BioCentury | Mar 11, 2020
Regulation

Intarcia’s path uncertain after second regulatory stumble for diabetes implant

Massive fund-raising over the past decade positioned Intarcia to enter the market with ITCA 650, a matchstick-sized implant that delivers a GLP-1R agonist to Type II diabetes patients subcutaneously for six months. But now that...
BC Extra | Oct 8, 2019
Company News

After remedies to NDA, Intarcia’s diabetes implant under FDA review again

More than two years after well-funded Intarcia received a complete response letter from FDA, an NDA for the company’s implantable pump to treat Type II diabetes is back under the agency’s review. The new PDUFA...
BC Extra | Mar 13, 2019
Politics & Policy

China releases timeline, priority diseases for revised reimbursement list

China's National Medical Insurance Administration released its plan for issuing a revised National Drug Reimbursement List Wednesday, describing which types of drugs will have priority for inclusion and sketching out a timeline for a revision...
BC Innovations | Feb 15, 2019
Tools & Techniques

Heartening predictors in diabetes

New biomarkers of cardiovascular risk could relieve a decade-old bottleneck for diabetes drug development, but validating them will require companies to invest in strategic trial designs, and public and private stakeholders to pool thinking. As...
BC Week In Review | Dec 1, 2017
Clinical News

CHMP recommends label update to AZ's Bydureon

EMA's CHMP recommended expanding the label of Bydureon exenatide from AstraZeneca plc (LSE:AZN; NYSE:AZN) to include treatment of Type II diabetes in combination with other glucose lowering treatments, including basal insulin, when use of Bydureon...
BC Week In Review | Aug 16, 2017
Clinical News

AZ's Bydureon improves motor function in Phase II for PD

Data published in The Lancet showed that diabetes drug Bydureon exenatide from AstraZeneca plc (LSE:AZN; NYSE:AZN) met the primary endpoint in the Phase II EXENATIDE-PD trial to treat moderate Parkinson’s disease. In the 60-patient trial,...
BC Innovations | Jun 21, 2017
Distillery Techniques

Drug delivery

TECHNOLOGY: Polymers PEG-based hydrogel microspheres that release peptide drugs continuously over several weeks could help treat Type II diabetes and other chronic diseases with once-monthly dosing. The microspheres are linked to peptide therapeutics via a...
BC Week In Review | Jun 2, 2017
Company News

AZ and Harvard Pilgrim sign two outcomes-based drug pricing contracts

Regional insurer Harvard Pilgrim Health Care Inc. (Boston, Mass.) signed two outcomes-based drug pricing contracts with AstraZeneca plc (LSE:AZN; NYSE:AZN). The insurer signed a three-year contract for AZ’s Brilinta ticagrelor, which is marketed in the...
BC Week In Review | May 19, 2017
Company News

3SBio acquires China rights to Lilly's Humulin

Eli Lilly and Co. (NYSE:LLY) granted 3SBio Inc. (HKSE:1530) exclusive rights to distribute and promote its diabetes drug Humulin in China, beginning July 1. Lilly's China unit will be responsible for manufacturing the drug, while...
BioCentury | May 19, 2017
Strategy

Contracting 2.0

Pricing doesn’t always cause business discontinuities -- but it’s always the double-edged sword at the center of the action, helping innovators and hobbling laggards. Discount brokers revolutionized consumer investing; discounted long-distance ultimately destroyed AT&T. Price...
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