After setback, Biohaven to seek approval of neurological disorder drug
Bio Pharma Dive
SEPTEMBER 23, 2024
With fresh, positive data in hand, Biohaven now believes its medicine could be the first to receive FDA approval for spinocerebellar ataxia.
Trending Articles
304 
September 24, 2024: GRACE Team Identifies Barriers to Integrating Acupuncture Into US Healthcare System
Rethinking Clinical Trials
SEPTEMBER 24, 2024
In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system. The review was published online ahead of print in the Journal of Integrative and Complementary Medicine. Acupuncture is widely practiced in the United States and has been shown to be effective in multiple clinical applications for a variety of conditions.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Top three trends in precision medicine
Pharmaceutical Technology
SEPTEMBER 19, 2024
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.
Scientists Just Identified Hundreds of Genes That Could Cause Cancer
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 22, 2024
(Richard Jones/Science Photo Library/Getty Images) Scientists have discovered hundreds of genes that could potentially promote cancer, new research shows. Cancer is typically triggered by some kind of change to our genetic coding that interferes with a cell’s ability to manage its growth.
AGC Biologics telegraphs layoffs, winds down production operations at Colorado plant
Fierce Pharma
SEPTEMBER 24, 2024
As CDMOs across the industry continue to face pressure from a fluctuating biopharma business environment, AGC Biologics is charting another round of staff cuts and pumping the brakes at one of its | As part of the new restructuring push, AGC will lay off 68 employees at its cell and gene therapy plant in Longmont, Colorado, 17 employees at its commercial mammalian plant in Boulder, Colorado, and 10 employees in Bothell, Washington, according to a Worker Adjustment and Retraining Notification ale
Can the Fed’s rate cut change biotech’s ‘new normal’?
Bio Pharma Dive
SEPTEMBER 19, 2024
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.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
September 18, 2024: Comparing Pragmatic Trials and Effectiveness-Implementation Trials, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
SEPTEMBER 18, 2024
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
The Dangers of Sleep Deprivation Are Very Real, Expert Warns
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 18, 2024
(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.
Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection
Fierce Pharma
SEPTEMBER 19, 2024
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. | Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.
Apellis eye drug again turned back in Europe
Bio Pharma Dive
SEPTEMBER 20, 2024
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.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
AI boom set to revolutionise healthcare in Europe
Pharmaceutical Technology
SEPTEMBER 20, 2024
The growth of AI in the healthcare sector is already having real-world impacts and promises a step-change in future care.
Grand Rounds June 28, 2024: Using ChatGPT to Facilitate Truly Informed Medical Consent (Fatima N. Mirza, MD, MPH)
Rethinking Clinical Trials
SEPTEMBER 24, 2024
                      Speaker Fatima N. Mirza, MD, MPH Chief Resident Department of Dermatology Warren Alpert Medical School of Brown University Slides Keywords Artificial Intelligence; ChatGPT; Informed Consent Key Points Artificial Intelligence (AI), when implemented thoughtfully in clinical settings, can lead to meaningful results for patients.
Deadly Fungal Infections Causing a ‘Silent Pandemic’, Scientists Warn
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 23, 2024
(Tanja Ivanova/Getty Images) The world is in the midst of an antibiotic resistance crisis that contributes to the death of nearly 5 million people a year. But bacteria aren’t the only mutating pathogens we need to worry about.
Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama
Fierce Pharma
SEPTEMBER 18, 2024
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.
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
Roche’s Xofluza reduces flu transmission in Phase 3 study
Bio Pharma Dive
SEPTEMBER 19, 2024
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.
Leading Artificial Intelligence (AI) Companies in Pharma
Pharmaceutical Technology
SEPTEMBER 23, 2024
View the top artificial intelligence (AI) companies in the pharmaceutical industry and download your free guide to AI in pharma here.
FDA greenlights first treatment for Niemann-Pick disease type C
Outsourcing Pharma
SEPTEMBER 24, 2024
The small molecule drug arimoclomol (Miplyffa) has got the green light from the U.S. Food and Drug Administration (FDA) for the treatment of the rare disease Niemann-Pick disease type C (NPC), which until now has lacked FDA-approved therapies.
DCA Telangana raids & seizes illegally made cough syrups in Hyderabad
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 19, 2024
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.
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.
GSK touts co-administration data for RSV, shingles vaccines as narrowed CDC guidance threatens sales
Fierce Pharma
SEPTEMBER 18, 2024
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.
Biogen, UCB get the lupus data they’ve waited two decades for
Bio Pharma Dive
SEPTEMBER 23, 2024
The companies now plan on starting this year another large study of their drug, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.
GC Therapeutics secures $65m to launch into off-the-shelf iPSC therapy spaceÂ
Pharmaceutical Technology
SEPTEMBER 20, 2024
The biotech has secured $65m in a Series A funding round led by Cormorant Asset Management and other investors.
How to Succeed in Generic Drug Market Entry
Drug Patent Watch
SEPTEMBER 23, 2024
The generic drug market has experienced significant growth over the past few decades, driven by the expiration of patents on branded drugs and the increasing demand for affordable healthcare solutions. However, the industry faces several challenges, including commoditization, regulatory hurdles, and intense competition.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
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.
Pharmexcil schedules EGM for September 25, 2024 to adopt new Articles of Association
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 18, 2024
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.
AstraZeneca's Fasenra plays catch-up with GSK's Nucala, gaining FDA nod for rare autoimmune disease
Fierce Pharma
SEPTEMBER 18, 2024
Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.
Metsera touts long-acting GLP-1 drug; Novartis strikes an AI deal
Bio Pharma Dive
SEPTEMBER 24, 2024
Metsera revealed Phase 1 data it claims could support a weight-loss medicine that's administered monthly. Elsewhere, Sanofi invested in a struggling biotech and shares of two Duchenne drug developers climbed.
FDA expands Novartis’ Kisqali label to include early breast cancer patients
Pharmaceutical Technology
SEPTEMBER 18, 2024
Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.
UCB, Biogen lupus drug scores in phase 3 trial
pharmaphorum
SEPTEMBER 24, 2024
UCB and Biogen say their first phase 3 trial of their systemic lupus erythematosus (SLE) candidate dapirolizumab pegol was a success, and a second is now expected to start before the end of the year.Data from the PHOENYCS GO study in moderate to severe SLE patients isn't available yet, but the partners say dapirolizumab pegol achieved a "clinical improvement" in the primary and secondary endpoints, including measures of disease activity and flares.
These Tiny Robots Can Patch Up Deadly Bleeds in Animal Brains
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 24, 2024
(Wang et al., Small, 2024) Swarms of spherical nanobots barely larger than a virus could one day save hundreds of thousands of lives globally each year by staunching deadly bleeds in the brain.
New migraine drugs less effective than previous generation of triptan meds: BMJ study
Fierce Pharma
SEPTEMBER 19, 2024
A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migra | A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.
Bluebird to lay off another 25% of workforce in latest restructuring
Bio Pharma Dive
SEPTEMBER 24, 2024
The announced job cuts are the latest in a series of steps Bluebird has taken to preserve cash and break even financially amid slow uptake of its marketed gene therapies.
The New Age of Decentralized Clinical Trials
Advertisement
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.
Let's personalize your content