IPP Bureau

FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

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