Shots:
During the initial part of conversation, Sergey discussed details about the BDTX-1535 and the trial design of the P-I study where 1535 is being investigated in NSCLC and GBM patients
He then discussed the insights drawn from the first 51 patients recruited in the dose escalation part of the P-I study
In the final…
Shots:
PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices
Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…
Shots:
Tim spoke about the development of THE-349, a fourth-generation small molecule for the treatment of EGFR-mutant NSCLC
Tim also talked about Thesus’ other small molecule, THE-630 in gastrointestinal stromal tumors (GIST) being evaluated in a P-I/II dose-escalation and expansion study
The interview gives an understanding of how Thesus is developing different treatment options to…
Shots:
Garret spoke about the approval of the first NGS-based companion diagnostic to aid in selecting NSCLC patients with HER2 activating mutations for treatment with ENHERTU
Garret also talked about the Oncomine Dx Target Test and its availability for different targeted therapies in multiple geographies
The interview highlights how Thermo Fisher is working to develop accessible CDx solutions…
Shots:
Kathy spoke about the major outcomes from the real-world evidence data presented at the ASCO 2022
Kathy also emphasized on how next-generation sequencing can improve genomic testing
The interview gives a view of Thermo Fisher’s vision to bring targeted sequencing that provides faster results for clinicians
Smriti: Tell us in detail about the key…
Active Ingredients: Pembrolizumab
Strength: 100 mg/4 mL (25 mg/mL)
Dosage Form: Syringe, Vial
Mechanism of Action: PD-1 ligands antagonists
First Approval: US (Sep 4, 2014), EU (Jul 17, 2015)
Revenue
Keytruda (pembrolizumab) has been a key player in Merck & Co. immuno-oncology drugs for the past years – reaching nearly $17B in annual sales in 2021. Despite the dampening impact…
In an interview with PharmaShots, Dr. Trevor Feinstein (Hematology Specialist in Fayetteville, GA) and Dr. Lan Huang (Co-founder, Chairman, and CEO at BeyondSpring) shared their views on the data of Plinabulin + Docetaxel in P-III DUBLIN-3 trial for NSCLC with EGFR Wild Type
Shots:
The P-III DUBLIN-3 trial evaluates plinabulin + docetaxel vs docetaxel alone in 599 patients with 2L & 3L NSCLC EGFR wild type,…
In an interview with PharmaShots, Dr. Ahmet Sezer, (Professor in the Department of Medical Oncology at Baskent University), Karl Lewis (Professor in the Division of Medical Oncology at the University of Colorado) and Israel Lowy (Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron) shared their views on the EC's approval of Libtayo for…
Shots:
In an interview with PharmaShots, Dr. Ahmet Sezer, Sanofi's Peter C. Adamson, and Regeneron's Israel Lowy shared their views on the US FDA's approval of Libtayo and the data supporting the approval.
Regeneron and Sanofi received the US FDA's approval for Libtayo for the 1L treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score =50%), as…
In a recent interview with PharmaShots, Kiran Patel, Vice President Clinical Development, Solid Tumor Franchise at Janssen shared his views on the regulatory submission of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
Shots:
Janssen reported the BLA submission to the US FDA seeking approval of Amivantamab for the…

