Top news
* AstraZeneca PLC said results from a five-year study of its diabetes drug Farxiga in patients with the type 2 version of the disease showed a 17% reduction in the risk of hospitalization for heart failure or cardiovascular death as compared to placebo. "That in itself is a very important new element and hasn't been shown before," Ruud Dobber, AstraZeneca's U.S. president, told S&P Global Market Intelligence.
* Tokyo-based Takeda Pharmaceutical Co. Ltd. will hold its extraordinary general meeting Dec. 5 during which shareholders will vote on the proposed $62 billion takeover of Dublin-based biotech Shire PLC. Takeda expects to close the deal Jan. 8, 2019, or as soon as practicable following EU approval.
On the policy front
* The top Democrat on the House Oversight and Government Reform Committee, Rep. Elijah Cummings, D-Md., confirmed he plans to probe high drug prices when he takes over as chairman of the panel in January 2019.
During a Nov. 11 appearance on CBS' "Face the Nation," House Minority Leader Nancy Pelosi, D-Calif., said protecting the ACA was her "main issue." Last week, Pelosi signaled she was willing to collaborate with Republicans to take on the biopharmaceutical industry.
Meanwhile, the U.S. Food and Drug Administration approved 110 generic drug applications and tentatively approved another 18 for a total of 128 — the most in a single month. The agency is on track to beat its 2017 calendar year record of 1,027 generic application approvals.
* China is tightening regulations on vaccine manufacturing and distribution as it seeks to restore public confidence following the recent scandal. The State Administration for Market Regulation published a draft law that proposes to develop a unified system that tracks the production and distribution information of vaccines.
M&A and capital markets
* Moderna Therapeutics Inc., a company developing messenger RNA therapies, filed for an IPO. The Cambridge, Mass.-based company plans to list on the Nasdaq Global Select Market and raise up to $500 million in what would be the largest IPO in the biotech sector.
* CStone Pharmaceuticals applied for an IPO on the Hong Kong Stock Exchange under the new listing rules implemented in April. The Suzhou, China-based biotech has 14 drugs in its pipeline, with six still in pre-clinical stage.
Drug and product pipeline
* The U.S. FDA approved Merck & Co. Inc.'s blockbuster cancer medicine Keytruda for treating hepatocellular carcinoma, a common type of liver cancer for which limited treatment options exist.
* Novartis AG said Entresto significantly improved the condition of heart failure patients when initiated for hospital use, results of a follow-on study showed. Entresto, which contains sacubitril and valsartan, was better than Bausch Health Cos. Inc.'s Vasotec in slowing down the disease progression of certain heart failure patients.
* The FDA granted approval to Chembio Diagnostics Inc.'s diagnostic test for Ebola to allow its use during public health emergencies. The DPP Ebola Antigen System tests viral antigens and has the potential to give results in 15 to 20 minutes.
Operational activity
* Australia-based Bionomics Ltd. appointed Greenhill & Co. to conduct a review of its strategic options, after its drug BNC210 failed to deliver clinical benefit in a mid-stage study in patients with post traumatic stress disorder.
* South Korean regulators are probing a local pharmaceutical wholesaler for allegedly smuggling Novo Nordisk A/S' obesity drug Saxenda to China, Korea Biomedical Review reported, citing industry sources.
Our features
Future of Montana's Medicaid expansion back in the hands of state legislature: Montana voters rejected a ballot initiative that would have funded Medicaid expansion past its current sunset date of June 30, 2019. Now the decision moves once again to the Republican-controlled state legislature.
Other features
* Out of desperation, Chinese patients who cannot afford or have no access to certain medicines make drugs on their own despite the accompanying risks, The New York Times reported.
The day ahead
Early morning futures indicators pointed to a weak opening for the U.S. market.
In Asia, the Hang Seng was up 0.12% to 25,633.18. The Nikkei 225 rose 0.09% to 22,269.88.
In Europe as of midday, the FTSE 100 retreated 0.17% to 7,093.37, and the Euronext 100 was down 0.21% to 992.32.
Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.
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