Fierce Pharma
DECEMBER 21, 2022
After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca. zbecker. Wed, 12/21/2022 - 17:50.
Pharmaceutical Technology
DECEMBER 21, 2022
Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Fierce Pharma
DECEMBER 21, 2022
AstraZeneca, Merck's Lynparza wins EU nod in advanced prostate cancer right after FDA delay. kdunleavy. Wed, 12/21/2022 - 09:08.
Medgadget
DECEMBER 21, 2022
Researchers at Florida Atlantic University have developed a belt that can monitor heart failure patients for signs of disease progression. The wearable device measures heart rate, thoracic impedance, electrocardiogram, and motion, all of which can provide information on a heart failure patient’s status and potentially enable early detection of disease exacerbation.
Advertisement
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
Fierce Pharma
DECEMBER 21, 2022
Editor's corner: Fierce Pharma's top 10 stories of 2022. esagonowsky. Wed, 12/21/2022 - 08:42.
MedCity News
DECEMBER 21, 2022
In a letter addressed to President Joe Biden, 25 governors argued that the Covid-19 public health emergency should end in April. An estimated 18 million people could lose Medicaid coverage if that happens, according to a recent report.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
DECEMBER 21, 2022
Ultimately, it is anticipated that CMS will further expand the use of reimbursable RTM beyond respiratory and MSK care and incorporate patient-reported information as a requirement for reimbursement of certain remote services.
European Pharmaceutical Review
DECEMBER 21, 2022
Fluoxetine was approved to treat depression 35 years ago. Since then, there have been few breakthrough innovations in treating neuropsychiatric diseases such as anxiety, depression, substance use disorders (SUDs), and post-traumatic stress disorder (PTSD). For many indications, progress has been incremental. Psychedelic research, in particular, is gaining momentum. .
MedCity News
DECEMBER 21, 2022
While levels have gone down from their pandemic peak, burnout remains high among clinical support staff, according to a new report. It found that 70% of clinical support staff experience moderate to severe burnout, with 32% categorizing their burnout as high to severe. Along with the obvious effect it has on support staff’s wellbeing, burnout also negatively impacts patient care.
European Pharmaceutical Review
DECEMBER 21, 2022
Ten young children all under the age of 5, who born with immunodeficiency disorder Artemis-SCID, have been able to return to normal life, thanks to a new gene therapy which allows diagnosed babies to be treated with their own cells, a significant milestone since the condition is normally treated via bone marrow transplant from a donor. A breakthrough treatment for Artemis-SCID.
Advertisement
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.
pharmaphorum
DECEMBER 21, 2022
We know that the global healthcare sector is a contributor to the warming of our planet. It is responsible for 4.4% of annual carbon emissions; if the sector were a country, it would be the world’s fifth biggest global carbon emitter. 1. Recent research also found that, as of 2022, the sector had one of the lowest proportions of Net Zero targets of all industries.
European Pharmaceutical Review
DECEMBER 21, 2022
The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 It defined LBPs as drug products containing live microorganism(s) to be used to prevent, treat or cure a disease or condition in human beings. 1 The European Directorate for the Quality of Medicines & Healthcare (EDQM) also accepted LBP as a new category of medicinal products for the European market in 2019. 2.
MedCity News
DECEMBER 21, 2022
Geographic atrophy has no FDA-approved treatments, and Merck is walking away from its contender in the chase for one. The pharmaceutical giant declined to exercise its option on several NGM Biopharmaceuticals eye programs, a decision that follows a Phase 2 clinical trial failure.
European Pharmaceutical Review
DECEMBER 21, 2022
The European Commission (EC) has approved Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for metastatic castration-resistant prostate cancer (mCRPC) in male adults in the European Union for whom chemotherapy is not clinically indicated, making it the first approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent.
Advertisement
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.
MedCity News
DECEMBER 21, 2022
It’s called ISO, short for isotonitazine, a deadly synthetic opioid that is 100X to 1000X stronger than morphine and 20X more potent than fentanyl.
European Pharmaceutical Review
DECEMBER 21, 2022
A grant of £970,688 is set to be given to the Medicines and Healthcare products Regulatory Agency (MHRA) to advance three key projects, which support one of the Agency’s core principles: unlocking scientific and digital innovation that keeps pace with the changing needs of patients, to ensure it delivers world-leading research innovation that focuses on protecting and improving patient health.
MedCity News
DECEMBER 21, 2022
While comprehensive travel health records for those using U.S. health systems are not available today, advances in technology and the legal environment are opening the necessary doors.
Medgadget
DECEMBER 21, 2022
Medgadget was recently invited to Taiwan to cover the 2022 Healthcareᐩ Expo in Taipei. As is the case for most trade shows, the exhibit hall comprised a large portion of the expo. Consisting of over 2000 exhibitors in two massive halls, the main hall showcased the best of Taiwan’s healthcare industry. Here are some notable trends we observed while roaming the aisles.
Advertisement
Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
MedCity News
DECEMBER 21, 2022
Kharraz made a bold declaration about telehealth back in December 2020. In the final episode of 2022, we ask him about that and more.
European Pharmaceutical Review
DECEMBER 21, 2022
AstraZeneca has announced it is expanding its current partnership with AI-based company G42 Healthcare, by signing an agreement to manufacture innovative drugs in Abu Dhabi, aligning with Abu Dhabi’s Industrial Strategy to double the size of its manufacturing sector by 2031. Manufacturing drugs in Abu Dhabi. The agreement focuses on collaboration in four key areas including localising innovative industries, R&D , innovation and sustainability at a global scale to enhance the United Ara
MedCity News
DECEMBER 21, 2022
Social determinants of health reflect conditions in the environment where an individual is born, lives, […].
European Pharmaceutical Review
DECEMBER 21, 2022
It is fair to say that patient-centred packaging is not mainstream for pharmaceutical packaging innovation and, furthermore, changing existing market‑approved packaging is unlikely to happen. It holds great promise, however, when there is opportunity for development of new packaging, provided a patient-centric approach is considered from the start. To achieve patient-centred packaging, multiple stakeholders (including the patients themselves) must be onboard and share a vision of treatment that
Advertisement
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.
PharmaTimes
DECEMBER 21, 2022
ACD856 has also been shown across preclinical studies to improve cognition and memory
European Pharmaceutical Review
DECEMBER 21, 2022
Optimising bispecific antibody clonal cell selection with high-throughput analytics. It is possible to manufacture monoclonal antibodies using traditional methods, but the challenges inherent in bispecific antibodies such as low titer, mismatched chains, unwanted fragments and higher aggregation levels require a heightened analytical focus on clonal cell selection.
PharmaTimes
DECEMBER 21, 2022
Therapy treats patients with metastatic non-small cell lung cancer and has completed successful phase 3 trial
European Pharmaceutical Review
DECEMBER 21, 2022
The potential of tryptamines in treatment-resistant depression. There is growing interest in the use of psychedelic-assisted therapy for treatment of mental health conditions. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial. mRNA therapeutics: a limitless revolution in medicine.
Advertisement
Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
pharmaphorum
DECEMBER 21, 2022
AstraZeneca and Daiichi Sankyo’s Enhertu will become an option for hundreds more people with breast cancer in England and Wales, thanks to new guidance from NICE that will make it available via the Cancer Drugs Fund. The HER2-targeting antibody-drug conjugate (ADC) can be used to treat HER2-positive, unresectable, or metastatic breast cancer after one or more prior anti-HER2 therapies, according to final draft guidance from the health technology assessment (HTA) agency, which is due to com
Penrod
DECEMBER 21, 2022
This recognition is based solely on millions of ratings from female employees in the previous 12 months. With over 15 million ratings across 70,000 companies, Comparably is one of the most trusted reputation platforms for assessing the quality of workplace culture and employee happiness. Comparably’s recognition follows CEO Chris Widmayer’s recognition of being one of the “Best CEOs for Women” and record-high employee satisfaction, as measured by Penrod’s engagement surveys.
pharmaphorum
DECEMBER 21, 2022
Jazz Pharma has lost little time in deciding to buy into Zymeworks’ HER2-directed bispecific antibody zanidatamab, paying $325 million upfront for rights to the drug just weeks after taking an option on the programme. The deal – which could be worth up to $1.76 billion with potential regulatory and commercial milestones plus 10% to 20% royalties on net sales – covers all markets outside Asia/Pacific territories already allocated to Chinese biotech BeiGene under a prior agreement, including
Impetus Digital
DECEMBER 21, 2022
For better or worse, 2022 will forever be a year to remember! Not only is the world getting used to the new normal of hybrid work, but we’re also adjusting to record inflation (as you may know, Impetus Digital is and will continue to be inflation-neutral ). . As we reflect back, there were a few standout moments: We officially launched multiple new programs , including HCP Community Boards , Ambassador programs , Digital Content Councils , educational e-learning portals , “build a caseR
Advertisement
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.
Expert insights. Personalized for you.
291 
Let's personalize your content