1. Pink Sheet

Viagra’s End Begins: Generic Sildenafil Launches For Revatio

 
• By Brenda Sandburg

Apotex has launched sildenafil for treatment of pulmonary arterial hypertension; its product is bioequivalent to Revatio, Pfizer’s sildenafil formulation for PAH, not Viagra; FDA also approved Watson, Dr. Reddy’s and Torrent sildenafil ANDAs.

Pfizer Inc.’s Viagra is in many ways the epitome of a lifestyle drug, and the end of its lifecycle may be as captivating as its launch in 1998.

Apotex Inc. launched generic sildenafil on Nov. 6, the day it received approval from FDA

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Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By Vibha Sharma

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.