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Results For "European-Medicines-Agency"

172 News Found

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19
News | September 23, 2024

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization


Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers
Diagnostic Center | September 20, 2024

Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers

Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma


Merck announces Phase 3 trial initiation for Bomedemstat
Diagnostic Center | August 27, 2024

Merck announces Phase 3 trial initiation for Bomedemstat

The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)


EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
News | August 19, 2024

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile


Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr
News | August 10, 2024

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr

This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.


Lupin completes  successful Phase 3 trials for Lucentis biosimilar
Biotech | August 06, 2024

Lupin completes successful Phase 3 trials for Lucentis biosimilar

The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B
Drug Approval | July 26, 2024

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)


Ligand to acquire Apeiron Biologics for US$100 million
News | July 09, 2024

Ligand to acquire Apeiron Biologics for US$100 million

Acquisition provides Ligand with the royalty rights to QARZIBA, a highly differentiated, commercial oncology drug marketed in 35 countries by global pharmaceutical company Recordati S.p.A.


Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
Drug Approval | July 03, 2024

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population