Lilly says tirzepatide supply issues are resolving
pharmaphorum
AUGUST 9, 2024
Eli Lilly raises guidance for 2024 by $3 billion on strong growth for tirzepatide in diabetes and obesity and improved supply capacity
Fri.Aug 09, 2024
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In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD
Bio Pharma Dive
AUGUST 9, 2024
The decision to turn down an application from Lykos Therapeutics comes at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.
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Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue
Pharmaceutical Technology
AUGUST 9, 2024
Days after competitor Novo Nordisk posted underwhelming Wegovy sales, Eli Lilly cited “strong performance” for Zepbound and Mounjaro.
With pharma in ‘catbird seat,’ biotechs get less upfront in drug partnerships
Bio Pharma Dive
AUGUST 9, 2024
Recent data from J.P. Morgan indicates early-stage startups are getting smaller upfront payments in alliances than a few years ago, a trend industry insiders attribute to weaker leverage in deal talks.
Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies
Worldwide Clinical Trials
AUGUST 9, 2024
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials. By allowing protocol adjustments based on interim data analysis, these designs preserve the integrity of studies while effectively addressing the unique challenges of multi-regional clinical trials (MRCTs).
Merck bets $700M on an antibody drug’s potential in immune diseases
Bio Pharma Dive
AUGUST 9, 2024
The deal hands Merck a cancer medicine already in human testing, but that the company sees as a potential treatment for autoimmune conditions, too.
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Purdue, after playing major role in US opioid epidemic, wins FDA nod for overdose-reversal injection
Fierce Pharma
AUGUST 9, 2024
As Purdue Pharma attempts to restore its image following its role in | As Purdue Pharma attempts to restore its image following its role in the U.S. opioid crisis, the Connecticut-based company has scored a win with a green light for a new overdose rescue treatment.
Gilead Sciences reports net income rise in Q2 2024
Pharmaceutical Technology
AUGUST 9, 2024
Gilead Sciences has reported net income attributable to the company at $1.61bn, up from $1.04bn in the corresponding quarter of 2023.
Gilead looks to 'redefine' HIV PrEP market with 2025 launch of long-acting Sunlenca
Fierce Pharma
AUGUST 9, 2024
With Gilead's stated focus to grow in oncology, the company's recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. | The HIV-focused drugmaker looks to position its long-acting Sunlenca as a prime PrEP option after the med aced a phase 3 study.
WuXi Biologics and Medigene link on T cell engagers for cancer
Pharmaceutical Technology
AUGUST 9, 2024
Global contract research, development and manufacturing organisation (CRDMO) WuXi Biologics has partnered with Medigene.
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
Lilly's tau drug for Alzheimer's flunks phase 2 test
pharmaphorum
AUGUST 9, 2024
Eli Lilly's oral tau drug fails to show efficacy in a phase 2 trial in Alzheimer's disease in another setback for the class
Recursion and Exscientia merge to form drug discovery company
Pharmaceutical Technology
AUGUST 9, 2024
Recursion has signed an agreement to merge with Exscientia to create a global technology-enabled drug discovery company.
Legend Biotech CEO takes ‘close look at business’ amid geopolitical risk, M&A rumor
Fierce Pharma
AUGUST 9, 2024
Legend Biotech CEO Ying Huang, Ph.D., already had a lot on his plate when speculations of a potential geopolitical crackdown and the option of a buyout emerged. | Legend Biotech CEO Ying Huang, Ph.D., already had a lot on his plate when speculations of a potential geopolitical crackdown and the option of a buyout emerged.
NICE supports Theramex’s Eladynos for post-menopause osteoporosis
Pharmaceutical Technology
AUGUST 9, 2024
Eladynos is a synthetic peptide analogue of parathyroid hormone-related protein (PTHrP) used to increase bone density.
Second time lucky at FDA for Citius' lymphoma drug
pharmaphorum
AUGUST 9, 2024
At the second attempt, the FDA has approved Citius Pharmaceuticals' Lymphir for rare lymphoma CTCL
AN2 slashes staff by 50% after lead antibiotic flunks in Phase II/III trial
Pharmaceutical Technology
AUGUST 9, 2024
The company stock was down by over 22.7% in premarket trading as AN2 shared trial termination plans for epetraborole.
Study reveals genetic variants are more common in Parkinson’s disease patients
Pharma Times
AUGUST 9, 2024
The study revealed that 13% of patients have a genetic form of the neurological disease
Momentum Biotechnologies and Cube Biotech link for therapeutic solutions
Pharmaceutical Technology
AUGUST 9, 2024
Momentum Biotechnologies has partnered with Cube Biotech for supporting clients regarding new therapeutic solutions.
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.
KCL and UCL scientists develop accurate AI brain imaging model for research
Pharma Times
AUGUST 9, 2024
In the UK, there are an estimated 11 million people living with a neurological condition
MSD sets sights on bispecific antibody market with Curon acqusition
Pharmaceutical Technology
AUGUST 9, 2024
For an upfront payment of $700m, MSD will gain access to the CD3 and CD19-targeting bispecific antibody CN201.
Using technology to transform clinical trials: An interview with PhaseV CEO Raviv Pryluk
Outsourcing Pharma
AUGUST 9, 2024
In a rapidly evolving landscape where speed and precision are critical, the integration of advanced technologies in clinical trials is essential.
Adaptimmune leads in soft tissue sarcoma therapy with first TCR approval
Pharmaceutical Technology
AUGUST 9, 2024
TCR therapies are minimally engineered and can target both cell surface antigens and intracellular antigens.
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
Antibody-drug conjugate for solid tumours enters Phase I trials
Drug Discovery World
AUGUST 9, 2024
The first patient has been dosed in a Phase I clinical trial of AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers. Developer Angiex is focused on nuclear-delivered antibody-drug conjugates (ND-ADCs), which release therapeutic payloads directly into the nucleus or cytosol, where the site of payload action is located.
New tentative approval for Alembic drug dabigatran etexilate mesylate
Drug Patent Watch
AUGUST 9, 2024
Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.
Amylyx Receives Orphan Drug Designation in Europe for Former ALS Drug in Wolfram Syndrome
XTalks
AUGUST 9, 2024
Amylyx Pharmaceuticals is still betting on former ALS drug Relyvrio (AMX0035), which it pulled from the US and Canadian markets this year, securing an Orphan Drug Designation for it from the European Medicines Agency (EMA) in Wolfram Syndrome. The EMA grants Orphan Drug Designation status for products intended for the treatment, prevention or diagnosis of rare, life-threatening or chronically debilitating conditions where the product may represent a significant benefit over existing treatments.
Introduction to EDC Systems in Clinical Trials
Cloudbyz
AUGUST 9, 2024
Over the past few decades, the landscape of clinical trials has undergone a dramatic transformation, largely driven by advancements in technology and data management practices. One of the most significant innovations in this field is the adoption of Electronic Data Capture (EDC) systems. These systems have revolutionized how clinical data is collected, managed, and analyzed, offering numerous benefits that enhance the efficiency and accuracy of clinical trials.
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.
First Successful Pediatric Liver Transplant with LIVERguard Donor Preservation System
XTalks
AUGUST 9, 2024
Paragonix Technologies, a leading innovator in organ transplant solutions, has performed the first successful pediatric liver transplant using its LIVERguard Donor Liver Preservation System. The procedure was performed by Dr. Deepak Vikraman, a liver transplant surgeon at Duke University Hospital in Durham, North Carolina. Paragonix Technologies specializes in the development and manufacturing of advanced organ preservation (AOP) devices.
Focusing on Psychosocial Factors
Pharmaceutical Commerce
AUGUST 9, 2024
In an interview with Pharma Commerce Editor Nicholas Saraceno, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, outlines the main challenges surrounding medication adherence.
Webinar: Bringing inclusivity to obesity research, featuring Beyond Type 1
Antidote
AUGUST 9, 2024
Obesity is a common condition, impacting nearly 3 in 4 adults over the age of 20 in the United States. Research into obesity medications has increased significantly in recent years, resulting in novel weight-management drugs that are continuing to drive interest and demand. However, although obesity disproportionately impacts people of color, many of these studies are still made up of predominantly white individuals, creating a gap in knowledge about the effectiveness of these medications.
This week in drug discovery (5-9 August)
Drug Discovery World
AUGUST 9, 2024
News round-up for 5-9 August by DDW Senior Digital Content Editor Diana Spencer. The news highlights this week all centre around significant US Food and Drug Administration (FDA) regulatory decisions, including new approvals for drugs for solid tumours, hepatitis B and glioma. The top stories: Retinoblastoma therapy gets FDA rare paediatric drug designation Theriva Biologics’ VCN-01 for retinoblastoma has been granted rare paediatric drug designation (RPDD) by the US Food and Drug Administration
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.
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