BioCentury | Sep 17, 2019
Regulation

FDA’s international drug review pilot could simplify cancer trials, get drugs to patients faster

FDA believes its new framework for the submission and review of cancer drugs concurrently in multiple countries will speed up patient access to new therapies and streamline drug development. The agency unveiled the framework, dubbed...
BC Extra | Apr 17, 2018
Politics & Policy

Australia to evaluate Lilly's Lartruvo under new provisional pathway

Australia's Therapeutic Goods Administration (TGA) said soft tissue sarcoma drug Lartruvo olaratumab from Eli Lilly and Co. (NYSE:LLY) was granted provisional approval determination, making the drug eligible for review under the country's new provisional approval...
BC Extra | Sep 16, 2016
Politics & Policy

Australia planning new approval pathways

Australia's Therapeutic Goods Administration said it plans to implement new approval pathways and allow companies to submit unredacted evaluation reports from comparable overseas regulators in an effort to improve and speed access to therapeutics. Among...
BC Week In Review | Sep 5, 2016
Company News

Merck sales and marketing update

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) recommended that Merck’s biosimilar Brenzys etanercept “could be marked as equivalent” to reference product Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS). The recommendation would give pharmacists the authority...
BC Extra | Aug 23, 2016
Company News

Australia's PBAC says Enbrel biosimilar can be substituted

Australia's Pharmaceutical Benefits Advisory Committee (PBAC) has given pharmacists the authority to substitute the biosimilar Brenzys etanercept for its reference product, autoimmune drug Enbrel etanercept. Merck & Co. Inc. (NYSE:MRK) holds rights to Brenzys in...
BC Week In Review | Feb 16, 2015
Clinical News

Deoxycholic acid regulatory update

Kythera submitted a regulatory application to Australia’s Therapeutic Goods Administration ( TGA ) for ATX-101 to reduce submental (under chin) fat. An NDA for the synthetic sodium deoxycholate is under FDA review, with a May 13 PDUFA...
BC Week In Review | Dec 15, 2014
Clinical News

Iclusig ponatinib regulatory update

Australia’s Therapeutic Goods Administration ( TGA ) approved Iclusig ponatinib from Ariad to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Ariad plans to launch the pan- BCR-ABL tyrosine kinase inhibitor (TKI)...
BC Week In Review | Oct 20, 2014
Clinical News

Jetrea ocriplasmin regulatory update

ThromboGenics said Australia's Therapeutic Goods Administration ( TGA ) approved Jetrea ocriplasmin to treat vitreomacular traction (VMT), including when associated with macular hole of diameter <=400 Ug. The Alcon Inc. ophthalmic unit of Novartis AG (NYSE:NVS; SIX:NOVN,...
BC Week In Review | Sep 1, 2014
Clinical News

Prosigna Breast Cancer Prognostic Gene Signature Assay regulatory update

Australia’s Therapeutic Goods Administration ( TGA ) approved NanoString’s Prosigna Breast Cancer Prognostic Gene Signature Assay for use as a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with hormone receptor-positive breast cancer....
BC Week In Review | Jul 28, 2014
Clinical News

RFVIIIFc regulatory update

Biogen Idec disclosed in its results for 2Q14 that in June Australia's Therapeutic Goods Administration ( TGA ) approved Eloctate for hemophilia A. In June, FDA also approved the long-acting recombinant fusion protein consisting of the Fc...
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