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...
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...
BC Extra | Jul 15, 2019
Company News

July 15 Company Quick Takes: Boehringer takes out cancer vaccine company Amal; plus Farxiga setback, Alkermes and more

Boehringer buying cancer vaccine play Amal  Boehringer Ingelheim (Ingelheim, Germany) is acquiring Amal Therapeutics S.A. (Geneva, Switzerland), a University of Geneva spinout developing cancer vaccines. Amal's shareholders will receive an undisclosed upfront payment; the total...
BC Extra | Jul 12, 2019
Company News

July 12 Company Quick Takes: Emflaza could be cost-effective for DMD at highest threshold; plus Darzalex, Skyrizi, Forxiga

ICER gives Emflaza pricing more leeway in updated report  The Institute for Clinical and Economic Review released an updated evidence report on Duchenne muscular dystrophy therapies that increased its range of acceptable prices at which...
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