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 | 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....
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 | Oct 21, 2019
Company News

Oct. 21 Company Quick Takes: Vertex's triplet gains FDA approval; plus Bavarian Nordic-GSK, Farxiga, Ultomiris, Stelara

FDA approves Vertex's triplet for CF  Vertex Pharmaceuticals Inc. priced triple combination cystic fibrosis therapy Trikafta elexacaftor/ivacaftor/tezacaftor at an annual wholesale acquisition cost of $311,503 after FDA approved the drug on Monday, almost five months...
BC Extra | Sep 20, 2019
Company News

Xospata poised for EU approval under accelerated assessment

EMA's CHMP recommended approval of Xospata for acute myelogenous leukemia in its September roundup. Under accelerated assessment, the agency backed Xospata gilteritinib from Astellas Pharma Inc. (Tokyo:4503) as monotherapy for relapsed or refractory AML in...
BC Extra | Sep 3, 2019
Clinical News

Entresto’s heart failure miss may not signal the end, given FDA’s openness to new endpoints

Despite narrowly missing its primary endpoint in the PARAGON-HF trial to treat heart failure patients with preserved ejection fraction, Entresto’s performance on secondary endpoints suggests the drug could still have a path forward in the...
BC Extra | Sep 3, 2019
Clinical News

AZ presents competitive Farxiga data in heart failure

Detailed data from AstraZeneca has shown SGLT2 inhibitors developed for Type II diabetes may be even more efficacious in heart failure than existing therapies. Joris Silon, SVP of cardiovascular, renal and metabolism at AstraZeneca plc...
BC Extra | Aug 21, 2019
Clinical News

AZ's Imfinzi/tremelimumab combo misses again, this time in another NSCLC

AstraZeneca announced Wednesday that its Imfinzi durvalumab/tremelimumab combination failed to show a survival benefit in first-line non-small cell lung cancer. While the miss marks an end to AZ's recent spate of clinical successes, investors appeared...
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