European Pharmaceutical Review

NOVEMBER 25, 2022

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

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Competition Food and Drug Administration Pharma Food 99

European Pharmaceutical Review

NOVEMBER 2, 2023

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.

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Food and Drug Administration FDA Side effects Safety 90

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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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

Pharmaceutical Technology

OCTOBER 28, 2022

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.

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Training Marketing Competition FDA 64

pharmaphorum

NOVEMBER 1, 2022

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.

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Competition Safety FDA Leads 52

PM360

DECEMBER 20, 2023

Learn more about why each company went with its respective strategy and the current outlook for each company in 2024 and beyond. The deal is expected to close in 2024. Many investors also prioritize companies with a substantial market opportunity and a unique product, particularly in competitive markets or crowded therapeutic areas.

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Management Marketing Healthcare Healthcare 109

PM360

SEPTEMBER 21, 2023

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.

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Management Manufacturing Sales Competition 105