European Pharmaceutical Review
OCTOBER 18, 2022
However, due to the small volumes required for dosage, small-scale providers are also gaining importance, findings from the report show. The oral solid dosage (OSD) form segment is expected to see the biggest rate spike during the forecast period, according to the projections.
Pharmaceutical Technology
MAY 19, 2023
AbbVie anticipates Rinvoq sales to exceed $7.5bn in 2025 and for the peak revenues from both drugs to exceed Humira’s peak sales by 2027. The FDA has recommended that patients start with 45mg Rinvoq once daily for 12 weeks, with a maintenance dosage of 15mg following the 12-week period.
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European Pharmaceutical Review
OCTOBER 12, 2023
A €25 million drug delivery manufacturing investment To boost capacity in producing user-friendly oral dosage forms, German CDMO HERMES Pharma announced in September it is investing €25 million in its manufacturing capabilities. Subject to planning permission, the site is expected to be opened by 2028.
Impact Pharmaceutical Services
JULY 7, 2023
It guarantees delivery of the right drug and the right dosage at precisely the right time , tailored specifically for that person. Cell and gene therapies have been subjects of research for some time, but they have gained traction in real-world medicine and are projected to reach a market value of more than $36 billion by 2027.
The FDA Law Blog
OCTOBER 12, 2023
Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R.
PharmaShots
FEBRUARY 22, 2023
Active Ingredient: dulaglutide Dosage Forms & Strengths: Injection: 0.75 In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026). mL, 3 mg/0.5 Hence, it needs to protect its patent as Trulicity patents are very vital to the company’s business as a whole.
The FDA Law Blog
MARCH 5, 2024
First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs.
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