Thu.Sep 05, 2024

article thumbnail

Lilly builds case for weekly insulin shot

Bio Pharma Dive

New data show Lilly’s longer-lasting insulin matched daily shots in controlling blood sugar, adding to positive findings the company disclosed in May.

Insulin 274
article thumbnail

Moderna mpox mRNA vaccine shows early promise in monkey study

Pharmaceutical Technology

Moderna is currently running a Phase I/II trial of the mRNA mpox vaccine mRNA-1769 in healthy participants.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Lykos CEO to depart after FDA rejection, layoffs

Bio Pharma Dive

The departure of Amy Emerson as CEO comes three weeks after the MDMA developer revealed plans to cut 75% of its staff.

article thumbnail

Lilly and EVA Pharma to expand baricitinib access in Africa

Pharmaceutical Technology

Eli Lilly and EVA Pharma have formed a partnership to increase the availability of baricitinib in 49 African countries by 2030.

246
246
article thumbnail

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

article thumbnail

September 5, 2024: Pragmatic Trial of Pain Management in a Military Population, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Ardith Doorenbos of the University of Illinois, Chicago, and Diane Flynn of Madigan Army Medical Center will present “Conventional, Complementary, and Integrative Pain Therapies in a Military Population With Chronic Musculoskeletal Pain: Results of a Pragmatic Clinical Trial Using SMART Design.” The Grand Rounds session will be held on Friday, September 6, 2024, at 1:00 pm eastern.

Nurses 147
article thumbnail

Lilly partners with Haya for lncRNA obesity target deal worth $1bn

Pharmaceutical Technology

Haya could secure up to $1bn after hitting preclinical, clinical, and commercial milestones with drugs that emerge from this deal.

Drugs 238

More Trending

article thumbnail

UK bans xylazine and 21 other substances to fight drug abuse

Pharmaceutical Technology

The UK government has taken a step towards banning xylazine and 21 other substances by introducing legislation in parliament.

Drugs 236
article thumbnail

China detains AstraZeneca workers in data, imports probe

pharmaphorum

A "small number" of AstraZeneca employees have been detained in China in an investigation into suspected data privacy and drug import breaches

Drugs 133
article thumbnail

As mpox spreads, ‘national governments have a moral responsibility to help’

Pharmaceutical Technology

Representatives of the WHO and the IFRC called for international cooperation to tackle the current mpox outbreak.

130
130
article thumbnail

AMBLor prognostic melanoma biomarker receives UKCA Mark

Pharma Times

New biomarker test aims to improve early-stage melanoma treatment

125
125
article thumbnail

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

article thumbnail

ESC 2024: Insights into RNA as therapeutic target and tool

Pharmaceutical Technology

A panel of researchers gave presentations on the clinical evidence for the role of RNA in therapy for cardiovascular conditions.

RNA 130
article thumbnail

European Commission grants orphan drug designation for Vivet’s VTX-806

Pharma Times

Pre-clinical data of VTX-806 in demonstrated normalisation of metabolic parameters

Drugs 125
article thumbnail

ESC 2024: New PACMAN-AMI trial analysis sheds insights on Praluent efficacy

Pharmaceutical Technology

The subanalyses recontextualised data from the PACMAN-AMI trial on the therapeutic role of Praluent (alirocumab) in coronary heart disease.

Trials 130
article thumbnail

J&J bolsters Rybrevant-Lazcluze's case against AZ's Tagrisso with survival analysis

Fierce Pharma

Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better chall | Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better challenge AstraZeneca’s Tagrisso.

article thumbnail

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

article thumbnail

eGenesis scoops $191m for genetically modified pig kidney transplant trial

Pharmaceutical Technology

eGenesis conducted the first-in-human porcine kidney transplant earlier this year, though the patient died two months later.

Genetics 130
article thumbnail

The Life Sciences Generative AI Council and a sustainable technological future

pharmaphorum

Listen to the podcast interview with Manny Belabe from ArisGlobal as he discusses The Life Sciences Generative AI Council and its role in creating a sustainable technological future. Gain insights into the future of AI in life sciences.

article thumbnail

NHS England offers MSD belzutifan for von Hippel-Lindau disease

Pharmaceutical Technology

NHS England has announced the availability of MSD UK’s belzutifan, a take-at-home pill for patients with von Hippel-Lindau disease.

130
130
article thumbnail

Cash-crunched ImmunityBio, on heels of FDA nod for Anktiva, lays off staffers

Fierce Pharma

With dwindling funds after a prior snub from the FDA, ImmunityBio’s journey to bag approval for its Merck-rivaling bladder cancer drug Anktiva wasn’t easy. | The drugmaker laid off 20 employees as it attempts to recoup from dwindling funds during its Anktiva launch in bladder cancer.

Drugs 119
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

IN8bio cuts staff and pipeline to focus on AML cell therapy

Pharmaceutical Technology

The company has reduced its headcount by about 49% and suspended enrolment in a Phase II glioblastoma trial.

Trials 130
article thumbnail

Advanz wins stay on EU revocation of Ocaliva license

pharmaphorum

EU General Court suspends decision to revoke the license for Advanz Pharma's primary biliary cholangitis drug Ocaliva.

Licensing 116
article thumbnail

ArsenalBio secures $325m to develop cell therapy programmes

Pharmaceutical Technology

ArsenalBio has secured $325m in a Series C financing round to propel its programmable cell therapy programmes through clinical development.

article thumbnail

Glenmark joins growing list of drugmakers to settle long-running US price-fixing claims

Fierce Pharma

After handing over $30 million in criminal penalties last summer, Glenmark Pharmaceuticals has agreed to settle with the U.S. | Glenmark will pay the U.S. Department of Justice $25 million to resolve claims that it worked with other drugmakers to rig prices of the cholesterol med pravastatin. The case forms part of a larger antitrust probe implicating numerous manufacturers.

article thumbnail

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.

article thumbnail

ArsenalBio raises $325m for programmable CAR-T platform

pharmaphorum

ArsenalBio raises $325m for programmable CAR-T platform Phil.

111
111
article thumbnail

HDA 2024 Traceability Seminar: Best Practices Amid the Forthcoming Stabilization Period

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.

article thumbnail

Company Profile: Medscape WebMD

pharmaphorum

Medscape WebMD is a leading provider of medical information and services online, catering to the Medical Affairs field. Learn more about their company profile and offerings.

110
110
article thumbnail

Pharma Pulse 9/5/24: FDA Wants Safer Cancer Drugs, Can Outcomes-Based Agreements Work for Weight Loss Drugs? & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

Drugs 105
article thumbnail

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

article thumbnail

Trial of Click's DTx for migraine sets up FDA filing

pharmaphorum

Click Therapeutics' digital therapeutic for migraine clears late-stage study using an endpoint used to test drugs, clearing the way for regulatory filing.

Trials 109
article thumbnail

The Role of Green Chemistry in Generic Drug Development: A Sustainable Approach to Medicine

Drug Patent Watch

The pharmaceutical industry is a significant contributor to global carbon emissions, with a projected increase of over 300% by 2050 if left unchecked. This alarming trend has led to a growing need for sustainable practices in the industry, particularly in the development of generic drugs.

article thumbnail

J&J sweetens controversial talc settlement deal

pharmaphorum

J&J is reported to have raised its offer to settle claims that its talc products caused cancer by $1.1bn, as it reaches agreement with a holdout law firm.

article thumbnail

BIOSECURE Act heads for possible vote in House of Representatives next week

Fierce Pharma

After running up against a roadblock earlier this summer, the controversial BIOSECURE Act could gain new momentum next week. | Next week, the U.S. House of Representatives is slated to consider the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with certain Chinese biotech equipment and service providers over national security concerns.

98
article thumbnail

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.