IPP Bureau

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

By IPP Bureau - October 16, 2024

Enhertu demonstrated clinically meaningful efficacy in previously treated patients

Tim Buckley elected to Pfizer’s Board of Directors
Tim Buckley elected to Pfizer’s Board of Directors

By IPP Bureau - October 16, 2024

Buckley served as Chairman and Chief Executive Officer at Vanguard from 2018 until his retirement in 2024

Strides Pharma's CDMO arm OneSource raises Rs. 801 crore in pre-listing round
Strides Pharma's CDMO arm OneSource raises Rs. 801 crore in pre-listing round

By IPP Bureau - October 16, 2024

The share subscription agreements are being executed at a pre-money equity value of US$ 1.65 billion

Wockhardt files fast-acting Insulin Aspart injection with DCGI
Wockhardt files fast-acting Insulin Aspart injection with DCGI

By IPP Bureau - October 16, 2024

The market size of Aspart in India is currently estimated over Rs. 260 crore with only 2 players

Akums Drugs enters into license and distribution agreement with Triple Hair, Canada
Akums Drugs enters into license and distribution agreement with Triple Hair, Canada

By IPP Bureau - October 16, 2024

Akums Drugs will undertake this development and commercialization in India

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

By IPP Bureau - October 16, 2024

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally

Granules India appoints Ramraj Rangarajulu as President and Head - Formulations Operations
Granules India appoints Ramraj Rangarajulu as President and Head - Formulations Operations

By IPP Bureau - October 15, 2024

He will join in place of Anil Arora, current President- Formulations Operations who will be superannuating in November, 2024

Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO
Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO

By IPP Bureau - October 15, 2024

Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w

Suven Pharma appoints Declan Ryan as CCO
Suven Pharma appoints Declan Ryan as CCO

By IPP Bureau - October 15, 2024

Declan brings over 25 years of expertise in the pharmaceutical and biotech sectors

CDSCO, NRAI meets WHO international standards for vaccine regulations
CDSCO, NRAI meets WHO international standards for vaccine regulations

By IPP Bureau - October 14, 2024

India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI

Indian Stroke Association launches the Bangalore chapter of ‘Mission Brain Attack’
Indian Stroke Association launches the Bangalore chapter of ‘Mission Brain Attack’

By IPP Bureau - October 14, 2024

Strokes are affecting approximately 1.8 million people annually

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

By IPP Bureau - October 14, 2024

Indoco is comprehensively working on the remedial action plan

Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP
Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP

By IPP Bureau - October 14, 2024

Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO

Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease
Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease

By IPP Bureau - October 14, 2024

The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease

AGC Biologics begins operations at new manufacturing building in Copenhagen
AGC Biologics begins operations at new manufacturing building in Copenhagen

By IPP Bureau - October 14, 2024

The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors

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