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3865 News Found

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Drug Approval | October 16, 2024

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

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


Lupin launches first generic of Pred Forte in US
News | October 16, 2024

Lupin launches first generic of Pred Forte in US

Prednisolone Acetate Ophthalmic Suspension is the first generic version of Pred Forte


Tim Buckley elected to Pfizer’s Board of Directors
News | October 16, 2024

Tim Buckley elected to Pfizer’s Board of Directors

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


Wockhardt files fast-acting Insulin Aspart injection with DCGI
News | October 16, 2024

Wockhardt files fast-acting Insulin Aspart injection with DCGI

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


Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO
Drug Approval | October 15, 2024

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

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


Indian Stroke Association launches the Bangalore chapter of ‘Mission Brain Attack’
News | October 14, 2024

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

Strokes are affecting approximately 1.8 million people annually


Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP
News | October 14, 2024

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

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


USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B
Drug Approval | October 12, 2024

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis


Alkem enters into licensing agreement with BioTherapeutics
News | October 11, 2024

Alkem enters into licensing agreement with BioTherapeutics

Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting