Tags : Recommendation

Pharma Regulatory

Novartis’ Enerzair Breezhaler (QVM149, IND/GLY/MF) Receives CHMP’s Recommendation for Approval

Shots: The CHMP’s recommendation is based on P-III IRIDIUM study assessing IND/GLY/MF (150/50/160 μg & 150/50/80 μg) vs IND/MF doses (150/320 μg & 150/160 μg) in 3,092 patients in a ratio (1:1:1) with uncontrolled asthma, as determined by pulmonary function testing and effects on asthma control The P-III IRIDIUM study resulted in improvements in lung […]Read More


Sanofi’s Insulin Aspart Biosimilar Receives CHMP’s Positive Recommendation for Approval

Shots: The CHMP’s positive recommendation is based on the clinical development program that comprises P-I PK/PD study that evaluates product’s similarity in exposure and activity1 and P-III Gemelli 12 study to evaluate the safety & efficacy The clinical program involves 600+ patients with T1D or T2D. Both the studies compared the biosimilar to insulin aspart […]Read More


AstraZeneca’s Lokelma Receives CHMP’s Recommendation for Approval for Patients with

Shots: The EMA’s CHMP has adopted a positive opinion on a dosing and administration label update for AstraZeneca’s Lokelma to include patients with hyperkalemia on stable hemodialysis The recommendation is based on P-IIIb DIALIZE study assessing Lokelma (qd) vs PBO in 196 patients on non-dialysis days for 8wks. The study demonstrated that patients-maintained pre-dialysis potassium […]Read More


AstraZeneca and Merck & Co Receive the US FDA Advisory

Shots: The US FDA’s ODAC voted 7 to 5 in favor of recommending Lynparza as 1L maintenance monotherapy for patients with gBRCAm metastatic adenocarcinoma of the pancreas that has not progressed on 1L platinum-based CT The ODAC recommendation is based on P-III POLO study assessing Lynparza vs PBO in 154 patients in a ratio (3:2) […]Read More


Merck Receives the US FDA Advisory Committee’s Recommendation on Approval

Shots: The US FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 9-4 in favor of recommending Keytruda for bacillus Calmette-Guérin-unresponsive, high risk NMIBC with carcinoma in-situ with/ out papillary tumors who are ineligible for or have elected not to undergo cystectomy The ODAC recommendation is based on the results of P-II KEYNOTE-057 study and supports […]Read More


Roche’s Kadcyla (trastuzumab emtansine) Receives CHMP’s Recommendation for Approval as

Shots: The CHMP’s recommendation is based on P-III KATHERINE study assessing Kadcyla vs Herceptin as an adjuvant therapy in patients with HER2+ early breast cancer with the residual invasive disease after neoadjuvant treatment which included Herceptin and Taxane-based CT The P-III KATHERINE study results: reduction in iDFS by 50%; @3yrs. iDFS (88.3% vs 77.0%) showing […]Read More