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3261 News Found

European Medicines Agency accepts Menarini’s application for Elacestrant
Drug Approval | August 20, 2022

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union


WuXi STA breaks ground for second manufacturing facility in US
News | August 19, 2022

WuXi STA breaks ground for second manufacturing facility in US

This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region


Growing investment in biotech startups likely to make CAR-T therapies affordable in India, says GlobalData
Startup | August 19, 2022

Growing investment in biotech startups likely to make CAR-T therapies affordable in India, says GlobalData

GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.


CureVac, GSK start Phase 1 clinical study of omicron-targeting COVID-19 vaccine candidate
Clinical Trials | August 19, 2022

CureVac, GSK start Phase 1 clinical study of omicron-targeting COVID-19 vaccine candidate

Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines


Jemincare inks licensing deal for prostate cancer drug with Roche
News | August 19, 2022

Jemincare inks licensing deal for prostate cancer drug with Roche

Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.


Sun Pharma gets OAI from USFDA for Halol facility
Drug Approval | August 18, 2022

Sun Pharma gets OAI from USFDA for Halol facility

The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved


Short Wave Pharma signs clinical trial agreement with the Sheeba Research Fund
Clinical Trials | August 16, 2022

Short Wave Pharma signs clinical trial agreement with the Sheeba Research Fund

The Trial, the first of its kind in Israel, recently obtained approval from the Israeli Ministry of Health and is preparing for participant recruitment.


NGL Fine-Chem planning greenfield expansion at Tarapur
News | August 16, 2022

NGL Fine-Chem planning greenfield expansion at Tarapur

The estimated capex is to the tune of Rs. 140 crore to be funded through debt and internal accrual


Unichem receives ANDA approval for quetiapine extended-release tablets
Drug Approval | August 16, 2022

Unichem receives ANDA approval for quetiapine extended-release tablets

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)


Fish & Richardson secures win for Exela Pharma Sciences in ELCYS patent infringement litigation
News | August 16, 2022

Fish & Richardson secures win for Exela Pharma Sciences in ELCYS patent infringement litigation

ELCYS is the only FDA-approved cysteine hydrochloride injection on the market for use as an additive to amino acid solutions