Bio Pharma Dive
JULY 22, 2022
The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines.
Pharmaceutical Technology
JULY 22, 2022
Pipeline therapies within the diabetic macular oedema (DME) space have recently gathered interest following the American Society of Retina Specialists (ASRS) Annual Meeting, which took place on 13–16 July. The spotlight was placed on many up-and-coming pharmacotherapies for retinal diseases, one of which was AbbVie’s/Regenxbio’s gene therapy RGX-314.
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Bio Pharma Dive
JULY 22, 2022
Trial results released earlier this year showed potential for the drug, which has become one of Vertex’s top pipeline prospects.
Pharmaceutical Technology
JULY 22, 2022
The European Commission (EC) has approved an advance purchase agreement (APA) amendment for Valneva’s inactivated whole-virus Covid-19 vaccine, VLA2001. The latest move follows remediation discussions based on the notice sent to the company regarding the termination of the initial APA for purchasing vaccine doses this year and the optional doses for next year.
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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
JULY 22, 2022
The pharma company plans to spend $70 million on the South San Francisco facility, which will house West Coast employees of Astellas Gene Therapies.
Pharmaceutical Technology
JULY 22, 2022
ARS Pharmaceuticals has signed a definitive agreement to merge with Silverback Therapeutics in an all-stock transaction. The combined company will operate under the name ARS Pharmaceuticals and be headquartered in San Diego, California, US, after the completion of the transaction. It will focus on the potential regulatory clearance and commercialisation of ARS’ investigational epinephrine nasal spray, neffy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 22, 2022
Pharmaceutical Technology lists five of the top tweets on infectious diseases in Q2 2022 based on data from GlobalData’s Pharmaceuticals Influencer Platform. The top tweets are based on total engagements (likes and retweets) received on tweets from more than 188 infectious diseases experts tracked by GlobalData’s Pharmaceuticals Influencer platform during the second quarter (Q2) of 2022.
STAT News
JULY 22, 2022
Jennifer Padgett has spent 2 1/2 years terrified for her immunocompromised daughter, Hannah. Hannah catches pneumonia like mosquito bites; what could Covid wreak? Their whole family locked down in the early days, rushed to get vaccines when they became available and kept masking and avoiding indoor dining in their small southern town even after the Centers for Disease Control and Prevention loosened restrictions.
NPR Health - Shots
JULY 22, 2022
The CDC confirmed that a patient in New York has contracted polio, the first U.S. case since 2013. But most people shouldn't be concerned about contracting the virus because of high vaccination rates.
Rethinking Clinical Trials
JULY 22, 2022
? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speaker. Stacey J. Adam, PhD. Associate Vice President, Research Partnerships. Foundation for the NIH. Slides. Keywords. ACTIV, COVID-19, FNIH. Key Points. The normal timeline for public-private partnerships is around 9 months of planning. ACTIV was stood up in about a month, launching on April 17, 2020, to develop a coordinated research response to speed COVID-19 treatment and vaccine options.
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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
JULY 22, 2022
Stalled confirmatory trials and lax enforcement plague the Food and Drug Administration's accelerated approval pathway for pharmaceuticals that target urgent medical needs.
STAT News
JULY 22, 2022
Many Americans are accustomed to shopping around for the best deal. We can access reams of information that help us make smarter decisions — except when it comes to health care services. For too long, we have been left in the dark when it comes to the cost of medical treatments and procedures. Without a true health care marketplace based on price transparency, Americans will continue to make uninformed decisions that result in spiraling costs for everyone.
NPR Health - Shots
JULY 22, 2022
Climate change is making heat waves more frequent and intense. With much of the U.S. facing a weekend of extreme temperatures, here are some tips for protecting yourself and your loved ones.
STAT News
JULY 22, 2022
When it comes to primary care, One Medical is hardly Amazon’s first rodeo. By the time the tech giant made the bombshell announcement that it was buying One Medical on Thursday, it had already aggressively scaled what began as a modest primary care pilot for its Seattle-area employees. Amazon has enlisted two different primary care companies — Care Medical and Crossover Health — to help it expand its services to all 50 states.
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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.
NPR Health - Shots
JULY 22, 2022
President Biden had a slightly elevated temperature last night but his physician says that "his symptoms have improved" as he receives treatment after testing positive for COVID-19 on Thursday.
pharmaphorum
JULY 22, 2022
Drugmakers Pfizer and Flynn Pharma have been fined £70 million ($84 million) by the UK Competition and Markets Authority (CMA) for overcharging the NHS for a widely-used epilepsy drug. The CMA delivered a preliminary judgment in the case last year which concluded that Pfizer and Flynn abused a dominant position in phenytoin sodium capsules, causing NHS spending on the drug to balloon from around £2 million a year in 2012 to £50 million the following year.
Pharma Times
JULY 22, 2022
The treatment has been developed for people aged six years and over will be available for use across the NHS
pharmaphorum
JULY 22, 2022
Amazon has accelerated its expansion into the healthcare sector with an all-cash deal to acquire One Medical, a US group that provides virtual and in-person primary care services using a subscription fee model. Amazon is buying One Medical for $18 per share, valuing the company at around $3.9 billion and making it one of the online retail giant’s largest-ever acquisitions – and by far its biggest within the health category.
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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.
STAT News
JULY 22, 2022
Cutibacterium acnes, a crunchy Cheeto-shaped bug that lives on human skin, loves the oily pocket around hair follicles. No face is quite as greasy as that of adolescents, flooded with hormones that grow hair, deepen voices, and ramp up production of sebum, a secretion that makes the skin a moist and protective barrier. Too little sebum means dry, flaky skin, like patches of eczema.
Intouch Solutions
JULY 22, 2022
What does a EVERSANA INTOUCH Web3 hackathon win mean for the future of healthcare? It’s a grand question… but let’s explain and see if you agree with us that it’s a very big deal indeed. The Hedera22 global hackathon, which hosted over 2500 participants across 95 different countries, is sponsored by Hedera Hashgraph, one of the leading platforms in the evolving Web3 distributed ledger landscape.
STAT News
JULY 22, 2022
The term “rare disease” is both an apt descriptor and a misnomer. Individually, each rare disease affects a relatively small number of people. But taken together, more than 30 million Americans , and 400 million people worldwide , are affected by one of the 10,000-plus rare diseases — 95% of which have no approved treatment. More than half of those with rare diseases are children, one-third of whom won’t live to celebrate their fifth birthdays.
Antidote
JULY 22, 2022
Skin cancer is more common than any other type of cancer, and melanoma causes a large majority of skin cancer-related deaths. While awareness surrounding melanoma and the importance of sun protection has risen in recent years, CDC research shows that melanoma rates have still doubled over the last three decades.
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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.
STAT News
JULY 22, 2022
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still getting sorted out, but we hope to catch up on our reading and hang with our oh-so-busy short person. And what about you? Normally, we would suggest you enjoy the great outdoors, but given the heat, we hesitate to do so, unless you have a Jetsons-like portable air conditioner you can strap on your back.
NPR Health - Shots
JULY 22, 2022
In the wake of the Supreme Court overturning Roe v. Wade , clinics report a surge in demand for sterilization procedures.
STAT News
JULY 22, 2022
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
pharmaphorum
JULY 22, 2022
The proposed European unitary patent and unified patent court represents one of the largest changes to the European patent system in a generation. It will usher in a new European patent right (the unitary patent) which will have unitary effect across participating member states. A new court system (the unified patent court or UPC) will also be established to handle litigation not only of the new unitary patents, but also of European patents under the current system that are validated nationally
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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.
Pharma Times
JULY 22, 2022
Molecular clamp technology is a protein tag that stabilises a wide range of complex viral proteins
NPR Health - Shots
JULY 22, 2022
American long-haul truckers share wisdom from the road on living where you work (Image credit: Meg Vogel for NPR)
Scienmag
JULY 22, 2022
Genome sequencing, where scientists use laboratory methods to determine a specific organism’s genetic makeup, is becoming a common practice in insect research. A greater understanding of insect biology helps scientists better manage insects, both those that are beneficial to the ecosystem and those that damage the food supply and threaten human health by carrying diseases. […].
Drug Channels
JULY 22, 2022
Today’s guest post comes from Ian Ocilka, Senior VP of Client Solutions at ConnectiveRx. Ian shares an overview of The Evolving Role of Hubs and Patient Services , his recent presentation at Informa Connect's Hub and Specialty Model East conference in June. Click here to watch Ian’s full presentation. Read on for Ian’s insights. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.
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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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