Bio Pharma Dive
OCTOBER 25, 2022
Chen, who discovered the cancer-protecting protein PD-L1, will work closely with startup Normunity to find targets that can help the immune system reach ‘cold’ tumors.
Pharmaceutical Technology
OCTOBER 25, 2022
Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).
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Bio Pharma Dive
OCTOBER 25, 2022
The company’s latest earnings presentation saw analysts press for more details about the Alzheimer’s drug it’s developing with Eisai — and how the partners plan to avoid some of the pitfalls experienced with Aduhelm.
Pharmaceutical Technology
OCTOBER 25, 2022
BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drug development. Under the joint research project, a new research team will be set up at the BioMed X Institute in Heidelberg, Germany. This team will focus on creating a versatile computational platform that can precisely forecast the first-in-class drug candidates’ efficacy in virtual patient groups.
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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
OCTOBER 25, 2022
The British drugmaker terminated the two alliances following disappointing results this year for a once highly touted cell-based treatment for solid tumors.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 25, 2022
We can add functional mouse hair follicles to body parts that scientists have successfully grown in the lab, outside the body. Using cells obtained from embryonic mice, for the first time researchers were able to produce hair follicle organoids – small, simple versions of an organ – that grew hair. Moreover, they were able to […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 25, 2022
The Siddha medical practitioners working under the Kerala ISM department and assigned with various Central and state government projects have joined hands to form an organisation of government Siddha medical officers on the lines of the Kerala Government Ayurveda Medical Officers Association. The new organisation of Siddha medical officers will be known as ‘Kerala Government […].
Bio Pharma Dive
OCTOBER 25, 2022
“Every struggle that I've had has woven a sense of persistence into my DNA,” said Zhang, in a wide-ranging interview about leading a biotech startup as a young CEO.
NPR Health - Shots
OCTOBER 25, 2022
SARS-CoV-2 is evolving "rapidly," spawning one new variant after another. But omicron continues to dominate, raising new questions about how evolution of the virus is headed.
STAT News
OCTOBER 25, 2022
As MacArthur Foundation fellow Jennifer Richeson noted in The Atlantic in 2020, Americans love to perpetuate narratives of racial progress , regardless of whether that narrative is aligned with reality. We saw this in a recent New York Times essay that claimed the change in Covid-19 death rates is a laudable example of the U.S. overcoming racial injustice.
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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
pharmaphorum
OCTOBER 25, 2022
Novartis has abandoned development of its drug to treat presbyopia, a common age-related loss of near distance vision, after it failed a phase 2b trial. The eyedrop formulation of UNR844 (lipoic acid/choline ester chloride) was acquired as part of the group’s buyout of privately-held ophthalmology biotech Encore Vision for $375 million upfront in 2017, and was designed to work by restoring the elasticity of the eye’s lens that declines with age.
STAT News
OCTOBER 25, 2022
Over the course of the pandemic, online prescribing has been embraced as a powerful tool in health care — not just by patients, but by a growing number of drug companies. Drawn in by the promise of direct access to patients, dozens of pages run by pharmaceutical companies now offer a way for people scrolling their sites to connect directly with a virtual provider who can write a prescription.
NPR Health - Shots
OCTOBER 25, 2022
Philips is trying to fix or replace 5 million of the devices because foam in them can deteriorate into harmful particles. But the process is taking years, forcing some patients to risk their health.
STAT News
OCTOBER 25, 2022
Over the past few weeks, cases of flu have begun to creep up across the U.S., with spikes in the southeast and south central part of the country. Flu hospitalizations are also on the rise. According to the Centers for Disease Control and Prevention’s influenza tracking team, all signs point to an earlier than usual flu season. At the same time, hospitals across the country are filling up with children who’ve contracted RSV — a virus that causes common cold-like symptoms that
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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.
pharmaphorum
OCTOBER 25, 2022
AstraZeneca’s IL-5 inhibitor Fasenra is already making blockbuster sales from its use in eosinophilic asthma, but the drugmaker’s efforts to expand its label keep running into difficulties. Earlier this year, the FDA rejected AZ’s application for Fasenra (benralizumab) as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) with a request for more data.
Pharma Times
OCTOBER 25, 2022
Millions will be invited to join the programme to ‘prevent, detect and treat’ diseases
STAT News
OCTOBER 25, 2022
Imagine that you are the parent of an 11-year-old soccer player who dreams of competing in the Women’s World Cup one day. You want to support her love for the sport while keeping her safe from harm. You are particularly concerned about brain injuries in youth sports, so you look up information about concussion protocols online. Information published by an international group of experts known as the Concussion in Sport Group (CISG) is reassuring.
pharmaphorum
OCTOBER 25, 2022
Healthware, as the key R&D partner, has been supporting Orion Corporation to design and develop a novel treatment, a Digital Therapeutics software solution “ Rohkea ” to treat Chronic Pain ( DTxP ) using Virtual Reality ( VR ). The efficacy and safety of the product has undergone a clinical trial, and the results were very promising.
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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.
STAT News
OCTOBER 25, 2022
The antitrust regulator in Spain has fined Merck approximately $39 million for preventing a competitor from marketing a generic version of a hormonal contraceptive, the latest effort by a European government to crack down on anti-competitive practices in the pharmaceutical industry. In explaining its decision , the National Markets and Competition Commission, or CNMC, pointed to a 2017 court action in which Merck accused another company, Insud Pharma, of violating a patent for a vaginal ring cal
BioPharma Reporter
OCTOBER 25, 2022
Addition, Talis Capital, and Speedinvest were among the investors participating in the round. Seqera Labs had previously secured â4.4m (US$4.3m) in seed funding, plus grants from the Chan Zuckerberg Initiative.
STAT News
OCTOBER 25, 2022
Pacific Biosciences, a Menlo Park, Calif., firm best known for its niche approach to DNA sequencing, on Tuesday announced plans to launch a new product that will put the company in direct competition with genomics juggernaut Illumina. The new DNA sequencer, dubbed Onso, reads the genome in small pieces and uses software to stitch that information together.
pharmaphorum
OCTOBER 25, 2022
The time of healthcare professionals is limited, but systems often rely on them as the principal means to help patients with chronic diseases. Ben Hargreaves finds Partha Kar, an advisor to the UK’s NHS, advocating a different approach – one where patients take the lead. Healthcare systems are currently going through a period of reflection on how to serve the needs of the greatest range of patients possible.
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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.
STAT News
OCTOBER 25, 2022
Top of the morning to you. Gray skies are hovering once again over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us.
BioSpace
OCTOBER 25, 2022
AstraZeneca released data Wednesday morning from two studies in breast cancer: the Phase III CAPItello-291 trial studying capivasertib and the Phase II SERENA-2 trial studying camizestrant.
STAT News
OCTOBER 25, 2022
Our best weapon against cancer may already live inside us — it just needs a little prodding. That’s the premise behind Normunity, which launched Tuesday with $65 million from investors to develop a suite of drugs that it dubs “immune normalizers” to help restore the natural ability of the immune system’s T cells to infiltrate and destroy tumors.
XTalks
OCTOBER 25, 2022
In the late 2010s, Beyond Meat developed the next generation of plant-based meat products, winning over consumers with its innovative new take on the veggie burger. Then it impressed investors in 2019 when it had the most successful stock market debut in over a decade. At its initial public offering (IPO) price, Beyond Meat was valued at $1.46 billion.
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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.
Pharma Times
OCTOBER 25, 2022
A series of virtual hackathons are open for innovators to create a technology-based dementia tool
BioSpace
OCTOBER 25, 2022
FDA scientists raised questions about the efficacy of Y-mAbs Therapeutics’ experimental neuroblastoma treatment, omburtamab, two days before the ODAC meets to discuss data supporting the BLA.
NPR Health - Shots
OCTOBER 25, 2022
In October, the National Institutes of Health reported an increased risk of hormone-related cancers in people who use hair straightening chemicals, which are often Black women.
BioSpace
OCTOBER 25, 2022
Final round interviews can be difficult, especially for those working in a competitive field. To help here are five impressive final-round interview questions for life science professionals.
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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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