Press Releases

Protalix BioTherapeutics, Inc., a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User F

Sedana Medical AB  announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care. The application has been submitted to the German Medicines Agency BfArM and a number of other European Medicines Agencies through a so-called DCP procedure. The application is the starting point of the review process of Sedaconda in 15 of the EU member states, including N

Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its Saragene™ COVID-19 2-gene multiplex RT-PCR test as an in vitro diagnostic

Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, announced today that Sirtex with the support of its shareholder, China Grand Pharmaceutical and Healthcare Holdings Limited (CGP), has been notified of the acceptance by the National Medical Products Administration (NMPA) of the People's Republic of China of its new drug application (NDA) of SIR-Spheres® Y-90 resin microspheres. With the NDA acceptance and according to relevant re

Polaryx Therapeutics, Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that it has received from the U.S. Food and Drug Administration (FDA) both Rare Pediatric Disease and Orphan Drug designations for the treatment of GM2 gangliosidosis with PLX-300. GM2 gangliosidosis, also known as Tay-Sachs and Sandhoff diseases, are ultra-rare and fatal pediatric neurodegenerative disorders caused by defects in Hexosaminidase A (HEX

Transaction Data Systems (TDS), the leader in pharmacy software solutions for the community pharmacy market, today announced the acquisition of KloudScript, a specialty pharmacy care solution. Currently 39% of community pharmacies dispense some sort of specialty medications, according the National Community Pharmacy Association. Demand for specialty medications has been steadily rising to treat specific disease states and the chronically ill. With the aging population and the increa

Mustang Bio, Inc., a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, and Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and manufacturing service provider for the cell and gene therapy industry, today announced that they have signed an agreement to enable technology transfer and GMP clin

Panaxia Global, the controlling owner of Panaxia Labs Israel Ltd. , Israel's largest manufacturer of medical cannabis products, and its partner, Neuraxpharm, Europe's leading pharmaceutical company specialized in the central nervous system (CNS) announced that they are expanding their strategic collaboration into the French market and that they have signed a binding memorandum of understanding between Panaxia and subsidiary Neuraxpharm France for the manufacture, commercialization and

HiFiBiO Therapeutics, a multinational biotherapeutics company with unique expertise in immune modulation and single cell science, today announced a partnership with Russian pharmaceutical company, Pharmsynthez PJSC (MOEX: LIFE), and Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS (IBCh). The partnership aims to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19, through clinical development and commercial sale in Russia, pending approval from t

Pfizer Inc. and BioNTech SE announced they will submit a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants wi