What’s next for AAV gene therapies in 2024?
Pharmaceutical Technology
MARCH 11, 2024
Upcoming regulatory events for pipeline AAV gene therapies, with a focus on neuromuscular and blood disorders, are setting high expectations for the space in 2024.
Mon.Mar 11, 2024
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Biotech stock fundings headed for best quarter in 3 years, Jefferies says
Bio Pharma Dive
MARCH 11, 2024
Publicly traded companies raised nearly $10 billion in follow-on stock offerings in January and February, a financing surge that’s driving a “sector recovery,” the investment bank said.
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Boehringer and Sosei Heptares partner on schizophrenia treatment
Pharmaceutical Technology
MARCH 11, 2024
Boehringer Ingelheim has entered a deal with Sosei Heptares for the development of treatments for all schizophrenia symptoms.
Amylyx CEOs look for a path forward following major setback
Bio Pharma Dive
MARCH 11, 2024
Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.
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
Sun Pharma initiates recall of Febuxostat for gout in US
Pharmaceutical Technology
MARCH 11, 2024
Sun Pharma has announced a recall of 55,000 bottles of Febuxostat, a medication used to treat gout, from the US market
Roche, following setbacks, turns to its next Alzheimer’s drug
Bio Pharma Dive
MARCH 11, 2024
Roche said its experimental Alzheimer’s disease drug trontinemab showed it might be able to clear brain plaques faster than other medicines.
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Boehringer, Sosei Heptares team up in schizophrenia drug deal
Bio Pharma Dive
MARCH 11, 2024
Sosei Heptares could receive more than 700 million euros in a deal to develop medicines aimed at the protein GPR52, an emerging drug target in multiple neurological diseases.
Corporate Hospitals forge path to TB elimination at Leadership Summit in New Delhi
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 11, 2024
In a resounding declaration of solidarity and commitment, Corporate Hospitals from across India convened in New Delhi for a seminal workshop aimed at fortifying the nation’s fight against tuberculosis (TB).
Advanced technologies in unlocking the future of drug manufacturing
Bio Pharma Dive
MARCH 11, 2024
Innovative technologies, such as flow chemistry and biocatalysis, are achieving not only sustainability goals but also unprecedented levels of quality and efficiency.
Mesoblast eyes accelerated approval filing for heart failure cell therapy
Pharmaceutical Technology
MARCH 11, 2024
The race for the first FDA-approved cell therapy for patients with heart failure heats up.
Can using SDoH data help identify patient populations who could benefit from weight loss drugs?
Bio Pharma Dive
MARCH 11, 2024
SDoH data can help companies understand the footprint of weight loss medications in the market and their impact across populations.
Celltrion files XOLAIR biosimilar for chronic spontaneous urticaria BLA
Pharmaceutical Technology
MARCH 11, 2024
Celltrion has filed a BLA with the US FDA for a biosimilar candidate to XOLAIR (omalizumab), CT-P39, for chronic spontaneous urticaria (CSU).
FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard
Fierce Pharma
MARCH 11, 2024
The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.
AD/PD 2024: Eli Lilly’s donanemab hit with FDA delay
Pharmaceutical Technology
MARCH 11, 2024
The FDA is still likely to approve donanemab, however, the delay will benefit Eisai and Biogen in allowing Leqembi to gain greater traction in the Alzheimer's market.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Cordless Tube Saw Delivers Precision Cuts for High Purity Pharmaceutical Applications
Pharma Mirror
MARCH 11, 2024
Reimagining conventional tube saw design has led to an innovative, cordless model that cuts the widest range of piping and tubing sizes and materials with greater precision, efficiency, and longevity. The pharmaceutical industry requires extensive piping and tubing systems to maintain stringent quality and regulatory standards. These specialized systems are designed to ensure the purity of critical fluids, such as pharmaceutical-grade water, raw materials, active pharmaceutical ingredients (APIs
AD/PD 2024: BioVie’s novel NE3107 shows promise but confirmatory trial needed
Pharmaceutical Technology
MARCH 11, 2024
However, a significant limitation of the early data is that the majority of trial participants were excluded from the analysis following GCP violations at multiple trial sites.
Bluebird bio inks first Medicaid coverage agreement for sickle cell gene therapy, signing on with Michigan
Fierce Pharma
MARCH 11, 2024
Bluebird Bio has secured its first Medicaid outcomes-based agreement for its sickle cell disease gene therapy Lyfgenia, signing on with Michigan.
Astellas wins FDA orphan drug status for approved antifungal Cresemba
Pharmaceutical Technology
MARCH 11, 2024
Cresemba will enjoy seven years and six months of market exclusivity for the treatment of invasive aspergillosis and invasive mucormycosis.
Study reveals children with amblyopia are at higher risk of serious disease in adulthood
Pharma Times
MARCH 11, 2024
The neurodevelopmental condition affects up to four in 100 children
The state of oligonucleotide therapeutic manufacturing: what biopharmaceutical players need to know
Pharmaceutical Technology
MARCH 11, 2024
In the genomic medicine toolbox, oligonucleotide therapeutics offer highly specific and effective treatments
Pain is reduced by almost half with cannabis-based medicines – report finds
Outsourcing Pharma
MARCH 11, 2024
On March 7, Celadon Pharmaceuticals plc, a leading UK-based pharmaceutical company specializing in cannabis-based medicines, unveiled promising findings from an early economic analysis of its chronic pain clinical trial, dubbed CANPAIN.
Sanofi’s amlitelimab shows best-in-class response in atopic dermatitis
Pharmaceutical Technology
MARCH 11, 2024
Sanofi presented the data as part of a late-breaking session at the American Academy of Dermatology (AAD) 2024 conference in San Diego, US.
The New Age of Decentralized Clinical Trials
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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.
Incyte's JAK cream Opzelura proves its worth in treating hidradenitis suppurativa in midstage study
Fierce Pharma
MARCH 11, 2024
After a pair of approvals in recent years and as its sales continue to climb, Incyte's topical JAK inhibitor Opzelura is adding to its clinical case with trial results that demonstrate its benefits | The company presented positive data from a phase 2 study in mild-to-moderate hidradenitis suppurativa at the American Academy of Dermatology's annual meeting on Sunday.
Novo expands Wegovy’s US label to reduce cardiovascular events
Pharmaceutical Technology
MARCH 11, 2024
Wegovy can now be used to reduce the risk of major cardiovascular events in obese or overweight patients with heart disease.
Amylyx plummets as confirmatory trial of ALS drug fails
pharmaphorum
MARCH 11, 2024
Shares in Amylyx have cratered after the company reported a confirmatory trial of its amyotrophic lateral sclerosis (ALS) therapy Relyvrio missed all its objectives, putting its accelerated approval in jeopardy.
Eagle Pharmaceuticals files patent for stable pemetrexed formulations for cancer treatment
Pharmaceutical Technology
MARCH 11, 2024
Discover Eagle Pharmaceuticals Inc.'s innovative patent for stable pemetrexed formulations, offering effective treatment for pleural mesothelioma and non-squamous lung cancer. Learn about the unique composition and storage options designed for patient convenience and efficacy.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
This week in clinical trials: 12th to 16th February 2024
pharmaphorum
MARCH 11, 2024
Stay updated on the latest developments in clinical trials with highlights from Medigene, Artax, and KalVista from 12th to 16th February 2024.
Macau regulator accepts Everest’s NDA for ulcerative colitis therapy
Pharmaceutical Technology
MARCH 11, 2024
Macau has accepted a NDA of Everest Medicines for VELSIPITY, a treatment for adults with active ulcerative colitis (UC).
AAD: J&J’s oral IL-23 drug shows durability in psoriasis
pharmaphorum
MARCH 11, 2024
J&J says oral IL-23 inhibitor JNJ-2113 shows a durable effect in psoriasis, making it a potential companion to its injectable Tremfya.
J&J’s growing rare disease focus brings a potential multi-use treatment to the table
Bio Pharma Dive
MARCH 11, 2024
The head of J&J’s autoantibody programs believes nipocalimab is unique among potential rare disease drugs because it can harness a common thread among them.
How Machine Learning Drives Clinical Trial Efficiency
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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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