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Oncology

Set Alert for Oncology

Novartis’ Kisqali Could Challenge Pfizer’s Ibrance After Phase II First-Line Aggressive Breast Cancer Success

The Swiss major’s CDK4/6 inhibitor has met the primary endpoint in a Phase II trial in first-line aggressive advanced breast cancer, supporting off-label use as the firm goes head to head with Pfizer’s rival drug Ibrance.

Clinical Trials Cancer

Safety Could Differentiate Nkarta’s CAR-NK Cell Therapy

Nkarta has updated its early results for its natural killer cell therapy, where it has shown promising efficacy and potentially superior safety to existing CAR-Ts.

Companies Clinical Trials

MorphoSys Teams Up Again With Novartis For Preclinical Cancer Program

The German biotech announced in March that it was terminating the early-stage oncology R&D projects that came with its purchase of Constellation last year and Novartis has snapped up one of them.

Deals Strategy

New Data Position Lazertinib As Strong Contender In 1L NSCLC

Yuhan’s oncology drug lazertinib is set to expand its indications in Korea to the first-line treatment of EGFR mutation-positive advanced NSCLC, based on new top-line Phase III data showing clinical benefits for all patient sub-groups.

Clinical Trials Cancer

Novartis Eyes Broader Market As Pluvicto Hits Mark In Pivotal Second-Line mCRPC Trial

The major’s radioligand therapy has succeeded in an earlier line of prostate cancer therapy that presents a large market opportunity, but some observers are keen to see full data before raising their sales projections.

Clinical Trials ImmunoOncology

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: safety debate as more lecanemab data reported; amyloid discussions continue at Alzheimer’s meeting; China COVID unrest affect country’s biotech sector; and Merck’s CMO talks about post-Keytruda plans.

Clinical Trials Business Strategies

Y-mAbs Shifts Focus To Approved Drug, Pipeline After Omburtamab CRL

The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.

Complete Response Letters ImmunoOncology

Rigel Ready To Hit The Ground Running After Early AML Drug Approval

Rezlidhia, which was only recently licensed by Rigal from Novo Nordisk-owned Forma Therapeutics, should challenge the market dominance of Servier's Tibsovo in the IDH-1 inhibitor subset of acute myeloid leukemia patients. 

Approvals Business Strategies

Frontline Success Bolsters IO ‘Backbone’ Hopes For GSK’s Jemperli

GSK’s PD-1 inhibitor will not be able to make up much ground on Keytruda, but new studies suggest it is a match for the market-leading PD-1 inhibitors.

Clinical Trials Companies

Nimbus Nips At BMS’s Heels With Psoriasis Results For TYK2 Inhibitor

Without disclosing data, Nimbus announced positive Phase IIb results for NDI-034858 in psoriasis. The company plans to initiate a Phase III trial next year.

Clinical Trials Business Strategies

BioNTech Bolsters Cancer Immunotherapy Ambitions In Pact With Cash-Poor Ryvu

Deal Snapshot: German firm gets license rights to Ryvu’s STING agonist portfolio in addition to collaborating on immunomodulators. Ryvu adds need cash via upfront and equity payments from BioNTech.

Deals Business Strategies

Roche Withdraws Tecentriq’s Frontline Bladder Cancer Indication, Ceding Market To Keytruda

The move marks the second time since last year that Roche has withdrawn a urothelial carcinoma indication after its confirmatory trial failed to show an overall survival benefit.

Cancer ImmunoOncology
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