IPP Bureau
Center for Breakthrough Medicines launches analytical testing
By IPP Bureau - February 17, 2022
More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline
Kato wins USFDA approval for studies in retinal disorder
By IPP Bureau - February 17, 2022
Resolv ER may remedy leading causes of blindness in adults
Jubilant Ingrevia commissions Diketene derivatives facility
By IPP Bureau - February 17, 2022
The commissioned facility has a capacity of 7,000 TPA to produce various Esters (Mono Methyl Acetoacetamide, Methyl Acetoacetate, Ethyl Acetoacetate, and Ter-Butyl Acetoacetate)
Rajiv Gupta to retire as chairman of Avantor
By IPP Bureau - February 17, 2022
Gupta to retire at the end of his current term on May 12, 2022, after more than a decade of service, during which time Avantor has transformed into a global life sciences leader
Swissmedic approves BeiGene's Brukinsa
By IPP Bureau - February 17, 2022
With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain
Pebble engages MD Anderson to evaluate multi-cannabinoid formulations in ovarian cancer
By IPP Bureau - February 17, 2022
Despite advances over the past 20 years, ovarian cancer treatment requires better standard of care
Asahi Kasei to build new filter assembly plant in Japan
By IPP Bureau - February 17, 2022
The construction is scheduled to begin in the third quarter of the calendar year 2022, with expected completion in early 2024
PerkinElmer’s SIRION Biotech and CRG to develop diabetes gene therapy
By IPP Bureau - February 17, 2022
Collaboration aims to evolve precision medicine with cell-specific delivery of gene therapy
USFDA approves Lupin’s Supplemental New Drug Application for Solosec
By IPP Bureau - February 17, 2022
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
Centauri Therapeutics closes £ 24 million Series A investment round
By IPP Bureau - February 17, 2022
Funding will support continued advancement of Centauri’s antimicrobial resistance research to identify novel therapeutic candidates using its proprietary Alphamer platform
USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi
By IPP Bureau - February 17, 2022
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Nirsevimab EMA regulatory submission accepted under accelerated assessment
By IPP Bureau - February 17, 2022
Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose
Moderna announces expansion in key Asian markets
By IPP Bureau - February 16, 2022
New subsidiaries to be established in Malaysia, Taiwan, Singapore, and Hong Kong
EMA approves Pfizer’s 20-valent pneumococcal conjugate vaccine
By IPP Bureau - February 16, 2022
Apexxnar is the first pneumococcal conjugate vaccine to help protect adults ages 18 years and older against 20 serotypes responsible for the majority of invasive disease and pneumococcal pneumonia
Rapid Medical receives USFDA designation for Comaneci
By IPP Bureau - February 16, 2022
The device will facilitate the treatment of cerebral vasospasm following hemorrhagic stroke
