Bio Pharma Dive
APRIL 13, 2023
The Danish drugmaker nearly doubled the 2023 forecasts for Wegovy and Ozempic in the latest indicator of the sales potential of an emerging and competitive class of weight loss drugs.
Pharmaceutical Technology
APRIL 14, 2023
Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Serum Institute of India (SIIPL), manufacturer and licence holder of the vaccine, has been notified of the registration by Ghana’s FDA.
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STAT News
APRIL 14, 2023
Black people in counties with more Black primary care physicians live longer, according to a new national analysis that provides the strongest evidence yet that increasing the diversity of the medical workforce may be key to ending deeply entrenched racial health disparities. The study , published Friday in JAMA Network Open, is the first to link a higher prevalence of Black doctors to longer life expectancy and lower mortality in Black populations.
NPR Health - Shots
APRIL 14, 2023
The chances of developing lingering symptoms after COVID appears to fall sharply from the first to the second time someone gets sick, new research finds. The risk is still significant.
Bio Pharma Dive
APRIL 12, 2023
For an upfront payment of $75 million, Novo gets an exclusive license to use Aspect Biosystems’ “bioprinting” technology to develop as many as four treatments for the diseases.
Pharmaceutical Technology
APRIL 13, 2023
Dyadic International has announced expansion of a licence agreement for its C1-cell protein expression platform with South African consortium Rubic One Health. The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Medical Xpress
APRIL 14, 2023
Multidrug-resistant E. coli were found in 40% of supermarket meat samples tested in a Spanish study. E. coli strains capable of causing severe infections in people were also highly prevalent, this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2023, Copenhagen, 15-18 April) will hear.
Bio Pharma Dive
APRIL 10, 2023
Drugmakers are announcing job cuts at a faster clip so far this year than during the same period in 2022, suggesting that fundraising remains difficult.
Pharmaceutical Technology
APRIL 14, 2023
Clinical-stage biopharmaceutical company TORL BioTherapeutics has raised $158m in a Series B financing round for advancing the development of new biologics for cancer treatment. TORL BioTherapeutics is a newly formed, US-based company focused on the development of novel antibody-based therapeutics for cancer patients. Led by Goldman Sachs Asset Management, the financing round has also seen participation from Deep Track Capital, Moore Strategic Ventures, Cowen Healthcare Investments, Bristol Myer
NPR Health - Shots
APRIL 14, 2023
At the Skoll World Forum this week, South Africa's Reach Digital Health was one of five honorees. They offer health advice via mobile phones to millions, focusing on pregnancy, babies and COVID.
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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
Medical Xpress
APRIL 12, 2023
A type of cell usually characterized as the brain's support system appears to play an important role in obsessive-compulsive disorder-related behaviors, according to new UCLA Health research published April 12 in Nature.
Bio Pharma Dive
APRIL 8, 2023
The decision imperils access to the drug more than two decades after its U.S. approval, and could carry consequences for the FDA’s authority over prescription medicines.
Pharmaceutical Technology
APRIL 14, 2023
Ginkgo Bioworks (Ginkgo) and the Wisconsin Alumni Research Foundation (WARF) have collaborated to discover next-generation GD2 CAR T-cell therapies to treat solid tumours. WARF is the patenting and licensing organisation for the University of Wisconsin–Madison in the US. Ginkgo will partner with researchers from Wisconsin-Madison to discover new and improved GD2 CAR designs with improved persistence, fitness and proliferation.
STAT News
APRIL 14, 2023
WASHINGTON — Even though the Biden administration is ending its highest-profile Covid-19 emergency declaration next month, it’s still going to hold on to some pandemic-era powers. The Department of Health and Human Services gave governors a heads-up on Friday that it is planning to keep pharmacists’ ability to administer Covid-19 and flu vaccines past the end of the public health emergency.
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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
APRIL 12, 2023
An international coalition of biomedical researchers co-led by Alexander Bick, MD, Ph.D., at Vanderbilt University Medical Center has determined a new way to measure the growth rate of precancerous clones of blood stem cells that one day could help doctors lower their patients' risk of blood cancer.
Bio Pharma Dive
APRIL 11, 2023
The shot appears to generate an immune response that matches or exceeds existing vaccines, but investigators aren’t yet sure how well it can prevent illness.
Pharmaceutical Technology
APRIL 11, 2023
The US government is reportedly investing more than $5bn in a programme to accelerate the development of new Covid-19 vaccines and treatments. Dubbed Project Next Gen, the new effort will follow an approach similar to that of Operation Warp Speed, which developed and delivered vaccines to Covid-19 patients in 2020 by forming private-public partnerships for the rapid development of new vaccines.
NPR Health - Shots
APRIL 10, 2023
When public health specialists look at the annual case counts, some see a trend that raises questions about how realistic the goal of a polio-free world might be.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
STAT News
APRIL 12, 2023
Prior to the early 20th century, America had no regulation of medications or food additives. Formaldehyde was used to preserve meat, morphine was included in infant “soothing syrups,” and marketing, not science, drove the promotion of tonics and medications. The 1906 Food and Drug Act was the first in a series of consumer protection laws focused on setting standards for safe and effective medications and food additives.
Bio Pharma Dive
APRIL 11, 2023
The pharma, which recently retreated from cell therapy research, will pay Adaptimmune about $37 million as part of an agreement to return rights to two cancer treatments.
Pharmaceutical Technology
APRIL 10, 2023
The Malaysian Ministry of Health (MoH) has reportedly approved additional indication of Astrazeneca ’s Evusheld 100mg/ml solution for injection (Tixagevimab 100mg/ml and Cilgavimab 100mg/ml) for Covid-19 prevention. Health director-general Tan Sri Dr Noor Hisham Abdullah stated that the approval of Evusheld was granted at the 383rd Drug Control Authority (DCA) meeting.
Medical Xpress
APRIL 10, 2023
For more than 100 million Americans who are obese, bariatric surgery may reverse complications related to diabetes, including regenerating damaged nerves, a Michigan Medicine study shows.
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STAT News
APRIL 13, 2023
Like many cardiologists, Manuela Thienel spends most days in the chlorinated, temperature-controlled halls of a large hospital. But one week in February 2019, her work brought her to a snowy Swedish forest, where she stood shuddering in a winter coat, looking on as veterinarians and rangers walked into a bear den to drug a hibernating bear and retrieve its blood.
NPR Health - Shots
APRIL 10, 2023
Strep throat is more prevalent this year, and amoxicillin manufacturers didn't make enough of the antibiotic to go around.
Pharmaceutical Technology
APRIL 10, 2023
Aviceda Therapeutics (Aviceda) has entered into a strategic partnership with the Patrick G Johnston Centre for Cancer Research at Queen’s University Belfast (QUB) for the development of next-generation glyco-immune therapeutics. Aviceda’s HALOS (high-affinity ligands of sigelcs) nanotechnology platform leverages glycobiology to modulate the innate immune system to develop advanced breakthrough therapeutics, focusing on immuno-oncology.
Medical Xpress
APRIL 12, 2023
A new study to be presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2023, Copenhagen April 15-18), and published in The Lancet, shows that compared with standard care that included low-dose corticosteroid use, treating hypoxic COVID-19 patients needing only oxygen therapy or no breathing support with higher-dose corticosteroids is associated with a 60% increased risk of death.
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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
APRIL 12, 2023
Last fall in STAT, Matt Herper questioned whether the biomedical research enterprise is really laying the necessary groundwork to gain the full benefit of innovation in “biology’s century.” “The biggest looming problem is that… new technologies in biology [could] outpace our ability to assess them,” he observed.
NPR Health - Shots
APRIL 12, 2023
The start of pregnancy — as well as exactly when that happens — is a hot topic in some state legislatures and U.S. courts. Understanding the nuances of what happens when has never been more important.
Pharmaceutical Technology
APRIL 14, 2023
The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. GIVI-MPC is intended to create new skeletal muscle with 100% full-length dystrophin, while ISX9-CPC is designed to create new functional cardiac muscle for indicated patients.
Medical Xpress
APRIL 14, 2023
A man in Chile is infected with a bird flu that has concerning mutations, but the threat to people from the virus remains low, U.S. health officials said Friday.
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