Bio Pharma Dive
MAY 1, 2023
Founded by Sam Waksal, Graviton Biosciences is developing drugs that block an enzyme called ROCK2, which drew the interest of neurology-focused Ovid.
Pharmaceutical Technology
MAY 4, 2023
Roche has opened a new institute to accelerate research and development (R&D) in the area of human model systems such as organoids. Situated in Basel, Switzerland, the newly launched Institute of Human Biology (IHB) will accommodate scientists and bioengineers from academia and the pharmaceutical sector. Researchers at IHB will study human biology and speed up the adoption of human model systems in pharmaceutical R&D in addition to clinical practice.
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Medical Xpress
MAY 4, 2023
Secondary bacterial infection of the lung (pneumonia) was extremely common in patients with COVID-19, affecting almost half the patients who required support from mechanical ventilation. By applying machine learning to medical record data, scientists at Northwestern University Feinberg School of Medicine found that secondary bacterial pneumonia that does not resolve was a key driver of death in patients with COVID-19.
Fierce Pharma
MAY 3, 2023
ImmunoGen touts 'home run' as ovarian cancer drug Elahere extends lives in landmark trial win aliu Wed, 05/03/2023 - 14:50
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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.
Bio Pharma Dive
MAY 3, 2023
The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.
Pharmaceutical Technology
MAY 1, 2023
Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share. Both the companies’ Boards of Directors have unanimously approved the deal.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
MAY 2, 2023
World Asthma Day 2023 is on May 2. This annual event is marked on the first Tuesday of May to boost awareness about asthma and help improve asthma care all over the world. The day was first organized in 1998 by the Global Initiative for Asthma (GINA) , a collaboration between healthcare professionals and public health officials, and has since been observed every year.
Bio Pharma Dive
MAY 2, 2023
Fresh off its success with the multiple myeloma treatment Carvykti, J&J is paying Cellular Biomedicine Group $245 million upfront for rights to two experimental cell therapies for blood cancer.
Pharmaceutical Technology
MAY 4, 2023
Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Gene therapy clients will gain access to coordinated scientific expertise, drug development services and AAV manufacturing capabilities, advancing the development of new gene therapies.
Medical Xpress
MAY 1, 2023
Reports of near-death experiences—with tales of white light, visits from departed loved ones, hearing voices, among other attributes—capture our imagination and are deeply engrained in our cultural landscape.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
XTalks
MAY 5, 2023
This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). GSK says the RSV vaccine will be available for older adults before this year’s RSV season, which usually starts before the winter months.
Bio Pharma Dive
MAY 3, 2023
The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.
Pharmaceutical Technology
MAY 4, 2023
Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results.
Medical Xpress
MAY 2, 2023
Rumors of artificial intelligence becoming sentient abound. In July of 2022, a Google engineer claimed that an AI chatbot he was working with had become self-aware. The same AI recently passed the Turing Test, once considered the gold standard for determining if something was human.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Fierce Pharma
MAY 1, 2023
Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy kdunleavy Mon, 05/01/2023 - 07:35
Bio Pharma Dive
MAY 1, 2023
The cash influx extends Maze’s financial runway into 2025, giving the South San Francisco company time to advance other drug candidates into testing.
Pharmaceutical Technology
MAY 3, 2023
Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. First generics are the first opportunity manufacturers have to market new generic drug products in the US. In recent years, first generics have improved patient access to essential treatments and offered affordable treatment options for patients with multiple sclerosis, asthma,
Medical Xpress
MAY 3, 2023
A new study shows that sleep spindles, brief bursts of brain activity occurring during one phase of sleep and captured by EEG, may regulate anxiety in people with post-traumatic stress disorder (PTSD).
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Fierce Pharma
MAY 4, 2023
J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year esagonowsky Thu, 05/04/2023 - 09:58
Bio Pharma Dive
MAY 2, 2023
The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.
Pharmaceutical Technology
MAY 5, 2023
Sanofi Canada has received approval from Health Canada for its Dupixent (dupilumab injection) to treat eosinophilic esophagitis (EoE) in adults and in adolescent patients aged 12 years and above. It is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In Canada, it is commercialised by Sanofi Canada and Regeneron Canada.
Medical Xpress
MAY 3, 2023
A team of researchers at Los Alamos National Laboratory recently published the most comprehensive study of global COVID-19 variant transitions, which showed significant diversity in variant spread around the globe related to vaccination rates, number of co-circulating variants and immunity from previous infection. The paper was published in eBioMedicine.
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XTalks
MAY 4, 2023
Celiac disease is an autoimmune disorder that is triggered by the consumption of gluten, a protein found in barley, wheat and rye. When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. The symptoms of celiac disease can vary and may involve abdominal pain, bloating, diarrhea, weight loss, fatigue and anemia.
Bio Pharma Dive
MAY 4, 2023
After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.
Pharmaceutical Technology
MAY 2, 2023
The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).
Medical Xpress
MAY 3, 2023
Antibiotics administered before and during surgery should be discontinued immediately after a patient's incision is closed, according to updated recommendations for preventing surgical site infections. Experts found no evidence that continuing antibiotics after a patient's incision has been closed, even if it has drains, prevents surgical site infections.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
XTalks
MAY 5, 2023
In the US, food waste is a pervasive problem, with an estimated 30 to 40 percent of the country’s food supply going to waste each year. This amounts to around 133 billion pounds of food, worth an estimated $161 billion, being discarded annually. To combat this issue, companies like Full Harvest and others have emerged to sell surplus or imperfect produce that would otherwise be thrown away.
Bio Pharma Dive
MAY 1, 2023
The company was co-founded by, among others, Jamie Cate, husband of CRISPR pioneer Jennifer Doudna, and Kevan Shokat, a chemical biologist whose previous work helped lead to KRAS-targeting cancer drugs.
Pharmaceutical Technology
MAY 3, 2023
The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). If successful, TN-201 would be a first-in-class disease-modifying gene therapy for MYBPC3-associated HCM. In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.
Medical Xpress
MAY 4, 2023
About a third of children with autism aren't able to speak—but that doesn't mean they're unable to listen and comprehend, a new study reports.
Advertiser: Aggregage
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