European Pharmaceutical Review

JULY 13, 2023

It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). 5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

Patients 98

Patients Recruitment Management Pharmacology 98

PM360

NOVEMBER 29, 2022

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. A drug label exploration tool was deployed using FDA Drug Labels, EMA Drug Labels, as well as several European local databases.

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Impetus Digital

AUGUST 2, 2024

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. Despite new partnerships and increasing traction, there were some setbacks.

Pharma 92

Pharma Manufacturing Medicine Marketing 92

Pharmaceutical Technology

MARCH 17, 2023

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. But creating a combined product is tricky from a regulatory perspective, says Sørensen.

Prescription 111

Prescription Pharmacology Medical Pharma 111

pharmaphorum

JANUARY 4, 2023

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.

Pharmacology 59

Pharmacology Marketing Pharma Competition 59

pharmaphorum

SEPTEMBER 26, 2022

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.

Pharmacology 52

Pharmacology FDA Marketing Pharma 52

Infuse Medical

DECEMBER 17, 2024

Whether you are marketing a new medical product or creating animations for instructional reasons, you must satisfy regulatory criteria established by the FDA, EMA, or another health authority. The mechanism of action (MoA), interaction with the body, and outcomes of clinical studies of a medicine can all be explained using these animations.

Medical 130

Medical Healthcare Healthcare Education 130

Contrarian Sales Techniques

FEBRUARY 25, 2023

During my pharmacology class, I learned that there are no safe drugs, only safe patients. This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication.

Side effects 52

Side effects Medical sales reps Insurance Medical sales 52

European Pharmaceutical Review

JULY 18, 2024

The potential to target more than one tumour antigen is interesting, as are the possible advantages for the patients receiving these investigational medicines. This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics.

Food and Drug Administration 59

Food and Drug Administration Engineering Pharmacology Side effects 59

Contrarian Sales Techniques

DECEMBER 5, 2023

Another game-changer has been the shift towards personalized medicine. Keeping abreast of the latest regulations, like FDA approvals and industry guidelines, ensures that you're not just a salesperson, but a trusted advisor to your clients. Moreover, regulatory compliance and adherence to industry standards are not just boxes to tick.

Pharmaceutical Sales 52

Pharmaceutical Sales Training Sales Pharmaceutical 52

Pharmaceutical Technology

AUGUST 8, 2022

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. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has recently expressed concern to the US PTO about some types of innovator patent strategies that potentially delay generic entry into the market. Evergreening of patents is the process of patenting post-approval or secondary changes to approved medicinal products. Letter to FDA, 06 July 2022.

Food and Drug Administration 96

Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

Clarivate

OCTOBER 7, 2024

Back in December 2022, President Biden signed a new law stating that novel medicines no longer needed to be tested on animals to receive U.S. Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Clinical Pharmacology and Therapeutics, 104(6), pp. Communications Medicine, 2(1).

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Engineering 52

Pharmaceutical Technology

OCTOBER 10, 2022

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 2015, the FDA approved Sprout Pharmaceuticals’s Addyi, also known under the generic name flibanserin, for use by pre-menopausal women with hypoactive sexual desire disorder (HSDD).

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

MAY 15, 2023

Pyridine derivatives contain one nitrogen atom in a six-membered aromatic ring and are the most extensively used heterocycles in the field of drug design, due to their promising effect on pharmacological activity, which has led to the discovery of numerous broad-spectrum therapeutic agents.

Pharmaceutical 52

Pharmaceutical Leads Pharmacology Medicine 52

Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. This knowledge can include pharmacology, therapeutic areas, and data from clinical trials with different medications.

Sales 52

Sales Pharmaceutical Ethics Pharmaceutical Sales 52

pharmaphorum

JANUARY 16, 2023

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. And all are predominantly prevented or treated with medicines that are decades old. Innovation will power the market.

FDA 98

FDA Healthcare Healthcare Medicine 98

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

Pharmaceutical Technology

DECEMBER 16, 2022

This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. The company now expects to complete its submission for a BLA with the FDA by the end of the year.

Pharmacology 105

Pharmacology Pharma Pharmaceutical Manufacturing 105

European Pharmaceutical Review

NOVEMBER 13, 2024

Lenacapavir for PrEP was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in October. This newly released data was presented at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) and will be published in The New England Journal of Medicine.

Food and Drug Administration 98

Food and Drug Administration Pharmacology Medicine Food 98