Bio Pharma Dive
DECEMBER 17, 2021
The Luxturna developer, now owned by Roche, will invest $575 million to build a huge research and development center on Drexel University's campus.
World of DTC Marketing
DECEMBER 17, 2021
The public has been told that pharma needs money to develop new drugs, but unfortunately, that’s a huge lie. As biopharmadive recently, “some of the biggest pharmaceutical companies, sitting on large and growing sums of cash, are funneling those funds into major share buyback programs and acquisitions of smaller biotech companies. On Thursday, Swiss drug-making giant Novartis announced plans to buy back up to $15 billion worth of its shares by end of 2023, a program it will fund wi
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Bio Pharma Dive
DECEMBER 17, 2021
The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks.
pharmaphorum
DECEMBER 17, 2021
The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug. The companies had already indicated that the CHMP looked likely to turn down their marketing application for Aduhelm (aducanumab), but the decision nevertheless is a heavy blow, coming as take-up of the drug has pretty much stalled in the US.
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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
Pharma Marketing Network
DECEMBER 17, 2021
The pharma industry has been slower to embrace digital technologies than other less-regulated sectors but the COVID-19 pandemic has greatly changed this long-standing mindset. In 2020 and 2021, we saw pharma forced to become more flexible and open-minded than ever before. In this article, R.J. Lewis, Founder & CEO of eHealthcare Solutions and Tap Native, offers his top ten predictions for what’s ahead for pharma in 2022.
pharmaphorum
DECEMBER 17, 2021
The EMA’s human medicines committee has said that EU member states can start to offer Pfizer’s oral antiviral Paxlovid as a treatment for people with COVID-19 outside hospital, ahead of a formal approval for the drug. The decision comes amid rising rates of infection and deaths due to COVID-19 across the EU, and with 529 new cases of the worrisome Omicron variant reported in member states yesterday, taking the total number to 3,158.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
DECEMBER 17, 2021
A judge in the US has rejected the bankruptcy plan proposed by Purdue Pharma to settle legal action over its role in the opioid crisis , because of the protection from civil litigation it includes for the Sackler family that owns the drugmaker. Judge Colleen McMahon has thrown out the plan in a New York court, in a move that would remove the shield handed to the Sackers in return for a $4.5 billion payout to projects intended to support victims of the opioid crisis over a nine-year period.
XTalks
DECEMBER 17, 2021
Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year continued to be dominated by COVID-19, and the second year of the pandemic was all about vaccines. With Pfizer-BioNTech and Moderna leading with their innovative mRNA-based COVID-19 vaccines, the first mRNA vaccines of any kind, other vaccine makers like AstraZeneca and Johnson & Johnson suffered more setbacks th
pharmaphorum
DECEMBER 17, 2021
There is no doubt that the COVID-19 pandemic has accelerated the adopt of digital health. As this issue’s contributors discuss, the rapid transition to digital has showcase the potential of technology across the industry, but how can we continue this momentum beyond the pandemic? Read on for a look at some of the biggest stories from Frontiers Health, how digital is making healthcare more patient-friendly and key ways to optimise decentralised clinical trials.
Drug Patent Watch
DECEMBER 17, 2021
Annual Drug Patent Expirations for NUPLAZID Nuplazid is a drug marketed by Acadia Pharms Inc and is included in two NDAs. It is available from one supplier. There are eighteen…. The post New patent for Acadia Pharms drug NUPLAZID appeared first on DrugPatentWatch - Make Better Decisions.
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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
pharmaphorum
DECEMBER 17, 2021
After three years of availability via the Cancer Drugs Fund (CDF), MSD’s checkpoint inhibitor Keytruda has now been approved for routine NHS use after surgery for people with melanoma to prevent the cancer returning. PD-1 inhibitor Keytruda (pembrolizumab) has been recommended by NICE for adjuvant treatment of adults with stage 3 melanoma that has spread to the lymph nodes, aiming to remove any cancer left behind after surgery.
Scienmag
DECEMBER 17, 2021
Bilge Yildiz’s research impacts a wide range of technologies. The members of her lab study fuel cells, which convert hydrogen and oxygen into electricity (and water). They study electrolyzers, which go the other way, using electricity to convert water into hydrogen and oxygen. They study batteries. They study corrosion. They even study computers that attempt […].
Outsourcing Pharma
DECEMBER 17, 2021
The company has released a survey of cancer doctors; 83% of those polled believe real-world data is crucial to accelerating cancer research and treatment.
Scienmag
DECEMBER 17, 2021
The world’s most consumed fruit and an important staple for many developing companies, bananas are increasingly threated by Blood disease, so named because cut banana stems look like they are bleeding. Blood disease causes fruit rot, leaf wilt, and plant death. There is no known cure for the disease. Banana Blood disease was first reported […].
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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.
pharmaphorum
DECEMBER 17, 2021
This episode of the pharmaphorum podcast is the second in a limited series focused on patient engagement that’s being led by clinician, consultant and patient advocate, Mark Duman. Joining him to discuss the importance of patient engagement are Johnson & Johnson’s global patient engagement leader Katherine Capperella, Novartis’ head of patient engagement Mark Boutin, and Astellas Pharma’s senior vice president and head of patient centricity, Anthony Yanni.
Scienmag
DECEMBER 17, 2021
Credit: Images provided by Jean Milot. Boulder, Colo., USA: Despite its prior status as a luxury commodity, silver became widely used for coinage in the Roman world from the 7th century BCE onward and provided a standardized monetary system for ancient Mediterranean civilizations. However, the sources of silver used to produce Roman coinage have largely […].
Pharma Times
DECEMBER 17, 2021
The European Medicines Agency has recommended approval for use of Kineret in COVID-19 to the European Commission, which will issue a final decision.
Scienmag
DECEMBER 17, 2021
The human health is suffering from effluent containing heavy metal ions (such as Cr(VI)) and organic dyes (such as rhodamine B). Among numerous strategies to remove pollutants from water, photocatalysis has attracted extensive attention due to its low energy consumption, simple operation and environmental friendliness. Bimetallic sulfides are apt to form the heterointerfaces which is […].
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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.
Pharma Times
DECEMBER 17, 2021
The approval follows a successful period of monitoring and patient access through the Cancer Drugs Fund.
Scienmag
DECEMBER 17, 2021
Earthquakes of similar magnitude can cause tsunamis of greatly varying sizes. This commonly observed, but not well-understood phenomenon has hindered reliable warnings of local tsunamis. Credit: Ocean Institute, modified by NOAA/ NWS/ CGS Earthquakes of similar magnitude can cause tsunamis of greatly varying sizes. This commonly observed, but not well-understood phenomenon has hindered reliable warnings […].
Clairnes
DECEMBER 17, 2021
The post Clinical trials: 2021 Recap and take-aways for 2022 and ahead. From Vaccine trials, new regulations, decentralized trials and patient-centricity appeared first on Clinical Trial Recruitment & Management Services.
Scienmag
DECEMBER 17, 2021
DURHAM, N.C. – Cooperation and aggression. Meerkats are showing us that one may not be possible without the other. Credit: Charli Davies DURHAM, N.C. – Cooperation and aggression. Meerkats are showing us that one may not be possible without the other. In a study appearing this week in the journal Nature Communications, a team […].
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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.
Clairnes
DECEMBER 17, 2021
The post Panel discussion at Clinical Monitoring and Patient Recruitment (CMPRR) appeared first on Clinical Trial Recruitment & Management Services.
Scienmag
DECEMBER 17, 2021
A recent study at the Medical University of South Carolina’s (MUSC) Digestive Disease Research Core Center (DDRCC) provides insight into why physicians should be cautious when using a certain liver function test to diagnose alcoholic cirrhosis. Credit: Sarah Pack, Medical University of South Carolina A recent study at the Medical University of South Carolina’s (MUSC) Digestive Disease Research […].
Drug Channels
DECEMBER 17, 2021
This week, I’m rerunning some popular posts while I prepare for today's live video webinar: Drug Channels Outlook 2022. See you soon! Click here to see the original post and comments from September 2021. Sometimes, a little knowledge can be a bad thing. I want to share with you, dear reader, the strange but true tale of my recent foray into the wonderful world of hospital price transparency for routine lab services.
Scienmag
DECEMBER 17, 2021
A medication typically used for treating diabetes, glucagon-like peptide-1 receptor agonists (GLP-1 RA), could also be used to prevent cardiovascular disease and major cardiovascular events, but a new study showed inequities in its use based on race, ethnicity, and socioeconomic status. Looking at four years of data, researchers from the Perelman School of Medicine at […].
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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
DECEMBER 17, 2021
Annual Drug Patent Expirations for LENVIMA Lenvima is a drug marketed by Eisai Inc and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Eisai Inc drug LENVIMA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
DECEMBER 17, 2021
Giant, long-necked sauropods, thought to include the largest land animals ever to have existed, preferred to live in warmer, more tropical regions on Earth, suggesting they may have had a different physiology from other dinosaurs, according to a new study led by researchers at UCL and the University of Vigo. Credit: Emiliano Troco Giant, long-necked […].
Drug Patent Watch
DECEMBER 17, 2021
Annual Drug Patent Expirations for AUSTEDO Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are six…. The post New patent for Teva Branded drug AUSTEDO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
DECEMBER 17, 2021
LOS ALAMOS, N.M., Dec. 16, 2021—A machine-learning approach developed for sparse data reliably predicts fault slip in laboratory earthquakes and could be key to predicting fault slip and potentially earthquakes in the field. The research by a Los Alamos National Laboratory team builds on their previous success using data-driven approaches that worked for slow-slip events […].
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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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