Press Releases

Moderna, Inc.  a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. “We are pleased to submit for a conditional marketing approval with the EMA for our booster candidate at the 50 µg dose level. The amended Phas

Eckert & Ziegler Radiopharma GmbH has successfully submitted an amendment to their Drug Master File (DMF) to the U.S. Food and Drug Administration for GalliaPharm®. Their proprietary Ge-68/Ga-68 generator from now on will additionally be available in sizes of up to 100 mCi with a shelf-life of 12 months or for a maximum of 700 elutions. Gallium-68 from GalliaPharm® is used for the preparation of diagnostic imaging drugs in Positron Emission Tomography (PET). “With

Saint-Gobain Life Sciences announced today the acquisition of Equflow B.V., located in Oss, Netherlands. Equflow is a leading designer and provider of Flowmeters, produced for a broad range of commercial and industrial applications, primarily serving the single-use bioprocessing market. The acquisition expands Saint-Gobain’s product capabilities within its Bio-Process Solutions (BPS) business. “We are pleased to welcome Equflow into our organization and are exc

 Cellect Biotechnology Ltd. announced the first ApoGraftTM transplantation in a Leukemia patient in the Company’s clinical trial at Washington University in the U.S. ApoGraftTM is a product based on the Company’s cell selection technology designed to optimize immune therapy, in this application - prevent graft-versus-host disease (GVHD) following bone marrow transplantation. Following the closing of the previously announced strategic merger transaction between Celle

BeiGene, Ltd. a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA (zanubrutinib) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). “We are delighted by today’s FDA approval for BRUKINSA in its second indication, offering a new treatment option with demonstrated efficacy and safety

Natco Pharma Inc., a subsidiary of Natco Pharma Limited, announced today the launch of PrNAT-LENALIDOMIDE Capsules, the first generic alternative to Revlimid® to be approved by Health Canada. PrNAT-LENADLIDOMIDE is used in combination with dexamethasone for the treatment of multiple myeloma in patients who are not eligible for stem cell transplant.  PrNAT-LENALIDOMIDE is also indicated for treatment of transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodys

the R&D Data Cloud company, announced today that Zymeworks Inc. has selected the Tetra Data Platform (TDP) to standardize and automate scientific data flow. As a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics, Zymeworks' R&D engine generates and analyzes large amounts of scientific data in its quest to revolutionize drug design. "In order to take advantage of innovative data science applicatio

Eagle Pharmaceuticals, Inc. announced that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,103,483, entitled “Formulations of Bendamustine.” Eagle is submitting the ‘483 patent for listing in the U.S. Food and Drug Administration’s Orange Book for both BENDEKA and BELRAPZO. Eagle had asserted several Orange Book-listed patents against Slayback Pharma LLC, Apotex Inc. et al, Mylan Laboratories Limited, and Fresenius Kabi US

Polaryx Therapeutics, Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation for PLX-200 to treat GM2 gangliosidoses. GM2 Gangliosidoses, also known as Tay-Sachs and Sandhoff diseases, are ultra-rare and fatal pediatric neurodegenerative disorders caused by defects in Hexosaminidase A (HEXA) and Hexosaminidase B (HEXB), key enzymes

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY® (COVID-19 Vaccine, mRNA) for distribution within Latin America. Eurofarma will perform manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities. T