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 […]readmore
Tags : Recommendation
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 […]readmore
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 […]readmore
Regulatory
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 […]readmore
Shots: The US FDA advisory committee voted 16 to 2 for Descovy’s approval to treat proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex […]readmore
Shots: The CHMP’s positive recommendation is based on P-III IMpower133 study results assessing Tecentriq + CT vs CT (carboplatin and etoposide) in 403 patients in a ratio (1:1) with ES-SCLC […]readmore
Shots: The opinion is based on P-II ELOQUENT-3 study assessing Empliciti (elotuzumab) + pomalidomide and dexamethasone (EPd) vs pomalidomide + dexamethasone (Pd) in 117 patients in a ratio (1:1) with […]readmore
Regulatory
Boehringer Ingelheim’s Ofev (nintedanib) Receives FDA’s Advisory Committee Recommendation for
Shots: The FDA’s Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) The FDA’s recommendation is based on P-III SENSCIS […]readmore
Biotech
Regulatory
Roche’s Tecentriq (atezolizumab) + Abraxane Receives CHMP’s Recommendation for its
Shots: The CHMP recommendation is based on P-III IMpassion130 study results assessing Tecentriq + Abraxane vs PBO + Abraxane in patients with 902 patients in ratio (1:1) with unresectable LA […]readmore
Pharma
Regulatory
Janssen’s Imbruvica (ibrutinib) Receives CHMP Positive Recommendation for its Expanded
Shots: The CHMP’s positive opinion for CLL is based on P-III iLLUMINATE (PCYC1130) study assessing Imbruvica + obinutuzumab vs chlorambucil + obinutuzumab in patients with newly diagnosed CLL, resulted in […]readmore