Sat.Nov 16, 2024 - Fri.Nov 22, 2024

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FDA endorses speedy approval path for Regenxbio Duchenne gene therapy

Bio Pharma Dive

The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.

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Scientists Say This One Particular Diet May Slow The Decline of The Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

(Flavio Coelho/Moment/Getty Images) While it’s not possible to stop the brain from aging – at least not yet – there might be ways to slow down its decline, and a new study shows the vital role blood sugar levels play in how rapidly the brain ages.

Scientist 174
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AHA 2024: Plozasiran demonstrates promising Phase III results in FCS adults

Pharmaceutical Technology

During AHA 2024, data were presented from the Phase III trial of plozasiran targeting adults with genetically or clinically diagnosed FCS,

Genetics 221
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November 20, 2022: In This Week’s PCT Grand Rounds, the HeLiX Pragmatic Trial in Patients Undergoing Liver Resection

Rethinking Clinical Trials

Dr. Paul Karanicolas In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern. Karanicolas is a professor of surgery at the University of Toronto and the Sherif and Mary-Lou Hanna Chair in Surgical Oncology Research, a joint appointment at the Sunnybrook Research

Trials 148
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Flagship, Pfizer alliance yields two more startup deals

Bio Pharma Dive

Pfizer will work with Ampersand Biomedicines and Montai Therapeutics to find drugs for obesity and lung cancer, respectively, adding to collaborations it previously formed with other Flagship startups.

Drugs 169
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New technologies and treatments revolutionizing diabetes care: Dr Ajay Aggarwal

AuroBlog - Aurous Healthcare Clinical Trials blog

As diabetes continues to rise globally, healthcare experts are increasingly turning to innovative tools and treatments to manage the condition. Dr Ajay Aggarwal, chairperson of the Department of Endocrinology & Metabolism at Sir Ganga Ram Hospital, sheds light on the latest advancements in diabetes care and emphasizes the importance of personalized treatment strategies.

More Trending

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November 19, 2024: NIH Collaboratory’s Greg Simon to Receive Inaugural HCSRN Founders’ Award

Rethinking Clinical Trials

Dr. Greg Simon Greg Simon, a longtime member of the Coordinating Center leadership team for the NIH Pragmatic Trials Collaboratory, was selected by the Health Care Systems Research Network (HCSRN) Governing Board of Directors to receive the organization’s inaugural Founders’ Award. The new award recognizes individuals who best exemplify the spirit of the HCSRN’s early founders in their service and lasting contributions to the network.

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Chasing new ‘checkpoints,’ startup Valora emerges from a Nobel winner’s lab

Bio Pharma Dive

Built around research by Stanford scientist Carolyn Bertozzi and MIT researcher Jessica Stark, Valora Therapeutics is designing drugs to target glyco-immune checkpoints.

Scientist 161
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‘Brain Training’ May Not Work, But There Is a Way to Boost Your Cognition

AuroBlog - Aurous Healthcare Clinical Trials blog

(Stefania Pelfini, La Waziya Photography/Getty Images) Some 2.3 million of U.S. adults over 65 – more than 4% – have a diagnosis of dementia. But even without a diagnosis, a certain amount of cognitive decline is normal as age sets in.

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FDA approves Syndax’s Revuforj to treat leukaemia

Pharmaceutical Technology

The US FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for treating acute leukaemia with KMT2A translocation.

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

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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

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Sage’s string of research failures continues

Bio Pharma Dive

Negative results from a Huntington’s trial add to a calamitous year for Sage, which last month decided to overhaul its research, reconfigure its executive team and lay off a third of its staff.

Research 152
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ICMR invites bids for advanced online intellectual property management software

AuroBlog - Aurous Healthcare Clinical Trials blog

In a move to streamline its growing intellectual property (IP) management needs, the Indian Council of Medical Research (ICMR) has issued an Expression of Interest (EOI) for the procurement of an online intellectual property management software. Technical proposals must be submitted by November 22, 2024, by 9:00 am.

Research 144
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Leading sales enablement, prospecting and automation providers and technology solutions for the pharmaceutical industry

Pharmaceutical Technology

Discover leading sales enablement and marketing intelligence solutions tailored for the pharmaceutical industry. Download our guide to market forecasts and industry insights.

Sales 130
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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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Caring for Yourself While Caring for Others: Practical Tips for Caregivers

Antidote

Being a caregiver is one of the most selfless and demanding roles you can take on. Whether you're looking after a parent, spouse, child, or loved one, juggling all of the daily responsibilities that come with it can quickly feel overwhelming. With so much focus on taking care of others, it’s easy to put yourself and your needs on the back burner. While your focus is understandably on your loved one, it’s important to remember that your own well-being matters too.

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Reducing variability in gene expression: bottlenecks and solutions

Bio Pharma Dive

Explore solutions to reduce variability in gene expression during cell line development.

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Study Finds Eggs Might Protect Brain Health And Lower Cholesterol

AuroBlog - Aurous Healthcare Clinical Trials blog

(SimpleImages/Getty Images) A high-cholesterol animal product eaten by billions of people worldwide is not as bad for your health as it’s often cracked up to be. It might even be good for you.

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Veeva Commercial Summit: Increased investment in medical affairs by pharma companies

Pharmaceutical Technology

Veeva’s VP of global medical, Christoph Bug, emphasises the importance of scientific exchange between clinical experts and pharmaceutical companies.

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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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Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

Fierce Pharma

Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr. may not rock the boat as much as feared for the biopharma industry.

Marketing 117
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Syndax secures FDA OK for new kind of leukemia drug

Bio Pharma Dive

Revuforj is the first so-called menin inhibitor cleared in the U.S., securing FDA approval for use in adults and certain pediatric patients with an aggressive form of acute leukemia.

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Indian healthcare industry makes significant strides in epilepsy treatment with access to new drugs & surgical options

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian healthcare industry has made significant strides in improving the accessibility and effectiveness of epilepsy treatments in recent years. With the advent of new drugs, advanced surgical options, better diagnostic tools and increased awareness, epilepsy management has seen a positive transformation.

Drugs 142
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AHA 2024: CV effectiveness of GLP-1RA + Empagliflozin therapy in adults with T2D

Pharmaceutical Technology

SGLT-2I therapies reduce the risk of heart failure and this study clearly demonstrates the benefit of adding them onto GLP-1RA therapy.

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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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FDA approves first-ever gene therapy to be directly administered to the brain

BioPharma Reporter

PTC Therapeutics has received FDA approval for a gene therapy to treat AADC deficiency, a rare genetic disorder that impairs the normal function of neurons.

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Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

Bio Pharma Dive

The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless founded a new startup and Novartis licensed another radiopharma drug.

Licensing 141
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Dr. Nimmy VS of Vaidyaratnam Ayurveda College wins first prize in All India Ayurveda Thesis Competition 2024

AuroBlog - Aurous Healthcare Clinical Trials blog

Dr Nimmy VS, a faculty member of the Vaidyaratnam Ayurveda College in Thrissur, has won the first prize in the 56th All India Ayurveda Thesis Competition 2024, conducted by the Kottakkal Aryvaidyasala (KAVS) in Malappuram district in Kerala. The award carries a cash prize of Rs 60,000 and a memento. Dr.

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UK life science startups have trouble “scaling up” says Lord Vallance

Pharmaceutical Technology

The UK Minister of State for Science praised the UK’s thriving startup scene at the annual Jefferies London Healthcare Conference held in November.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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Incyte shares sink on setback for drugs acquired in $750M buyout

Bio Pharma Dive

The company paused testing of one candidate acquired in its April deal for Escient and scrapped another in a blow to its diversification plans.

Drugs 161
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Grifols linked to €7bn takeover offer from Brookfield

pharmaphorum

Private equity company Brookfield has reportedly moved closer to taking control of Grifols, after months of disruption at the Spanish pharma company.A report in Spanish newspaper El Confidencial suggests that Brookfield is preparing to make a bid to take a 65% controlling stake in the drugmaker for €10.50 per share, worth around €7 billion ($7.4 billion).

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Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time 

Pharmaceutical Technology

The UK’s NICE has rejected a deal for the reimbursement of Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu for the third time.

Drugs 130
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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.