Bio Pharma Dive
JULY 12, 2022
A former Celgene executive, Jackie Fouse has led Agios since 2019, overseeing its transformation into a company focused solely on uncommon diseases. In August, she will transition to chair its board of directors.
Pharmaceutical Technology
JULY 12, 2022
Vertex Pharmaceuticals has signed a definitive agreement for the acquisition of biotechnology company ViaCyte in a deal totalling $320m in cash. ViaCyte focuses on offering new stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D). Through the acquisition, Vertex plans to advance its potentially curative VX-880 programmes in T1D.
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Bio Pharma Dive
JULY 12, 2022
A patient in New Zealand became the first person to receive the biotech’s medicine, which uses base editing to turn off a specific gene in the liver and thereby lower cholesterol.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 12, 2022
The World Health Organization said Wednesday it will reconvene its monkeypox experts to decide if the worsening outbreak now constitutes a global public health emergency – the highest level of alert. The UN health agency’s director-general Tedros Adhanom Ghebreyesus said he would hold a second meeting of the emergency committee on monkeypox, with more than […].
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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
JULY 12, 2022
Areteia Therapeutics will receive $350 million from Bain and others to advance a drug that was previously licensed to Biogen for testing as an ALS treatment.
Pharmaceutical Technology
JULY 12, 2022
Health Canada has accepted to review Arcutis Biotherapeutics’ New Drug Submission (NDS) for roflumilast cream 0.3% (ARQ-151) to treat plaque psoriasis in adult and adolescent patients. The Roflumilast cream is a once-a-day topical formulation of the selective phosphodiesterase type 4 (PDE4) inhibitor, roflumilast. A validated target in dermatology, PDE4 is an enzyme that induces overactive immune responses.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 12, 2022
Novavax has signed an agreement with the US Department of Health and Human Services (HHS), in partnership with the Department of Defense, under which the US government will procure 3.2 million doses of the company’s Covid-19 vaccine, NVX-CoV2373, in the initial stage. The order is contingent on the vaccine obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) as well as the Centers for Disease Control and Prevention (CDC) recommendation.
STAT News
JULY 12, 2022
The death certificate made everything worse. Seth Fischer was already angry: a physical feeling, an overwhelming internal buzz. He would go for runs, only to find himself passing the white bulk of mobile morgues, refrigeration whirring — and his mind would end up back on his dad, in respiratory distress, dying of Covid or Alzheimer’s, he’d never know which.
Pharmaceutical Technology
JULY 12, 2022
The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands. An analysis of GlobalData’s Pharma Intelligence Centre for cell therapies in major oncology indications in the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan and China) suggests that acute lymphocytic leukaemia (ALL) dominates that pipeline, with mo
Rethinking Clinical Trials
JULY 12, 2022
The NIA IMPACT Collaboratory will publish new funding opportunities on August 15 for a pilot grants program and a demonstration projects program. The 1-year pilot grant awards will be eligible for funding of up to $175,000. The awards will support pilot projects that aim to generate preliminary data for the design and conduct of full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons living with Alzheimer disease and related dementias and
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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
JULY 12, 2022
Mentions of digitalization within the filings of companies in the pharmaceutical industry fell 38% between the first and second quarters of 2022. In total, the frequency of sentences related to digitalization between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.
NPR Health - Shots
JULY 12, 2022
Doctors say they're seeing a surge in the number of women who want their "tubes tied." But hospital capacity, paperwork, religion and personal opinion are just some of the reasons requests get denied.
pharmaphorum
JULY 12, 2022
Going beyond the pill is proving to be a win/win for patients and pharma alike – because improved outcomes are better for everyone. With growing numbers of people around the world living with long-term conditions, the pharmaceutical industry has a golden opportunity to use its expertise to truly enhance lives. But innovative new products are only part of the equation, because even the most efficacious drugs will only work as part of a holistic programme of care that includes mental health suppor
NPR Health - Shots
JULY 12, 2022
Monkeypox has been a developing problem for decades and the current global outbreak was avoidable, but the looming threat was largely ignored, according to a leading expert on the virus.
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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.
STAT News
JULY 12, 2022
Resistance to medicines for combating superbugs has considerably worsened during the pandemic, with deaths and infections from several serious pathogens increasing at least 15% during the first year of the crisis, according to a new report by the Centers for Disease Control and Prevention. The increased rates for some infections, however, were much larger.
NPR Health - Shots
JULY 12, 2022
A new study finds American companies are using remote work as a way to avoid giving workers raises; so much so that it's helping to moderate inflation.
BioSpace
JULY 12, 2022
An NIH-sponsored trial assessing a combination of Humanigen's lenzilumab and Gilead Sciences’ remdesivir in hospitalized COVID-19 patients failed to achieve the primary endpoint.
STAT News
JULY 12, 2022
After a decade-long wait, the Food and Drug Administration finally issued a proposed rule in late June that would make it easier for pharmaceutical companies to switch products from prescription-only to over-the-counter status while still retaining a prescription version. Under the rule, patients would enjoy access to medications that previously required an office visit and a prescription, while payers would reap the financial benefits of fewer medical and prescription claims.
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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.
BioPharma Reporter
JULY 12, 2022
Vertex Pharmaceuticals will acquireÂViaCyte, a privately held biotech focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), forÂ$320m.
STAT News
JULY 12, 2022
Somewhere in New Zealand, the first patient ever has been dosed with a kind of gene-editing treatment known as a base editor, a newer way of utilizing CRISPR for gene editing. The company studying the treatment, Verve Therapeutics, announced the news Tuesday. The treatment is aimed at a relatively common form of high cholesterol that affects millions of people, a very different population than those normally treated with gene therapies.
BioSpace
JULY 12, 2022
Sanofi, Certara, Pfizer and Thermo Fisher are facing hiring challenges head-on with a common strategy: upskilling programs. They use these programs to fill open roles while training and retaining existing talent.
STAT News
JULY 12, 2022
A standard screening test given to newborns minutes after birth is a less accurate predictor of infant mortality for Black babies than other children, a new study shows, but the authors said the Apgar test should still be used. The study , published Tuesday in PLOS Medicine, found that more Black infants were assigned low Apgar scores than white infants and that the scores were better at predicting death in the first year of life in white infants compared with Black babies.
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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.
XTalks
JULY 12, 2022
Magnetic resonance imaging specialist Bruker has developed a new nuclear magnetic resonance (NMR)-based molecular research tool for the assessment of the risk of Long COVID, also known as Post-Acute Covid Syndrome (PACS), including multi-organ damage and cardiovascular disease risk associated with the infection. The phenomics clinical research tool is called the PhenoRisk PACS RuO and is currently being developed for research use only.
STAT News
JULY 12, 2022
Jackie Fouse is stepping down as CEO of Agios Pharmaceuticals, replaced by Brian Goff, a former executive with Alexion Pharmaceuticals, the company announced Tuesday. Fouse will remain with Agios as its new board chairperson. Agios is framing the management reshuffle as the latest in a series of deliberate, strategic decisions to bolster the company’s future by pivoting toward the development of drugs for genetically-defined diseases.
BioSpace
JULY 12, 2022
Atara announced that it has completed an interim analysis of its Phase II EMBOLD trial for the use of its candidate ATA188 in patients with progressive multiple sclerosis.
XTalks
JULY 12, 2022
The Kellogg Company is partnering with television channel Nickelodeon to launch Apple Jacks Slime cereal in a green apple flavor. The new Apple Jacks flavor features the classic orange and green cereal loops with the addition of green specks that turn milk a bright green shade, the same color as the Nickelodeon channel’s infamous slime. “Both known for our bright orange and green colors, Kellogg’s Apple Jacks and Nickelodeon Slime are a perfect pairing,” said Sadie Garcia, director of brand mark
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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.
BioSpace
JULY 12, 2022
???????Early data from Amgen's ongoing trial on Lumakras for non-small cell lung cancer hinted at positive results from what could be a transformative combination of drugs versus cancer.
Olympian Clinical Research
JULY 12, 2022
Depression is an illness that affects nearly 280 million people worldwide. There are several types of depression, each with its own set of symptoms and recommended treatment methods. Therefore, overcoming depression requires understanding the type of depression you may be facing and getting the proper help. 1. Major Depressive Disorder. Major depressive disorder ( MDD ), also known as clinical depression, is characterized by a persistent feeling of sadness or emptiness lasting for at least two w
BioSpace
JULY 12, 2022
The pace of unicorn creation – which is still quite fast – is slowing as economists predict a coming recession. BioSpace sought out the perspective of four experts.
Pharma Tutor
JULY 12, 2022
FACTOR AFFECTING ON THE DANDRUFF GROWTH AND THE IMPACT OF NATURAL HERBS AS AN ANTI-DANDRUFF AGENT. About Authors. Avdesh Thassu. MPharm.(Nat. Chem.); MBA (Mkt.). Associate Vice President. Global Regulatory Affairs, Emami Limited, 7044455199. athassu@hotmail.com. Chandra Mohan Nandi. MSc.(Med. Chem.). Deputy Manager, Global Regulatory Affairs, Emami Limited, 9051706947. chandramohannandi@yahoo.in. admin.
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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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