Data needed to forge the link between AI and mRNA
Pharmaceutical Technology
JUNE 6, 2024
While the potential for using AI to develop mRNA therapeutics is now a real possibility, accurate and diverse data is needed to make it a reality.
Thu.Jun 06, 2024
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In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection
Bio Pharma Dive
JUNE 6, 2024
The agency is seeking input from an advisory panel on whether donanemab is effective across different groups of Alzheimer's patients, and on an unusual dosing strategy used by Lilly.
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I-Mab and BMS assess givastomig for gastric and oesophageal cancer
Pharmaceutical Technology
JUNE 6, 2024
I-Mab has agreed with Bristol Myers Squibb (BMS) to assess the givastomig regimen for advanced gastric and oesophageal cancers.
As biotech recovers, venture firms’ preferences appear to shift
Bio Pharma Dive
JUNE 6, 2024
Venture investment into U.S. biotechs is back at pre-COVID levels. But firms seem more selective in the companies they favor, and some are looking toward M&A rather than IPOs for an exit.
ArriVent partners Alphamab to develop ADCs for cancer
Pharmaceutical Technology
JUNE 6, 2024
ArriVent BioPharma has entered a partnership with Jiangsu Alphamab Biopharmaceuticals for developing new ADCs to treat cancer.
FDA advisers back updating COVID shots to target JN.1 virus family
Bio Pharma Dive
JUNE 6, 2024
The unanimous recommendation from the panel should help Novavax, which would have had difficulty adapting its shot in time if the committee picked a more specific subvariant.
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GSK acquires oligonucleotide drug startup Elsie
Bio Pharma Dive
JUNE 6, 2024
The deal, worth up to $50 million, adds to a pipeline GSK is building around nucleic acid drugs, including its hepatitis B candidate bepirovirsen.
Are Frozen Vegetables as Healthy as Fresh? You Might Be Surprised.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 6, 2024
The cost of living crisis is affecting how we spend our money. For many people, this means tightening the budget on the weekly supermarket shop. One victim may be fresh fruit and vegetables. Data from the Australian Bureau of Statistics (ABS) suggests Australians were consuming fewer fruit and vegetables in 2022–23 than the year before.
Seres, indebted and in need of cash, agrees to sell microbiome pill to Nestle
Bio Pharma Dive
JUNE 6, 2024
Seres did not disclose financial details for the deal, but said it would help extend the company's cash runway by one year.
Podcast #3: Doing Digital Deals in Life Sciences | Defining & Valuing the Asset
Pharmaceutical Technology
JUNE 6, 2024
In this series, life sciences industry M&A veteran John Easton will discuss how digital deals differ from traditional life science deals
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
Germany’s ITM raises $205M as radiopharma field booms
Bio Pharma Dive
JUNE 6, 2024
The funding will help ITM advance a pipeline that includes a potential competitor to Novartis' neuroendocrine cancer treatment Lutathera.
Novartis, Genentech and others named in Italian anti-competition probe
Pharmaceutical Technology
JUNE 6, 2024
Italy’s anti-trust regulator AGCM has launched an anti-competition probe into several pharma companies over alleged anti-competitive conduct.
June 6, 2024: BEST-ICU Trial Transitions to Implementation Phase
Rethinking Clinical Trials
JUNE 6, 2024
The NIH Pragmatic Trials Collaboratory Coordinating Center is pleased to announce that the BEST-ICU trial received approval to transition from the planning phase to the implementation phase of the study. Congratulations to the BEST-ICU principal investigators and study team for reaching this important milestone! BEST-ICU, an NIH Collaboratory Trial, is a pragmatic trial that aims to develop pragmatic and sustainable strategies to increase the delivery of evidence-based practices that lead to imp
The tiny pills that may send shockwaves across immunology
Pharmaceutical Technology
JUNE 6, 2024
The tiny pills transforming the landscape: a significant shift within psoriasis treatment and the larger immunology market is taking shape
Buoyed by new obesity data, Structure files $476m offering
pharmaphorum
JUNE 6, 2024
Riding high from positive clinical trial results for its oral weight-loss therapy, Structure Therapeutics has filed a public offering that it hopes will raise $476 million
Osteal raises $50m to bring joint infection drug/device combo to market
Pharmaceutical Technology
JUNE 6, 2024
Osteal Therapeutics has raised $50m in Series D financing, as it turns its eyes to a regulatory submission for its lead candidate VT-X7.
Underutilized Opportunities: Exploring Patent Term Extensions for Medical Devices
Drug Patent Watch
JUNE 6, 2024
In a recent study published in the Expert Review of Medical Devices, researchers investigated the utilization of patent term extensions (PTEs) to extend regulatory timeframes for medical devices in the… Source
Moderna and Myrtelle among those picked for FDA rare disease programme
Pharmaceutical Technology
JUNE 6, 2024
Moderna is developing mRNA-3705 for methylmalonic acidemia (MMA), and Myrtelle is developing rAAV-Olig001 for Canavan disease (CD).
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.
FDA cracks down on China's Hengrui in scathing manufacturing write-up
Fierce Pharma
JUNE 6, 2024
When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. | In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps, including poor contamination controls, subpar cleaning protocols, failure to promptly hand over documentation to inspectors and quality control shortfalls.
Merck opens $195.7m expanded distribution centre in Germany
Pharmaceutical Technology
JUNE 6, 2024
Germany's Merck KGaA has announced the opening of its expanded Life Science distribution centre at Schnelldorf.
Nirmatrelvir-Ritonavir and Symptoms of Postacute Sequelae of SARS-CoV-2 Infection
JAMA Internal Medicine
JUNE 6, 2024
This randomized clinical trial evaluates the efficacy of oral nirmatrelvir-ritonavir for treatment of moderate to severe postacute sequelae of SARS-CoV-2 infection of 3 months or longer duration.
Revolutionising cystic fibrosis treatment: advances, challenges, and future prospects
Pharmaceutical Technology
JUNE 6, 2024
CF treatment has been transformed by advances in disease understanding and the development of targeted therapies.
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
Italy opens antitrust case against Novartis, Roche and others, claiming collusion to delay biosim launch
Fierce Pharma
JUNE 6, 2024
A new antitrust investigation in Italy has ensnared Novartis, Genentech, Biogen and Samsung Bioepis for allegedly colluding to suppress competition of a Lucentis biosimilar in the country. | Italy's antitrust agency is going after Novartis, Genentech, Biogen and Samsung Bioepis for allegedly working together to delay the launch of a Lucentis biosimilar in Italy.
FDA recommends updated Covid-19 vaccines targeting JN.1
Pharmaceutical Technology
JUNE 6, 2024
An FDA advisory committee voted unanimously in favour of updating Covid-19 vaccines to target the JN.1 variant.
Mexican man dies in first human case of H5N2 bird flu
pharmaphorum
JUNE 6, 2024
A man in Mexico has died in what the WHO has said is the first lab-confirmed human infection with the H5N2 strain of bird flu
European pharma regulation changes signal tumult and transformation
Pharmaceutical Technology
JUNE 6, 2024
Experts dig into the evolving EU regulatory landscape to identify the key details that could change this space.
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.
Telix prices $200m IPO in big week for radiopharma financing
pharmaphorum
JUNE 6, 2024
Trio of radiopharma financings this week, as Telix files $200m US IPO, ITM raises $202m in a private round, and AstraZeneca invests in CDMO Nucleus.
India’s DCGI approves Orchid Pharma’s API Enmetazobactam
Pharmaceutical Technology
JUNE 6, 2024
Orchid Pharma has secured DCGI approval to manufacture and market its new chemical entity API, Enmetazobactam.
Amgen preps Uplizna filing for a second indication
pharmaphorum
JUNE 6, 2024
Amgen's Uplizna could become the first FDA-approved treatment for rare disease IgG4-RD, after showing efficacy in the phase 3 MITIGATE trial
Alchemab receives grant to advance promising antibody for Parkinson’s disease
BioPharma Reporter
JUNE 6, 2024
Alchemab Therapeutics, an antibody discovery company focused on identifying antibodies from individuals resilient to disease, has been awarded a grant of $595,000 by The Michael J. Fox Foundation for Parkinsonâs Research (MJFF) to propel its Parkinsonâs disease program forward.
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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