
Almirall’s Ebglyss is predicted to hit blockbuster status in two years in the crowded atopic dermatitis market.
BioSpace
JULY 9, 2024
Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
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.
Bio Pharma Dive
JULY 8, 2024
Myricx Bio is developing a type of payload that it thinks could work in tumors resistant to the toxins contained in ADCs like Enhertu and Trodelvy.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 10, 2024
By focusing on clinical excellence, comprehensive education, and cutting-edge research, the Arya Vaidya Pharmacy Research Foundation (AVPRF) based in Coimbatore is ensuring that ayurvedic practices are validated, credible, and relevant for future generations. This holistic approach not only enhances the field of Ayurveda but also promises better health outcomes for patients worldwide, says Dr.
Pharmaceutical Technology
JULY 8, 2024
Morphic’s lead asset MORF-057 is being investigated in three IBD clinical trials, with data in ulcerative colitis expected next year.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
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.
Fierce Pharma
JULY 12, 2024
Several challenges across Bristol Myers Squibb’s business have Leerink Partners analysts worried about the future—despite a few promising growth opportunities the team has identified. | Several challenges across Bristol Myers Squibb’s business have Leerink Partners analysts worried about the drugmaker—despite a few promising growth opportunities they identified.
Bio Pharma Dive
JULY 8, 2024
Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 8, 2024
The National Institutes of Pharmaceutical Education and Research (NIPERs) need to establish more comprehensive ecosystem that includes mentorship, support for incubation, funding methods, and industrial alliances to promote entrepreneurship in the pharmaceutical sector, which can also substantially help these institutes to foster self-reliance, according to a study.
Pharmaceutical Technology
JULY 8, 2024
GSK and MMV have announced the launch of tafenoquine to prevent the relapse of P. vivax malaria in Brazil and Thailand.
BioSpace
JULY 10, 2024
Preliminary data from a late-stage trial of Alnylam’s RNAi therapy for ATTR amyloidosis with cardiomyopathy appear strong, but details expected later this summer are critical.
pharmaphorum
JULY 12, 2024
Pfizer is advancing on a broad front in its attempt to catch up with Novo Nordisk and Eli Lilly in the obesity drug category – but has now decided on a lead candidate.The company said that, based on a pharmacokinetic study, it has plumped for a once-daily, modified-release formulation of GLP-1 agonist danuglipron that will start dose optimisation studies later this year.
Bio Pharma Dive
JULY 10, 2024
Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.
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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.
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