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NEWS

Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Shots:The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to followThe Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…
September 17, 2025

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NEWS

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab) 

Shots: Xbrane and Intas have entered into a global licensing and co-development agreement for Xbrane's biosimilar of Opdivo (nivolumab). Intas, through its Accord Healthcare, will commercialize the biosimilar, leveraging its oncology expertise and significant market presence in the EU As per the agreement, Intas will fund and manage clinical as well as regulatory development, and…
November 19, 2024

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Viewpoints_Jennifer Fernandez
VIEWPOINTS

TCOC Management in Oncology: Jennifer Fernandez from The Oncology Network in a Dialogue Exchange with PharmaShots

Shots: Prominent oncology drugs like pembrolizumab and nivolumab were initially approved with weight-based dosing and gradually transitioned to fixed dozing. With the transformation in the dosing model, the average dose amount administered to patients increased dramatically in the Oncology Care Model Today, at PharmaShots, we have Jennifer Fernandez from The Oncology Network, shedding light on…
August 7, 2024

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BMS
NEWS

BMS Receives the CHMP’s Positive Opinion for Opdivo (Nivolumab) as a 1L Treatment of Urothelial Carcinoma 

Shots: The CHMP has granted positive opinion to Opdivo + CT (cisplatin & gemcitabine) as 1L treatment of metastatic or unresectable urothelial carcinoma adults (n=608). The decision is anticipated in Jun 2024  The opinion was based on a sub-study of the P-III (CheckMate–901), assessing Opdivo (360mg, Q3W, 6 cycles) + CT (cisplatin & gemcitabine) followed…
April 26, 2024

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New Drug Designations - October 2023
INSIGHTS+

New Drug Designations – October 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA and the EMA. This month’s report includes 2 biological drugs, 12 small molecules, 10 cell and gene therapies, 2 vaccines, 1 peptide, 1 exosome-based therapy and 3 devices HuidaGene Therapeutics’ HG204 CRISPR RNA-editing therapy, focused on the treatment of MECP2 duplication…
November 20, 2023

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Viewpoints_Dr. Ian Waxman
VIEWPOINTS

PharmaShots Interview: BMS’ Dr. Ian Waxman Shares Insights on the Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC

In an interview with PharmaShots, Dr. Ian Waxman, MD, Development Lead, Gastrointestinal Cancer at BMS shared his views on the EC's approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for the Treatment of dMMR or MSI-H mCRCShots:The approval is based on P-II CheckMate -142 study evaluating Opdivo + Yervoy in patients with dMMR or MSI-H mCRC whose disease had…
September 28, 2021

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Viewpoints_Dr. Med. Steven Hildemann
VIEWPOINTS

PharmaShots Interview: Ipsen’s Dr. Med. Steven Hildemann Shares Insight on the EC’s Approval of Cabometyx + Nivolumab for Advanced Renal Cell Carcinoma

In an interview with PharmaShots, Prof. Dr. Med. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs, and Patient Safety of Ipsen share his views on the approval of the combination regimen for aRCC. He also shed light on the company's near-term goals in the coming years.Shots:The EC approval is based…
May 11, 2021

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