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The FDA on Wednesday approved Viatris and Ocuphire’s Ryzumvi, also known as phentolamine ophthalmic solution, to treat pharmacologically-induced mydriasis, or dilation of the pupils. Viatris just notched a win on its quest to reach $1 billion in eye care sales by 2028. | The partners plan to make Ryzumvi available in the U.S.
On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.
Nuvectis Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for NXP900. The approval also includes clearance for a Phase I clinical trial protocol of NXP900.
Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported.
At the time of the Encore Vision takeover, there were pharmacological therapies for presbyopia, but that changed last year when AbbVie secured FDA approval for Vuity , a once-daily eyedrop formulation of pilocarpine, as the first drug for the common eye condition. Image by Oscar Aznar from Pixabay .
Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease. FDA is a validation of the quality of the NV354 pre-clinical program and another important milestone for Abliva.
Companies are testing the use of digital platforms along with pharmacological treatments. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging. Securing reimbursement for digital therapeutics also continues to impede its uptake.
Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA. Example: Top Pharma Company Using NLP to Explore Drug Label Data.
It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.
There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Difficile at the end of November 2022, but in 2023 they will be joined by Seres, which expects an FDA decision in April 2023 on its C.
It's the secret sauce to thriving in the pharma industry. From cutting-edge training techniques that break the mold, to the latest industry trends making waves, and the career development hacks every pharma rep should know – we've got it all covered. Welcome to the world where sales training isn't just a formality.
Spearheaded by collaborations between non-profit groups and pharma players, new treatments are edging closer to late-stage trials in malaria and neglected tropical diseases such as sleeping sickness. The company now expects to complete its submission for a BLA with the FDA by the end of the year.
Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.
The road to the development of treatments for non-alcoholic steatohepatitis (NASH) is littered with failed projects, but US biotech Madrigal Pharma thinks it now has enough evidence for its drug resmetirom to support regulatory filings. Although, so far efforts to bring a therapy to market have failed.
During my pharmacology class, I learned that there are no safe drugs, only safe patients. The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States. This is before a drug can be approved for public use.
Pharmaceutical representatives (pharma reps) are facing new challenges as a result of these transformations that have drastically altered the pharmaceutical sales landscape. Essential Competencies in Pharmaceutical Sales First, let’s review the competencies of a successful sales rep in pharma.
The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection. Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles.
In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. But the pharmacology to quantify adherence also depends on race, gender, weight, and other factors.
Food and Administration (FDA) approval, a change long sought by animal welfare organizations. They became integral to physiological and pharmacological research during the 19th century and started to be systematically used for drug development during the 20th century. Clinical Pharmacology and Therapeutics, 104(6), pp.
After more than a decade in development, Freya Pharma Solutions plans to advance an oral tablet dubbed Lybrido into Phase III trials to treat female sexual interest/arousal disorder (FSIAD). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds.
In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.
For example, Ontario, Canada-based Verity Pharmaceuticals’s Trelstar was FDA approved for palliative treatment of advanced prostate cancer and the other two are indicated for treating central precocious puberty and endometriosis, respectively.
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