Tags : Recommendation

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

BMS’ Opdivo (nivolumab) Receives CHMP Recommendation for Approval of its

Shots: The EMA’s CHMP has recommended approval of Opdivo flat dosing schedule 240 mg infused over 30min. (q2w) or 480mg infused over 60min. (q4w) for the adjuvant treatment of adult patients with melanoma involvement of lymph nodes or metastatic disease who have undergone complete resection The positive CHMP opinion for two and four-week dosing of […]Read More

AstraZeneca’s Qtrilmet Receives CHMP’s Recommendation for its Approval to Treat

Shots: The CHMP’s positive opinion is based on five P-III studies assessing Forxiga (dapagliflozin) + Onglyza (saxagliptin) + Metformin vs the Forxiga + Metformin/Onglyza + Metformin/Glimepiride/Metformin in patients with inadequately controlled T2D The P-III studies results demonstrated that Qtrilmet resulted in a reduction of HbA1c and is not inferior to the combined use of insulin […]Read More

Ziopharm Oncology’s Controlled IL-12 Platform Receives EMA’s COMP Positive Recommendation

Shots: EMA’s Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending Ziopharm’s Controlled IL-12 platform (Ad-RTS-hIL-12 + veledimex) for ODD candidate for the treatment of glioma EMA’s ODD provides regulatory and financial incentives to the company for developing & commercializing therapies for life-threatening diseases no more than five in 10,000 persons in […]Read More