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.

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Trials Clinical Trials Clinical Trials Medicine 182

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.

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Insulin Drugs Clinical Trials Clinical Trials 234

Bio Pharma Dive

JULY 9, 2024

The company has begun searching for a successor to Dolsten, who oversaw more than 35 drug and vaccine approvals but also some notable setbacks during his time as Pfizer’s top scientist.

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Scientist Research Vaccination Vaccine 300

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.

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Development Clinical Development 264

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Fierce Pharma

JULY 11, 2024

Even as pharma companies have yet to feel the full effects of the Inflation Reduction Act, Senate lawmakers have turned their attention to another facet of drug pricing with a bill meant to cr | The bill looks to limit the number of patents that companies can assert in litigation on individual products. It's intended to crack down on "patent thickets," which can delay and thwart generic competition.

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Pharma Companies Production Drugs 139

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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Scientist Clinical Trials Clinical Trials Clinical Research 209

Pharmaceutical Technology

JULY 12, 2024

The subcutaneous formulation of Roche’s blockbuster Ocrevus will cut hospital treatment time for patients.

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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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Production Trials 136

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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Drugs Manufacturing Clinical Trials Clinical Trials 198

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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Medicine Drugs 294

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Clinical Supply

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.

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Clinical Trials Clinical Trials Trials 246

Fierce Pharma

JULY 10, 2024

It’s well known that obesity drugs from Novo Nordisk and Eli Lilly are on a high-flying growth trajectory that doesn’t look to be letting up anytime soon. | Novo Nordisk's Ozempic is slated to take over No.1, while Merck's Keytruda falls to No.9 on Evaluate's predicted rankings of top drugs by 2030 sales.

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Drugs Sales 129

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” […]

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Clinical Trials Clinical Trials Clinical Research Trials 183

Bio Pharma Dive

JULY 8, 2024

Acquiring Apeiron will hand Ligand rights to royalties on sales of the neuroblastoma drug Qarziba. Elsewhere, Aerovate said it’s considering strategic alternatives and CSL reported a notable milestone.

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Sales Drugs 265

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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

Clinical Trials

Pharmaceutical Technology

JULY 10, 2024

Almirall’s Ebglyss is predicted to hit blockbuster status in two years in the crowded atopic dermatitis market.

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Marketing 264

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.

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Development 125

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.

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Research Clinical Trials Clinical Trials Clinical Research 173

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.

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Containment Development 286

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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.

Clinical Trials

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.

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Medicine 256

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.

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Trials Medicine Drugs 123

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.

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Medicine Pharmacy Research Clinical Trials 163

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.

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Regulation Development 272

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.

Clinical Research

Pharmaceutical Technology

JULY 12, 2024

Ipsen has entered an exclusive global licensing agreement with Foreseen Biotech for FS001, a potentially first-in-class ADC.

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Licensing Licensing 246

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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Pharma Companies Medicine Drugs 120

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 8, 2024

Do you find that you daydream a lot? Are you often sluggish and tend to disengage easily when doing a task? You might have cognitive disengagement syndrome, or CDS.CDS was first described by psychologists in the 1960s and 1970s when they noticed that some people display these traits more persistently than others.

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Clinical Trials Clinical Trials Clinical Research Trials 147

Bio Pharma Dive

JULY 12, 2024

Patent litigation has opened the door to generic copies of Bristol Myers’ Sprycel arriving in the U.S. as soon as September.

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Clinical Supply

Pharmaceutical Technology

JULY 10, 2024

Evotec and Pfizer have entered a multi-year partnership that will focus initially on early discovery research.

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Drugs Research 246

pharmaphorum

JULY 10, 2024

Learn how to successfully transition pilots into production with GenAI in the pharmaceutical industry. Discover strategies to create, scale, and achieve success with this innovative technology.

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Production 119

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.

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FDA Approval Marketing Antibody 121

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.

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Vaccination Vaccine Trials 269

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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.

Clinical Trials