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

article thumbnail

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 240
article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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 162
article thumbnail

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.

article thumbnail

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

article thumbnail

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 173
article thumbnail

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.

More Trending

article thumbnail

AbbVie’s Elahere wins European approval for certain ovarian cancers

Pharmaceutical Technology

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

Drugs 264
article thumbnail

November 21, 2024: Are Pragmatic Trials Living Up to the Promise of Improving Representativeness?

Rethinking Clinical Trials

In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.

Trials 316
article thumbnail

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.

article thumbnail

BridgeBio heart drug approved by FDA, setting up battle with Pfizer

Bio Pharma Dive

The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.

Drugs 312
article thumbnail

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

article thumbnail

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 258
article thumbnail

November 21, 2024: JAMA Commentary Highlights Need for Virtual Vigilance in Decentralized Clinical Trials

Rethinking Clinical Trials

In a JAMA Viewpoint published online this week , coauthors Adrian Hernandez and Chris Lindsell caution that, although the use of decentralized trials creates meaningful efficiencies, there are major threats to the validity of these trials not captured by traditional monitoring and oversight practices. In a decentralized clinical trial, some or all of the trial-related activities take place at locations other than the trial site, which can result in decrease in travel, time, and burden for patien

article thumbnail

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

AuroBlog - Aurous Healthcare Clinical Trials blog

Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.

article thumbnail

Versant startup sets out to make a new type of obesity drug

Bio Pharma Dive

The startup, Pep2Tango, is combining four methods of accelerating weight loss into one medicine in the hopes of developing a treatment that can improve upon drugs like Wegovy and Zepbound.

Drugs 312
article thumbnail

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

article thumbnail

Health Canada issues NOC to J&J’s CARVYKTI for multiple myeloma

Pharmaceutical Technology

Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.

article thumbnail

Scientists identify key mechanism in development of skin cancer

Medical Xpress

LMU researchers have discovered how the interplay between a key protein and an endolysosomal ion channel promotes tumor development in skin cancer.

article thumbnail

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 187
article thumbnail

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 297
article thumbnail

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.

article thumbnail

“No magic wand” for Novo Nordisk, as CagriSema pen supply rumours swirl

Pharmaceutical Technology

Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.

246
246
article thumbnail

Printable organic X-ray sensors may transform treatment for cancer patients

Medical Xpress

An international research team, led by the University of Wollongong (UOW), has found wearable organic X-ray sensors could offer safer radiotherapy protocols for cancer patients.

Research 130
article thumbnail

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.

131
131
article thumbnail

CRISPR therapy from Intellia may ameliorate rare heart disorder, data suggest

Bio Pharma Dive

Phase 1 data indicate Intellia’s medicine could be a powerful treatment for a cardiac form of ATTR amyloidosis. But rival drugs are further ahead.

Medicine 298
article thumbnail

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.

article thumbnail

Kura Oncology partners Kyowa Kirin to advance AML treatment

Pharmaceutical Technology

Kura has partnered Kyowa Kirin in a strategic global collaboration for developing and commercialising oral ziftomenib to treat AML

article thumbnail

Eli Lilly’s Tirzepatide Shows Promise for Keeping Prediabetic Patients Diabetes-Free

XTalks

Eli Lilly shared new data last week from a study, which highlights the long-term efficacy of tirzepatide in preventing diabetes progression among prediabetic patients. Results from the Phase III SURMOUNT-1 three-year study (176-week treatment period) showed that nearly 99 percent of participants remained diabetes-free over three years. SURMOUNT is the longest completed study to date of tirzepatide.

Sales 105
article thumbnail

Roche files patent suit to fend off potential Evrysdi generics from Zydus, Natco

Fierce Pharma

Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. | The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics.

article thumbnail

Johns Hopkins surgeon Makary is Trump’s pick to lead FDA

Bio Pharma Dive

A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.

Vaccine 278
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Wes Streeting says patients should view data sharing ‘the same as taxes’

Pharmaceutical Technology

UK Health Secretary Wes Streeting outlaid the key shifts needed to fix a “fragmented” NHS at the Jefferies London Healthcare Conference.

246
246
article thumbnail

Woman receives world's first robotic double-lung transplant

Medical Xpress

A 57-year-old woman with COPD has received the world's first fully robotic double lung transplant.

116
116
article thumbnail

Johnson & Johnson, Merck lay off workers in China as local headwinds take a toll

Fierce Pharma

Johnson & Johnson and Merck are laying off workers in Chi | Johnson & Johnson and Merck are laying off workers in China, according to a story from Bloomberg which cites reports from Chinese news outlets.

128
128
article thumbnail

Biotech startups are built on venture capital. Track funding rounds here.

Bio Pharma Dive

Venture capital firms incubate, grow and finance dozens of new drug companies each year. Follow the money they channel into the industry with this database.

Drugs 274
article thumbnail

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.