IPP Bureau

Zydus receives final approval from the USFDA for Pitavastatin Tablets
Zydus receives final approval from the USFDA for Pitavastatin Tablets

By IPP Bureau - February 25, 2023

EMA recommends refusal of the marketing authorization for Lagevrio
EMA recommends refusal of the marketing authorization for Lagevrio

By IPP Bureau - February 25, 2023

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

By IPP Bureau - February 25, 2023

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Pfizer’s Elranatamab receives FDA and EMA filing acceptance

By IPP Bureau - February 25, 2023

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma

No link between the use of ranitidine and cancer risk, claims Nature
No link between the use of ranitidine and cancer risk, claims Nature

By IPP Bureau - February 24, 2023

N-nitroso dimethylamine (NDMA) is a probable human carcinogen and tts effects on humans rely on observational studies.

SERDA therapeutics submits IND for wound debridement agent
SERDA therapeutics submits IND for wound debridement agent

By IPP Bureau - February 24, 2023

Clinical studies are expected to start in Q2 2023.

Novartis appoints Gilbert Ghostine Chairman-Designate of Sandoz Board of Directors
Novartis appoints Gilbert Ghostine Chairman-Designate of Sandoz Board of Directors

By IPP Bureau - February 24, 2023

Ghostine has served as CEO of Geneva-based Firmenich, the world's largest privately owned perfume and taste company, since 2014.

Sanofi India posts Q4 CY22 PAT at Rs. 130.9 Cr
Sanofi India posts Q4 CY22 PAT at Rs. 130.9 Cr

By IPP Bureau - February 24, 2023

The company has reported total income of Rs. 691.9 crores during the quarter ended December 31, 2022

Govt. appoints Rajeev Raghuvanshi new DGCI
Govt. appoints Rajeev Raghuvanshi new DGCI

By IPP Bureau - February 24, 2023

MEI Pharma and Infinity Pharmaceuticals inks merger agreement to advance three promising clinical oncology candidates
MEI Pharma and Infinity Pharmaceuticals inks merger agreement to advance three promising clinical oncology candidates

By IPP Bureau - February 24, 2023

Projected ~US$100 million cash balance of combined company expected to fund operations through mid-2025 and to clinical data over the next 12 to 24 months

Briefs: Alkem and Krsnaa Diagnostics
Briefs: Alkem and Krsnaa Diagnostics

By IPP Bureau - February 24, 2023

Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.

National Health Authority facilitating Quick OPD registration in 365 hospitals
National Health Authority facilitating Quick OPD registration in 365 hospitals

By IPP Bureau - February 24, 2023

More than 5 lakh patients availed the benefit of queue-less OPD registration using this service

Venus Remedies gets marketing approval for cancer drugs from Uzbekistan, Palestine
Venus Remedies gets marketing approval for cancer drugs from Uzbekistan, Palestine

By IPP Bureau - February 23, 2023

The marketing authorisations for three generic drugs signifying advances in cancer treatment will considerably benefit thousands of patients by improving access, ensuring affordability

Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940
Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940

By IPP Bureau - February 23, 2023

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial

AIIA Goa conducts induction programme for first batch of BAMS student
AIIA Goa conducts induction programme for first batch of BAMS student

By IPP Bureau - February 23, 2023

Ayurveda is one of the most advanced sciences of its times

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