Latest News

Regulatory

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis

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

Biosimilars

Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & T2D

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.

Pharma

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

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

M&A MedTech

Hologic to Acquire Bolder Surgical for $160M

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

Clinical Trials

AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III HIMALAYA Study for 1L Treatment of Unresectable Liver Cancer

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

Clinical Trials

Lilly Presents Updated Data of Verzenio (abemaciclib) in P-III monarchE Trial Presented at ESMO and Published in the Annals of Oncology

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

Regulatory

Regeneron Reports the US FDA’s Acceptance of Priority Review for REGEN-COV for the Treatment and Prophylaxis of COVID-19

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

Regulatory

Asieris Receives NMPA’s IND Approval to Evaluate APL-1202 + Tislelizumab as Neoadjuvant Therapy for MIBC Patients

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

Regulatory

Novartis Reports the US FDA and EMA Filing Acceptance of Beovu for Patients with Diabetic Macular Edema

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