PharmaShots

Sorrento’s Partner Mabpharm Files NDA to the NMPA for Infliximab Biosimilar in China

January 7, 2020January 7, 2020Shiwani Sharma

Shots: Mabpharm files Infliximab Biosimilar’s NDA to the NMPA based on the trial evaluating Infliximab Biosimilar vs Infliximab and has used CHO expression [Read More...]

AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) Receives NMPA’s Approval for Patients with Hyperkalaemia

January 6, 2020January 6, 2020Shiwani Sharma

Shots: The approval is based on four trials assessing Lokelma vs PBO in patients with hyperkalemia treated for up to 12 months The [Read More...]

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for Patients with Mantle Cell Lymphoma Who Received At least One Prior Therapy

BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

December 31, 2019December 31, 2019Shiwani Sharma

Shots: The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months The [Read More...]

Zai Lab and Novocure’s Optune Receive NMPA’s Innovative Medical Device Designation for its Tumor Treating Field Delivery System

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy for Patients with Recurrent Ovarian Cancer in China

December 30, 2019December 30, 2019Shiwani Sharma

Shots: Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial [Read More...]

AstraZeneca’s Triple Combination Regimen Receives NMPA’s Approval as the Maintenance Treatment for COPD in China

December 26, 2019December 26, 2019Tuba Khan

Shots: The approval follows PR designation and is based on P-III KRONOS study assessing budesonide/glycopyrronium/formoterol fumarate vs Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 [Read More...]

Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval for HIV-1 Infection in Japan

Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Receives NMPA’s Approval for Chronic Hepatitis C Infection Who Require Re-Treatment

December 23, 2019December 26, 2019Shiwani Sharma

Shots: The approval is based on two P-III studies POLARIS-1 and POLARIS-4 assessing Vosevi in patients with HCV genotype 1-6 with or without [Read More...]

AstraZeneca Divests Rights of Seroquel and Seroquel XR to Cheplapharm in Europe and Russia

AstraZeneca’s Imfinzi (durvalumab) Receives NMPA’s Approval for Unresectable Stage III Non-Small Cell Lung Cancer

December 12, 2019December 13, 2019Tuba Khan

Shots: The approval is based on P-III PACIFIC study assessing Imfinzi vs PBO in 713 ‘all-comer’ patients (regardless of PD-L1 status) with unresectable, [Read More...]

AffaMed Therapeutics’ AMT901 (biosimilar, trastuzumab) Receives NMPA’s Approval to Initiate P-III Clinical Study in China

December 11, 2019December 11, 2019Tuba Khan

Shots: The NMPA has granted CTA approval to AffaMed to conduct a clinical study evaluating AMT901/ SB3, a biosimilar referencing Roche’s Herceptin. The [Read More...]

Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar of Stelara (ustekinumab)

December 6, 2019December 6, 2019Tuba Khan

Shots: Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & [Read More...]