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1281 News Found

Roche’s Vabysmo improved vision in underrepresented populations with DME in a first-of-its-kind study
News | October 19, 2024

Roche’s Vabysmo improved vision in underrepresented populations with DME in a first-of-its-kind study

Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies


Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Drug Approval | October 16, 2024

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients


Akums Drugs enters into license and distribution agreement with Triple Hair, Canada
News | October 16, 2024

Akums Drugs enters into license and distribution agreement with Triple Hair, Canada

Akums Drugs will undertake this development and commercialization in India


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


OneSource unveils new brand identity at CPHI Milan
News | October 11, 2024

OneSource unveils new brand identity at CPHI Milan

Aims to achieve CDMO sales of US$ 400 million by 2028


FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777
Drug Approval | October 08, 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy


Calquence granted priority review in US for patients with untreated mantle cell lymphoma
Drug Approval | October 06, 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy


Suven Life Sciences to present positive results from Phase-2a Proof-of-Concept Study of Ropanicant
News | October 05, 2024

Suven Life Sciences to present positive results from Phase-2a Proof-of-Concept Study of Ropanicant

The company plans to advance Ropanicant into double-blind, placebo-controlled Phase-2b clinical study in MDD patients, anticipated to start in early 2025


Biocon Biologics refinances US$ 1.1 billion debt through USD bonds, new syndicated facility
News | October 04, 2024

Biocon Biologics refinances US$ 1.1 billion debt through USD bonds, new syndicated facility

US$ 800 million senior secured notes, the largest high yield debut USD bond issuance from India in the last 10 years


BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months
Clinical Trials | September 27, 2024

BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months

At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high and low dose cohorts