IPP Bureau

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets
Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

By IPP Bureau - October 19, 2024

Granules now has a total of 67 ANDA approvals from the USFDA

Roche’s Vabysmo improved vision in underrepresented populations with DME in a first-of-its-kind study
Roche’s Vabysmo improved vision in underrepresented populations with DME in a first-of-its-kind study

By IPP Bureau - October 19, 2024

Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies

Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years
Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years

By IPP Bureau - October 19, 2024

Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years

Gland Pharma appoints Shyamakant Giri as CEO
Gland Pharma appoints Shyamakant Giri as CEO

By IPP Bureau - October 19, 2024

Giri is currently the President (India Business & Emerging Markets) of Amneal Pharmaceuticals

AstraZeneca advances science of infectious disease protection at IDWeek 2024
AstraZeneca advances science of infectious disease protection at IDWeek 2024

By IPP Bureau - October 18, 2024

Data demonstrate the importance of protecting against serious respiratory infections caused by respiratory syncytial virus, human metapneumovirus and COVID-19

FDA approves VYALEV for adults living with advanced parkinson's disease
FDA approves VYALEV for adults living with advanced parkinson's disease

By IPP Bureau - October 18, 2024

VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease

MedGenome completes 10 years in genomics in India
MedGenome completes 10 years in genomics in India

By IPP Bureau - October 18, 2024

MedGenome reaffirms its commitment to broaden access to quality and affordable genetic solutions for all

Lupin launches first generic of Pred Forte in US
Lupin launches first generic of Pred Forte in US

By IPP Bureau - October 16, 2024

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

Lupin launches Aptivate Achi Bhookh Fest in Mumbai and Suburbs
Lupin launches Aptivate Achi Bhookh Fest in Mumbai and Suburbs

By IPP Bureau - October 16, 2024

The first phase of the Aptivate Achi Bhookh Fest reached over 8,200 households

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

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