Bio Pharma Dive
JUNE 15, 2021
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
World of DTC Marketing
JUNE 15, 2021
QUICK POINTS: Telemedicine claims as a proportion of all commercial health insurance claims decreased by 5.1% nationwide from February to March, after a steeper decline of 15.7% from January to February as vaccination efforts increased and COVID-19 increased. Cases declined as a result. Telehealth claims accounted for 7% of all medical claims positions in January, before falling to 5.9% in February and 5.6% in March, suggesting a steady slowdown in virtual care demand this year.
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Bio Pharma Dive
JUNE 15, 2021
A deal with biotech startup Capsida, which recently raised $140 million, gives CRISPR access to a Caltech technology that aims to improve the delivery of genetic medicines.
pharmaphorum
JUNE 15, 2021
NHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot study of the technology, according to chief executive Sir Simon Stevens. The diabetics will be offered the closed-loop systems, which continually monitor glucose levels in the blood and uses the data to automatically adjust the dose of insulin delivered by an externally worn pump, at around 25 specialist centres across England.
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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
JUNE 15, 2021
Another gene therapy from Nightstar Therapeutics, which Biogen bought for $800 million in 2019, has failed in a key clinical study.
Pharma Times
JUNE 15, 2021
New real world data from PHE shows vaccines can protect against hospitalisation caused by variant
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JUNE 15, 2021
Repurposed drugs became the front-line defense against COVID-19 within a few months of the pandemic’s emergence. Now bucillamine, currently in Phase III trials in the U.S., may be poised to join them.
BioPharma Reporter
JUNE 15, 2021
Ocugen has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVID-19 vaccine candidate COVAXIN, ready for potential commercial manufacture for the US and Canadian markets.
pharmaphorum
JUNE 15, 2021
When Biogen acquired Nightstar Therapeutics in 2019, it added a pair inherited retinal disorder (IRD) gene therapies that it hoped would accelerate a push into the fast-evolving category. . Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal.
BioPharma Reporter
JUNE 15, 2021
New analysis by PHE shows for the first time that two doses of the COVID-19 vaccines produced by Pfizer and AstraZeneca offer are highly effective against hospitalization from the Delta variant.
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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
Drug Patent Watch
JUNE 15, 2021
Annual Drug Patent Expirations for ARMONAIR+RESPICLICK Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are nineteen…. The post New patent for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
JUNE 15, 2021
Co-administration of Novavaxâs COVID-19 vaccine candidate and an approved influenza vaccine induced robust immune responses, according to data from a clinical trial. âThe findings suggest simultaneous vaccination may be a viable immunization strategy,â says the company.
Drug Patent Watch
JUNE 15, 2021
Annual Drug Patent Expirations for AIRDUO+DIGIHALER Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from three suppliers. There are twenty-five…. The post New patent for Teva Pharm drug AIRDUO DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 15, 2021
Small island hosts world’s largest night roost for whimbrel Credit: Matt Aeberhard/Cornell Lab of Ornithology CHARLESTON, S.C. (June 15, 2021) – It’s not every day that someone discovers a new-to-science bird migration spectacle. It’s even more unexpected that such an encounter – in this case, tens of thousands of shorebirds gathering during their annual journey […].
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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.
Drug Patent Watch
JUNE 15, 2021
Annual Drug Patent Expirations for DEXYCU+KIT Dexycu Kit is a drug marketed by Eyepoint Pharms and is included in one NDA. There are five patents protecting this drug. This drug…. The post New patent for Eyepoint Pharms drug DEXYCU KIT appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 15, 2021
Credit: University of Notre Dame Many cosmetics sold in the United States and Canada likely contain high levels of per- and polyfluoroalkyl substances (PFAS), a potentially toxic class of chemicals linked to a number of serious health conditions, according to new research from the University of Notre Dame. Scientists tested more than 200 cosmetics including […].
Drug Patent Watch
JUNE 15, 2021
Annual Drug Patent Expirations for AIRDUO+RESPICLICK Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from three suppliers. There are twenty-one…. The post New patent for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 15, 2021
Newly FDA-approved imaging agent now available for patients Credit: Images courtesy of Lantheus Holdings, Inc., Billerica, MA. Reston, VA (Embargoed until 3:00 p.m. EDT, Tuesday, June 15, 2021)–A phase III clinical trial has validated the effectiveness of the prostate-specific membrane antigen (PSMA)-targeted radiotracer 18F-DCFPyL in detecting and localizing recurrent prostate cancer.
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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
JUNE 15, 2021
Both MannKind and United Therapeutics entered into a global and exclusive licensing and collaboration agreement to develop and commercialize Tyvaso DPI.
Scienmag
JUNE 15, 2021
Credit: Green Science Policy Institute Makeup wearers may be absorbing and ingesting potentially toxic per- and polyfluoroalkyl substances (PFAS), according to a new study published today in Environmental Science & Technology Letters. The researchers found high fluorine levels–indicating the probable presence of PFAS–in most waterproof mascara, liquid lipsticks, and foundations tested.
BioSpace
JUNE 15, 2021
?The new data shows REGEN-COV reduced the risk of death in hospitalized patients unable to mount their own immune response by 20%.
Scienmag
JUNE 15, 2021
Credit: Purdue Univeristy/Rebecca McElhoe Humans can do lots of things that plants can’t do. We can walk around, we can talk, we can hear and see and touch. But plants have one major advantage over humans: They can make energy directly from the sun. That process of turning sunlight directly into usable energy – called […].
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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.
Drug Patent Watch
JUNE 15, 2021
Annual Drug Patent Expirations for ARMONAIR+DIGIHALER Armonair Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are twenty-one…. The post New patent for Teva Pharm drug ARMONAIR DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 15, 2021
Credit: Virginia Tech “The picture we have in our mind of air pollution is black smoke billowing out of a smokestack or tailpipe,” said Gabriel Isaacman-VanWertz, assistant professor of civil and environmental engineering. “But the truth is that it is much more complicated.” The atmosphere behaves like a giant chemical reactor driven by the sun, […].
BioSpace
JUNE 15, 2021
The Paris-based biotech will use the funds to create targeted immuno-oncology treatments for a broader range of patients with its next-generation CAR-T and epigenetics platform.
Scienmag
JUNE 15, 2021
Credit: Mark Stirling For the first time, researchers have used precariously-balanced rocks to set the formal design earthquake motions for a major existing engineered structure–the Clyde Dam, the largest concrete dam in New Zealand. Mark Stirling of the University of Otago and colleagues identified and assessed the ages of these gravity-defying rock formations located about […].
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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.
BioSpace
JUNE 15, 2021
In an eight page letter to U.S. DOH and Human Services Secretary Xavier Becerra, Public Citizen said Woodcock and other FDA officials should resign.
Scienmag
JUNE 15, 2021
Convergence of semiconductor physics and electrochemistry leads to effective inhibition of dendrite formation using semiconducting passivation layers Credit: Korea Institute of Science and Technology(KIST) Despite rapid development of electric vehicles (EVs), the safety of the lithium-ion (Li-ion) batteries remains a concern as they are as a fire and explosion risk.
XTalks
JUNE 15, 2021
Kraft Heinz announced last week it has completed the sale of its nut business to fellow food giant Hormel Foods for $3.35 billion. The deal, originally announced on February 11 , includes most products sold under the Planters brand, as well as Cheez Balls, Cheez Curls and Corn Nuts branded products. The sale also includes global intellectual property rights to the Planters and Corn Nuts brands and three associated production facilities. .
Scienmag
JUNE 15, 2021
Responsibility for the safety, integrity and scientific validity of the trials fell to 12 experts of the COVID-19 Vaccine Data and Safety Monitoring Board, who now have taken the unusual step of publishing details of their review process Credit: UAB BIRMINGHAM, Ala. – Clinical evaluation of three COVID-19 vaccine candidates in 2020-21 during a worldwide […].
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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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