Sat.Apr 08, 2023 - Fri.Apr 14, 2023

article thumbnail

A new biotech wants to ease a bottleneck in cell and gene therapy production

Bio Pharma Dive

Founded by University of Pennsylvania researchers, VintaBio will manufacture the viral vectors that are essential in cell and gene therapy production, but which have been in shorter supply as more companies entered the space.

article thumbnail

Ghana becomes first country to approve Oxford’s malaria vaccine

Pharmaceutical Technology

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.

Vaccine 279
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

US Scientist to Live Underwater For 100 Days in Record-Breaking Experiment

AuroBlog - Aurous Healthcare Clinical Trials blog

As nightmares go, being trapped in a small box deep underwater is probably high on many people’s lists. But one US professor is doing this on purpose.

Scientist 239
article thumbnail

In counties with more Black doctors, Black people live longer, ‘astonishing’ study finds

STAT News

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.

Doctor 145
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

Novo boosts sales outlook on strong demand for obesity drug

Bio Pharma Dive

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.

Sales 331
article thumbnail

Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Pharmaceutical Technology

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.

More Trending

article thumbnail

Demand for home health aides is soaring. So why are they still so undervalued?

STAT News

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.

145
145
article thumbnail

Biotech layoffs gather pace as industry downturn persists

Bio Pharma Dive

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.

325
325
article thumbnail

TORL BioTherapeutics raises funds to develop new oncology therapies

Pharmaceutical Technology

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

article thumbnail

Thrust on R&D to develop better medicines & demand for technologies driven by AI transforming patient care

AuroBlog - Aurous Healthcare Clinical Trials blog

The pharma companies’ thrust on R&D to develop better medicines and the demand in hospitals for advanced medical technologies driven by artificial intelligence, remote patient monitoring and wearables are transforming patient care.

Medicine 184
article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

You're less likely to get long COVID after a second infection than a first

NPR Health - Shots

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.

article thumbnail

Novo’s latest deal targets cell therapy for diabetes, obesity

Bio Pharma Dive

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.

Licensing 321
article thumbnail

US launches $5bn effort for new Covid-19 vaccines development

Pharmaceutical Technology

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.

Vaccine 264
article thumbnail

Panel asks Ayush Ministry to converge all Ayush drug related standard setting exercises to a single authority

AuroBlog - Aurous Healthcare Clinical Trials blog

A parliamentary panel which looked into the budget allocation for the Ministry of Ayush and its schemes to strengthen the Indian Systems of Medicines (ISM) for the year 2023-24 said that there is an urgent need for converging all the Ayush drug related standard setting exercises to a single authority in accordance with the drug […]

Drugs 183
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Multidrug-resistant bacteria found in 40% of supermarket meat samples

Medical Xpress

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.

Bacteria 145
article thumbnail

New data raise more doubts about Moderna’s flu vaccine

Bio Pharma Dive

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.

article thumbnail

Malaysia approves additional indication for Astrazeneca’s Evusheld

Pharmaceutical Technology

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.

article thumbnail

CDSCO revises its list of FDCs declared as rational to bring in certain corrections

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has re-issued the list of fixed dose combinations (FDCs), declared as rational by the Prof Kokate Committee earlier and was released in February in connection with their new drug status and the procedure to be followed by the applicants when approaching the state licensing authority, with some corrections.

Licensing 181
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

The dream of wiping out polio might need a rethink

NPR Health - Shots

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.

145
145
article thumbnail

GSK outlines deal to send cell therapies back to Adaptimmune

Bio Pharma Dive

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.

Research 278
article thumbnail

Ginkgo Bioworks partners with WARF for new GD2 CAR T-cell therapies

Pharmaceutical Technology

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.

In-Vivo 264
article thumbnail

The brain's support cells may play a key role in OCD

Medical Xpress

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.

Research 145
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

A robot answers questions about health. Its creators just won a $2.25 million prize

NPR Health - Shots

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.

144
144
article thumbnail

Biogen, aiming for a better Alzheimer’s therapy, licenses a Denali program

Bio Pharma Dive

The program is part of Denali’s “transport vehicle” platform, which uses drugmaking technology to shepherd large therapeutic molecules like antibodies across the so-called blood-brain barrier.

Licensing 195
article thumbnail

Aviceda, QUB to develop next-generation glyco-immune therapeutics

Pharmaceutical Technology

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.

article thumbnail

The Biden administration will hang on to some Covid pandemic emergency powers

STAT News

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.

Vaccine 142
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Strep is bad right now — an antibiotic shortage is making it worse

NPR Health - Shots

Strep throat is more prevalent this year, and amoxicillin manufacturers didn't make enough of the antibiotic to go around.

article thumbnail

Century Therapeutics changes leadership as CEO steps down

Bio Pharma Dive

The resignation of top executive Lalo Flores comes three months after a restructuring, marking the latest change of direction for the once high-flying cell therapy startup.

195
195
article thumbnail

FDA grants rare paediatric drug status for IPS HEART’s stem cell drugs

Pharmaceutical Technology

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.

Drugs 246
article thumbnail

A rare and lethal virus is spreading in Europe, prompting hunt for tests and cures

Medical Xpress

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.

Vaccine 141
article thumbnail

The New Age of Decentralized Clinical Trials

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.