Latest News
Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis
Tuba Khan
October 15, 2021
Shots: The CHMP’s recommendation is based on P-III True North study evaluating Zeposia as an induction and maintenance therapy vs PBO in adult patients with moderately to severely active UC The study demonstrated improvements across
Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & T2D
Tuba Khan
October 15, 2021
Shots: The company completes two P-III studies that compares proposed biosimilar Gan & Lee insulin glargine (GL-GLA) to a reference biologic n subjects with type 1 (n=576) and type 2 diabetes mellitus (n=567) for 26wks.
Exelixis In-Licenses Second Anti-Cancer Compound from Aurigene Following the US FDA’s Acceptance of IND for P-I Study of XL114 in Non-Hodgkin’s Lymphoma
Tuba Khan
October 15, 2021
Shots: Exelixis has exercised its exclusive option under the companies’ July 2019 agreement to in-license XL114 (formerly AUR104), following the US FDA’s IND acceptance for P-I study in NHL Exelixis has assumed responsibility for the
Hologic to Acquire Bolder Surgical for $160M
Tuba Khan
October 15, 2021
Shots: Hologic to acquire Bolder Surgical for ~$160M which is a provider of advanced energy vessel sealing surgical devices. The acquisition is expected to be closed by 2021 The transaction will add laparoscopic vessel sealing, dividing and
AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III HIMALAYA Study for 1L Treatment of Unresectable Liver Cancer
Tuba Khan
October 15, 2021
Shots: The P-III HIMALAYA study Imfinzi monothx. and the STRIDE regimen (single priming dose of tremelimumab 300mg + Imfinzi 1500mg followed by Imfinzi q4w vs sorafenib in ~1,324 patients with unresectable, advanced HCC who had
Lilly Presents Updated Data of Verzenio (abemaciclib) in P-III monarchE Trial Presented at ESMO and Published in the Annals of Oncology
Tuba Khan
October 15, 2021
Shots: The P-III monarchE trial assessed Verzenio (150mg, bid) + SOC vs SOC alone in patients with EBC in a ratio (1:1) for 2yrs. Patients in both treatment arms were instructed to continue to receive
Regeneron Reports the US FDA’s Acceptance of Priority Review for REGEN-COV for the Treatment and Prophylaxis of COVID-19
Tuba Khan
October 14, 2021
Shots: The US FDA has accepted for priority review a BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals The BLA is based on P-III study
Asieris Receives NMPA’s IND Approval to Evaluate APL-1202 + Tislelizumab as Neoadjuvant Therapy for MIBC Patients
Tuba Khan
October 14, 2021
Shots: NMPA’s CDE has approved the IND application of oral APL-1202 in combination with BeiGene’s tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer. The US FDA has cleared the IND of the
Novartis Reports the US FDA and EMA Filing Acceptance of Beovu for Patients with Diabetic Macular Edema
Tuba Khan
October 14, 2021
Shots: The US FDA has accepted the sBLA and EMA has validated the type-II variation application for Beovu (brolucizumab, 6mg) for the treatment of DME. Additionally, the PMDA has accepted an application for Beovu for
