Bio Pharma Dive
DECEMBER 16, 2022
The EMA’s drug review committee recommended five new drugs be approved in Europe during its December meeting, including CSL’s Hemgenix, AstraZeneca’s Imjudo and Amicus’ Pombiliti.
Pharma Mirror
DECEMBER 16, 2022
The COVID-19 pandemic challenged researchers to discover life-saving treatments at an unprecedented pace. While these researchers rose to the occasion by discovering drugs faster than ever before, variants continue to challenge the world in addressing COVID-19. New innovations in computer-aided drug discovery tools could dramatically accelerate the study of new variants.
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Bio Pharma Dive
DECEMBER 16, 2022
Days after inking one of the largest deals for an unapproved drug, the CEO spoke with BioPharma Dive about the company’s unusual origins and decision to remain private — for now.
Pharmaceutical Technology
DECEMBER 16, 2022
The pharmaceutical industry must improve its environmental footprint by investing in technology and expertise, as well as through better design of new drugs early in their development, according to a GlobalData survey of the pharmaceutical industry. The report, Pharmaceutical Manufacturing ESG Survey – Towards a Sustainable Supply Chain (November 2022), reveals that most pharma industry insiders believe the sector is not doing enough to limit harm to the environment.
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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
DECEMBER 16, 2022
The pharma will pay Sosei $37 million upfront to discover new candidates for diabetes and metabolic diseases that target G protein-coupled receptors.
Pharmaceutical Technology
DECEMBER 16, 2022
The endometriosis market is expected to grow from $1.05bn in 2020 to $2.72bn in 2030 at a compound annual growth rate (CAGR) of 10.0% across the seven major markets (7MM: the US, 5EU [France, Germany, Italy, Spain and the UK], and Japan), according to GlobalData’s recently published Endometriosis: Global Drug Forecast and Market Analysis – Update. This growth is primarily due to market release of several gonadotropin-releasing hormone (GnRH) receptor antagonists, including Myovant’s Myfembree (r
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
DECEMBER 16, 2022
The rheumatology market is a rapidly growing and highly lucrative industry, but there are still major untapped opportunities for cellular therapies to enter this space, in particular the systemic lupus erythematosus (SLE) market. The example of rituximab, originally a cancer drug, now used for lupus, has shown the potential of adopting cancer medications for lupus.
pharmaphorum
DECEMBER 16, 2022
CSL’s gene therapy for haemophilia B has been recommended for approval by the EMA’s human medicine committee, setting up a decision by the European Commission early next year. The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).
Pharmaceutical Technology
DECEMBER 16, 2022
Sosei Heptares and Eli Lilly and Company have signed a partnership for the discovery, development and commercialisation of small molecules that modulate new G protein-coupled receptor (GPCR) targets linked to diabetes and metabolic diseases. This alliance will utilise Sosei’s StaR technology and structure-based drug design (SBDD) platform along with wide-ranging drug development and marketing capabilities and therapeutic area abilities of Lilly in these disease areas.
Medical Xpress
DECEMBER 16, 2022
Workers at Beijing crematoriums said Friday they are overwhelmed as China faces a surge in COVID cases that authorities warn could hit its underdeveloped rural hinterland during upcoming public holidays.
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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
STAT News
DECEMBER 16, 2022
My grandmother died in the hospital, alone, the day after she was “found down” at home by emergency medical services. I lived near my Nani, as I called her but, even though I am a physician, was not allowed to see her after she had been admitted to her local hospital because of the strict, Covid-related no-visitor policy. I spent most of the evening sitting in my car in the hospital parking lot, paralyzed.
Medical Xpress
DECEMBER 16, 2022
While the World Health Organization hopes COVID-19 will soon no longer be considered a public health emergency, it has warned the virus itself is here to stay.
STAT News
DECEMBER 16, 2022
This year’s abnormally early flu season is showing signs it may be peaking in parts of the country, data the Centers for Disease Control and Prevention released on Friday suggested. The percentage of outpatient visits to health care providers that were for respiratory illnesses declined for a second week in a row, CDC’s weekly influenza report, FluView , showed.
Medical Xpress
DECEMBER 16, 2022
Clearing sidewalks and driveways of snow may be essential to keep from being shut in, however, the American Heart Association, the world's leading nonprofit organization focused on heart and brain health for all, urges caution when picking up that shovel or even starting the snowblower. Research shows that many people may face an increased risk of a heart attack or sudden cardiac arrest after shoveling heavy snow.
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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.
STAT News
DECEMBER 16, 2022
Researchers at the Centers for Disease Control and Prevention released data Friday indicating that the newer two-strain Covid booster shots provide substantial protection against illness and hospitalization, even in the previously vaccinated. The Food and Drug Administration said Friday that it will convene an advisory hearing next month to discuss what vaccines should look like going forward, including whether people who have never received any Covid vaccines should receive the bivalent as thei
ACRP blog
DECEMBER 16, 2022
Get into the 2022 holiday spirit with these hand-picked tunes—both old and new—from the staff at ACRP. No matter if you’re resolutely committed to the Christmas classics that have been part of the collective holiday soundtrack for decades or if you prefer your tunes with a more modern twist, grab an eggnog, cozy up to your family and friends, and settle in for some great holiday listening.
STAT News
DECEMBER 16, 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 quickly filling up. Besides the usual promenading with the official mascot, we plan to hang with at least two of our short people, one of whom returns from an institution of higher learning.
Medical Xpress
DECEMBER 16, 2022
World Trade Organization members agreed Friday to push back Saturday's deadline on whether to expand an agreed patent waiver for COVID-19 vaccines to tests and treatments, drawing fierce criticism from NGOs.
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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
DECEMBER 16, 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.
Medical Xpress
DECEMBER 16, 2022
As the ball drops on the new year, exercise often tops the list of people's resolutions. According to Zhen Yan, whose research highlights the benefits of exercise in improving health and preventing disease, science supports that choice for more than just getting in shape.
pharmaphorum
DECEMBER 16, 2022
Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional, and global life science communications to offer some little tips for enjoying a big business career. In this year-end column, he reflects on measures to ensure your festive break becomes that – festive, and a proper break – and that you’re not burning through precious off-time without any relaxation.
BioPharma Reporter
DECEMBER 16, 2022
BioNTech will create its first regional clinical trial sites in East Asia: with the launch of activities in Taiwan for an mRNA head and neck cancer candidate.
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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.
Medical Xpress
DECEMBER 16, 2022
The next time you message your doctor to ask about a pesky cough or an itchy rash, you may want to check your bank account first—you could get a bill for the question.
NPR Health - Shots
DECEMBER 16, 2022
The Biden administration is trying to give Americans with opioid addictions access to life-saving medical treatments. Most people using fentanyl and other opioids never receive medical care.
pharmaphorum
DECEMBER 16, 2022
Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. Further, with a pandemic treaty in development, there are reasons to believe that many countries and the WHO want to see a more equitable distribution of medical products for future pandemics. The world was caught unprepared for the global pandemic that struck in 2020.
Medical Xpress
DECEMBER 16, 2022
Worries about what emergency care might cost them have kept some older adults from seeking medical attention even when they felt they might need it, a new study shows.
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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
DECEMBER 16, 2022
Partnership will support development of new algorithm and identify at risk patients
Fierce Pharma
DECEMBER 16, 2022
After prior rejection, Ferring finally nabs FDA nod for bladder cancer gene therapy. esagonowsky. Fri, 12/16/2022 - 15:19.
Pharma Times
DECEMBER 16, 2022
Gene therapy involves adults with haemophilia B and brings renewed hope to patients across Europe
Medical Xpress
DECEMBER 16, 2022
Scientists from Trinity College Dublin have made an important breakthrough in understanding how inflammation is regulated. They have just discovered that a key immune alarm protein previously believed to calm down the immune response actually does the opposite.
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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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