AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2022
The husband-and-wife team who co-founded BioNTech, the biotechnology company that partnered with Pfizer to develop an effective messenger-RNA (mRNA) shot against COVID-19, has predicted that a cancer vaccine could be widely available within the next decade. “Yes, we feel that a cure for cancer, or to changing cancer patients’ lives, is in our grasp,” said […].
STAT News
OCTOBER 16, 2022
In an unusual step, the European Public Prosecutor’s Office (EPPO) confirmed it has opened an investigation into the Covid-19 contracts signed by the European Union, a move that comes shortly after numerous members of the European Parliament harshly criticized a lack of transparency surrounding an agreement with Pfizer. The EPPO is an independent public prosecution office that is responsible for investigating, prosecuting, and bringing to judgment crimes such as fraud, money laundering an
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NPR Health - Shots
OCTOBER 16, 2022
A theory about online candle reviews and COVID cases was put under the microscope, and has taken on new relevance amid concern at the lack of official data heading into another winter.
STAT News
OCTOBER 16, 2022
When it comes to eradicating infectious diseases, there can be no half measures: it’s an all-or-nothing proposition. For more than three decades, eradicating polio — removing it from the face of the earth — has been the sole mission of the Global Polio Eradication Initiative (GPEI). But now, after helping drive down the global number of cases by 99.9%, and with the wild poliovirus only endemic in just two countries, this incredible initiative is in danger of becoming a victi
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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
NPR Health - Shots
OCTOBER 16, 2022
If you often have pain, bloating, urgency or other symptoms of gastrointestinal distress, you may have IBS. Here's how to find relief, using the latest science and a new generation of apps.
FDA Law Blog
OCTOBER 16, 2022
By Kurt R. Karst — Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that James E. Valentine will become the firm’s newest Director beginning on January 1, 2023. James’s practice focuses on regulatory considerations for developing new drug and biologic products and FDA regulatory requirements for approval/licensure. James has been involved with the approval of many new molecular entities, often for serious and rare diseases, several which utilized the accelerated approval
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 16, 2022
An analysis of un-blinded interim data showed fosgonimeton provided clinically meaningful improvements in cognition and function in patients with mild-to-moderate Alzheimer's disease.
NPR Health - Shots
OCTOBER 16, 2022
NPR's Ayesha Rascoe talks with Dr. Matthew Durstenfeld, co-author of a new study looking at the effects of long COVID on a person's ability to exercise.
BioSpace
OCTOBER 16, 2022
In the wake of a global pandemic and economic downturn, the hiring market has turned on its head. BioSpace spoke with PharmaLogics Recruiting to learn how employers can stay competitive.
JAMA Internal Medicine
OCTOBER 16, 2022
This cohort study assesses whether exposure to particulate matter 2.5 ?m or less in diameter and its constituents was associated with increased mortality, worse baseline lung function, and more rapid decrease in lung function among patients with fibrotic interstitial lung disease.
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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 16, 2022
Kineta struck a collaboration deal with Merck to pair its anti-VISTA monoclonal antibody with Keytruda (pembrolizumab) as a potential treatment for advanced solid tumors.
Fossil Remedies
OCTOBER 16, 2022
When you launch a PCD pharma company , you have to do several preparations. Of course, the first and foremost thing is to arrange funds. Without money, it is impossible to launch a business. The next important consideration is a proper distribution channel from the manufacturer to end customers. In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies.
BioSpace
OCTOBER 16, 2022
Sage Therapeutics and Biogen’s zuranolone met its primary and key secondary endpoints in the Phase III SKYLARK study of women with postpartum depression (PPD).
Drug Patent Watch
OCTOBER 16, 2022
Annual Drug Patent Expirations for WELCHOL Welchol is a drug marketed by Cosette and is included in four NDAs. It is available from three suppliers. There are two patents protecting…. The post New patent expiration for Cosette drug WELCHOL appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioSpace
OCTOBER 16, 2022
Finding chemistry jobs in the life sciences industry doesn't have to be difficult. Discover the top chemistry job options in the life sciences in our comprehensive guide.
Drug Patent Watch
OCTOBER 16, 2022
Annual Drug Patent Expirations for EPRONTIA Eprontia is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. The generic ingredient in EPRONTIA…. The post New patent for Azurity drug EPRONTIA appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 16, 2022
Shares of Massachusetts-based Minerva Neurosciences dropped Monday after the FDA issued a Refuse to File letter for the company's schizophrenia drug, roluperidone.
Drug Patent Watch
OCTOBER 16, 2022
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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.
BioSpace
OCTOBER 16, 2022
Biogen announced the FDA has extended its review for ALS drug tofersen by three months. The regulator set a new PDUFA action date set of April 25, 2023.
Drug Patent Watch
OCTOBER 16, 2022
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BioSpace
OCTOBER 16, 2022
SURGE Therapeutics announced $26 million in Series A financing to address surgery-induced immune suppression and prevent post-surgical cancer recurrence and metastasis.
Drug Patent Watch
OCTOBER 16, 2022
This chart shows the drugs with the most patents in Croatia. 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 Croatia? appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioSpace
OCTOBER 16, 2022
Milestone Pharmaceuticals reported highly positive data from its Phase III RAPID trial of etripamil in paroxysmal supraventricular tachycardia (PSVT) patients.
BioSpace
OCTOBER 16, 2022
NeuBase announced a strategic restructuring, diverting resources from its Huntington's program and shedding 60% of its workforce.
BioSpace
OCTOBER 16, 2022
After suffering a blow to its multi-billion dollar liver cancer program, BridgeBio presented early but promising data in ultra-rare Canavan disease.
BioSpace
OCTOBER 16, 2022
With military precision and academic ingenuity, Israel is building a thriving biotech ecosystem. Venture capitalists would do well to pay attention.
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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.
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