Bio Pharma Dive
OCTOBER 26, 2021
A new alliance with Mammoth Biosciences marks the latest evidence of Vertex's interest in gene editing, which has already been the focus of multiple deals with emerging biotechs.
World of DTC Marketing
OCTOBER 26, 2021
LEAD-IN: “What is the reason to believe?” It seems like a simple question, doesn’t it yet? In today’s micro-segmented audience environment, it’s often hard to come up with one reason that might resonate with everyone in your target audience. I’ve noticed a trend that’s been emerging in the last couple of years.
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Bio Pharma Dive
OCTOBER 26, 2021
Outside experts are reviewing Pfizer's application for emergency authorization of its vaccine in 5- to 11-year-olds. Follow their discussion with BioPharma Dive reporters live.
Pharma Mirror
OCTOBER 26, 2021
Castle Creek Biosciences Inc., a clinical-stage cell and gene therapy company focused on developing and commercializing disease-modifying therapies for patients suffering from rare diseases for which there is a lack of available treatment options, has formed a new research collaboration with Mayo Clinic. The partnership was forged under the leadership of Castle Creek President and CEO, Mathew Gantz, and direction from Founder and Chairman Jeff Aronin.
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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
OCTOBER 26, 2021
The expert panel pressed Pfizer and the FDA on the shot's safety, but ultimately were convinced by the potential for significant benefit in 5- to 11-year-olds.
BioSpace
OCTOBER 26, 2021
The decision to move forward with the trial comes on the heels of the FDA's approval of its IND application, allowing Cleveland Clinic and Anixa Biosciences to proceed.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
OCTOBER 26, 2021
COVID-19 demonstrated the importance of robust supply chains and the dangers of an over reliance on overseas manufacturing. But can the Pharmaceutical Strategy for Europe help to redress the balance? Only sustainable, robust supply chains and business models will allow innovation to flourish, secure access to medicines, and minimise the industry’s impact on the environment.
Bio Pharma Dive
OCTOBER 26, 2021
The generic drug unit has struggled in recent years, while Novartis has moved to focus more narrowly on higher-margin branded medicines.
pharmaphorum
OCTOBER 26, 2021
Novartis revealed today that it may consider divesting its generic medicines subsidiary Sandoz – amongst other options – which would further narrow its focus to innovative medicines. The company said in its third-quarter results statement that it was weighing options for Sandoz to “maximise shareholder value,” adding that could include retaining the business or a separation – which could involve a spin-off or outright sale.
Bio Pharma Dive
OCTOBER 26, 2021
Alongside a new earnings report, Lilly announced plans for a late-stage study to evaluate whether donanemab is better than Aduhelm at clearing amyloid beta plaques.
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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
BioSpace
OCTOBER 26, 2021
Nuravax is developing a vaccine to induce therapeutically potent concentrations of antibodies against pathological proteins associated with both AD and Parkinson's disease.
Outsourcing Pharma
OCTOBER 26, 2021
Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma.
pharmaphorum
OCTOBER 26, 2021
The EMA has started a rolling review of Merck & Co and Ridgeback Biotherapeutics’ much-anticipated oral antiviral molnupiravir as a treatment for COVID-19 in adults. Molnupiravir is already filed for approval in the US and Canada – where Merck is known as MSD – amid hopes that the drug could be used to protect vulnerable people with mild or moderate COVID-19 from developing severe disease with a drug that can be delivered outside the hospital.
BioPharma Reporter
OCTOBER 26, 2021
The Biosimilars Forum, in partnership with the Pacific Research Institute (PRI), recently released a report and interactive tool highlighting the significant costs that biosimilars can save US states.
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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.
Pharma Times
OCTOBER 26, 2021
The drug acts by inhibiting SARS-CoV-2 from replicating in the human system
BioPharma Reporter
OCTOBER 26, 2021
Researchers say a new technique they have developed paves the way for stem cell therapies to treat central nervous system (CNS) injuries and disease.
XTalks
OCTOBER 26, 2021
After initial rejection from the National Institute for Health and Care Excellence (NICE) last year, the non-departmental public body of the Department of Health in England has now given the green light to the gene silencing treatment Givlaari (givosiran) for the treatment of the rare metabolic disorder, acute intermittent porphyria (AIP). AIP is a type of acute hepatic porphyria (AHP) that can cause severe pain and neurological symptoms, including seizures, due to a buildup of toxic neuroprotei
Triage Cancer
OCTOBER 26, 2021
Nearly two years into the pandemic, COVID-19 policy is helping the cancer community in often unapparent ways. This new legislation is giving relief to people who have lost their jobs, had their hours reduced, lost their insurance, can’t pay their rent, and so much more. But these provisions have also afforded (quite literally) members the cancer community time, financial assistance, resources, and long overdue grace to manage their disease.
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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.
Intouch Solutions
OCTOBER 26, 2021
The dangers of misinformation are often discussed in the context of social media, but this subject is similarly pressing in search. Over the past few years, Google has heightened its scrutiny in a few key verticals, including health, due to the real, human consequences of getting it wrong. Non-branded patient and healthcare provider (HCP) disease awareness (DA) websites present unique challenges when it comes to establishing expertise, authoritativeness, and trustworthiness (E-A-T) in the eyes o
XTalks
OCTOBER 26, 2021
The beloved breakfast bagel is the latest food to experience a better-for-you makeover. While it looks and tastes like a normal one, the Better Bagel has the same carbohydrate content as two slices of bananas, the same sugar content as a stalk of celery and the same protein content as four eggs. So, how did Better Foods, the California-based startup behind the Better Bagel, become the “Beyond Meat of carbs?”.
Scienmag
OCTOBER 26, 2021
Scientists at Cincinnati Children’s appear to have flipped another piece in the underexplored puzzle of male infertility. Credit: Cincinnati Children’s Scientists at Cincinnati Children’s appear to have flipped another piece in the underexplored puzzle of male infertility. In findings published Oct. 26, 2021, in Cell Reports, a team led by co-first authors Anna Heinrich, BS, […].
NY Times
OCTOBER 26, 2021
Once the experts weigh in, the Food and Drug Administration itself makes a decision and then a similar process happens at the Centers for Disease Control and Prevention.
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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.
Scienmag
OCTOBER 26, 2021
For the first time, researchers at the Technical University of Munich (TUM) have successfully used a new X-ray method for respiratory diagnostics with patients. Dark-field X-rays visualize early changes in the alveolar structure caused by the lung disease COPD and require only one fiftieth of the radiation dose typically applied in X-ray computed tomography.
Outsourcing Pharma
OCTOBER 26, 2021
Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma.
Scienmag
OCTOBER 26, 2021
Writing in EMBO reports, researchers at University of California San Diego School of Medicine and Moores Cancer Center at UC San Diego Health describe how a pair of fundamental genetic and cellular processes are exploited by cancer cells to promote tumor survival and growth. Credit: Dr. Cecil Fox , National Cancer Institute Writing in EMBO […].
Pharma Times
OCTOBER 26, 2021
Tucatinib, a tyrosine kinase inhibitor, works by blocking a specific area of the HER2 gene in cancer cells
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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.
Scienmag
OCTOBER 26, 2021
WASHINGTON, October 26, 2021 — Climate change and its consequences are becoming increasingly obvious, and solar cells that convert the sun’s energy into electricity will play a key role in the world’s future energy supply. Credit: Marius Franckevicius WASHINGTON, October 26, 2021 — Climate change and its consequences are becoming increasingly obvious, and solar cells […].
BioSpace
OCTOBER 26, 2021
Pennsylvania-based Ocugen has submitted an Investigational New Drug (IND) to the FDA to run a Phase III trial of India’s BBV152 (Covaxin), a vaccine against COVID-19.
Scienmag
OCTOBER 26, 2021
A new collaboration between UC Santa Barbara researchers and Cisco Systems aims to push the boundaries of quantum technologies. Assistant professors Yufei Ding and Galan Moody have received research awards from the technology giant to work with its new Quantum Research Team, which was formed to pursue the research and development required to turn quantum hardware, software and applications […].
BioSpace
OCTOBER 26, 2021
The growth includes the tripling of its headcount to 120 employees and more than 30 partnerships with leading universities and institutions.
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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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