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Flaws in the manufacturing process can cause some drugs to be contaminated, ineffective, or labeled incorrectly. Overlooked quality control processes can then cause these drugs to slip through the cracks and be dispensed. Patients who take one of these drugs could end up being harmed or getting an incorrect product. For some patients, experiencing a serious adverse event from a drug can be a harrowing, or even life-threatening, event.
Ensuring potential microbial contaminants are not transferred into cleanroom environments is a key aspect of risk mitigation strategies. In a review, pharmaceutical microbiologist and contamination control expert Tim Sandle, reviewed several methods of material transfer, listing the decontamination methods based on efficacy and commenting on their weaknesses. .
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
The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. That’s the conclusion of a GlobalData report , which notes that AI is being used to enhance computer-aided drug design (CADD) in a bid to reduce the time and costs involved in getting a new drug to market.
David Pope, PharmD, CDE, the EVP of Innovation and Industry Relations at OmniSYS, discusses the FDA’s announcement updating pharmacists’ prescriptive authority for the COVID-19 antiviral Paxlovid.
David Pope, PharmD, CDE, the EVP of Innovation and Industry Relations at OmniSYS, discusses the FDA’s announcement updating pharmacists’ prescriptive authority for the COVID-19 antiviral Paxlovid.
Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.
As established facilities age, various risk considerations emerge. While some may continue to function effectively without any additional considerations, many will require additional checks and assessment. In an article published in the Journal of Validation Technology (JVT), pharmaceutical microbiologist and contamination control expert Tim Sandle identified ten categories of risk presented by aging.
People have been taking probiotics to support digestive health for centuries, but researchers in the pulmonary field have turned their attention toward how microbiome science can be used to support the lungs.
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
AstraZeneca has signed a deal to buy US biotech TeneoTwo in a deal worth up to $1.27 billion that will boost its position therapies for haematological cancers. The big pharma is paying $100 million upfront for the company, and offering up to $805 million in milestone payments if TeneoTwo’s drug candidates meet development objectives, plus up to $360 million if they hit sales targets.
After more than 20 years of environmental action, Pfizer has committed to further reduce its greenhouse gas (GHG) emissions and aims to achieve the voluntary Net-Zero Standard by 2040 – a full 10 years ahead of the standard’s proposed timeline. To achieve these goals, Pfizer aims to decrease its GHG emissions by 95 percent and its value chain emissions by 90 percent from 2019 levels by 2040.
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.
GSK’s recently-unveiled plan to develop a bioscience cluster close to its main R&D site in Stevenage, UK, has moved closer to fruition, now that the first partners have joined the initiative. The asset management arm of Swiss back UBS has formed a joint venture with property developer Reef Group that will develop the 33-acre campus in Stevenage, Hertfordshire.
Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. Following the option exercise, Vir will receive the option exercise fee, regulatory and commercial milestone payments as well as tiered royalties on net product sales from Brii Bio.
If approved, the 16-week dosing regimen could offer certain individuals a potentially longer treatment interval and physicians with greater flexibility to individualize treatment.
Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.
Trial organisers face intense competition to find and recruit eligible patients for atopic dermatitis studies. With more than 500 dermatology clinical trials currently underway, it is often heard that there is a ‘’competition for participants’’. Yet evidence from research studies and a survey with 4,000+ atopic dermatitis patients conducted by Clariness shows that this ‘race to recruit’ is actually not the primary reason for the growing discontinuation rate of atopic dermatitis trials.
The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in
Cell therapy specialist Mogrify has struck a deal with Japanese drugmaker Astellas to look at ways to deploy regenerative medicine to treat hearing loss caused by factors such as chronic exposure to loud noises. The two partners will take an in vivo approach to the problem of so-called sensorineural hearing loss (SNHL) looking at ways to replace sound-detecting hair cells in the inner ear (cochlea) that become damaged in this type of deafness.
Dr Eric Hughes joins Teva with experience in all phases of drug development at global pharmaceutical companies, most recently Boston-based Vertex Pharmaceuticals, which he joined last year. He will be based out of Teva’s US headquarters in Parsippany, New Jersey. . “Eric brings nearly 20 years of leadership roles with a proven track record in a variety of R&D functions for global pharmaceutical companies, and has a successful record of accomplishment fostering productive collaborations with
Pfizer is still waiting for the green light to complete an acquisition of digital health company ResApp, a deal that looks even better now that its smartphone app for people with obstructive sleep apnoea (OSA) has been approved by the FDA. Brisbane, Australia-based ResApp has claimed a 510(k) clearance for SleepCheckRx as a prescription-only digital therapy in the software-as-a-medical device (SaMD) category, clearing the path for a commercial launch in the US.
Europe was the fastest growing region for data analytics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Europe made up 11.8% of total data analytics jobs - up from 11.1% in the same quarter last year. That was followed by North America, which saw a -0.4 year-on-year percentage point change in data analytics roles.
Bacterial spores are a significant concern for aseptic pharmaceutical manufacturers due to their ubiquitous nature and intrinsic resistance to environmental stressors such as heat, as well as chemical and radiation inactivating strategies. As much as 10 percent of microbes in a pharmaceutical cleanroom are spore-forming bacteria, with strains such as Bacillus species, able to cause human disease.
Hypervitaminosis D, a condition characterized by elevated vitamin D levels, is associated with potential serious health issues, such as psychosis, abdominal pain, vomiting, pancreatitis, and renal failure.
Cancer drugs will be flown from a facility in Portsmouth to a hospital on the Isle of Wight by drone, in the first pilot study of the technology by NHS England. The trial – announced this morning and said to be the first of its type worldwide – will mean that the lifesaving treatment can be picked up and dropped off to patients on the same day, said NHS chief executive Amanda Pritchard.
Genetic mutations, both germline and acquired, are behind a large proportion of the most debilitating and sometimes life-threatening human diseases. But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. For many decades, investigators have been working on innovative therapeutic modalities known as cell and gene therapies, which use modified versions of the body’s own cellular and genetic material to treat and potentially cure the
Lonza announced that it is investing approximately CHF 500 million (€500m) to build a new flexible fill and finish facility in Stein, Switzerland. The facility will be located on the same campus as Lonza’s clinical drug product facility, allowing the company to leverage existing infrastructure, capabilities and talent. . According to the company, the investment completes the company’s strategic commitment to offer an integrated end-to-end service that includes commercial drug product manufacturi
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