Bio Pharma Dive
DECEMBER 7, 2022
The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.
Pharmaceutical Technology
DECEMBER 7, 2022
Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The vaccine is indicated to be administered as a primary regimen comprising two doses for active immunisation to prevent Covid-19 in adolescents of this age group.
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Bio Pharma Dive
DECEMBER 7, 2022
The new biotech launches with $169 million in venture funding and plans to advance its first drug into clinical testing next year.
Pharmaceutical Technology
DECEMBER 7, 2022
On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps. GlobalData anticipates that this safety update will likely raise physician and regulator vigilance regarding long-term Dupixent use but is unlikely to impact overall prescribi
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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 7, 2022
Editas said its gene editing therapy appeared safe and was well tolerated in two patients. The data comes five months after U.S. regulators lifted a partial hold on the trial.
Pharmaceutical Technology
DECEMBER 7, 2022
AbbVie has entered an exclusive global partnership and option to licence agreement for HotSpot Therapeutics’ interferon regulatory factor 5 (IRF5) programme, which is in the discovery stage, to treat autoimmune diseases. The partnership will utilise the Smart Allostery drug discovery platform of HotSpot to develop the first and only small molecule inhibitor of IRF5 for these diseases.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
DECEMBER 7, 2022
Pfizer has entered a research partnership and exclusive licence agreement with Clear Creek Bio to progress new SARS-CoV-2 papain-like protease (PLpro) inhibitors’ discovery and development for the oral treatment of Covid-19. A vital enzyme, PLpro, along with the main protease (Mpro), has a key role in the replication of the virus. . The latest programme is anticipated to bolster the innovative anti-infective pipeline of Pfizer.
STAT News
DECEMBER 7, 2022
For many patients, one of the most antagonizing parts of a hospital visit is paying for parking. Those parking fees aren’t just an annoyance for the sick and injured, according to a new paper in the Journal of Medical Imaging and Radiation Sciences. The charges are actually eating into their financial well-being, particularly for people who have cancer and have to make frequent visits to the hospital for treatments like radiation and chemotherapy.
Pharmaceutical Technology
DECEMBER 7, 2022
GSK , Sanofi and Takeda are set to collaborate with researchers from the Agency for Science, Technology and Research (A*STAR), National University of Singapore (NUS), Nanyang Technological University, Singapore (NTU Singapore), NTUitive and Singapore Institute of Technology (SIT) to boost biologics and vaccine manufacturing expertise in the country.
STAT News
DECEMBER 7, 2022
Touted by celebrities, raved about by TikTok users and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications. Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it’s authorized for so far.
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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
DECEMBER 7, 2022
Their accounts contrast sharply with what chemical giants have said about worker safety at their facilities. At an Olin plant outside of McIntosh, Ala., workers recall decades of asbestos exposure.
STAT News
DECEMBER 7, 2022
Americans may be returning to their pre-pandemic habits , but most have not returned to their primary care doctors. Primary care visits are down 10.3% on average across U.S. cities relative to pre-pandemic levels. That, combined with more people with chronic diseases like diabetes, obesity, and cancer, and accelerating health care costs as inflation soars, signal a troubled future for the health of Americans and the U.S.
pharmaphorum
DECEMBER 7, 2022
Elon Musk’s brain computer interface (BCI) company Neuralink is being investigated by law enforcement authorities in the US amid allegations of animal welfare violations in its testing facilities. Neuralink’s BCI is intended to treat conditions like blindness and spinal cord injury, as well as provide a way to interact with digital devices using the brain and, according to Musk, is on the brink of moving into the human testing stage.
STAT News
DECEMBER 7, 2022
An investigative medicine from Prometheus Biosciences met its goals in a pair of Phase 2 studies enrolling patients with inflammatory bowel disease, setting the stage for pivotal trials and nearly doubling the company’s stock price. In an ulcerative colitis study enrolling about 130 volunteers, Prometheus’ drug helped nearly 27% of patients reach clinical remission, defined as an absence of serious symptoms, compared to 1.5% for the placebo group, the company said.
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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
DECEMBER 7, 2022
Juul Labs has reached settlements covering cases brought by about 10,000 plaintiffs related to its vaping products. Buffeted by lawsuits, Juul announced hundreds of layoffs last month.
STAT News
DECEMBER 7, 2022
About a year ago, a grad student came running up to Wolfgang Kuebler, looking all excited: The mice , he said — well, to be honest, the mice didn’t look great, but they looked a heck of a lot better than they did before. Not long before, Kuebler’s students at The Charité in Berlin had anesthetized mice and dropped a bit of Streptococcus pneumoniae down their throats, just enough to sicken but not kill.
FDA Law Blog
DECEMBER 7, 2022
By Mark A. Tobolowsky & James E. Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
STAT News
DECEMBER 7, 2022
Two years after an independent laboratory began pushing the Food and Drug Administration to analyze various medicines for traces of carcinogens, the agency sent inspectors to the company and cited it for failing to comply with federal law. In a Dec. 5 letter , the agency wrote Valisure that its online pharmacy failed to take several basic steps to ensure that suspect or illegitimate medicines were investigated and that distributors were alerted.
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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.
Medical Xpress
DECEMBER 7, 2022
A three-month pilot study of patients with hypertension appearing in the Canadian Journal of Cardiology demonstrates that adding yoga to a regular exercise training regimen supports cardiovascular health and well-being and is more effective than stretching exercises. Incorporation of yoga reduced systolic blood pressure and resting heart rate and improved 10-year cardiovascular risk.
STAT News
DECEMBER 7, 2022
When tumors like melanoma form, the immune system mobilizes for war. White blood cells called lymphocytes rush to assault the tumor — but cancer has ways of disabling the immune system. Once the immune cells penetrate the area in and around the tumor, they can be caught in chemical snares that render them inert or exhausted, so they cease working.
Medical Xpress
DECEMBER 7, 2022
Scientists at Dana-Farber Cancer Institute have developed a drug that potently neutralizes SARS-CoV-2, the COVID-19 coronavirus, and is equally effective against the Omicron variant and every other tested variant. The drug is designed in such a way that natural selection to maintain infectiousness of the virus should also maintain the drug's activity against future variants.
STAT News
DECEMBER 7, 2022
Oncologist Otis Brawley has dedicated his career to advocating for orthodoxy in medicine. Now, he says, advances in cancer treatments and early-detection screenings are fast outpacing the medical community’s ability to assess them — warranting more caution lest doctors inadvertently cause more harm to cancer patients. “I think we need to actually start policing ourselves better,” Brawley, a professor of oncology and epidemiology at John Hopkins University and former c
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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 7, 2022
Researchers at the University of Southern California Alfred E. Mann Department of Biomedical Engineering have developed a "heart attack on a chip," a device that could one day serve as a testbed to develop new heart drugs and even personalized medicines.
XTalks
DECEMBER 7, 2022
In this episode, Ayesha talked about the FDA approval of Ferring Pharmaceuticals’ fecal matter-based therapy Rebyota for the treatment of recurrent C. difficile infections. While fecal matter transplants (FMT) have been a standard of care for recurrent CDIs, despite not having formal approval, Rebyota has become the first FDA approved FMT-based treatment for CDIs.
Medical Xpress
DECEMBER 7, 2022
Watching short, web-based tutorials that inspire health care workers to contemplate awe, gratitude and kindness can promote enduring improvements in mental health outcomes such as depression and emotional exhaustion.
STAT News
DECEMBER 7, 2022
Good morning, everyone, and how are you today? We are doing just fine, thank you. Given that this is already the middle of the week and we have survived this far, no reason not to continue, yes? Just consider the alternatives. In fact, this modest accomplishment calls for celebration. So please join us in quaffing a ritual cup of needed stimulation.
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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.
Medical Xpress
DECEMBER 7, 2022
Chronic Obstructive Pulmonary Disease (COPD)—a debilitating chronic lung disease that includes emphysema and chronic bronchitis—has previously been linked to mental health problems, such as depression, anxiety, and substance use disorders. But a new study by University of Toronto researchers found that, even though adults without the disease were mentally flourishing at higher rates, a strong majority of those diagnosed with COPD were in excellent mental health.
Pharma Times
DECEMBER 7, 2022
Data reinforces potential to deliver new standards across HER2-targetable breast cancer
Medical Xpress
DECEMBER 7, 2022
People who take medical opioid drugs without a doctor's prescription are 37% more likely than non-users to plan suicide—and the risk is even greater for those with disabilities, who have 73% higher odds of attempting to take their own life.
Drug Channels
DECEMBER 7, 2022
In yesterday’s post , I highlighted the largest pharmacy chains that will participate in the 2023 Medicare Part D prescription drug plans (PDP). Today, I update our annual analyses of how smaller pharmacies will participate as preferred cost sharing pharmacies via the pharmacy services administrative organizations (PSAOs) that represent them in negotiations with plans.
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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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