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...
BC Extra | Nov 13, 2019
Clinical News

Hua Phase III diabetes data make good on glucokinase but disappoint investors

Hua’s announcement that glucokinase activator dorzagliatin met its endpoints in a Phase III diabetes study marks a watershed moment for a target whose disease-modifying potential was long stymied by the limitations of previous compounds. Yet...
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 25, 2019
Company News

Sept. 24 Company Quick Takes: FDA approves smallpox vaccine; plus Epidyolex, Vitrakvi, Oral semaglutide, Takeda-Evotec, Guerbet-IBM Watson

FDA approves Bavarian Nordic’s smallpox/monkeypox vaccine  FDA approved Jynneos MVA-BN from Bavarian Nordic A/S (CSE:BAVA; Pink:BVNRY) to prevent smallpox and monkeypox, making the vaccine the only approved non-replicating smallpox vaccine in the U.S. and the...
BC Extra | Sep 20, 2019
Company News

Approval of Novo’s Rybelsus gives diabetes patients first oral option in GLP-1R class

FDA’s approval Friday of Rybelsus, the first oral GLP-1R agonist for diabetes, brings across the finish line a critical drug for Novo Nordisk’s growth strategy after the company prioritized best-in-class R&D three years ago. After...
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 20, 2019
Clinical News

AZ's Farxiga data kicks off race for SGLT2s in heart failure

Positive data for AstraZeneca's Farxiga dapagiflozin could signal the start of what is for now a two horse race to expand the SGLT2 class beyond diabetes and into heart failure. But the real opportunity in...
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