Sat.May 25, 2024 - Fri.May 31, 2024

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A biotech working on a new approach to IVF raises $33M in fresh funding

Bio Pharma Dive

The Series B funding from Two Sigma Ventures, RA Capital and others will help Gameto develop technology it says could replace hormonal injections and shorten the IVF process.

Hormones 189
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Interview: Has Cybin hit the biggest breakthrough in 40 years to treat psychiatric disorders?

Outsourcing Pharma

In an intriguing interview with Cybinâs CEO, Doug Drysdale, OSP senior editor, Liza Laws found out how second-generation psychedelics could be the biggest breakthrough in psychiatry in 40 years.

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Who Will the Next “Big Pharma” Players Be?

BioSpace

As AstraZeneca looks to climb toward the top of biopharma companies by revenue by the end of the decade, smaller companies are looking to join the ranks of the unofficial Big Pharma club.

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This Protein Could Help Us Unravel The Mystery of Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

There are a lot of connected, moving biological parts in our brains, which makes the study of brain diseases particularly challenging. Now new research has shed light on a key brain process potentially involved in Alzheimer’s disease.

Protein 208
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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May 29, 2024: INSPIRE Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Shruti Gohil In this Friday’s PCT Grand Rounds, Shruti Gohil of the University of California, Irvine, will present “The INSPIRE Abdominal and Skin/Soft Tissue Infection Trials: Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients.” The Grand Rounds session will be held on Friday, May 31, 2024, at 1:00 pm eastern.

Trials 147
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Can robots break the cell therapy bottleneck?

Bio Pharma Dive

A partnership between cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could address manufacturing hurdles, the CEOs said.

More Trending

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NABL launches comprehensive training programme to enhance competence in reference material production

AuroBlog - Aurous Healthcare Clinical Trials blog

Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.

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May 28, 2024: Program Leadership Attends Annual Steering Committee Meeting to Tackle Challenges, Share Lessons From Pragmatic Trials

Rethinking Clinical Trials

Drs. Kevin Weinfurt, Lesley Curtis, and Adrian Hernandez, co–principal investigators of the Coordinating Center Leaders of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, on May 9 and 10 for the program’s 2024 Annual Steering Committee Meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research.

Trials 147
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FDA staff outline shortcomings of Lykos data for MDMA therapy

Bio Pharma Dive

Ahead of an advisory panel meeting, agency staff identified several sticking points in the clinical results backing Lykos’ ecstasy-based treatment for PTSD.

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FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea

Pharmaceutical Technology

The US FDA approved Teva Pharmaceuticals’ AUSTEDO XR as a once-daily treatment option for tardive dyskinesia and Huntington’s disease chorea.

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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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Something In Pomegranates May Help The Brain Stave Off Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

A substance found in foods like pomegranates, strawberries, and walnuts restored the ability to detect and remove damaged cells in mice modeling Alzheimer’s disease, scientists report in a new paper. The same research team previously found a form of vitamin B3 called nicotinamide riboside (NR) helps remove damaged mitochondria from the brain.

Scientist 216
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COVID-19 vaccinations now ‘alarmingly low’ in Europe

pharmaphorum

COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.

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J&J antidepressant eases symptoms, improves sleep in key trial

Bio Pharma Dive

The company has put high expectations on the drug, an orexin-2 antagonist called seltorexant, as a cornerstone of its neuropsychiatry pipeline.

Trials 235
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FDA accepts Sanofi’s Sarclisa sBLA for priority review

Pharmaceutical Technology

The US FDA has accepted for priority review Sanofi's sBLA for Sarclisa regimen for transplant-ineligible newly diagnosed multiple myeloma.

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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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Scientists Think This Psychedelic Drug Could Help Treat Anorexia

AuroBlog - Aurous Healthcare Clinical Trials blog

The psychedelic drug psilocybin (as found in ‘magic’ mushrooms) has promising potential as a treatment for the eating disorder anorexia nervosa, according to new research that looked at its effects on an animal model of the condition.

Scientist 211
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Takeda, amid restructuring campaign, plots 641 layoffs at two Massachusetts sites

Fierce Pharma

A recently announced $900 million restructuring drive is already making waves at Takeda, wi | From early July to March 2025, the Japanese drugmaker will cut 495 staffers at its Cambridge location and 146 in Lexington, Massachusetts. Takeda is the largest life sciences employer in the state.

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CinCor’s ‘hub-and-spoke’ parent nabs new funding to build its next biotechs

Bio Pharma Dive

The $73 million round for CinRx Pharma, which created a startup AstraZeneca bought last year, will help fund subsidiaries making drugs for obesity, irritable bowel syndrome and gastroparesis.

Drugs 183
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Roche’s PI3K inhibitor wins FDA priority review for breast cancer

Pharmaceutical Technology

The US FDA has set an action date of 27 November for the combination therapy of Roche’s inavolisib, Pfizer’s Ibrance, and fulvestrant.

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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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DoP launches portal and constitutes ICPMR for implementation of R&D policy

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department of Pharmaceuticals (DoP) has said that it has developed a portal for monitoring the implementation of the research and development (R&D) policy and has constituted the Indian Council for Pharmaceuticals and Medtech Research and Development (ICPMR), as envisaged in the National Policy on Research and Development and Innovation in the Pharma-Medtech Sector in […]

Research 181
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Short reads, big impact: How genomics is revolutionising cancer research

pharmaphorum

Discover how genomics is transforming cancer research through the study of DNA, RNA, and ctDNA. Learn about the latest breakthroughs in the field in this insightful short read.

Genome 126
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Agios cashes in on cancer drug again with $905M Royalty Pharma deal

Bio Pharma Dive

The deal involves royalties for a brain cancer drug Agios previously sold off and that Royalty Pharma thinks could generate more than $1 billion in U.S. sales.

Drugs 189
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QUT team receives US DoD funding for Parkinson’s treatment

Pharmaceutical Technology

Scientists of QUT have secured A$4m ($2.65m) grant from the US DoD for developing new treatments for Parkinson's disease.

Scientist 246
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Indian pharma deploys new-gen air solutions to meet the stringent standards set by revised Schedule M

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharmaceutical industry is adapting to the revised Schedule M guidelines by considering the deployment of new-generation quality air solutions. This is because air moisture is a critical factor in pharmaceutical manufacturing processes, as it can affect the quality and stability of medications.

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BioNTech, flush with $145M from CEPI, looks to expand mRNA vaccine production in Africa

Fierce Pharma

As various efforts to produce next-generation vaccines in Africa are being carried forward by the likes of the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, BioNTech | Under an expansion of the partners’ existing deal, the Coalition for Epidemic Preparedness Innovations (CEPI) is committing up to $145 million to bolster BioNTech’s efforts to establish vaccine R&D and manufacturing capabilities at the German company’s facility in Kigali, Rwanda.

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Immunovant changes up plans for closely watched autoimmune drugs

Bio Pharma Dive

The company is prioritizing development of an earlier so-called FcRn inhibitor, a type of medicine that’s shown promise treating multiple inflammatory conditions.

Medicine 177
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Verona prepares for anticipated US launch of ensifentrine for COPD in Q3 2024

Pharmaceutical Technology

Ensifentrine is a first-in-class dual phosphodiesterase 3/4 inhibitor to treat chronic obstructive pulmonary disease (COPD).

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The New Age of Decentralized Clinical Trials

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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Healthcare ads emerge as most violative as ASCI releases Annual Complaints Report

AuroBlog - Aurous Healthcare Clinical Trials blog

The Advertising Standards Council of India (ASCI) has released its Annual Complaints Report, which offers a comprehensive analysis of advertisements that were considered objectionable in the fiscal year 2023–24. ASCI examined 10,093 complaints and investigated 8,299 advertisements.

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AZ’s Dato-DXd misses survival endpoint in lung cancer trial

pharmaphorum

The overall survival (OS) data has come in from the TROPION-Lung01 study of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in lung cancer – and the result likely isn’t what they were hoping for.

Trials 127
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Merck to buy eye drug developer for $1.3B

Bio Pharma Dive

An acquisition of EyeBio will hand Merck a treatment for diabetic macular edema and age-related macular degeneration that’s ready for pivotal testing.

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FDA approves Amgen’s interchangeable biosimilar Bkemv

Pharmaceutical Technology

The US FDA has approved Amgen's Bkemv as an interchangeable biosimilar to Soliris for the treatment of specific rare diseases.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.