AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 27, 2022
The US Food and Drug Administration (FDA) is now warning that breast implants filled with either silicone or saline may, on rare occasions, give rise to cancer in the scar tissue around breast implants. The safety notice was published this month and is based on an extensive review of the emerging literature on breast implants. […].
Pharmaceutical Technology
SEPTEMBER 27, 2022
Pfizer and BioNTech have submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a 10µg booster of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine in children. The companies sought authorisation for booster vaccine usage in children aged five to 11 years. Their application is based on bivalent Omicron BA.1-adapted vaccine’s safety and immunogenicity findings, non-clinical and manufacturing data of 10µg bivalent Omicron BA.4/
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STAT News
SEPTEMBER 27, 2022
The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.
NPR Health - Shots
SEPTEMBER 27, 2022
Montana is one of the latest states to suggest many nonprofit hospitals aren't giving back enough in charitable contributions to the community to justify their tax-exempt status.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 27, 2022
The Indian Institute of Science (IISc) researchers from the Centre for Nano Science and Engineering (CeNSE) have developed fabricated pressure sensors that use paper as the medium which find applications in healthcare. This is because medical treatments depend considerably on accurate and precise measurement of pressure. Now flexible and wearable pressure sensors are typically fabricated […].
STAT News
SEPTEMBER 27, 2022
At the Los Angeles LGBT Center’s sexual health clinic, patients are normally seen within 24 hours. Recently, amid the monkeypox outbreak , it’s been a five-day wait. At Open Door Health, an LGBTQ+ community clinic in Providence, R.I., a standard test for a sexually transmitted infection might take 15 minutes. Testing for monkeypox — between authorizing the test and donning and doffing PPE — has dragged up to an hour.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
SEPTEMBER 27, 2022
Google Cloud and Fitbit are rolling out a new offering they hope will ease some of the challenges hospitals face collecting and processing data from wearable devices. The offering, called Device Connect for Fitbit, is one of the first joint public initiatives since Google acquired Fitbit for $2.1 billion in 2021. The effort underscores the health care opportunities created by the union, pulling from Google’s data crunching expertise and Fitbit’s wearables know-how to re
pharmaphorum
SEPTEMBER 27, 2022
The emergence of PD-(L1) treatments has provided patients options where previously none existed, and the leading forms of these therapies have gone on to blockbuster sales. Ben Hargreaves finds that the next step to enhance these treatments further could be to find synergies with emerging therapies employing similar modes of action, such as therapeutic cancer vaccines.
STAT News
SEPTEMBER 27, 2022
You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system. Sign up here to get it in your inbox. The latest in the Medicare Advantage Discourse. We are at the point in the Medicare Advantage Discourse where health insurers have convinced themselves, and are continuing to try to convince the public, that MA saves taxpayers oodles of money.
FDA Law Blog
SEPTEMBER 27, 2022
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — Similar to what was done with COVID-19, the National Institute for Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has established a Monkeypox Independent Test Assessment Program (ITAP) and it currently accepting new proposals on a rolling basis to address the outbreak.
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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
NPR Health - Shots
SEPTEMBER 27, 2022
Pfzier-BioNTech and Moderna are asking the Food and Drug Administration to authorize the new omicron boosters for young children.
Pfizer
SEPTEMBER 27, 2022
Making a Global Impact in Breast Cancer Care. kimkevin. Tue, 09/27/2022 - 16:39. Making a Global Impact in Breast Cancer Care. Wednesday, May 19, 2021 - 08:00am. Every year, more than 2.1 million people around the world are diagnosed with breast cancer. [1]. While the community has seen many advances in the management of breast cancer, we know that innovation in science does not ensure access to care, quality information and needed support.
Drug Discovery World
SEPTEMBER 27, 2022
Terumo Blood and Cell Technologies (BCT) has launched the Quantum Flex Cell Expansion System, a bioreactor platform that supports process development through to commercial manufacturing for the cell and gene therapy (CGT) sector. . Responding to the industry’s need for earlier automation to potentially limit additional and time-consuming steps such as bridging studies and technology transfers, Terumo BCT says that Quantum Flex allows developers to complete their early process development
Pfizer
SEPTEMBER 27, 2022
Calling All Creatives! We need YOU to design for science! kimkevin. Tue, 09/27/2022 - 17:00. Calling All Creatives! We need YOU to design for science! Monday, April 26, 2021 - 08:00am. More of us than ever need science to restore not just the health of our loved ones, but life as we remember it. The power of science is the key to unlocking the answers to the world’s most challenging medical questions.
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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.
BioPharma Reporter
SEPTEMBER 27, 2022
iBio is jockeying for position as a leading player in AI-powered drug discovery while also expanding its immuno-oncology pipeline after closing on the acquisition of multiple assets from its partner, RubrYc Therapeutics.
Drug Patent Watch
SEPTEMBER 27, 2022
Annual Drug Patent Expirations for MYRBETRIQ+GRANULES Myrbetriq Granules is a drug marketed by Apgdi and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent expiration for APGDI drug MYRBETRIQ GRANULES appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
SEPTEMBER 27, 2022
Emercell has selected Cell-Easy as a long-term CDMO partner for the scale-up and manufacturing operations of its allogeneic NK cell-based product, NK-001.
Drug Patent Watch
SEPTEMBER 27, 2022
Annual Drug Patent Expirations for MYRBETRIQ Myrbetriq is a drug marketed by Apgdi and is included in two NDAs. It is available from three suppliers. There are eight patents protecting…. The post New patent expiration for APGDI drug MYRBETRIQ appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pfizer
SEPTEMBER 27, 2022
Wisconsin is Ready for Cures. kimkevin. Tue, 09/27/2022 - 15:55. Wisconsin is Ready for Cures. Thursday, April 15, 2021 - 08:00am. Pfizer is focused on increasing treatment options for patients through research and development as well as innovative, technically advanced manufacturing practices. We’re proud to be strengthening our capacity to develop and produce more advanced medicines that can help improve the lives of patients.
Drug Patent Watch
SEPTEMBER 27, 2022
Annual Drug Patent Expirations for LYNPARZA Lynparza is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are eleven patents protecting…. The post New patent for Astrazeneca drug LYNPARZA appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
SEPTEMBER 27, 2022
Biogen has finalised a $900 million payment to settle a whistleblower lawsuit claiming that it paid kickbacks to US doctors to prescribe its multiple sclerosis drugs. According to a Department of Justice statement , the payment resolves the suit filed on behalf of the federal government by former Biogen employee Michael Bawduniak, under the whistleblower (qui tam) provisions of the False Claims Act.
Drug Patent Watch
SEPTEMBER 27, 2022
Annual Drug Patent Expirations for TAUVID Tauvid is a drug marketed by Avid Radiopharms Inc and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Avid Radiopharms drug TAUVID 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.
Pfizer
SEPTEMBER 27, 2022
B1801132. vega. Mon, 09/26/2022 - 15:59. Enbrel etanercept PHASE IV Thu, 05/05/2011 - 12:00 Wed, 04/03/2013 - 12:00. NCT01298531 B1801132 Public Disclosure Synopsis.pdf. (1.17 MB).
BioPharma Reporter
SEPTEMBER 27, 2022
Ginko Bioworks, Inizio and Neuway Pharma are among the companies welcoming new faces to top jobs.
Pfizer
SEPTEMBER 27, 2022
Michigan is Ready for Cures. kimkevin. Tue, 09/27/2022 - 15:59. Michigan is Ready for Cures. Monday, March 29, 2021 - 08:00am. Pfizer is focused on increasing treatment options for patients through research and development as well as innovative, technically advanced manufacturing practices. We’re proud to be strengthening our capacity to develop and produce more advanced medicines that can help improve the lives of patients.
Drug Patent Watch
SEPTEMBER 27, 2022
This chart shows the drugs with the most patents in Ukraine. 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 Ukraine? appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pfizer
SEPTEMBER 27, 2022
Improving Access to Cures Through Innovation. kimkevin. Tue, 09/27/2022 - 16:02. Improving Access to Cures Through Innovation. Tuesday, August 18, 2020 - 08:00am. Patients deserve affordable access to the best healthcare possible. That’s why Pfizer invests in research and development: to produce groundbreaking treatments, like the COVID-19 vaccine, that improve people’s lives.
pharmaphorum
SEPTEMBER 27, 2022
While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. Seagen is paying $50 million upfront for global rights to the programme, a bispecific T cell engager intended as a treatment for EGFR-positive solid tumours, with another $650 million at the back end in milestone payments.
Pfizer
SEPTEMBER 27, 2022
Get to Know Our Breakthrough Fellows! kimkevin. Tue, 09/27/2022 - 16:18. Get to Know Our Breakthrough Fellows! Wednesday, July 28, 2021 - 08:00am. At Pfizer, we are so excited to welcome our first class of Breakthrough Fellows to our organization. We believe these students have so much to offer as they grow into the next generation of Pfizer leadership.
XTalks
SEPTEMBER 27, 2022
With a list price of $3 million and a recent accelerated US Food and Drug Administration (FDA) approval, bluebird bio’s gene therapy Skysona (elivaldogene autotemcel, eli-cel), has officially become the world’s most expensive drug. Skysona received FDA approval for the treatment of the rare neurological disorder cerebral adrenoleukodystrophy (CALD).
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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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