Shots: The approval is based on the P-III GEMINI 1 & 2 studies to evaluate the efficacy, safety, and tolerability of Vuity vs PBO in a ratio (1:1) in 750 […]readmore
Tags : US
Shots: The US FDA’s VRBPAC voted 17 to 0 with 1 abstention in favor of recommending the EUA for COVID-19 vaccine in children aged 5 to <12yrs. with COVID-19 The […]readmore
Shots: The approval is based on the P-III PEACHTREE trial to evaluate Xipere in 160 patients with macular edema associated with uveitis. The therapy is expected to be available in […]readmore
Shots: The approval is based on P-III Archway study evaluates Susvimo (100 mg/mL, IV, q3mos.) via ocular implant vs ranibizumab (0.5mg, IV) in 415 patients with wet AMD prior responded […]readmore
The US FDA has approved 5 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and […]readmore
Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The results showed a 65% avg. […]readmore
Biosimilars
Viatris’ Interchangeable Insulin Biosimilar Listed on Express Scripts’ Largest Formulary
Shots: Viatris’ interchangeable biosimilar Semglee (insulin glargine-yfgn) injection will be added in Express Scripts as a preferred insulin brand on its NPF for diabetic patients in the US Biocon and […]readmore
Regulatory
Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Low-Dose Tablet Receives the US FDA’s
Shots: The approval is based on cohort 3 of a P-II/III study that evaluates Biktarvy (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in 22 Pediatric patients with HIV-1 who are virologically suppressed […]readmore
Shots: Lipocine to receive $11.0M up front, $5.0M as licensing fees in Jan’25 & $5.0M in Jan’26, ~$160.0M as sales-based commercial milestone based on Tlando net sales, if Antares exercises […]readmore
Biosimilars
Regulatory
Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA
Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed […]readmore