Food and Drug Administration (FDA) recently accepted the company's recommended Phase 2 dose regimen for repotrectinib in the registrational
This approval for the registrational
study in China marks a big milestone for us, commented Dr Frank Jiang, chairman and CEO.
The planned global registrational
trial will assess the potential of rFVIIIFc to prolong protection from bleeding and to reduce the frequency of injections needed for haemophilia A treatment.
development program and Mylan will be responsible for costs for the program up until the approval of the first new drug application, after which costs will be shared.
19 October 2009 - Swedish biopharma firm Biovitrum AB (STO: BVT) and US sector player Biogen Idec Inc (NASDAQ: BIIB) said today they plan to advance their fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational
clinical trial in hemophilia B patients.
Key findings presented include that the recommended initial dose for the registrational
study was defined as 15mg/m2 QD with subsequent maximum dose increase to 25mg/m2.
Chinese biopharmaceutical company Sinovant Sciences said on Friday that its Clinical Trial Application (CTA) for derazantinib has passed the Center for Drug Evaluation at the China National Medical Products Administration's (NMPA) approval for the launch of registrational
clinical trial in patients with second-line intrahepatic cholangiocarcinoma (iCCA) in the second half of 2019.
His operational and regulatory experience, highlighted by the regulatory approval of antivirals such as interferon alpha-2b/ribavirin and entecavir, will greatly benefit Achillion as we accelerate our development plans and seek to initiate registrational
studies with sovaprevir and ACH-3102 during the latter part of next year," said Michael D.
"We expect that many of the patients in the satraplatin Phase 3 registrational
trial will have been pre-treated with and failed on a taxane-based therapy prior to entering our study.
The FDA approval of Rinvoq is supported by data from the SELECT program, one of the largest registrational
Phase 3 programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies.2-6 The studies include assessments of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naive or inadequate responders to methotrexate.
Net proceeds from the offering may be used by the company to fund activities in connection with its Hepatitis Delta Virus (HDV) clinical programmes, advancing peginterferon lambda into a potentially registrational
programme, supporting pipeline activities, and for working capital and general corporate purposes.