Trending Articles

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Gritstone to lay off 40% of workforce after costly study delay

Bio Pharma Dive

The restructuring comes ahead of a key study readout for Gritstone, which, like Moderna, is developing a type of personalized vaccine for cancer.

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Beacon Therapeutics unveils promising interim results for gene therapy AGTC-501

Pharmaceutical Technology

AGTC-501 is in Phase II development for retinitis in the SKYLINE trial (NCT03316560) and addresses unmet needs within the retinitis space

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Viking data suggest obesity drug could rival Zepbound, Wegovy

Bio Pharma Dive

The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.

Drugs 300
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California Man Free of HIV And Cancer in Astonishing Medical Recovery

AuroBlog - Aurous Healthcare Clinical Trials blog

On the list of illnesses that nobody wants, cancer and HIV both rank pretty high, and Californian man Paul Edmonds had both. But ever since one particular treatment five years ago, he’s been free of both cancer and HIV.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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February 28, 2024: A Randomized Trial of a Food-as-Medicine Program, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern. Doyle is the Erwin H.

Medicine 147
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Insights from Industry Experts: Examining the Patient Experience in Clinical Trial Design

Worldwide Clinical Trials

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success. It plays a significant role in patient recruitment and retention, both of which are vital to maintaining timelines, decreasing program costs, and gaining market approval.

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Microplastics Found in Every Human Placenta Tested, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s been over three years since scientists first found microplastics swimming in four different human placentas, and as it turns out, that was just the tip of the iceberg. A few years later, at the start of 2023, researchers announced they had found microscopic particles of plastic waste in no fewer than 17 different placentas.

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With Sanofi left as the lone supplier of tetanus shots in the US, CDC warns of shortage

Fierce Pharma

It’s time to add another vaccine to the shortage list in the U.S. | It’s time to add another vaccine to the shortage list in the United States as the CDC has urged healthcare providers to conserve their supply of tetanus shots. The warning from the national public health agency comes after one of the two providers of tetanus shots in the U.S., MassBiologics, discontinued production of its tetanus and diphtheria vaccine.

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Rare Disease Day: Understanding the power of diagnosis and connection

Antidote

Rare Disease Day, typically observed on February 28th, will be celebrated this year on February 29th! Rare Disease Day is an awareness holiday intended to generate change for the 300 million people who are diagnosed with a rare disease worldwide, as well as their families and caregivers.

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Obesity drug from Boehringer, Zealand succeeds in MASH trial

Bio Pharma Dive

Zealand shares rose by more than one-third on the data, which provide further evidence so-called incretin drugs could help treat people with the liver disease.

Drugs 274
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Roles and Responsibilities of Specialized Clinical Supply Experts

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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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

Trials 331
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Tiny Doses of LSD Boost Unique Signals in The Human Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Even small doses of LSD could have therapeutic benefits for mental health and task performance, a new study shows. Researchers from the US and Germany gave 21 adults either a placebo or 13 or 26 micrograms of LSD – small doses that rarely lead to hallucinatory effects.

Research 171
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Moderna lays off parts of manufacturing team after resizing COVID footprint

Fierce Pharma

Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.

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Live from SCOPE 2024: Talk of the Towne featuring Rare Patient Voice

Antidote

We’re here with Antidote’s tenth installment of Talk of the Towne, and it’s a very special one! We recently attended SCOPE 2024, where we met up with our partners at Rare Patient Voice and recorded our first Talk of the Towne episode live and in person.

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How Machine Learning Drives Clinical Trial Efficiency

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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Pfizer, looking for a jumpstart, leans into cancer drug research

Bio Pharma Dive

Reeling from a difficult year financially, the pharma unveiled a new oncology division it says will produce eight billion-dollar medicines by 2030.

Research 282
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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate

Pharmaceutical Technology

LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.

Drugs 237
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Simple Experiment Reveals Why Your Next Antibiotics May Prove Useless

AuroBlog - Aurous Healthcare Clinical Trials blog

Do bacteria mutate randomly, or do they mutate for a purpose? Researchers have been puzzling over this conundrum for over a century. In 1943, microbiologist Salvador Luria and physicist turned biologist Max Delbrück invented an experiment to argue that bacteria mutated aimlessly.

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Pfizer fleshes out oncology strategy, targeting 8 blockbuster cancer drugs by 2030

Fierce Pharma

In what CEO Albert Bourla called an update to a top priority at Pfizer, the company on Thursday systemically laid out its new oncology strategy following the $43 billion acquisition of antibody-dru | Pfizer on Thursday systemically laid out its new oncology strategy following the $43 billion acquisition of Seagen. The company aims to have at least eight blockbuster cancer drugs by 2030, with a focus on four main cancer types.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Vaccine successfully lowers cholesterol in preclinical studies

Drug Discovery World

New studies have demonstrated that Vaxxinity’s vaccine VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in non-human primates. The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease. VXX-401 is a synthetic peptide vaccine designed to stimulate the immune system to produce antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), whi

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Janux shares triple on early cancer immunotherapy data

Bio Pharma Dive

Analysts viewed results for one of Janux’s drug, a T cell engager aimed at metastatic prostate cancer, as potentially best-in-class in a field that’s crowded with competitors.

Drugs 265
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Shifting the paradigm – novel approaches to amyotrophic lateral sclerosis therapy

Pharmaceutical Technology

Amyotrophic lateral sclerosis (ALS) is a swiftly advancing, fatal neurodegenerative condition marked by muscle weakness, atrophy, and spasticity.

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Panel asks govt to persuade private insurance companies to cover Ayush treatments

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department-related Parliamentary Standing Committee on Health and Family Welfare has recommended to the government to persuade private insurance companies to include Ayurveda, Yoga, Unani, Siddha and Homoeopathy (Ayush) treatments in their products and look at global acceptance for these systems of medicines through legalisation and insurance support in other countries.

Medicine 165
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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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Perrigo plots hundreds of job cuts as it embarks on restructuring initiative

Fierce Pharma

Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.

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Rare Disease Day: Enhancing clinical trial success in rare diseases

pharmaphorum

Rare Disease Day is an opportunity to highlight the importance of enhancing clinical trial success in rare diseases for the benefit of patients.

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CDC panel mulls changes to RSV vaccine recommendation

Bio Pharma Dive

The expert committee is discussing whether, for certain older adults, to make a universal recommendation for vaccination, rather than the current policy of “shared decisionmaking.

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NHS expedites availability of Belumosudil for chronic GVHD

Pharmaceutical Technology

The NHS has expedited the availability of the new drug, Belumosudil for cancer patients with chronic graft versus host disease (GVHD).

Drugs 246
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Pharmaceuticals export grows 6.8% in January

AuroBlog - Aurous Healthcare Clinical Trials blog

Exports of drugs and pharmaceuticals during the month of January posted a growth of 6.84 per cent as compared to the same month of previous year. For the first 10 months of the current fiscal year pharma exports grew 8.07 per cent, according to the Central government.

Drugs 147
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AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure

Fierce Pharma

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.

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Researchers reveal COVID-19 could have small impacts on cognition and memory

Pharma Times

Different factors, such as illness duration and virus variant, impacted patients cognitive abilities

Research 119
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Abingworth invests in Trodelvy development in deal with Gilead

Bio Pharma Dive

The unusual deal will see one of the investment firm’s startups work with Gilead to expand the cancer drug’s label, with Abingworth receiving payment if successful.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!