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 Pharma Marketing 52

European Pharmaceutical Review

FEBRUARY 14, 2024

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.

Food and Drug Administration 76

Food and Drug Administration Manufacturing Engineering Pharmacology 76

pharmaphorum

JANUARY 16, 2023

The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023. Innovation will power the market.

FDA 88

FDA Healthcare Healthcare Medicine 88

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. Securing reimbursement for digital therapeutics also continues to impede its uptake.

Prescription 111

Prescription Pharmacology Pharma Medical 111

Pharmaceutical Technology

DECEMBER 16, 2022

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.

Pharmacology 105

Pharmacology Pharma Pharmaceutical Manufacturing 105

Pharmaceutical Technology

OCTOBER 10, 2022

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.

Pharmacology 59

Pharmacology Side effects FDA Safety 59