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 74

Food and Drug Administration Pharmaceutical products FDA Pharmacology 74

Contrarian Sales Techniques

DECEMBER 5, 2023

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. From social media platforms to e-detailing, the ability to navigate and capitalize on these digital landscapes can give you a significant edge in a competitive market.

Pharmaceutical Sales 52

Pharmaceutical Sales Training Sales Pharmaceutical 52

Evolve Your Success

OCTOBER 24, 2023

We may not be aware of that next-gen situation, or perhaps it’s a competitive situation or what have you. A lot of times, these are very confidential programs because their competition is so fierce. It’s pretty competitive. They understand the American and European requirements of the FDA and the EU.

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. 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.

FDA 85

FDA Healthcare Healthcare Medicine 85

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.

FDA 115

FDA Side effects Pharmacology Patients 115