BioSpace
AUGUST 15, 2021
?In a preclinical study published in PNAS, scientists from Feinstein Institutes for Medical Research presented a new approach to treating diseases that involve inflammation and pain, like arthritis.
pharmaphorum
AUGUST 15, 2021
In the latest episode of the podcast Dominic Tyer speaks with Dr Maria Ines ‘Mari’ Mitrani, chief science officer at the clinical-stage biopharmaceutical company Organicell Regenerative Medicine. They looked at the development of regenerative medicine and where Organicell hopes to add to that field. Then, with the company pivoting to try and help tackle Covid, they also discussed how that change was made possible and where Organicell’s focus will be.
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BioSpace
AUGUST 15, 2021
In a patent infringement lawsuit filed against Eli Lilly, Teva Pharmaceuticals won three and lost six patents. The patent lawsuit was over Teva’s Ajovy (fremanezumab-vfrm) to prevent migraines.
FDA Law Blog
AUGUST 15, 2021
By Jeffrey K. Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. It is embodied in parallel drug and device regulatory definitions of intended use (21 C.F.R. §§ 201.128 (drugs), 801.4 (devices)).
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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
BioSpace
AUGUST 15, 2021
Codiak has two engineered exosome programs in Phase I, each showing different types of engineering possibilities to deliver targeted payloads that pharmaceutical companies haven’t managed to push all the way through the clinic.
JAMA Internal Medicine
AUGUST 15, 2021
This cohort study evaluates symptoms following vaccination and antibody measurements in hospital workers who received an mRNA SARS-CoV-2 vaccine and had prior SARS-CoV-2 infection.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
JAMA Internal Medicine
AUGUST 15, 2021
This cohort study examines the association between prenatal antipsychotics exposure and the risk of birth and neurodevelopmental problems.
BioSpace
AUGUST 15, 2021
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.
Pharma Business Blog
AUGUST 15, 2021
ESG stands for ‘environmental, social and governance’ – without a doubt a global mega trend, and even more so in the post Covid-19 world. During this webinar, we will look at how a strong ESG proposition can create value. In particular, we will illustrate the value creation process by providing a framework tailored to the pharma value chain to describe the various options.
BioSpace
AUGUST 15, 2021
?The book is being released on August 17 and has a tagline, “A young entrepreneur makes the case that politics has no place in business, and sets out a new vision for the future of American capitalism.
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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
The Pharma Data
AUGUST 15, 2021
Even as several safe and effective COVID-19 vaccines are being administered to people worldwide, scientists are still hard at work developing different vaccine strategies that could provide even stronger or longer-lasting immunity against SARS-CoV-2 and its variants. Now, researchers reporting in ACS Central Science have immunized mice with nanoparticles that mimic SARS-CoV-2 by displaying multiple copies of the receptor binding domain (RBD) antigen, showing that the vaccine triggers robust anti
BioSpace
AUGUST 15, 2021
As the COVID-19 pandemic continues with surges in the U.S. in unvaccinated people, biopharma companies are still working on new vaccines and therapies against the disease.
The Pharma Data
AUGUST 15, 2021
The research found that those with more severe COVID-19 symptoms scored lower on an online series of tests, with performance on reasoning and problem-solving tasks being most affected. Further analysis of the data indicated that those who received mechanical ventilation to help them breathe whilst in hospital had the greatest impairment on cognitive tasks.
BioSpace
AUGUST 15, 2021
This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions.
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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.
The Pharma Data
AUGUST 15, 2021
Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.
BioSpace
AUGUST 15, 2021
If you find yourself in a hybrid work environment where you will be splitting your working hours between the office and home, here are a few tips to help you succeed while working.
The Pharma Data
AUGUST 15, 2021
TICOVAC may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. today announced that the U.S. Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic ar
BioSpace
AUGUST 15, 2021
The U.S. FDA had a very packed calendar for this week, but almost everything on it was under a Priority Review pathway.
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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.
The Pharma Data
AUGUST 15, 2021
WELIREG Approved for Adult Patients With VHL Disease Who Require Therapy for Associated Renal Cell Carcinoma, Central Nervous System Hemangioblastomas, or Pancreatic Neuroendocrine Tumors, Not Requiring Immediate Surgery. WELIREG Expands Merck’s Oncology Portfolio as the First and Only Systemic Therapy Approved for These Patients With VHL Disease. known as MSD outside the United States and Canada, today announced that the U.S.
BioSpace
AUGUST 15, 2021
Merck’s Welireg won FDA approval for adult patients with von Hippel-Lindau disease who require therapy for associated RCC, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors that do not require immediate surgery.
The Pharma Data
AUGUST 15, 2021
Ethicon*, part of the Johnson & Johnson Medical Devices Companies**, today announced the results of a new real-world study that shows its ECHELON CIRCULAR Powered Stapler was associated with a 74% reduction in anastomotic leak rates (1.8% vs. 6.9%) [1] and a 44% reduction in 30-day inpatient hospital readmission rates (6.1% vs.10.8%) after colorectal surgery compared with manual circular staplers. [2].
BioSpace
AUGUST 15, 2021
By administering a vaccine directly into the nasal cavity, the mucus membranes of the nose and throat would provide better protection than the intramuscular alone.
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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
AUGUST 15, 2021
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. The CRL requested an additional clinical trial on the safety of roxadustat in both the NDD and DD patient populations.
BioSpace
AUGUST 15, 2021
Patient enrollment in the Phase I study will resume, the company announced this morning.
Drug Patent Watch
AUGUST 15, 2021
Annual Drug Patent Expirations for BALCOLTRA Balcoltra is a drug marketed by Avion Pharms and is included in one NDA. There is one patent protecting this drug. Drug patent litigation…. The post New patent expiration for Avion Pharms drug BALCOLTRA appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
AUGUST 15, 2021
Eli Lilly has announced the success of its clinical trial on lebrikizumab as a treatment for people diagnosed with moderate to severe atopic dermatitis.
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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.
Drug Patent Watch
AUGUST 15, 2021
Annual Drug Patent Expirations for TRADJENTA Tradjenta is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from three suppliers. There are nine patents…. The post New patent for Boehringer Ingelheim drug TRADJENTA appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
AUGUST 15, 2021
There was plenty of clinical trial updates last week. Here’s a look.
Drug Patent Watch
AUGUST 15, 2021
This chart shows the drugs with the most patents in Portugal. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Portugal? appeared first on DrugPatentWatch - Make Better Decisions.
Clinical Trial Gurus
AUGUST 15, 2021
The clinical research coordinator - clinical research associate work dynamic is one of the most important relationships in all of clinical research. In this video, one of my clinical research coordinators explains what she does to get ready for her interim monitoring visits.
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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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