Bio Pharma Dive
APRIL 25, 2023
Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.
Pharmaceutical Technology
APRIL 25, 2023
Assertio Holdings has reached a definitive agreement to purchase all outstanding shares of Spectrum Pharmaceuticals in an all-stock and contingent value rights (CVR) deal. Spectrum is a commercial-stage biopharmaceutical company focused on the acquisition, development and commercialisation of novel and targeted oncology treatments. The company has its own clinical development organisation equipped with regulatory and data management competencies.
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Bio Pharma Dive
APRIL 25, 2023
The company cut about 20 early-stage projects, including nine solid tumor programs, after reviewing their strategic fit and commercial potential.
Pharmaceutical Technology
APRIL 25, 2023
After missing the previous Q1 deadline, bluebird bio has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its sickle cell disease gene therapy lovo-cel, based on an April 24 company announcement. The BLA filing brings bluebird closer to its competitors CRISPR Therapeutics and Vertex Pharmaceuticals , which finished a rolling BLA for their CRISPR-based gene therapy exa-cel for the same condition earlier this month.
Bio Pharma Dive
APRIL 25, 2023
Results from a small trial suggested Morphic's pill could be effective in treating inflammatory bowel disease, briefly lifting the company’s valuation by hundreds of millions of dollars.
Pharmaceutical Technology
APRIL 25, 2023
Cidara Therapeutics announced the receipt of a $20m milestone payment from Melinta Therapeutics following the US Food and Drug Administration (FDA) approval of its antifungal treatment Rezzayo. Rezzayo (rezafungin for injection) is a once-weekly echinocandin for the treatment of invasive candidiasis and candidemia. In July 2022, Cidara gave Melinta US licensing rights for rezafungin following submission to the FDA.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
APRIL 25, 2023
Eli Lilly and Company (Lilly) has entered a definitive agreement to sell its dry nasal spray, Baqsimi, to Amphastar Pharmaceuticals for a cash consideration of $500m. Lilly will receive an additional payment of $125m on the first anniversary of the completion of the deal. Amphastar is expected to make up to $450m in milestone payments based on sales of Baqsimi.
Bio Pharma Dive
APRIL 25, 2023
The planned IPO by the pharma’s consumer arm would value the new standalone company at over $40 billion.
Pharmaceutical Technology
APRIL 25, 2023
Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US. The audit was focused on the quality management systems and platform AAV manufacturing process of the facility.
STAT News
APRIL 25, 2023
As the overdose crisis rages on and the pandemic-fatigued public runs low on empathy, there have been increasing calls for expanded involuntary commitment for people with substance use disorder. Some of the advocacy for more coercive treatment seems rooted in a disdain for people who use drugs, most especially when their drug use occurs visibly and in close geographic proximity to affluence, for example in San Francisco or in the Massachusetts Avenue and Melnea Cass area of Boston which borders
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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 25, 2023
Rhythm Pharmaceuticals has launched Imcivree (setmelanotide) in Germany to treat obesity and control of hunger associated with Bardet-Biedl syndrome (BBS). A melanocortin-4 receptor (MC4R) agonist, Imcivree has been designed for the treatment of hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases. The German Federal Joint Committee (G-BA) has approved the eligibility of Imcivree for federal reimbursement by statutory health insurance for BBS in the count
Medical Xpress
APRIL 25, 2023
In a new study, scientists explored the links between three measures known to independently predict healthy aging: nutrient intake, brain structure and cognitive function. Their analysis adds to the evidence that these factors jointly contribute to brain health in older adults.
Pharmaceutical Technology
APRIL 25, 2023
German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. The deal provides Novartis with exclusive rights across the globe to create and commercialise therapeutic and imaging solutions for 3BP’s entire FAP-targeting peptide technology, including FAP-2286. 3BP receives an initial payment of $40m, and $425m as development, regulatory and commercial milestone
Medical Xpress
APRIL 25, 2023
Research shows that given the difficulties in navigating social relationships, children with more autistic traits might be prone to less attuned self-conscious emotions after transgression (displaying less guilt and embarrassment and more shame).
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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 25, 2023
Global healthcare company AmerisourceBergen has launched a cell and gene therapy (CGT) integration hub. Powered by the company’s customer relationship management system, the CGT integration hub is a platform-agnostic system that aims to improve connectivity across the CGT treatment journey, enhancing the experience for patients and healthcare providers.
Medical Xpress
APRIL 25, 2023
In a study published online in the Schizophrenia Bulletin, researchers from Dr. Wang Wei's lab at the Center for Excellence in Brain Science and Intelligence Technology of the Chinese Academy of Sciences, and Dr. Wang Jijun' team at Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, demonstrated spatial and temporal abnormalities of spontaneous fixational saccades and their correlates with positive and cognitive symptoms in schizophrenia, suggesting that fixational
FDA Law Blog
APRIL 25, 2023
By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.
STAT News
APRIL 25, 2023
This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about The Obesity Revolution. S hira Rosenbluth went on her first diet at 10 years old. It was her own idea: She’d learned that a neighbor was doing some sort of junior WeightWatchers program, and her parents encouraged her to stick with it even after Rosenbluth changed her mind.
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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.
Medical Xpress
APRIL 25, 2023
What is shyness? Research has shown that shyness is characterized by fear and nervousness in response to social novelty and/or social evaluation. Shyness can manifest on behavioral, affective, and physiological levels, but little is known about how these components cluster. Longstanding theories note that shyness may be conceptualized as a trait that is relatively stable across development, which is described as temperamental shyness.
Fierce Pharma
APRIL 25, 2023
FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time aliu Tue, 04/25/2023 - 14:16
Medical Xpress
APRIL 25, 2023
Even mild concussion can cause long-lasting effects to the brain, according to researchers at the University of Cambridge. Using data from a Europe-wide study, the team has shown that for almost a half of all people who receive a knock to the head, there are changes in how regions of the brain communicate with each other, potentially causing long term symptoms such as fatigue and cognitive impairment.
STAT News
APRIL 25, 2023
WASHINGTON — Consumers turning to melatonin gummies to get some help falling asleep might be getting a lot more help than they bargained for, according to a new study published Tuesday in the Journal of the American Medical Association. Researchers tested the melatonin concentration in more than two dozen gummy dietary supplements that recently launched and that were available at mainstream retailers like Amazon and Walmart.
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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.
Medical Xpress
APRIL 25, 2023
An anonymous San Diego resident has become a fascinating example of how the human immune system fights SARS-CoV-2. In a new investigation, scientists from La Jolla Institute for Immunology (LJI) have shown how antibodies, collected from this clinical study volunteer, bind to the SARS-CoV-2 "Spike" protein to neutralize the virus.
STAT News
APRIL 25, 2023
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.
Medical Xpress
APRIL 25, 2023
Researchers at National Jewish Health have found that a subset of children suffering recurring fevers as a result of long COVID-19 have benefited from a daily medication treatment commonly used for gout and periodic fever syndrome. Using the drug colchicine, researchers saw rapid improvement not only in their fevers but also with other long COVID symptoms such as brain fog, fatigue, and achiness.
Drug Discovery World
APRIL 25, 2023
UK-based pharmaceutical company AstraZeneca has seen its market value overtake its US rival Pfizer’s, just days before the company releases its quarterly earnings. AstraZeneca is now topping the London Stock Exchange with a market value of £189 billion – a rise of 19.60% since the same time last year. On the New York Stock Exchange, rival Pfizer’s market value has dropped over 20% this year and currently stands at around £182 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.
Medical Xpress
APRIL 25, 2023
Research has shown that repeated exposure to racism, directly or indirectly, impacts long-term mental health. Now, a licensed professional counselor and psychologist have released a toolkit to not only identify racial trauma but also to heal from it.
XTalks
APRIL 25, 2023
As the 2023-24 US wheat marketing year approaches, there are concerns over a lack of moisture, which could limit yields and production of two of the three largest wheat varieties grown in the US, increasing the risk of above-average flour prices into 2024. The hard red winter and hard red spring wheat classes are facing challenges due to a severe lack of moisture, which could potentially limit yields and production in 2023.
Medical Xpress
APRIL 25, 2023
In the majority of cases, graft failure after heart transplantation is attributable to abnormalities like severe coronary artery disease. As donors with extended criteria like advanced age and pre-existing heart conditions become eligible for heart transplantation, careful screening for congenital abnormalities has become crucial. Invasive coronary angiography is an essential screening tool that can detect coronary artery disease (CAD), a condition characterized by cholesterol deposits in the he
Pharma Times
APRIL 25, 2023
Therapy provides immunisation against infection caused by hepatitis A in children aged 12 months to 15 years
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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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