IPP Bureau
FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis
By IPP Bureau - April 01, 2024
Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux
Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
By IPP Bureau - April 01, 2024
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
Biocon's European partner Zentiva receives approval from UK MHRA for Liraglutide
By IPP Bureau - April 01, 2024
The company had earlier announced about the approval received from the MHRA for Liraglutide
Venus Remedies receives Rs. 2.50 crore under PLI scheme
By IPP Bureau - April 01, 2024
The company has now received 100% of the incentive owed to the company for the financial year 2022-23 under the PLI scheme
Concept Medical receives USFDA approval for sirolimus drug-coated balloon
By IPP Bureau - April 01, 2024
For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure
Mankind Pharma introduces 'Digital Smart Class' initiative across rural India
By IPP Bureau - March 30, 2024
Establishment of 220 smart classrooms across Uttar Pradesh, Uttarakhand, and Himachal Pradesh
Aragen operationalizes first phase of its US$ 30 million Biologics manufacturing facility in India
By IPP Bureau - March 30, 2024
Executes the first project for developing and manufacturing a novel anticancer mAb
Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer
By IPP Bureau - March 30, 2024
First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations
NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
By IPP Bureau - March 30, 2024
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
WuXi Biologics breaks ground on CRDMO Center in Singapore
By IPP Bureau - March 28, 2024
The CRDMO site will add 120,000L manufacturing capacity to WuXi Biologics’ global network
Biocon to obtain approval for diabetes drug, Liraglutide in UK
By IPP Bureau - March 28, 2024
Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus
Tata Elxsi and Dräger collaborate to drive critical care innovation in India
By IPP Bureau - March 28, 2024
This partnership combines Tata Elxsi's design and technology expertise along with Dräger's expertise in medical and safety technology
lpca Laboratories enters into Technology Transfer Agreement with Omexa Formulary
By IPP Bureau - March 28, 2024
Under this agreement, lpca will grant to Omexa a non-exclusive right to research, develop, manufacture and market an anti-cancer biosimilar for the global market
Briefs: Alkem Laboratories and Zydus Lifesciences
By IPP Bureau - March 28, 2024
USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant
Dr Reddy's partners with Sanofi India to distribute vaccine brands in India
By IPP Bureau - March 28, 2024
Under the arrangement, Dr. Reddy's will have exclusive rights to promote and distribute Sanofi's vaccine brands Hexaxim, Pentaxim, Tetraxim, Menactra, FluQuadri, Adacel and Avaxim 80U