Remove FDA Remove Safety Remove Sales Remove Side effects
article thumbnail

FDA approves first Stelara biosimilar, Wezlana

European Pharmaceutical Review

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection. US sales of Stelara totalled $6.4 billion in 2022, according to J&J’s financial results.

article thumbnail

FDA clears Incyte’s Opzelura as first vitiligo therapy

pharmaphorum

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The company is gunning for sales in atopic dermatitis alone of $1.5 million people in the US.

FDA 93
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

The debate on DTC marketing is going to heat up again

World of DTC Marketing

The FDA needs to study what people do when they see a DTC ad. Some DTC budgets are only released when certain sales targets are hit. 3hree: DTC marketing minimizes the side effects of prescription drugs – One of the top pages within prescription drug websites continues to be “safety information.”

Marketing 285
article thumbnail

GSK’s daprodustat will have to face FDA advisory committee

pharmaphorum

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug early next year. The safety data has one element, however, that might be expected to stimulate discussion at the advisory committee meeting.

FDA 52
article thumbnail

Why There's No Such Thing as a 'Safe' Drug?

Contrarian Sales Techniques

A point of view from a Medical Sales Rep I strongly believe that the most effective insurance policy is not to get sick. This includes potential side effects or adverse reactions to medications. The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States.

article thumbnail

FDA slaps partial hold on Biogen, InnoCare MS drug

pharmaphorum

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The post FDA slaps partial hold on Biogen, InnoCare MS drug appeared first on.

FDA 68
article thumbnail

Pennsylvania-based Highmark Inc. Joins Theranica’s Coverage with Evidence Program for Nerivio® Drug-Free Migraine Treatment Device

Legacy MEDSearch

Under the new program, Highmark members prescribed by providers participating in the program will receive access to Nerivio ®, the first FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals aged 12 and older.