Remove 2024 Remove Competition Remove FDA Remove Safety
article thumbnail

Promising schizophrenia drug faces tough competition

European Pharmaceutical Review

GlobalData’s report showed LY03010 is expected to launch in the US in 2024. Thus, LY03010 could be more convenient to administer and improve patient compliance by optimising the initial dosing regimen, while ensuring efficacy and safety. If successful, the drug is forecasted to reach sales of $63.5 million in 2031, representing 0.6

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). Sustainable biosimilar competition in Europe: can it be achieved? “We However, he did note that Stelara does have a composition of matter patent expiry in mid-2024 in Europe.

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

Digital Therapeutics Alliance Summit 2024: 4 Takeaways for DTx Innovators

Nixon Gwilt Law

The Digital Therapeutics Alliance Summit 2024 , held in Washington, D.C., Companies that proactively address these aspects create a foundation for sustainable growth and competitive advantage in the digital health ecosystem. For more insights into navigating FDA regulations for DTx products, check out our article here.

FDA 52
article thumbnail

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

Marketing 103
article thumbnail

Vaxcyte trains its sight on a lucrative market with pneumococcal vaccine

Pharmaceutical Technology

The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy. In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Competition in an increasingly heated market.

article thumbnail

Nicox glaucoma drug works, but not as well as hoped

pharmaphorum

On the plus side, the Mont Blanc trial of the drug showed that it was as effective in treating the eye disease as prostaglandin analogue latanoprost 0.005%, a standard therapy for glaucoma, which bodes well for NCX 470 to meet the criteria for FDA approval – assuming, of course, a second phase 3 study called Denali is also positive.

article thumbnail

Key Developments from AMCP 2023 on Blockbuster Generics, Diabetes Drugs, PBM Legislation, and More

PM360

Attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) , manufactured by Takeda, also is facing generic competition. In the respiratory area with inhalers, it’s tough to get drugs approved, so the competition comes slowly,” he said. In 2024, ARPA removes the 100% AMP cap.