BioCentury | Mar 23, 2020
Product Development

March 23 Quick Takes: Venclexta combo hits in AML; plus Jardiance rebuffed, Zolgensma approved in Japan and Zealand-Boehringer

Venclexta combo shows survival benefit in AML  Partners Roche (SIX:ROG; OTCQX:RHHBY) and AbbVie Inc. (NYSE:ABBV) said Venclexta venetoclax plus azacitidine significantly improved overall survival and composite complete remission rate among acute myelogenous leukemia (AML) patients...
BioCentury | Mar 11, 2020

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...
BioCentury | Mar 11, 2020
Product Development

Novo’s year of obesity

Novo Nordisk is set to deliver six clinical readouts in obesity in 2020. If successful, they could deliver Novo an opportunity to dramatically expand a mostly untapped market that could become a major future growth...
BioCentury | Mar 9, 2020

FDA dropping CVOT requirement for diabetes drugs

Editor’s note: This story has been updated to reflect details contained in FDA’s guidance. Twelve years after FDA issued draft guidance that made it exorbitantly expensive to bring a new diabetes therapy to market, the...
BioCentury | Feb 26, 2020
Product Development

Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

FDA is reviewing four earlier or additional indications for a slate of cancer drugs, plus a first-time application for MacroGenics’ anti-HER2 mAb. The agency also approved the first quadrivalent flu vaccine and a CV application...
BioCentury | Feb 25, 2020
Product Development

NGM pops on additional Phase II NASH data for aldafermin

Positive histology data helped NGM snap a losing streak for NASH therapies and lifted the biotech’s stock on a day where the sector and broader markets saw mostly red. Shares of NGM Biopharmaceuticals Inc. (NASDAQ:NGM)...
BC Extra | Feb 1, 2020
Company News

Alnylam’s Givlaari, Novo’s Rybelsus among CHMP’s latest recommendations

Among a series of recommendations issued Friday, EMA’s CHMP backed approval of what would be Alnylam’s second approved RNAi drug in the EU, as well as an oral diabetes therapy that Novo Nordisk is relying...
BioCentury | Jan 29, 2020
Product Development

Industry leaders applaud CVS zero co-pay diabetes drug access

CVS is answering the call to decrease the cost burden of diabetes medications on patients with a new plan that eliminates co-pays, and industry leaders committed to the social contract are applauding the news as...
BC Extra | Jan 17, 2020
Company News

Jan. 17 Company Quick Takes: FDA expands label of Novo’s Ozempic; plus Intercept, Durect, Coherus-Innovent, CoImmune-Formula and Momenta

Label expansion for Novo’s Ozempic  FDA approved Ozempic subcutaneous semaglutide from Novo Nordisk A/S (CSE:NOVO B; NYSE:NOVO) to reduce the risk of major adverse cardiovascular events in adults with Type II diabetes and heart disease....
BioCentury | Jan 11, 2020

Why buysiders say 2020 could be the year of the CNS

A pair of CNS approvals in the final days of 2019 has only added to the growing momentum buysiders were already tracking for 2020 in the once neglected disease area. Positive regulatory signals are converging...
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