BioCentury | Jun 27, 2020
Product Development

BARDA no longer funding immunomodulators as support for the therapeutic class to treat COVID-19 grows

A slew of therapies entered the clinic this week aimed at tamping down the immune system to treat excessive lung inflammation in COVID-19 patients, even as BARDA announced it would no longer fund the class...
BioCentury | Jun 19, 2020
Product Development

Hua shows sustained benefit in diabetics with glucokinase activator

Hua announced Phase III follow-up data showing its first-in-class diabetes therapy led to sustained HbA1c reductions at one year -- a long-term effect that EVP and CFO George Lin told BioCentury hasn’t been observed with...
BioCentury | May 8, 2020
Product Development

May 7 Quick Takes: Gaboxadol meets in Phase II for Fragile X; plus Innovent, Lilly, Tetraphase and more

Ovid’s gaboxadol meets in Phase II for Fragile X   Ovid Therapeutics Inc. (NASDAQ:OVID) said gaboxadol (OV101) met its primary safety endpoint and reduced behavioral and functional symptoms in the Phase II ROCKET trial to...
BioCentury | Mar 31, 2020
Product Development

March 30 Quick Takes: Axsome misses in treatment-resistant depression, on track for NDA; plus AstraZeneca and Innovent-Alector

Axsome dips on Phase III depression data  AXS-05 from Axsome Therapeutics Inc. (NASDAQ:AXSM) missed the primary endpoint of depressive symptoms compared with bupropion at week 6 in the Phase III STRIDE-1 trial for treatment-resistant depression....
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 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 Twelve years after FDA issued draft guidance that made it exorbitantly expensive to bring a new diabetes therapy to market, the...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 | 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 7, 2020
Company News

Jan. 6 Company Quick Takes: China approvals for AZ, Sanofi and Gene+; plus Apollomics-GlycoMimetics, Pfizer-Merck KGaA and more

Trio of approvals from China’s NMPA   China’s National Medical Products Administration approved NDAs for Lokelma sodium zirconium cyclosilicate from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat hyperkalemia and anti-PCSK9 mAb Praluent alirocumab from Sanofi (Euronext:SAN;...
BC Extra | Nov 18, 2019
Clinical News

Heart failure notches another win as Merck, Bayer's sGC stimulator meets in Phase III

Another new mechanism for heart failure passed a major hurdle as partners Merck and Bayer announced Monday that vericiguat met the primary endpoint in the Phase III VICTORIA trial in patients with worsening chronic heart...
BC Extra | Nov 14, 2019
Company News

Nov. 13 Company Quick Takes: FDA panel rebuffs Jardiance; plus Nucala, Cellular Biomedicine, BeiGene, Autolus and Noile-Immune

Panel rebuffs Jardiance for Type I diabetes  FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 Wednesday that available data do not support approval of Jardiance empagliflozin from Boehringer Ingelheim GmbH. The panel was asked...
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