Bio Pharma Dive
APRIL 20, 2023
The company, which previously raised $32 million in Series A funding, joins a growing list of new startups working to develop targeted radiation treatments.
Pharmaceutical Technology
APRIL 20, 2023
Chinese firm Hasten Biopharmaceutic has raised $315m for business development of its pipeline assets in a financing round co-led by Singapore-based CBC Group and Abu Dhabi sovereign wealth fund Mubadala Investment, The funding round was supported by additional institutional investors. Hasten will also use the proceeds from the round to fund future acquisitions.
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Bio Pharma Dive
APRIL 20, 2023
The agency’s decision also converts the biologic drug's approval from accelerated to full, confirming an earlier OK based on tumor responses.
Pharmaceutical Technology
APRIL 20, 2023
European life sciences venture capital firm Forbion has raised €1.35bn ($1.47bn) across its two new funds. The latest fundraising brings the total funds managed by the company to €3bn ($3.28bn). The Forbion Ventures Fund VI and the Forbion Growth Opportunities Fund II both exceeded their original target sizes. The Forbion Ventures Fund VI’s final close reached the hard cap of €750m ($821.76m), while the Forbion Growth Opportunities Fund II secured €600m ($657.41m).
Bio Pharma Dive
APRIL 20, 2023
With the court victory, the biotech giant could stave off a set of generic competitors for the top-selling drug until 2028.
Pharmaceutical Technology
APRIL 20, 2023
Targovax has unveiled plans to rebrand as Circio , reflecting its strategic shift to focus on expediting the development of its innovative circular RNA (circRNA) platform. Initially reported in 2011, CircRNA is a naturally occurring class of RNA. CircRNA is resistant to the main cellular RNA degradation mechanisms and therefore has a prolonged half-life compared to linear mRNA.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
APRIL 20, 2023
The face of clinical research is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. The result is an improved experience for patients, whose participation no longer rests on long journeys to and from sites.
Pharma Mirror
APRIL 20, 2023
Copenhagen, Denmark, 20 April 2023 – Breye Therapeutics ApS (Breye), a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology, today announces the appointment of Peter Adamson as Chief Scientific Officer (CSO) and Gabriela Burian as a new member of its Board of Directors. Dr. Adamson has over 20 years of experience in ophthalmology drug development.
Pharmaceutical Technology
APRIL 20, 2023
Maxion Therapeutics announced it has been awarded a £2m ($2.5m) grant from Innovate UK as part of a biomedical R&D funding competition. The funds will support Maxion’s KnotBody platform to develop antibodies to treat autoimmune diseases. Antibody-based therapies provide enhanced efficacy and safety whilst reducing the need for frequent administration for autoimmune disease treatment.
NPR Health - Shots
APRIL 20, 2023
The U.S. desperately needs more Black and Hispanic doctors, research shows. But financial pressures and discrimination can keep young people from even applying to med school.
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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
Pharmaceutical Technology
APRIL 20, 2023
Medidata, part of Dassault Systèmes, has partnered with Lambda Therapeutics to automate and consolidate data management processes for improved clinical trial efficiency. Through the tie-up, both companies aim to safely provide advanced data for faster insights. Lambda Therapeutics will employ Medidata’s Rave EDC, Rave RTSM, and Rave Imaging cloud-driven clinical solutions to access centralised data to address the entire clinical research process.
Rethinking Clinical Trials
APRIL 20, 2023
The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5 day pre-conference workshop at the 2023 Annual Research Meeting in Seattle, Washington. The workshop, “ Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials Workshop ,” will provide an introduction to the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide re
Pharmaceutical Technology
APRIL 20, 2023
As of 1 April 2023, Japan’s latest ‘off-year’ National Health Insurance (NHI) drug price revisions for FY2023 have now come into effect. While roughly 100 drugs received additional price premiums, the majority of products saw their price reduced as a result of discrepancies between their NHI and market prices. GlobalData, therefore, reviews the impact these price changes have on the Japanese market by comparing the recent NHI-related price adjustments against the manufacturer price changes of al
STAT News
APRIL 20, 2023
The rate of suspected suicide attempts by self-poisoning among children and adults aged 10 to 19 in the U.S. rose by 30% in 2021 compared with pre-pandemic rates, according to a new study published Thursday. The largest surge was among the youngest in that age group — the rate rose 73% for 10- to 12-year-olds and about 49% for 13- to 15-year-olds, compared to 11% for 16- to 19-year-olds.
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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
Pharmaceutical Technology
APRIL 20, 2023
Zucara Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug application for ZT-01 to prevent night-time (nocturnal) hypoglycaemia in type 1 diabetes (T1D) patients. ZT-01 is a first-in-class, SST receptor 2 antagonist and is designed to prevent dangerously low levels of blood glucose by restoring the body’s counter-regulatory mechanisms, preventing hypoglycaemic episodes.
Medical Xpress
APRIL 20, 2023
Drinking cranberry juice has long been a mythical prevention strategy for women who develop a urinary tract infection—and new medical evidence shows consuming cranberry products is an effective way to prevent a UTI before it gets started.
Pharmaceutical Technology
APRIL 20, 2023
Tubulis has signed a strategic licence agreement with Bristol Myers Squibb for the development of differentiated antibody-drug conjugates (ADCs) to treat cancer patients. Bristol Myers Squibb will have exclusive rights to access Tubulis’ Tubutecan payloads, combined with its P5 conjugation platform, to develop the ADCs. P5 and the Tubutecan payloads can create ultra-stable ADCs that could actively minimise undesirable target-independent toxicities.
Medical Xpress
APRIL 20, 2023
A new HIV vaccine from Scripps Research has shown a significantly improved ability to neutralize the virus in preclinical tests, and it will soon be studied in healthy people who volunteer to participate in 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.
Pharmaceutical Technology
APRIL 20, 2023
Biopharmaceutical company Abdera Therapeutics has raised $142m in combined Series A and B financing to engineer and advance antibody-based radiopharmaceuticals to treat cancer. The Series A financing round was led by Amplitude Ventures and Versant Ventures, with Northview Ventures, AbCellera and adMare BioInnovations as participants. Led by venBio Partners, the Series B round involved both existing and new investors including Qiming Venture Partners USA, RTW Investments and Viking Global Investo
Medical Xpress
APRIL 20, 2023
A mysterious illness causing fevers and headaches and leading to rapid development of acute encephalitis (within a couple of weeks of symptom onset), caused an outbreak of nearly 300 reported cases and over 100 fatalities in Malaysia and Singapore between September 1998-May 1999. Over 90% of these cases originated from contact with sick pigs.
Pharmaceutical Technology
APRIL 20, 2023
The US Food and Drug Administration (FDA) has approved Roche ’s Polivy (polatuzumab vedotin-piiq), along with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP), to treat certain types of previously untreated diffuse large B-cell lymphoma (DLBCL) in adult patients. The combination therapy is indicated to treat adult patients with DLBC not otherwise specified, or high-grade B-cell lymphoma, who also have an International Prognostic Index (IPI) score of at least two.
Medical Xpress
APRIL 20, 2023
Degeneration of myelin, an insulating sheath required for rapid communication between nerve cells, and neuroinflammation are notable hallmarks of Multiple Sclerosis (MS) and related neurodegenerative disorders such as Alzheimer's disease and Huntington's disease, which affect roughly 2.8 million people in the world. However, little is known about the precise molecular steps by which demyelination leads to the loss of neurons and glia, the two major types of brain cells.
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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.
Pharmaceutical Technology
APRIL 20, 2023
Roquette has inaugurated its new Pharmaceutical Innovation Center in Pennsylvania , US, with an investment of $25m. Situated at the hub of the country’s northeastern pharmaceutical corridor, the new facility is staffed by research, application and formulation specialists. The facility complements the company’s current pharma innovation centres in France and Singapore, and intends to improve the patient experience with modern oral dosage forms.
Medical Xpress
APRIL 20, 2023
Progressive loss of neurons is the underlying cause for a diverse spectrum of severe diseases called neurodegenerative diseases, which include Parkinson's disease, amyotrophic lateral sclerosis (ALS) and retinitis pigmentosa. While strategies for regenerating or replacing lost neurons from stem cells are being developed, an alternative treatment option is the protection of existing neurons to prevent their degeneration, a recent study published in Stem Cell Reports suggests.
Fierce Pharma
APRIL 20, 2023
'The Top Line': How Pfizer became the first in Big Pharma history to break $100B in sales, plus this week's headlines tcarey Thu, 04/20/2023 - 14:46
Medical Xpress
APRIL 20, 2023
What type of music do you use while studying? What type of music would you use to fall asleep at night? Have you ever wondered why you choose certain types of music? It turns out that the music used for both these situations is actually pretty similar.
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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.
STAT News
APRIL 20, 2023
President Biden will nominate oncologist Monica Bertagnolli, director of the National Cancer Institute, to lead the National Institutes of Health, three people familiar with the White House’s plans told STAT. Bertagnolli last fall became the first woman to direct NCI, the largest of the NIH’s 27 departments, amid the president’s efforts to relaunch the Cancer Moonshot with the goal of halving cancer deaths and vastly curbing new cases.
Medical Xpress
APRIL 20, 2023
Gut bacteria that break down a sugar called fucose could be dampening our immune response to the COVID-19 mRNA vaccine, according to a study led by researchers from the Okinawa Institute of Science and Technology (OIST).
STAT News
APRIL 20, 2023
The United States is in poor health. Life expectancy rates have dropped precipitously , and racial health disparities continue, with white adults living more than five and a half years longer than Black adults on average. Child and teen mortality rates have also climbed, particularly among youth of color. Our maternal mortality rate is three times higher than those of other developed countries and is especially elevated for Black women.
Medical Xpress
APRIL 20, 2023
In the spiraling cycle that can lead to vision loss in premature newborns, Medical College of Georgia scientists have found a new target and drug that together appear to stop the destruction in its tracks.
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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.
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