Pharmaceutical Technology
JUNE 20, 2023
The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.
Bio Pharma Dive
JUNE 20, 2023
The company said limitations on "bridging treatment" used to hold cancer in check could be to blame, and is working with the FDA to change the study's protocol.
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Pharmaceutical Technology
JUNE 20, 2023
Santhera Pharmaceuticals and Catalyst Pharmaceuticals have signed an exclusive licence and collaboration deal for Santhera’s vamorolone in the US, Canada and Mexico. Catalyst Pharmaceuticals will gain exclusive rights to commercialise vamorolone across the region. The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity.
Bio Pharma Dive
JUNE 20, 2023
Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2023
Scientists have discovered cannabidiol, a compound in cannabis known as CBD, in a common Brazilian plant, opening potential new avenues to produce the increasingly popular substance, a lead researcher said Thursday.
Bio Pharma Dive
JUNE 20, 2023
The deal adds to recent M&A activity as well as signals pharma’s continued interest in pills for inflammatory conditions, which are meant to approach the potency of injectable therapies.
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Bio Pharma Dive
JUNE 20, 2023
A spinout of Alamar Biosciences, Attovia Therapeutics aims to create nanobody-based drugs that could be more effective in treating autoimmune diseases and cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2023
Indian pharma scouts for domain expertise in replacement hiring with skills in data analytics, artificial intelligence (AI) & machine learning (ML). The positions are in the domain of biosimilars, gene therapy, immune therapy like chimeric antigen receptor T-cell (CART), healthcare analytics, clinical studies, and active pharmaceutical ingredients (API) manufacturing skills.
Bio Pharma Dive
JUNE 20, 2023
The shot, which the Danish company acquired from Emergent BioSolutions, spurred protective antibodies against the mosquito-borne virus in older adults.
Pharmaceutical Technology
JUNE 20, 2023
The Department of Health Abu Dhabi (DoH) has signed a memorandum of understanding with integrated healthcare company M42 and AbbVie Biopharmaceuticals to advance personalised medicine and genomics in the city. M42 was created through the combination of Mubadala Health and G42 Healthcare. The collaboration aims to advance precision medicine for the diagnosis and treatment of non-small cell lung cancer (NSCLC) and multiple myeloma.
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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
Bio Pharma Dive
JUNE 20, 2023
When developing a new drug product, quality, safety and timing are critical. A CDMO can be a valuable partner to help mitigate risks.
Pharmaceutical Technology
JUNE 20, 2023
Lallemand Health Solutions has received approval from the Brazilian Health Regulatory Agency, ANVISA, for Probiokid for use in infants and children aged from three to 36 months. Probiokid is a probiotic supplement for children which combines Lallemand Health Solutions’ probiotic strains L helveticus Rosell-52, B bifidum Rosell-71 and B infantis Rosell-33.
Bio Pharma Dive
JUNE 20, 2023
Avoid costly delays, don't let development oversights derail your advanced therapy commercialization. Read the article.
Pharmaceutical Technology
JUNE 20, 2023
The University of Melbourne and Australia’s Victoria state government have unveiled the building design and location for the new A$650m Australian Institute for Infectious Disease (AIID). The AIID will provide quick responses to existing and future infectious diseases and pandemics for Australians. It will be located at 766–780 Elizabeth Street and 213–223 Berkely Street in the Melbourne biomedical precinct.
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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
Fierce Pharma
JUNE 20, 2023
Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean f | Agepha Pharma, a family-owned company based in Slovakia, has gained an FDA approval for Lodoco, which becomes the first drug to target cardiovascular inflammation.
Pharma Times
JUNE 20, 2023
The treatment is administered intravenously prior to surgery, lighting up cancer during surgery - News - PharmaTimes
Fierce Pharma
JUNE 20, 2023
Three weeks after the FDA warned that some pharmacies are making unauthorized versio | Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy. Novo also is planning action against other unlawful sellers, the company said.
BioPharma Reporter
JUNE 20, 2023
Vera Therapeutics, a late-stage biotech company focused on developing treatments for patients with serious immunological diseases, has announced the results of its phase 2 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN).
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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.
Fierce Pharma
JUNE 20, 2023
After Merck filed a bombshell lawsuit challenging some measures in the Inflation Reduction Act (IRA), Bristol Myers Squibb has followed on with a case of its own. | After Merck took the first legal stab at the Inflation Reduction Act with a lawsuit against the Department of Health and Human Services (HHS), Bristol Myers Squibb is the latest drugmaker to allege Constitutional violations.
Intouch Solutions
JUNE 20, 2023
Artificial intelligence is reinventing the digital world – we’re moving from searching to doing, from content curation to creation, from linear to predictive experiences. And AI is changing the world of pharma digital – media, content strategy, social media, strategy and planning, SEO, pharmacovigilance, patient support, operations, finance, HR, etc.
Fierce Pharma
JUNE 20, 2023
Immune checkpoint inhibitors haven’t had tons of success in stomach cancer. Now, Merck has added one failure to the mix. | Immune checkpoint inhibitors haven’t had tons of success in stomach cancer. Now, Merck has added one failure to the mix.
XTalks
JUNE 20, 2023
Roche’s T-cell engaging bispecific immunotherapy Columvi (glofitamab-gxbm) received accelerated approval from the US Food and Drug Administration (FDA) last week for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) arising from follicular lymphoma who have received two or more prior lines of systemic therapy.
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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.
Fierce Pharma
JUNE 20, 2023
When Sanofi made an asset swap with Boehringer Ingelheim in 2016, the French company acquired BI’s healthcare business, which included heartburn medicine Zantac. | An International Chamber of Commerce arbitration tribunal has sided with Sanofi, rejecting Boehringer Ingelheim's attempt to receive liability protections for cancer claims in the United States tied to heartburn medicine Zantac.
XTalks
JUNE 20, 2023
BetterBrand, a leader in the refined carb space, has once again made waves in the food industry with the introduction of two new flavors of its flagship product, The Better Bagel. The unveiling of “The Pretzel” and “The Sesame” marks the continued expansion of the company’s product line, joining the existing flavors of “The Classic,” “The Everything,” “The Cinnamon” and “The Chocolate Chip.” “The Better Bagel is the h
Fierce Pharma
JUNE 20, 2023
AstraZeneca, the largest multinational pharma company in China, has reportedly made plans to separate its local business there in case geopolitical tensions worsen. | The largest multinational pharma company in China has reportedly made plans to separate its local business in case geopolitical tensions worsen. But the company is hitting back at the recent news report.
Pharma Times
JUNE 20, 2023
Immunological disorder therapy data to be shared at International Conference on Redox Medicine - News - PharmaTimes
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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.
Fierce Pharma
JUNE 20, 2023
A year after a Florida man was arrested for his alleged involvement in a nationwide scheme to distribute fake HIV medicines, a U.S. | After reaping millions from selling adulterated HIV meds, one of the men involved in a fraud ring has been sentenced to 15 years in prison for his role in the crime.
XTalks
JUNE 20, 2023
Uber Technologies, Inc. (Uber), globally recognized for its ride-hailing, food delivery, package delivery and freight transport services, has announced an extension of its healthcare division, Uber Health. This new addition will allow patients to get groceries and over-the-counter (OTC) items delivered directly to their homes, utilizing the infrastructure of Uber Eats.
BioSpace
JUNE 20, 2023
The startup launches with $50 million to improve its Chemilogics platform, which is designed to speed up the identification and development of small molecule drug candidates.
pharmaphorum
JUNE 20, 2023
Boehringer loses bid to be shielded from Zantac litigation Phil.
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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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