Bio Pharma Dive
JUNE 26, 2021
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.
NY Times
JUNE 26, 2021
The settlement agreement came just days before opening arguments in a sweeping trial of several defendants, including the company.
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Scienmag
JUNE 26, 2021
Credit: Mareike Koppik A few males are enough to fertilise all the females. The number of males therefore has little bearing on a population’s growth. However, they are important for purging bad mutations from the population. This is shown by a new Uppsala University study providing in-depth knowledge of the possible long-term genetic consequences of […].
Drug Patent Watch
JUNE 26, 2021
Annual Drug Patent Expirations for SEEBRI Seebri is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are twelve patents protecting…. The post New patent expiration for Novartis drug SEEBRI appeared first on DrugPatentWatch - Make Better Decisions.
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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
Clinical Trial Gurus
JUNE 26, 2021
The 2020s in clinical research are going to be full of opportunities for those willing to spot them out. A recent CRA Academy student just got hired as a remote site monitor for a large contract research organization. Inspiring!
Drug Patent Watch
JUNE 26, 2021
Annual Drug Patent Expirations for APTIOM Aptiom is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are eleven…. The post New patent expiration for Sunovion Pharms drug APTIOM appeared first on DrugPatentWatch - Make Better Decisions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
JUNE 26, 2021
Annual Drug Patent Expirations for UTIBRON Utibron is a drug marketed by Novartis and is included in one NDA. There are thirteen patents protecting this drug. Drug patent litigation for…. The post New patent expiration for Novartis drug UTIBRON appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JUNE 26, 2021
VISION manuscript shows that 177 Lu-PSMA-617 plus standard of care (SOC) significantly improved overall survival and radiographic progression-free survival for patients with metastatic castration-resistant prostate cancer (mCRPC) compared to SOC alone 1 US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to 177 Lu-PSMA-617; regulatory submissions to US and EU Health Authorities on track for 2H21 Novartis is a global leader in radioligand therapy, uniquely positioned wi
Drug Patent Watch
JUNE 26, 2021
UTIBRON (glycopyrrolate; indacaterol maleate) Novartis Patent: 8,956,661 Expiration: Jun 27, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com…. The post Drug Patent Expirations for the Week of June 27, 2021 appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JUNE 26, 2021
Pemetrexed is indicated for patients with non-squamous Non-Small Cell Lung Cancer (NSCLC), who represent over 3 in 4 patients with lung cancer 1 New ready-to-dilute format and 1,000 mg strength option helps avoid unnecessary handling steps to reduce associated contamination risks and patient waiting times 2 The Pemetrexed launch will expand the Sandoz hospital portfolio in key European markets, strengthening access to treatment options for patients.
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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
BioTech 365
JUNE 26, 2021
Investigational 2.0 mg dose of Ozempic® (semaglutide) demonstrates superior reductions in blood sugar vs Ozempic® 1.0 mg in adults with type 2 diabetes in a phase 3 trial Investigational 2.
The Pharma Data
JUNE 26, 2021
Sanofi l aunches € 3 million Planet Mobilization f und to support employees’ environmental projects. This year, Sanofi will fund three employee teams for their environmental programs in Vietnam, Ireland, France, Belgium and Italy In April 2021, Sanofi expanded its social commitments, including its global environmental sustainability program, Planet Mobilization.
BioTech 365
JUNE 26, 2021
Sana Biotechnology Presents Data at ISSCR 2021 Virtual Annual Meeting Showing Survival of Transplanted Hypoimmune Stem Cells Without Immunosuppression in Non-Human Primates Sana Biotechnology Presents Data at ISSCR 2021 Virtual Annual Meeting Showing Survival of Transplanted Hypoimmune Stem Cells Without … Continue reading →
The Pharma Data
JUNE 26, 2021
Sanofi partner ing with leading academic cooperative groups to study a mcenestrant in the adjuvant setting for patients with estrogen receptor positive breast cancer. Sanofi partnering with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and Alliance Foundation Trials (AFT), which are world-leading academic groups delivering practice-changing breast cancer clinical research Collaborating on the Phase 3 AMEERA-6 study expected to be the
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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.
BioTech 365
JUNE 26, 2021
Italfarmaco Announces Topline Data from Phase 2 Trial with Givinostat in Patients with Becker Muscular Dystrophy Italfarmaco Announces Topline Data from Phase 2 Trial with Givinostat in Patients with Becker Muscular Dystrophy — MRI data showed that Givinostat counteracted muscle … Continue reading →
The Pharma Data
JUNE 26, 2021
Sanofi launches its new global employee share ownership plan Sanofi today launches Action 2021, its global employee share ownership plan, open to 92,000 employees in 73 countries. The program, similar to programs carried out since 2013, clearly demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve all employees, across all its territories, in the future development and results of the company. “The record level of employee participation in last year’s share
BioTech 365
JUNE 26, 2021
Arbutus Announces New Data on AB-729 and AB-836 Programs with Presentation of Five Abstracts at the EASL International Liver Congress™ 2021 – All Selected for Best of ILC™ Arbutus Announces New Data on AB-729 and AB-836 Programs with Presentation of … Continue reading →
The Pharma Data
JUNE 26, 2021
Sanofi announced today that its Q2 2021 Memorandum for modelling purposes is available on the “Investors” page of the company’s website: [link]. As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group’s quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count.
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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.
BioTech 365
JUNE 26, 2021
Arrowhead Presents Additional Clinical Data on Investigational ARO-AAT Treatment in Patients with Alpha-1 Liver Disease at EASL International Liver Congress Arrowhead Presents Additional Clinical Data on Investigational ARO-AAT Treatment in Patients with Alpha-1 Liver Disease at EASL International Liver Congress … Continue reading →
The Pharma Data
JUNE 26, 2021
Bone cancer is hard to treat and prone to metastasis. Research teams at Rice University and Baylor College of Medicine have a new strategy to attack it. Chemist Han Xiao at Rice and biologist Xiang Zhang at Baylor and their labs have developed an antibody conjugate called BonTarg that delivers drugs to bone tumors and inhibits metastasis. Their open-access study, which appears in Science Advances, shows how Xiao’s pClick technology can be used to link bone-targeting antibodies and therapeu
Drug Patent Watch
JUNE 26, 2021
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Ireland. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Ireland? appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JUNE 26, 2021
Novartis and Hewlett Packard Enterprise (HPE)announced a collaboration that aims to accelerate the use of data and digital technologies within Novartis efforts to reimagine global health and improve access to healthcare and medicines. The collaboration will focus on three global health enablers: identifying and integrating complex data sources related to health; advancing the application of artificial intelligence, machine learning and geo-spatial analytics to these data; and expanding access to
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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.
BioTech 365
JUNE 26, 2021
Intellia and Regeneron Announce Landmark Clinical Data Showing Deep Reduction in Disease-Causing Protein After Single Infusion of NTLA-2001, an Investigational CRISPR Therapy for Transthyretin (ATTR) Amyloidosis Intellia and Regeneron Announce Landmark Clinical Data Showing Deep Reduction in Disease-Causing Protein After … Continue reading →
The Pharma Data
JUNE 26, 2021
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalised adults and paediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The Pharma Data
JUNE 26, 2021
The U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.
The Pharma Data
JUNE 26, 2021
Application seeks two pediatric indications, including an age-appropriate new weight-based oral suspension formulation to help minimize dosing errors If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in appropriate pediatric patients. RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S.
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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
JUNE 26, 2021
Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Trial will evaluate potential of next generation of influenza vaccines with combined mRNA technology and flu vaccine development expertise Positive preclinical safety and immunogenicity data for mRNA influenza vaccine candidates support initiation of Phase 1 clinical trial Interim data anticipated by the end of 2021; outcomes from this clinical trial will inform next steps of our mRNA-based influenza vaccine prog
The Pharma Data
JUNE 26, 2021
Hip dislocation post hip replacement surgery remains one of the most common causes of revision surgery [i] · Research shows half of acetabular cup implants are unable to achieve their target orientation [ii] due to surgical placement, which can contribute to the risk of hip dislocation, [iii] hip joint wearing out and discomfort [iv] · Johnson & Johnson Medical has entered into an agreement with Navbit to launch Navbit Sprint in Australia – a new navigation system utilising smart senso
The Pharma Data
JUNE 26, 2021
The U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboem
The Pharma Data
JUNE 26, 2021
Early in the COVID-19 pandemic, scientists identified how SARS-CoV-2, the virus that causes COVID-19, gets inside cells to cause infection. All current COVID-19 vaccines and antibody-based therapeutics were designed to disrupt this route into cells, which requires a receptor called ACE2. Now, researchers at Washington University School of Medicine in St.
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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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