IPP Bureau

ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens
ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens

By IPP Bureau - February 28, 2023

First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China

Agilent announces cell analysis workflow automation for immuno-oncology, virology, and vaccine development markets
Agilent announces cell analysis workflow automation for immuno-oncology, virology, and vaccine development markets

By IPP Bureau - February 27, 2023

New workflow integrates the xCELLigence RTCA HT with the BioTek BioSpa 8 Automated Incubator

AlloVir appoints Derek Adams to Board of Directors
AlloVir appoints Derek Adams to Board of Directors

By IPP Bureau - February 27, 2023

Dr. Adams brings more than two decades of experience leading the manufacturing of biologic and gene therapies at all stages of development.

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg
Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

By IPP Bureau - February 27, 2023

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.

Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData
Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData

By IPP Bureau - February 27, 2023

The British-Swedish pharma major certainly has a strong competitive edge for BTC treatment in the country

Porton Advanced and Yinjia Biosciences partner to enhance CDMO technology platform
Porton Advanced and Yinjia Biosciences partner to enhance CDMO technology platform

By IPP Bureau - February 27, 2023

Yinjia Biosciences will provide Porton Advanced with high-quality core protein raw materials and testing reagent products for quality control and evaluation systems.

Strides flagship facility in Bangalore receives USFDA inspection closure
Strides flagship facility in Bangalore receives USFDA inspection closure

By IPP Bureau - February 25, 2023

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

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