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.
Bio Pharma Dive
APRIL 14, 2023
Newly launched TORL BioTherapeutics wants to develop a variety of antibody drugs, and comes equipped with $158 million as well as a close partnership with the lab of pioneering breast cancer researcher Dennis Sloman.
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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
Bio Pharma Dive
APRIL 14, 2023
The agency rejected the partners’ copycat version of AbbVie’s blockbuster drug for a second time, citing problems spotted during the inspection of a manufacturing facility.
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.
Bio Pharma Dive
APRIL 14, 2023
The drugmaker said it is working with the FDA to resolve the issues so it can launch the medicine, an ulcerative colitis treatment known as mirikizumab, “as soon as possible.
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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.
Pharmaceutical Technology
APRIL 14, 2023
Twist Bioscience has introduced Twist T-cell receptor (TCR) and Twist chimeric antigen receptor (CAR) libraries to facilitate the development of cell therapies. Researchers will now be able to speed up the creation of tailor-made libraries that can help in identifying and developing new cell therapies. Both libraries feature up to 10,000 gene fragment combinations, and allow the high-throughput screening and characterisation of new and known sequence variants to develop therapeutic solutions.
STAT News
APRIL 14, 2023
On most days around 2pm, home health aide Duane Crichlow can be found in an apartment in Sunset Park, Brooklyn, playing catch with his client — a man in his 30s with a developmental disability who is quick to give Crichlow hugs and kisses. If it’s nice outside, Crichlow will walk his client, who is nonverbal and in a wheelchair half the time, down three flights of stairs, hauling the wheelchair back and forth separately.
Pharmaceutical Technology
APRIL 14, 2023
Biotechnology company Tiziana Life Sciences has revealed plans to assess intranasal foralumab as a potential treatment for long Covid. Long Covid is a health condition characterised by the continuation or development of new symptoms three months after an initial SARS-CoV-2 infection. The work is supported by the role of foralumab in dampening activated microglia cells, said to be an important component of the pathogenesis of this disease.
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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
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.
Pharmaceutical Technology
APRIL 14, 2023
Alvotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab). The CRL stated that the BLA application cannot be approved until deficiencies identified at the company’s manufacturing facility in Reykjavik, Iceland, are satisfactorily resolved.
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.
Pharmaceutical Technology
APRIL 14, 2023
The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label. Eli Lilly executive vice-president Patrik Jonsson said: “We remain confident in mirikizumab’s pivotal Phase III clinical data and its potential to help people with ulcerative coliti
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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
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.
Pharmaceutical Technology
APRIL 14, 2023
The US Food and Drug Administration (FDA) has granted Fast Track designation to SAB Biotherapeutics’ SAB-176 to treat high-risk Type A and Type B influenza illness patients, including those with antiviral-resistant strains. The new, highly potent neutralising immunoglobulin antibody has been developed for preventing or reducing severe outcomes of Type A and Type B influenza infection in patients at high risk for severe complications, including immunocompromised individuals.
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.
Pharmaceutical Technology
APRIL 14, 2023
Madrigal Pharmaceuticals’ resmetirom for nonalcoholic steohepatitis (NASH) could be fairly priced at a higher range than Intercept Pharmaceuticals’ obeticholic acid, based on a revised evidence report published by the Institute for Clinical and Economic Review (ICER). According to ICER’s Health Benefit Price Benchmark (HBPB), resmetirom would be fairly priced between $39,600 and $50,100, while obeticholic acid would be fairly priced between $32,800 and $40,700.
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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
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.
NPR Health - Shots
APRIL 14, 2023
The Taliban has banned Afghan women working for the U.N. or other aid agencies. The repercussions could be devastating for programs in which women play a vital role.
Medical Xpress
APRIL 14, 2023
As a deadly disease that people can catch from ticks moves across the continent, the EU is seeking new tests and a vaccine for the infection.
NPR Health - Shots
APRIL 14, 2023
As the debate over mifepristone makes its way to the Supreme Court, the pharmaceutical industry has raised concerns that ruling against the FDA could chill the development of new drugs.
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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.
Medical Xpress
APRIL 14, 2023
Alzheimer's disease (AD) can be divided into rare early onset familial AD (fAD) and common late onset sporadic AD (sAD) that impairs the memory and cognitive functions of older people worldwide.
NPR Health - Shots
APRIL 14, 2023
A Texas judge ruled that the Food and Drug Administration wrongly approved mifepristone in 2000 and accused it of doing a rush job. Here's what really went down.
STAT News
APRIL 14, 2023
For 10 years, I have depended on Adderall to help me function. But in February, for the first time, the pharmacy down the street was unable to fill my prescription. In fact, 19 pharmacies in a row told me that they were out of stock. Thankfully, the 20th was able to fill it — though it meant a 50-minute drive. The quest to find my daily medication left me struggling to function and feeling utterly helpless.
Medical Xpress
APRIL 14, 2023
Strokes cause numerous changes in gene activity in affected small blood vessels in the brain, and these changes are potentially targetable with existing or future drugs to mitigate brain injury or improve stroke recovery, according to a study led by Weill Cornell Medicine scientists.
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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.
STAT News
APRIL 14, 2023
Access to the abortion pill mifepristone will remain unchanged until next Wednesday, after a U.S. Supreme Court justice on Friday issued a stay on last week’s ruling from a conservative Texas judge banning the medicine. Supreme Court Justice Samuel Alito issued an administrative stay preserving access to mifepristone, which has been approved by the Food and Drug Administration since 2000, until 11:59 p.m.
Medical Xpress
APRIL 14, 2023
A multidisciplinary group of tuberculosis experts from the TBnet and RESIST-TB networks have reached a consensus on key issues related to the molecular prediction of Mycobacterium tuberculosis antibiotic sensitivity or resistance and its clinical implications. The consensus document provides guidance for the design of therapeutic regimens and the optimization of treatments, and is intended to help clinicians manage tuberculosis patients.
XTalks
APRIL 14, 2023
The US Environmental Protection Agency (EPA) is proposing stricter restrictions on ethylene oxide emissions from commercial sterilization facilities. Ethylene oxide is a chemical used in the sterilization of medical devices as well as spices. It is a colorless and odorless gas that is highly flammable under low temperatures. It is also known to be carcinogenic, with long-term exposure being linked to an increased risk of cancers such as breast cancer, myeloma, lymphocytic leukemia and non-Hodgki
Medical Xpress
APRIL 14, 2023
The Austrian Institute for Health Technology Assessment (AIHTA) has analyzed international care models and pathways as well as the situation in Austria with regard to perinatal mental health. The two reports published are part of a project by the Austrian Science Fund (FWF) to improve perinatal mental health in Tyrol, which is led by the Medical University of Innsbruck.
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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.
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