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FDA Grants RMAT Designation to Autolus’ CAR-T Cell Therapy
FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.
Back to INTERPHEX
Spring has returned, and with it comes INTERPHEX.
Bio-Rad’s Three New Fluorescent Dyes are Intended to Enhance Multiplex Flow Cytometry
Bio-Rad Laboratories introduces three new fluorescent dyes under the StarBright product range to support multicolor flow cytometry panels.
Arrayjet Launches New Range of Next-Generation Microarray Printers
A new range of five instruments for ultra-low-volume liquid dispensing for microarray and microfluidics applications, Mercury, has been introduced by Arrayjet.
CN Bio Launches PhysioMimix, an “In-a-Box” Reagent Kit for NASH
CN Bio’s PhysioMimix “in-a-box” reagent kit is designed to harness liver-on-a-chip technology to improve accuracy and efficiency in drug discovery.
Societal CDMO Awarded Manufacturing and Packaging Task by National Cancer Institute
Societal CDMO has been awarded a new manufacturing and packaging task order agreement by National Cancer Institute.
Thermo Fisher Scientific Expands R&D Facility in Hyderabad
Thermo Fisher Scientific has expanded its state-of-the-art R&D facility in Hyderabad, India.
USPTO Issues Malaria Vaccine Patent to GeoVax
GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.
Pfizer and BioNTech Submit EUA Application for Pediatric COVID-19 Vaccine Booster Dose
Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.
Johnson & Johnson Launches Next Satellite Center for Global Health Discovery
Johnson & Johnson has launched its next Satellite Center for Global Health Discovery at Holistic Drug Discovery and Development Centre, University of Cape Town.
Tremelimumab Accepted Under Priority Review in the US
Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.
FDA Approves Veklury for Treatment of COVID-19 in Pediatric Patients
FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.
Pfizer Issues Voluntary Nationwide Recall of Lots of Accupril
Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.
EMA Recommends EU Conditional Approval of Roche’s Mosunetuzumab
EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.
Novo Nordisk Announces Positive Scientific Opinion from EMA on Human Insulin
EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.
FDA Requesting Comment on Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange
FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”
FDA Approves Kite’s CAR T-Cell Therapy Manufacturing Facility in Maryland
FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
Catalent to Invest $350 Million in Manufacturing Facility in Bloomington, Indiana
Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.
EIB Provides €15 million to IRBM
The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.
Otsuka Pharmaceutical and Osaka University Enter Exclusive License Agreement
Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.
Takeda’s TAKHZYRO Prefilled Syringe Now Available for Patients with Hereditary Angioedema
Takeda’s TAKHZYRO prefilled syringe is now available for patients with hereditary angioedema aged 12 years and older in the United States.
Clinical Trial Diversity Advances in Regulatory Agenda
New guidance from FDA and legislation from Congress promote clinical trial diversity.
AmoyDX and AstraZeneca Enter Master Collaboration Agreement
AmoyDX has entered a Master Collaboration Agreement with AstraZeneca for multiple companion diagnostics programs in China, EU, and Japan.
Thermo Fisher Scientific Launches New GMP-manufactured Cas9 Protein
Thermo Fisher Scientific has launched its first GMP-manufactured Cas9 protein for clinical genome editing research.
High Purity New England Launches Third Facility
High Purity New England has launched its third facility, focused on single-use assemblies.
GSK to Acquire Sierra Oncology for $1.9 Billion
GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9 billion.
Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection
Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.
ReiThera and Exothera Collaborate on Manufacturing Vaccines for Low and Middle-income Countries
ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.
Achilles Therapeutics Announces Manufacturing Expansion in the UK and US
Achilles Therapeutics has announced that it will expand its clinical manufacturing capabilities in the UK and enter a partnership agreement for expansion in the US.
Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine
Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.
