Bio Pharma Dive
SEPTEMBER 21, 2021
The large drugmaker has acquired Arctos Medical and its preclinical research into optogenetics, an area Novartis already showed interest in with its buyout of Vedere Bio last year.
pharmaphorum
SEPTEMBER 21, 2021
RwHealth , the leading provider of Artificial Intelligence to the healthcare industry, has today reported 160 per cent year-on-year growth as its data-led solutions are increasingly embraced by NHS trusts, private healthcare providers and major pharmaceutical companies. RwHealth’s unique Data Science Platform combines Artificial Intelligence (AI), Machine Learning and Data Science to give healthcare providers access to the best and most in-depth data available, helping them to make better decisi
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Bio Pharma Dive
SEPTEMBER 21, 2021
Long-awaited results from a Phase 3 study run by J&J could support use of a booster dose, although the drugmaker has not officially applied for FDA clearance yet.
Pharma Times
SEPTEMBER 21, 2021
Ronapreve will be targeted at hospitalised patients who have not mounted an antibody response against COVID-19
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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
Bio Pharma Dive
SEPTEMBER 21, 2021
Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.
BioSpace
SEPTEMBER 21, 2021
Monoclonal antibodies play a key role in the treatment of COVID-19, but new research suggests that nanobodies derived from llamas could provide an alternative to monoclonal antibodies.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Outsourcing Pharma
SEPTEMBER 21, 2021
According to a leader from the health engagement solutions firm, intelligent use of technology tools can add patient-centricity and realism to a study.
pharmaphorum
SEPTEMBER 21, 2021
With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this age group, although there is still no clear consensus about the need for widespread vaccination in children, particularly as they are less likely to develop severe disease.
BioSpace
SEPTEMBER 21, 2021
As of September 11, slightly over 100 Alzheimer’s patients had received the drug, reported to be dramatically below Biogen’s internal projections and Wall Street expectations.
BioPharma Reporter
SEPTEMBER 21, 2021
Naobios says its development work and GMP manufacturing of vaccine clinical batches will enable FluGen to prepare its 2022 clinical trials in the US.
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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
NY Times
SEPTEMBER 21, 2021
The pandemic has exposed flaws in services for people who can’t easily access a drive-through window for Covid shots or testing or can’t read prescription labels.
Scienmag
SEPTEMBER 21, 2021
A group of researchers including a Concordia PhD student have developed a new method of bioprinting adult neuron cells. They’re using a new laser-assisted technology that maintains high levels of cell viability and functionality. Credit: Concordia University A group of researchers including a Concordia PhD student have developed a new method of bioprinting adult neuron […].
BioPharma Reporter
SEPTEMBER 21, 2021
Boehringer Ingelheim wants to develop novel cancer therapies by leveraging Abexxaâs unique technology and breakthrough antibody-based drugs.
BioSpace
SEPTEMBER 21, 2021
The survey of 20,699 Americans found that the unvaccinated – 35% of respondents – didn’t trust that the vaccines were safe or effective.
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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.
Pharma Times
SEPTEMBER 21, 2021
Cabometyx found to reduce the risk of disease progression or death versus placebo in this patient population
Delveinsight
SEPTEMBER 21, 2021
Win-win for Biogen as its Biosimilar Gets Approval for AMD. Samsung Bioepis and Biogen’s biosimilar drug, Byooviz , received USFDA approval for the treatment of vision loss, Age-related macular degeneration and has become the first biosimilar to Lucentis in the AMD market. The Lucentis copycat had also managed to score regulatory approval in the United Kingdom and Europe last month.
pharmaphorum
SEPTEMBER 21, 2021
Global Gene’s Craig Martin introduces a new patient identification initiative that strives to improve diagnosis and access to clinical trials for all patients with rare CNS conditions. Rare diseases impact more than 30 million Americans, and 400 million people around the globe. Less than 5% of the more than 7,000 rare diseases have approved treatments.
BioPharma Reporter
SEPTEMBER 21, 2021
Byooviz is the first ophthalmology biosimilar to gain approval by the US Food and Drug Administration (FDA).
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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.
Pharma Times
SEPTEMBER 21, 2021
Adagrasib is an investigational oral small-molecule inhibitor of KRAS G12C
BioSpace
SEPTEMBER 21, 2021
Triumvira’s inaugural program is directed against HER2, a well-known tumor-associated antigen that is expressed in multiple tumors.
Pharma Times
SEPTEMBER 21, 2021
Results showed vaccine has favourable safety profile in this age group
BioSpace
SEPTEMBER 21, 2021
The investor trees are dropping their leaves. Here's who's benefiting this week in the life sciences industry.
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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.
pharmaphorum
SEPTEMBER 21, 2021
AstraZeneca has unveiled plans to build a brand new manufacturing facility at a site in Ireland operated by its recent acquisition Alexion, providing employment for around 100 workers including scientists and engineers. The company has earmarked $360 million for the new-build project at the 41-acre campus at College Park in Blanchardstown, Dublin, which will be used to manufacture active pharmaceutical ingredients (APIs) for small-molecule drugs.
BioSpace
SEPTEMBER 21, 2021
The startup’s initial focus will be on rare blindness conditions affecting pediatric patients.
Outsourcing Pharma
SEPTEMBER 21, 2021
A report from the industry eventâs organizers indicates American companies have an edge on drug delivery innovation but lag in operational sustainability.
BioSpace
SEPTEMBER 21, 2021
On Wednesday, the company said that its adjuvanted protein-based COVID-19 vaccine candidate, dubbed SCB-2019 (CpG 1018/Alum), hit the primary and secondary efficacy endpoints in a Phase II/III clinical trial.
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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.
Drug Patent Watch
SEPTEMBER 21, 2021
Annual Drug Patent Expirations for SPY+AGENT+GREEN+KIT Spy Agent Green Kit is a drug marketed by Novadaq Tech and is included in one NDA. It is available from one supplier. There…. The post New patent expiration for Novadaq Tech drug SPY AGENT GREEN KIT appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
SEPTEMBER 21, 2021
By embedding machine learning into the design process, ML-GA dramatically speeds up computer-aided virtual prototyping, shrinking the product development phase from a few months to a few days while also bringing down computational costs. Credit: (Image by Argonne National Laboratory.) By embedding machine learning into the design process, ML-GA dramatically speeds up computer-aided virtual prototyping, shrinking the product development […].
Drug Patent Watch
SEPTEMBER 21, 2021
Annual Drug Patent Expirations for TIROSINT-SOL Tirosint-sol is a drug marketed by Institut Biochimique and is included in one NDA. There is one patent protecting this drug. This drug has…. The post New patent for Institut Biochimique drug TIROSINT-SOL appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
SEPTEMBER 21, 2021
Two University of Wyoming researchers decided to pick each other’s brain, so to speak. Specifically, they examined the importance of the frontal cortex, the portion of the brain used in decision-making, expressive language and voluntary movement. Credit: Zhaojie Zhang Two University of Wyoming researchers decided to pick each other’s brain, so to speak.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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