PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA). Challenges in Working with Label Data.

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

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 57

Pharmacology Pharma Marketing Competition 57

European Pharmaceutical Review

OCTOBER 19, 2022

2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” Letter to FDA, 06 July 2022. Internet] [link]. Cited 25 September 2022].

Food and Drug Administration 79

Food and Drug Administration Pharmaceutical products FDA Pharmacology 79

Contrarian Sales Techniques

DECEMBER 5, 2023

As treatments become more tailored to individual patients, sales reps must understand complex scientific concepts and communicate them effectively. You need to comprehend and convey how these products can truly make a difference in patients' lives. Another game-changer has been the shift towards personalized medicine.

Pharmaceutical Sales 52

Pharmaceutical Sales Training Sales Pharmaceutical 52

Evolve Your Success

OCTOBER 24, 2023

It might need to be something that allows it to be moved, bent, put over the patient, maneuvered through a hospital or a doctor’s office, or what have you to provide either additional functionality, transport, or whatever the case may be. We may not be aware of that next-gen situation, or perhaps it’s a competitive situation or what have you.

Sales 64

Sales Medical Manufacturing Medical sales 64

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. More approvals, in larger patient population conditions will elevate the ongoing discussion of how to pay for these therapies.

FDA 90

FDA Healthcare Healthcare Medicine 90

Pharmaceutical Technology

FEBRUARY 17, 2023

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. What is drug dose optimisation?

FDA 115

FDA Side effects Pharmacology Patients 115