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818 News Found

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


Finerenone meets primary endpoint in Phase III FINEARTS-HF cardiovascular study
Clinical Trials | August 05, 2024

Finerenone meets primary endpoint in Phase III FINEARTS-HF cardiovascular study

Finerenone significantly reduced the composite of cardiovascular death and total (first and recurrent) heart failure events compared to placebo in addition to usual therapy


Supriya Lifescience names Dr. Saloni Wagh as MD
People | August 03, 2024

Supriya Lifescience names Dr. Saloni Wagh as MD

Shivani Satish Wagh takes on the role of Joint Managing Director


Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause
Drug Approval | August 01, 2024

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause

The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo


Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers
Drug Approval | July 31, 2024

Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers

The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2


Fischer MVL and Bio Angle Vacs partner to launch livestock and aquaculture vaccines to India
News | July 31, 2024

Fischer MVL and Bio Angle Vacs partner to launch livestock and aquaculture vaccines to India

BAV has revolutionized the animal vaccination industry with its ground-breaking delivery methods that prioritize quality, safety, and efficacy


GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s  CHMP opinion for adults aged 50-59
Drug Approval | July 30, 2024

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024


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


Mankind Pharma to acquire 100% stake in Bharat Serums from Advent for Rs. 13,630 Cr
News | July 26, 2024

Mankind Pharma to acquire 100% stake in Bharat Serums from Advent for Rs. 13,630 Cr

Acquisition in line with Mankind’s stated objective to expand its presence in high entry barrier complex portfolios and high potential OTX brands


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)