J&J touts success of nipocalimab in two rare disease trials
Pharmaceutical Technology
FEBRUARY 6, 2024
J&J’s nipocalimab met primary endpoints in Phase III and II trials for myasthenia gravis and Sjogren’s disease, respectively.
Tue.Feb 06, 2024
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Cystic fibrosis patients ask DPIIT to allow local manufacturing of CFTR modulators to bring down price
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 6, 2024
Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. 2.66 crore.
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Alternative therapies are needed to combat the impending threat of AMR
Pharmaceutical Technology
FEBRUARY 6, 2024
The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.
US Woman Receives Revolutionary Brain Implant For OCD And Epilepsy
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 6, 2024
American Amber Pearson used to wash her hands until they bled, terrified by the idea of contamination from everyday items, a debilitating result of her obsessive compulsive disorder (OCD).
Health Canada approves Chiesi’s MYALEPTA for lipodystrophy
Pharmaceutical Technology
FEBRUARY 6, 2024
Health Canada has approved Chiesi Global Rare Diseases’ MYALEPTA as a treatment for individuals with lipodystrophy, an ultra-rare condition.
Khosla Ventures’ Alex Morgan on biotech’s challenges and solving drug delivery
Bio Pharma Dive
FEBRUARY 6, 2024
The life sciences investor has backed a number of startups working on technologies for delivering and manufacturing cell and gene medicines.
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Eisai falls behind on Leqembi patient goal
Bio Pharma Dive
FEBRUARY 6, 2024
The Alzheimer’s drug was administered to a total of 2,000 U.S. patients as of Jan. 26, signaling to analysts that an earlier goal of 10,000 may take longer than expected to hit.
Novartis eyes $2.9bn MorphoSys buyout to expand oncology pipeline
Pharmaceutical Technology
FEBRUARY 6, 2024
Pending a successful acquisition, Novartis will obtain pelabresib for myelofibrosis and tulmimetostat for solid tumours or lymphomas.
Lilly sales surge on obesity, diabetes drug demand
Bio Pharma Dive
FEBRUARY 6, 2024
The company also reported trial results suggesting tirzepatide, the drug Lilly now sells as Mounjaro and Zepbound, could treat a common liver disease.
China NMPA grants IND clearance for Fermion’s TYK2 JH2 inhibitor
Pharmaceutical Technology
FEBRUARY 6, 2024
The China NMPA has granted clearance for the investigational new drug (IND) application of Guangzhou Fermion Technology’s FZ007-119.
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
MorphoSys to sell to Novartis for $2.9B, offloads cancer drug to Incyte
Bio Pharma Dive
FEBRUARY 6, 2024
The deals hand Novartis a myelofibrosis drug with uncertain regulatory prospects and Incyte a marketed lymphoma medicine that hasn’t sold well.
Rani reports positive data for non-injectable Stelara biosimilar
Pharmaceutical Technology
FEBRUARY 6, 2024
RT-111 could offer an alternative dosing regimen for patients with psoriasis and other conditions compared to injectable biologics.
February 6, 2024: Racial and Ethnic Minority Injury Survivors See Greater Improvements in PTSD Symptoms in the TSOS Study
Rethinking Clinical Trials
FEBRUARY 6, 2024
Injury survivors from racial and ethnic minority groups experienced greater improvements than White injury survivors in their posttraumatic stress disorder (PTSD) symptoms after receiving a stepped collaborative care intervention. This was the finding of a secondary analysis of data from the Trauma Survivors Outcomes and Support (TSOS) study, an NIH Pragmatic Trials Collaboratory Trial.
Silence announces $120m private placement for depositary shares
Pharmaceutical Technology
FEBRUARY 6, 2024
Silence Therapeutics has announced a private placement of its 5,714,286 American depositary shares (ADS) priced at $21 each.
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
RWE’s Impact on Product Lifecycle for Biopharma Startups
Pharma Mirror
FEBRUARY 6, 2024
By Barbara Arone, Vice President, Real World Solutions, IQVIA The use of real-world evidence (RWE) in the development of pharmaceutical treatments has grown exponentially in the past 10 years, fueled by availability of higher quality data, trial competitiveness and growing investments in personalized and rare disease treatments. It has transformed from a “nice-to-have” into a “must-have” part of the evidence package, helping to contextualize clinical research and improve treatment understanding.
Incyte acquires global rights to MorphoSys’ tafasitamab
Pharmaceutical Technology
FEBRUARY 6, 2024
Incyte has acquired sole worldwide rights to tafasitamab immunotherapy through an asset purchase agreement with MorphoSys.
Already rolling in diabetes and obesity, Eli Lilly touts tirzepatide's midstage MASH win
Fierce Pharma
FEBRUARY 6, 2024
In a midstage trial, Eli Lilly’s star diabetes and weight-loss drug tirzepatide showed promise in fatty liver disease, a difficult-to-treat condition that doesn’t yet have an FDA-approved therapy.< | Eli Lilly's star diabetes and weight loss drug tirzepatide showed promise in fatty liver disease with a massive anti-MASH benefit accompanied by a "clinically meaningful" anti-fibrosis effect.
Rani Therapeutics announces promising phase 1 results for oral Stelara biosimilar
BioPharma Reporter
FEBRUARY 6, 2024
Rani Therapeutics, a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has announced encouraging results from its phase 1 study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43.
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.
AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires
Fierce Pharma
FEBRUARY 6, 2024
Following a slew of cell therapy biotech team-ups, AstraZeneca is taking manufacturing into its own hands. | AstraZeneca is plugging $300 million into a new facility in Rockville, Maryland, to launch its cell therapy platforms in the United States for cancer trials and future commercial supply. In turn, AZ will create more than 150 new jobs.
First UK patients receive experimental mRNA therapy for cancer
Drug Discovery World
FEBRUARY 6, 2024
The first UK patients have received an mRNA cancer therapy – mRNA-4359 – as part of a Phase I/II clinical trial investigating its potential for treating melanoma, lung cancer and other solid tumour cancers. The Mobilize trial is run in partnership between Imperial College London and Imperial College Healthcare NHS Trust, with the first patients in the UK receiving the treatment at the NIHR Imperial Clinical Research Facility at Hammersmith Hospital.
The Correlation Between a New York State Law Repeal and Vaccine Coverage in Schools
Pharmaceutical Commerce
FEBRUARY 6, 2024
A cohort study investigates the impact of Senate Bill 2994A and answers the question: does the repeal of school-entry nonmedical vaccination exemptions result in a rise in school vaccinations?
Medable's enhanced electronic consent making patients feel more human and less like study subjects
Outsourcing Pharma
FEBRUARY 6, 2024
Results from a new research project have been announced by technology provider Medable on the enhanced electronic informed consent (elC) in clinical trials.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
A clearer harmony and attractiveness for EU Clinical Trials Regulation
pharmaphorum
FEBRUARY 6, 2024
For the latest episode of the pharmaphorum podcast, web editor Nicole Raleigh sat down with Chris Bamford, director of clinical trial regulatory management at IQVIA, and Shirley Rutter, associate director and strategic quality lead of global quality management at IQVIA Biotech.
Brainomix 360 platform helping decision making in stroke endorsed by NICE
Outsourcing Pharma
FEBRUARY 6, 2024
An artificial intelligence (AI)-powered tool from UK-based Brainomix was one of only two products to be endorsed by health assessor the National Institute of Health and Care Excellence (NICE).
Changing Faces: Pharma and biotech hires from January 2024
pharmaphorum
FEBRUARY 6, 2024
Stay updated with the latest news on hiring trends in the pharmaceutical and biotech industries. Learn about the companies and professionals making waves in the field from January 2024 in a new instalment of Changing Faces.
How Good Measures Is Revolutionizing Health with its Good Food Prescription Program
XTalks
FEBRUARY 6, 2024
Good Measures has made a significant leap forward by showcasing the positive outcomes of its Good Food Prescription program in its first year. This program, designed to combat diet-related conditions, combines expert clinical coaching, personalized meal planning and medically tailored grocery deliveries in partnership with Instacart. The Emergence of Good Measures Founded with a vision to revolutionize the intersection of nutrition and health management, Good Measures has established itself as a
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.
Eli Lilly mounts clinical and commercial case for tirzepatide as Mounjaro, Zepbound chalk up major gains
Fierce Pharma
FEBRUARY 6, 2024
Locked in a heated battled with Novo Nordisk’s semaglutide franchise, Eli Lilly’s tirzepatide is beginning to come into its own—both with regards to sales and amid attempts to show the dual GIP/GLP | Locked in a heated battled with Novo Nordisk’s semaglutide franchise, Eli Lilly’s tirzepatide is beginning to come into its own—both with regards to sales and amid attempts to show the dual GIP/GLP-1 agonist can strike out beyond diabetes and obesity.
Cedars-Sinai mental health app launches on Apple Vision Pro
pharmaphorum
FEBRUARY 6, 2024
Right after the official launch of the new Apple Vision Pro mixed reality headset, Cedars-Sinai has launched a generative artificial intelligence (genAI) app that will use the technology to provide mental health support for patients.
Phesi's huge repository of data in its Trial Accelerator platform reaches 100 million milestone
Outsourcing Pharma
FEBRUARY 6, 2024
Phesiâs artificial intelligence (AI) driven platform, Trial Accelerator, has reached a milestone and now contains global data from more than 100 million patients.
Study reveals blood test can pinpoint cause of brain injury in newborns
Pharma Times
FEBRUARY 6, 2024
Hypoxic-ischaemic encephalopathy affects around three million babies worldwide every year
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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