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2285 News Found

Lupin acquires 3 Trademarks from Boehringer Ingelheim for diabetes portfolio
News | December 14, 2024

Lupin acquires 3 Trademarks from Boehringer Ingelheim for diabetes portfolio

The trademark rights for these brands will be transferred to Lupin by March next year.


Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium
Diagnostic Center | December 11, 2024

Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium

Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity (clinical benefit rate


EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
Drug Approval | November 13, 2024

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections


Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years
News | October 19, 2024

Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years

Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years


Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
Drug Approval | September 23, 2024

Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA


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


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


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


Arkema grants technology license to Seqens to manufacture PEKK for sale in medical implantable applications
News | June 25, 2024

Arkema grants technology license to Seqens to manufacture PEKK for sale in medical implantable applications

PEKK is a high-performance polymer family used in aerospace and other demanding markets


EMA approves Biocon Biologics’ new mAbs facility in India
News | June 24, 2024

EMA approves Biocon Biologics’ new mAbs facility in India

Renews GMP certifications for India and Malaysia sites