Fri.Aug 09, 2024

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Lilly says tirzepatide supply issues are resolving

pharmaphorum

Eli Lilly raises guidance for 2024 by $3 billion on strong growth for tirzepatide in diabetes and obesity and improved supply capacity

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With pharma in ‘catbird seat,’ biotechs get less upfront in drug partnerships

Bio Pharma Dive

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.

Drugs 328
Insiders

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Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue

Pharmaceutical Technology

Days after competitor Novo Nordisk posted underwhelming Wegovy sales, Eli Lilly cited “strong performance” for Zepbound and Mounjaro.

Sales 246
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In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD

Bio Pharma Dive

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.

Research 325
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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

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Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Worldwide Clinical Trials

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).

Trials 200
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Merck bets $700M on an antibody drug’s potential in immune diseases

Bio Pharma Dive

The deal hands Merck a cancer medicine already in human testing, but that the company sees as a potential treatment for autoimmune conditions, too.

Antibody 299

More Trending

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Study reveals genetic variants are more common in Parkinson’s disease patients

Pharma Times

The study revealed that 13% of patients have a genetic form of the neurological disease

Genetics 133
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MSD sets sights on bispecific antibody market with Curon acqusition

Pharmaceutical Technology

For an upfront payment of $700m, MSD will gain access to the CD3 and CD19-targeting bispecific antibody CN201.

Antibody 130
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KCL and UCL scientists develop accurate AI brain imaging model for research

Pharma Times

In the UK, there are an estimated 11 million people living with a neurological condition

Scientist 132
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NICE supports Theramex’s Eladynos for post-menopause osteoporosis

Pharmaceutical Technology

Eladynos is a synthetic peptide analogue of parathyroid hormone-related protein (PTHrP) used to increase bone density.

Hormones 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Legend Biotech CEO takes ‘close look at business’ amid geopolitical risk, M&A rumor

Fierce Pharma

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.

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AN2 slashes staff by 50% after lead antibiotic flunks in Phase II/III trial

Pharmaceutical Technology

The company stock was down by over 22.7% in premarket trading as AN2 shared trial termination plans for epetraborole.

Trials 130
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Lilly's tau drug for Alzheimer's flunks phase 2 test

pharmaphorum

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

Drugs 124
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WuXi Biologics and Medigene link on T cell engagers for cancer

Pharmaceutical Technology

Global contract research, development and manufacturing organisation (CRDMO) WuXi Biologics has partnered with Medigene.

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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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Gilead looks to 'redefine' HIV PrEP market with 2025 launch of long-acting Sunlenca

Fierce Pharma

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.

Marketing 119
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Gilead Sciences reports net income rise in Q2 2024

Pharmaceutical Technology

Gilead Sciences has reported net income attributable to the company at $1.61bn, up from $1.04bn in the corresponding quarter of 2023.

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Purdue, after playing major role in US opioid epidemic, wins FDA nod for overdose-reversal injection

Fierce Pharma

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.

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Adaptimmune leads in soft tissue sarcoma therapy with first TCR approval

Pharmaceutical Technology

TCR therapies are minimally engineered and can target both cell surface antigens and intracellular antigens.

Engineer 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Second time lucky at FDA for Citius' lymphoma drug

pharmaphorum

At the second attempt, the FDA has approved Citius Pharmaceuticals' Lymphir for rare lymphoma CTCL

Drugs 111
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Recursion and Exscientia merge to form drug discovery company

Pharmaceutical Technology

Recursion has signed an agreement to merge with Exscientia to create a global technology-enabled drug discovery company.

Drugs 130
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Minutes to answers: Compliant chat builds more meaningful HCP relationships

pharmaphorum

Compliant chat ensures that Healthcare Professionals (HCPs) receive accurate information in a timely manner, fostering more meaningful relationships. Learn how to navigate compliance in your interactions with HCPs.

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Momentum Biotechnologies and Cube Biotech link for therapeutic solutions

Pharmaceutical Technology

Momentum Biotechnologies has partnered with Cube Biotech for supporting clients regarding new therapeutic solutions.

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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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Using technology to transform clinical trials: An interview with PhaseV CEO Raviv Pryluk

Outsourcing Pharma

In a rapidly evolving landscape where speed and precision are critical, the integration of advanced technologies in clinical trials is essential.

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US Drug Wholesaling 2024: Staying the Course

Pharmaceutical Commerce

Even as pharma technology evolves, and payers argue over reimbursement practices throughout healthcare, drug wholesaling is a thriving business.

Drugs 64
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More bad news for TIGIT as MSD stops another trial

pharmaphorum

MSD abandons another phase 3 TIGIT inhibitor trial, in another setback for the beleaguered cancer immunotherapy class

Trials 64
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Which pharmaceutical companies have the most SPCs in Austria?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Austria.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Amylyx Receives Orphan Drug Designation in Europe for Former ALS Drug in Wolfram Syndrome

XTalks

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.

Drugs 52
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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

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.

Drugs 52
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Enhancing Patient Access and Support Through Technology: A Comprehensive Assessment

Pharmaceutical Commerce

Why the integration of AI-enabled solutions has the potential to boost patient support and engagement across numerous patient care settings.

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Introduction to EDC Systems in Clinical Trials

Cloudbyz

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.

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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.