Pharma Stock Roundup: MRK, GSK, ABBV, LLY's Pipeline & Regulatory Updates

 | Nov 15, 2019 07:12AM ET

This week, Merck’s (NYSE:MRK) investigational vaccine for Ebola Zaire disease, V920, received approval in Europe. While Roche and Glaxo (NYSE:GSK) announced positive data from pivotal studies, Pfizer’s (NYSE:PFE) late-stage gastric cancer study on its PD-L1 inhibitor, Bavencio, failed. AbbVie (NYSE:ABBV) , Bristol-Myers (NYSE:BMY) , Merck, AstraZeneca (NYSE:AZN) and Lilly (NYSE:LLY) provided FDA updates.

Recap of the Week’s Most Important Stories:

EU Approval for Merck’s Ebola Vaccine & AstraZeneca’s New Diabetes Tablet: The European Commission' has granted conditional marketing approval to Merck’s investigational vaccine for Ebola Zaire disease, V920, which will be marketed by the trade name of Jardiance, 2.5 mg, for type I diabetes. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 that the benefits of Jardiance 2.5 mg do not outweigh the risks to support approval for the indication. The companies are seeking approval for Jardiance, 2.5 mg for type I diabetes under a separate brand name.

Meanwhile, Lilly and partner Boehringer Ingelheim initiated the first ever study to evaluate its SGLT2 inhibitor, Jardiance in patients with and without type II diabetes hospitalized for acute heart failure who have been stabilized. The aim of the study, EMPULSE, is to understand whether Jardiance has the potential to improve outcomes in this patient population. It is the sixth phase III study in the Jardiance heart failure program.

Novartis’ Sandoz Strengthens Presence in Japan’s Generic Market: Novartis’ generic subsidiary, Sandoz, announced an agreement to acquire Aspen Global Incorporated’s (“AGI”) Japanese operations and associated assets. Sandoz will make an initial cash payment of 300 million euros to AGI on closing of the deal. The deal will expand Novartis’ presence in Japan, which is the world’s third-largest generics market. Aspen’s portfolio in Japan consists primarily of off-patent branded medicines with focus on anesthetics and specialty brands, which will complement Sandoz broad hospital portfolio and pipeline in Japan.

The NYSE ARCA Pharmaceutical Index rose around 1% in the last five trading sessions.

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