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 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.
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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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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
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 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.
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
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 3, 2023
Scientists of the Princess Máxima Center for pediatric oncology and Hubrecht Institute in the Netherlands have revealed new scientific insights into the features of fibrolamellar carcinoma (FLC), a rare type of childhood liver cancer.
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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
Fierce Pharma
MAY 2, 2023
Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets kdunleavy Tue, 05/02/2023 - 09:27
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 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 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.
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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.
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 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 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 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).
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.
Antidote
MAY 3, 2023
Every May is dedicated to Skin Cancer Awareness Month — a national observance designed to raise awareness around skin cancer and encourage people to practice smart prevention tactics as spring transitions into summer. Though skin cancer is the most common type of cancer , forming good sun safety habits can have a direct link to a reduction in its prevalence.
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.
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.
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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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.
BioPharma Reporter
MAY 2, 2023
Cytiva and the life sciences business of Pall Corporation are now united as one business under the Cytiva brand, with the completion of the integration announced this morning. Emmanuel Ligner, Danaher Group Executive, President and CEO of Cytiva, tells us how the company will focus its efforts moving forward to support long-term growth of the biotech industry.
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.
Pharma in Brief
MAY 1, 2023
On April 20, 2023, the federal government tabled legislation ( Bill C-47 ) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment ( PTA ) into Canada. Canada is required under the Canada-United States-Mexico Agreement ( CUSMA ) to adopt a PTA system by 2025. The PTA system is intended to compensate patentees for “unreasonable delays” by the patent office in issuing a patent.
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.
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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.
ACRP blog
APRIL 30, 2023
Achieving a clinical research environment that is more diverse, equitable, and inclusive relies on all stakeholders deliberately moving from intention to action, attendees of the ACRP 2023 conference in Dallas, Texas, were told on Sunday morning (April 30). During a panel discussion moderated by Audrey Cavenecia, Chief Experience Officer for Reveles Clinical Services, thought leaders in the realm of increasing representation of persons of all types among both the members of the clinical research
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.
XTalks
MAY 1, 2023
It has been a little over a year since Axonics released its “Find Real Relief” TV ad campaign for overactive bladder and incontinence issues, and the company’s annual performance numbers are in. Axonics reported a 2022 revenue of $273.7 million, an increase of 52 percent compared to 2021. The company’s CEO Raymond W. Cohen said in a recent news release that “We continue to make progress on several key initiatives, including our direct-to-consumer advertising campaign.
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.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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