IPP Bureau
European Commission approves Pfizer’s Elrexfio for multiple myeloma
By IPP Bureau - December 09, 2023
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease
By IPP Bureau - December 09, 2023
Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment
Zepbound is now available in US for adults living with obesity
By IPP Bureau - December 09, 2023
Express Scripts to add Zepbound to National Preferred Formulary
Operations disrupted at NATCO Pharma's Manali, Chennai factory
By IPP Bureau - December 08, 2023
NATCO temporarily shut down the operations due to cyclone with flooding/water logging of the factory premises
TTK Healthcare halts operation at ortho implants plant at Ambattur
By IPP Bureau - December 08, 2023
The company is assessing the situation and simultaneously undertaking all the requisite action
Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant
By IPP Bureau - December 08, 2023
Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone
Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
By IPP Bureau - December 08, 2023
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
AbelZeta Pharma, AstraZeneca to co-develop a novel GPC3 armored CAR-T therapy in China
By IPP Bureau - December 08, 2023
C-CAR031 is based on a novel GPC3-targeting CAR-T (AZD5851) designed by AstraZeneca using their transforming growth factor-beta receptor II
Akums acquires new facility in Baddi to enhance tablet manufacturing capacity
By IPP Bureau - December 07, 2023
his marks the 12th formulation facility under Akums, and the second in Baddi, a strategic move with an aim to enhance Akums’ manufacturing capabilities.
Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug
By IPP Bureau - December 07, 2023
Dr. Reddy's will make a US$ 7.5 million upfront payment to Coya
Zydus receives final approval from the USFDA for methylene blue injection
By IPP Bureau - December 07, 2023
Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product
Venus Remedies gets marketing approvals from Philippines, Saudi Arabia for three drugs
By IPP Bureau - December 07, 2023
Venus Remedies is supplying the drug to many countries like Colombia, Thailand, Tanzania, Morocco, Myanmar, Indonesia, Saudi Arabia, Malaysia, Zimbabwe, Sri Lanka, Pakistan, Kenya, and Botswana
Lupin receives approval from U.S. FDA for Varenicline Tablets
By IPP Bureau - December 07, 2023
Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.
Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets
By IPP Bureau - December 07, 2023
This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa
Sun Pharmaceutical inks licensing agreement with Aclaris Therapeutics
By IPP Bureau - December 06, 2023
The agreement includes an upfront payment of US$15 million, regulatory and commercial milestones, and royalties
