Bio Pharma Dive
APRIL 27, 2022
The agency indicated another trial of the drug, developed by Molecular Partners, will be needed. But whether such a study is doable is yet to be determined, according to Novartis' CEO Vas Narasimhan.
pharmaphorum
APRIL 27, 2022
As the landscape of healthcare changes, so too must the way that we interpret and measure performance and success. This is particularly evident in marketing. Before the COVID-19 pandemic, measuring engagement typically involved detailed follow-ups, contacting a pool of practitioners to gauge their awareness of a particular product and then extrapolating that information across the country.
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Bio Pharma Dive
APRIL 27, 2022
HilleVax and Belite Bio could soon become the first biotechs to go public in almost two months, representing a key test of investors’ willingness to support emerging life sciences companies.
Scienmag
APRIL 27, 2022
Since the first successful fabrication of a two-dimensional structure of carbon atoms about 20 years ago, graphene has fascinated scientists. A few years ago, researchers discovered that two layers of graphene, slightly twisted against each other, can conduct electric current without loss. In recent years, this discovery has prompted scientists to explore such layered materials […].
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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
APRIL 27, 2022
The company is the latest in a growing list of gene therapy developers to restructure and cut jobs during an industry-wide downturn.
pharmaphorum
APRIL 27, 2022
Trust in life science companies has fluctuated since the start of the pandemic. The reputation of COVID-19 vaccine makers understandably soared early on, as clinical trials were started and completed in record time, giving hopes to millions of people in lockdown. Since then, inconsistent messaging around the need for booster shots, as well as side effects – no matter how rare – have tarnished their name.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
APRIL 27, 2022
MMM is a global campaign which raises awareness of high blood pressure and its long-term implications
Scienmag
APRIL 27, 2022
India’s bidi cigarette workers need to be at the heart of discussions about finding alternatives to working in the tobacco industry, according to a new study. Credit: Pavan Mukherjee India’s bidi cigarette workers need to be at the heart of discussions about finding alternatives to working in the tobacco industry, according to a new study. […].
pharmaphorum
APRIL 27, 2022
GlaxoSmithKline has made a promising start to 2022 with a 32% rise in group sales, albeit measured against a downbeat first-quarter result in 2021. Vir Biotechnology-partnered COVID-19 antibody Xevudy (sotrovimab) was the big contributor to the improved result, adding £1.3 billion ($1.6 billion) to the company’s top-line of £9.8 billion with no sales recorded in the prior year.
Scienmag
APRIL 27, 2022
The lake level of the Dead Sea is currently dropping by more than one metre every year – mainly because of the heavy water consumption in the catchment area. However, very strong lake level drops due to climate changes are also known from earlier times. At the end of the last ice age, for example, […].
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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
Pharma Times
APRIL 27, 2022
GARDP neonatal sepsis study was carried out in 19 hospitals across four continents
Scienmag
APRIL 27, 2022
A Boston University–led team that has pioneered major advances in our understanding of the bubble protecting the solar system—and all life on Earth—has won a major new grant from NASA. The SHIELD (Solar wind with Hydrogen Ion Exchange and Large-scale Dynamics) DRIVE Science Center has been awarded a new five-year grant to continue advancing its breakthrough work […].
pharmaphorum
APRIL 27, 2022
AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after showing the drug extended survival in patients with HER2-low metastatic breast cancer. The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of c
Scienmag
APRIL 27, 2022
Researchers led by Azusa Inoue at the RIKEN Center for Integrative Medical Sciences (IMS) in Japan have discovered a gene responsible for prenatal death when critical transgenerational instructions are missing from egg cells. Published April 28 in Genes & Development, the study shows that in mice, failed epigenetic suppression of an X-chromosome gene called Xist […].
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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.
NY Times
APRIL 27, 2022
The consulting firm’s top executive was apologetic before Congress but denied that advising both opioid manufacturers and their federal regulator posed a conflict of interest.
Scienmag
APRIL 27, 2022
AMHERST, Mass. – Researchers at the University of Massachusetts Amherst recently announced that they have engineered a new class of material, called a “polyzwitterionic complex,” or “pZC,” which is able to both withstand the harsh acidic conditions of the stomach and then dissolve predictably in the comparatively gentle environment of the small intestine.
NY Times
APRIL 27, 2022
Pills and suppositories that promise to balance the vaginal microbiome are lining drugstore shelves and online marketplaces. But are they backed by science?
Scienmag
APRIL 27, 2022
Scientists at the Centro Nacional de Investigaciones Cardiovasculares (CNIC), in collaboration with an international scientific team, have described a new mechanism of modulation of the mechanical properties of the heart, based on the oxidation of the protein titin, which is the main protein responsible for the passive elasticity of the heart muscle.
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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.
Antidote
APRIL 27, 2022
Antidote and other digital vendors work closely with clinical trial sites to ensure patient enrollment runs smoothly. Among the recruitment solutions we offer to sponsors is site follow-up services. We sat down with Lauren Schill, Senior Manager, Clinical Site Operations, to get her take on why site follow-up is a key component of clinical trial recruitment.
Scienmag
APRIL 27, 2022
Researchers at University of California San Diego School of Medicine and Jacobs School of Engineering, with colleagues at Baylor College of Medicine, have used a systems biology approach to parse the genetic diversity of Clostridioides difficile, a particularly problematic pathogen in health care settings. Clostridoides difficile bacillus”> Credit: Centers for Disease Control and Prevention Researchers […].
BioPharma Reporter
APRIL 27, 2022
Xbiome Inc, a China headquartered AI-based microbiome therapeutics startup, has acquired the clinical-stage M201 program developed by Assembly Biosciences, a firm developing therapeutics targeting hepatitis B virus and other viral diseases.
Scienmag
APRIL 27, 2022
The glass used in vehicle windows and windshields is carefully designed. It must be transparent and strong enough to withstand high-speed winds, resist impacts from debris and provide structural support during collisions. Automotive glass is challenging to make and as a result, challenging to recycle. But researchers are now finding innovative ways to reuse the […].
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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.
The Pharma Data
APRIL 27, 2022
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceutical manufacturing and packaging industry. The Congress gathers pharmaceutical companies, CMOs and CDMOs, governmental bodies together with pharmaceutical equipment providers and service companies. It takes place on June, 20-21, 2022 in Berlin, Germany.
Scienmag
APRIL 27, 2022
Quantum computing holds the potential to be a game-changing future technology in fields ranging from chemistry to cryptography to finance to pharmaceuticals. Compared to conventional computers, scientists suggest that quantum computers could operate many thousand times faster. To harness this power, scientists today are looking at ways to construct quantum computer networks.
The Pharma Data
APRIL 27, 2022
RATIONALE 306 trial met primary endpoint at interim analysis, demonstrating tislelizumab plus chemotherapy significantly improved overall survival compared to chemotherapy alone in patients with previously untreated advanced esophageal squamous cell carcinoma (ESCC) 1 Positive readout in first-line ESCC adds to clinical evidence for tislelizumab in esophageal cancer and follows FDA and EMA filing acceptances for second-line setting Results support development of tislelizumab in potentially syner
Scienmag
APRIL 27, 2022
CHAPEL HILL, NC – Inside embryonic cells, specific proteins control the rate at which genetic information is transcribed from DNA to messenger RNA – a crucial regulatory step before proteins are created. Then, organs develop and hopefully function properly. Those specific “regulatory” proteins are called transcription factors, and they do their thing by binding to […].
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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.
The Pharma Data
APRIL 27, 2022
Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a significant improvement in both progression-free survival and overall survival Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers. The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious conditio
Scienmag
APRIL 27, 2022
The way land resources – soil, water and biodiversity – are currently mismanaged and misused threatens the health and continued survival of many species on Earth, including our own, warns a stark new report from the United Nations Convention to Combat Desertification (UNCCD). Credit: UNCCD The way land resources – soil, water and biodiversity – […].
Drug Patent Watch
APRIL 27, 2022
Annual Drug Patent Expirations for FINTEPLA Fintepla is a drug marketed by Zogenix Inc and is included in one NDA. It is available from one supplier. There are eleven patents…. The post New patent for Zogenix Inc drug FINTEPLA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 27, 2022
Leesburg, VA, April 26, 2022—According to ARRS’ American Journal of Roentgenology (AJR), routine visual ordinal coronary artery calcium (CAC) assessment on all chest CT examinations could identify a large number of patients who might benefit from preventive therapies. Credit: American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR) Leesburg, VA, April 26, 2022—According to […].
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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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