Protalix & Chiesi: Phase III BRIDGE Trial Evaluating Pegunigalsidase Alfa Meets Key Objectives
JERUSALEM (dpa-AFX) - Protalix BioTherapeutics, Inc. (PLX), and Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici, reported final study results from the BRIDGE phase III switch-over clinical trial evaluating Pegunigalsidase Alfa for the treatment of Fabry Disease. Final results showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to pegunigalsidase alfa (PRX-102). Following the switch to PRX-102, there was a decrease in patients with progressing or fast progressing kidney disease, and most patients achieved a stable status post-switch. PRX-102 was well-tolerated in the study.
Bristol Myers Squibb: EMA Validates Marketing Authorization Application For Zeposia
NEW YORK CITY (dpa-AFX) - Bristol Myers Squibb (BMY) said the European Medicines Agency has validated its Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis. This confirms the submission is complete and begins the EMA s centralized review process.
Mary Beth Harler, head of Immunology and Fibrosis Development, Bristol Myers Squibb, said: This validation is an important step toward making Zeposia available to eligible patients in the European Union, who are in need of new treatment options offering proven efficacy and safety, as well as oral administration.
TMCnet News
Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
[December 28, 2020]
Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
â Company plans to complete rolling submission in the first half of 2021 â
â The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of
non-pancreatic NET patients with an acceptable risk/benefit ratio â
â The pivotal Phase III SANET-p trial demonstrated surufatinib reduced risk of progression or death by 51%, extending PFS of
pancreatic NET patients with an acceptable risk/benefit ratio â
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of .
Hutchison China MediTech LimitedDecember 28, 2020 GMT
– Company plans to complete rolling submission in the first half of 2021 –
– The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of non-pancreatic NET patients with an acceptable risk/benefit ratio –
– The pivotal Phase III SANET-p trial demonstrated surufatinib reduced risk of progression or death by 51%, extending PFS of pancreatic NET patients with an acceptable risk/benefit ratio –
(2)
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for the Company s 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults. The acceptance of the MAA filing begins the EMA s review process. The EMA acceptance of our MAA marks an important milestone for VBI in our effort to enable broad access to our 3-antigen prophylactic hepatitis B vaccine, which we believe has the potential to be an important intervention in the fight to eliminate hepatitis B infections, said Jeff Baxter, President CEO. We are committed to working collaboratively with the EMA during the regulatory process and we look forward to communicating developments related to the MAA th