Sat.Sep 14, 2024 - Fri.Sep 20, 2024

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This Drug Shows Potential to Stop Migraines Before They Begin

AuroBlog - Aurous Healthcare Clinical Trials blog

(Francesco Carta Fotografo/Moment/Getty Images) Migraines and headaches affect billions of people worldwide, and a new study suggests the drug ubrogepant can put a stop to the pain even before a migraine has fully kicked in.

Drugs 210
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After the Lykos debacle, what’s next for psychedelic therapies?

Pharmaceutical Technology

While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.

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ESMO: Pfizer drug helps cancer patients gain weight

pharmaphorum

Pfizer's anti-GDF-15 antibody ponsegromab was able to achieve weight gain in cancer patients with cachexia in a phase 2 trial presented at ESMO

Antibody 114
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Ten-year survival data show long-term benefit of immunotherapy in melanoma

Bio Pharma Dive

Final follow-up results suggest Opdivo and Yervoy could be close to a cure for some people with advanced melanoma, shifting how doctors administer follow-up care.

Doctors 310
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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J&J talc appeal upends $260M award to Oregon woman with mesothelioma

Fierce Pharma

Three months after a jury awarded $260 million to an Oregon woman who claimed | Three months after a jury awarded $260 million to an Oregon woman who claimed that her use of Johnson’s Baby Powder caused her to develop mesothelioma, a state judge has overturned the verdict and granted the company a new trial.

Trials 92
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Top three trends in precision medicine

Pharmaceutical Technology

An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.

Medicine 264

More Trending

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Can the Fed’s rate cut change biotech’s ‘new normal’?

Bio Pharma Dive

Industry insiders hope the Fed’s decision to cut rates for the first time in years will boost biotech investment. But the long-awaited move won’t cure all that ails the sector, others cautioned.

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September 16, 2024: Researchers Examine Feasibility of Enhanced TSOS Intervention for Trauma Survivors in Australia

Rethinking Clinical Trials

Researchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of persistent posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. They found the intervention was highly valued by most participants and could be implemented at low cost in the trauma system in Victoria, Australia.

Research 162
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AI boom set to revolutionise healthcare in Europe

Pharmaceutical Technology

The growth of AI in the healthcare sector is already having real-world impacts and promises a step-change in future care.

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Scientists Discover a Brain Network Twice The Size in Depression Patients

AuroBlog - Aurous Healthcare Clinical Trials blog

(Andrew Brookes/Connect Images/Getty Images) The more we know about how depression takes hold in the brain, the better we can prevent and treat it, and new research has identified a brain network that seems to be twice its typical size in most people with depression.

Scientist 186
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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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Apellis eye drug again turned back in Europe

Bio Pharma Dive

The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple times and, according to an analyst, will lead to a restructuring of the company’s operations in Europe.

Drugs 284
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September 18, 2024: Comparing Pragmatic Trials and Effectiveness-Implementation Trials, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. John Fortney In this Friday’s PCT Grand Rounds, John Fortney of the University of Washington will present “Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.” The Grand Rounds session will be held on Friday, September 20, 2024, at 1:00 pm eastern. Fortney is a professor of psychiatry and behavioral sciences in the University of Washington School of Medicine and a senior research career scientist in the HSR Center of Innovat

Trials 147
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GC Therapeutics secures $65m to launch into off-the-shelf iPSC therapy space 

Pharmaceutical Technology

The biotech has secured $65m in a Series A funding round led by Cormorant Asset Management and other investors.

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NABH introduces 6th edition of accreditation standards for hospitals

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has unveiled a major update to its accreditation standards for hospitals, with the release of the 6th edition.

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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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Ascendis trial data piles pressure on BioMarin

Bio Pharma Dive

Summary study results show Ascendis’ drug for achondroplasia could be competitive to BioMarin's Voxzogo, which is the foundation of the latter company's growth plans.

Trials 279
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Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Fierce Pharma

With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

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FDA expands Novartis’ Kisqali label to include early breast cancer patients

Pharmaceutical Technology

Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.

Sales 246
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The Dangers of Sleep Deprivation Are Very Real, Expert Warns

AuroBlog - Aurous Healthcare Clinical Trials blog

(Niklas Hamann/Unsplash) Most of us will be all too familiar with that dopey, groggy feeling of being tired after a restless night. Some social media users have taken tiredness to the extreme, however, by taking part in what they call a “no-sleep challenge.

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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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ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial

Bio Pharma Dive

The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.

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Bristol Myers Squibb axes 79 more in NJ as $1.5B cost-reduction program rolls on

Fierce Pharma

The hits just keep on coming for Bristol Myers Squibb staffers amid the company's cost-savings program. | Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program.

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MHLW accepts GSK’s multiple myeloma treatment NDA for review

Pharmaceutical Technology

Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.

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DCA Telangana raids & seizes illegally made cough syrups in Hyderabad

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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Nura Bio gets another $68M, new CEO to advance ‘neuroprotective’ brain drugs

Bio Pharma Dive

The funding will support mid-stage testing of a drug the company believes to have the potential to treat a range of neurodegenerative conditions.

Drugs 301
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PBM strikes back at FTC over drug pricing report

pharmaphorum

PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted

Drugs 124
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FDA approves Roche’s Ocrevus Zunovo with Halozyme Enhanze delivery tech

Pharmaceutical Technology

Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.

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Pharmexcil schedules EGM for September 25, 2024 to adopt new Articles of Association

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced an Extra Ordinary General Meeting (EGM) scheduled for 25th September, 2024 at 3:00 pm (IST). The meeting will take place in a hybrid format, allowing both physical attendance at the Pharmexcil head office in Hyderabad and virtual participation.

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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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Roche’s Xofluza reduces flu transmission in Phase 3 study

Bio Pharma Dive

According to the company, the results are the first time an antiviral drug has reduced transmission of a respiratory virus in a global Phase 3 trial.

Trials 260
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GSK touts co-administration data for RSV, shingles vaccines as narrowed CDC guidance threatens sales

Fierce Pharma

This summer, GSK cut its yearly vaccine sales projection o | In the study, co-administration of GSK's RSV vaccine Arexvy and shingles shot Shingrix elicited non-inferior immune responses compared with separate administration of the vaccines.

Sales 111
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Lilly’s EBGLYSS gains FDA approval for patients aged 12 and older

Pharmaceutical Technology

Eli Lilly and Company has announced the FDA approval of EBGLYSS for treating atopic dermatitis in adults and children over 12.

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NITI Aayog’s Expert Group recommends CDSCO to be made an independent regulatory authority

AuroBlog - Aurous Healthcare Clinical Trials blog

An expert group constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, has recommended making the Central Drugs Standard Control Organisation (CDSCO) an independent regulatory authority.

Drugs 153
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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.