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 Extra | Mar 5, 2019
Company News

Intarcia licenses Numab's autoimmune therapy

Ahead of an NDA resubmission for its Type II diabetes therapy, Intarcia exercised an option to license from Numab exclusive, worldwide rights to autoimmune disorder therapy, ND016. ND016 is a trispecific antibody fragment that blocks...
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 Innovations | Jan 3, 2019
Distillery Therapeutics

Endocrine/metabolic

INDICATION: Obesity Cell culture, mouse and non-human primate (NHP) studies suggest inhibiting the GIP receptor alone or in combination with GLP-1R agonists could help treat obesity. In a mouse model of diet-induced obesity, a mouse...
BioCentury | Dec 8, 2018
Strategy

Novo gets serious about AI-guided drug design

Novo Nordisk A/S is fashioning its R&D makeover to integrate artificial intelligence across its drug discovery and development process, after a pilot program delivered the cost and time savings the pharma was looking for. In...
BC Innovations | Nov 9, 2018
Distillery Techniques

Chemistry; drug platforms

TECHNOLOGY: Synthetic chemistry; conjugates A method for linking methionine residues to small molecules could be used to generate novel therapeutic protein-drug conjugates. The method involves two steps: adding a diazo-iodonium salt to a protein or...
BC Innovations | Nov 6, 2018
Distillery Techniques

Drug delivery

TECHNOLOGY: Targeting domains Conjugating ASOs to a GLP-1R agonist construct could enhance the delivery of antisense therapies to pancreatic islet β cells for metabolic diseases. The conjugates consist of 5’-hexylamino ASOs against the selected therapeutic...
BioCentury | Oct 20, 2018
Product Development

CVOT damage in diabetes

As FDA reconsiders its requirement for cardiovascular outcomes trials of new diabetes candidates, it’s clear that the development of new therapies has slowed since it was implemented. In December 2008, FDA issued guidance requiring diabetes...
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