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Regulators in Japan have granted approval for the manufacturing plant of Kite in El Segundo, California, US, to produce Yescarta for the Japanese market. The delivery of the product is anticipated to begin early next year.
Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). The regulator has also cleared the investigational new drug (IND) application for APB-102.
The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]
C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product.
Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.
Oncology products monopolise the list of best-selling drugs. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products.
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.
Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients.
Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.
The product was later approved to prevent organ rejection for heart ( 2006 ) and kidney ( 2009 ) transplants, the latter based on a single prospective clinical trial. A number of Camargo clients are stuck in situations similar to this, with such inspections being the only remaining hurdle before their products are approved. Stay tuned.
While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?
DEA agents interviewed former Cerebral employees about clinician licensing issues and allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported , citing sources. Many claims may or may not accurately reflect what these products offer, “It’s the wild west.”. Does this mean we should give up?
E-cigarettes are currently regulated as consumer products so cannot be promoted as smoking cessation aids, he explains. Nicholas Hopkinson at Imperial College London welcomes the move, saying this will give doctors another means to help smokers quit.
To launch the best PCD pharma franchise company, you will have to acquire the necessary licenses from authorities. The next important thing is the license. Every pharma company needs a drug license number to begin distribution, marketing, and manufacturing activities. License required to start a Pharmaceutical Business in India.
The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. Food and Drug Administration (FDA) regulation as a medical device.
The company plans to submit its biologic license application (BLA) to China’s National Medical Products Administration (NMPA) and other regulators worldwide.
Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . It takes around 20 minutes of game play to provide a reading.
billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). billion product at peak. Two years after signing a $3.9
With CBD and THC infused beverages and edibles continuing to grow in popularity as more states legalize recreational cannabis, one company is hoping its technology will make these products safer for consumption. RSE’s quality control manager, about the importance of manufacturing and regulating safe CBD and THC infusions. .
As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. Additions to PDUFA meeting types.
Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. One way is by effectively monitoring the environmental factors which impact the quality of the product.
The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.
HP&M has been helping clients navigate the challenges of state licensingregulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.
The company said that Microtox BT already satisfies many of the criteria set out in a document published by the UK regulator, setting out standards for COVID-19 breath tests. It has licensed in a patented breathalyser, the analysts noted.
“The FDA views wellness apps as akin to over-the-counter homeopathic treatments—products with minimal risks and low potency – and they are unregulated. There are approximately 20,000 mental health apps and the overwhelming majority are considered “wellness” products. As few as 2% have peer-reviewed research to back up their claims. ”.
This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.
The regulator approved Nuvaxovid for use as a primary series in adolescents aged 12 to 17 years in August last year. SK bioscience is manufacturing Nuvaxovid’s drug substance, and drug product for domestic use after the companies signed a licensing agreement in Korea.
The Trader Joe’s recall situation has garnered significant attention in the past week, as the popular retail chain declared three different product recalls during the last week of July. ” The Trader Joe’s recall appears to be a voluntary move , a common practice amongst companies facing contaminated food products.
Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.
It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas. The therapy has also received orphan drug and fast-track designations.
Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 92P-0405 (Aug.
M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. In addition to having attractive products, ensuring the supply chain of those products is secure is an increasing concern for companies.
The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. BMS provides its products in the US, Europe, and Japan.
According to a recent report from LegitScript, a leading provider of healthcare product verification and monitoring services, there has been a whopping 1200 percent increase in violative and misleading advertisements related to compounded GLP-1 medications.
With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional. FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.
Dietary supplement trade associations, including the Natural Products Association (NPA) and the Center for Responsible Nutrition (CRN) have filed citizen petitions challenging FDA’s interpretation several times. The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect.
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
As biopharma products become more common, so must biopharma packaging. Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution. General Regulations (From Section 112.1) General Regulations (From Section 112.1)
Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products.
T-cell activation can be measured by assessing proliferation, up-regulation of activation markers and production of effector cytokines (IFN-gamma and TNF-alpha). Activation of T-cell proliferation specifically in a tumour is crucial for reducing the autoimmune side effects of antitumour immunotherapy.
Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. Depending on the ingredients of the product and the objectives of the study, the product may be classified as a drug by the FDA and required to comply with 21 CFR 312.
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