IPP Bureau
Alembic announces USFDA final approval for Brexpiprazole Tablets
By IPP Bureau - January 16, 2025
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby
By IPP Bureau - January 16, 2025
Morepen Laboratories approves hiving off of medical devices business
USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs
By IPP Bureau - January 16, 2025
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
atulya launches winter essential kit for hair and skin care
By IPP Bureau - January 16, 2025
atulya keratin & wheat protein shampoo has force of natural ingredients like extract of wheat, fenugreek, reetha & almond oil
DBT hosts webinar on Biomanufacturing for Climate Resilient Agriculture
By IPP Bureau - January 15, 2025
Need for inter-sectoral collaboration, enhanced research, and innovative practices to address growing burden of NCDs: Health Secretary Srivastava
By IPP Bureau - January 15, 2025
The conference featured comprehensive discussions, field visits, and knowledge-sharing sessions addressing different aspect of major NCDs
Bayer’s pharma growth strategy progressing well as pipeline advances
By IPP Bureau - January 15, 2025
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Odisha to implement AB PM-JAY scheme
By IPP Bureau - January 14, 2025
The scheme is fully digitized and covers approximately 45% of India's population
Cube Biotech acquires IBA Lifesciences
By IPP Bureau - January 14, 2025
The combined entity will leverage its complementary strengths to deliver unparalleled solutions in protein purification and stabilization
Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer
By IPP Bureau - January 13, 2025
If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population
Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP
By IPP Bureau - January 13, 2025
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
Apotex acquires US rights to PROVIGIL and NUVIGIL
By IPP Bureau - January 13, 2025
PROVIGIL and NUVIGIL are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy
Steven R. Smith joins Zealand Pharma as Senior Global Medical Advisor in Obesity
By IPP Bureau - January 13, 2025
Dr. Smith brings 30 years of clinical and translational research experience in obesity, diabetes, and metabolism with over 300 scientific publications
USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
By IPP Bureau - January 13, 2025
Biocon Biologics remains committed to global standards of quality and compliance
Zaynich achieves over 97% efficacy in clinical study for meropenem-resistant gram-negative pathogens
By IPP Bureau - January 13, 2025
The overall clinical efficacy of Zaynich across indications was 98% at the test-of-cure
