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EMA backs Merck & Co.'s Ebola vaccine; J&J to pay $117M in mesh implant case

Top news

* The European Medicines Agency recommended approving seven new therapies in October, including Merck & Co. Inc.'s Ebola vaccine Ervebo. AbbVie Inc.'s rheumatoid arthritis drug Rinvoq, Eli Lilly and Co.'s low blood sugar medicine Baqsimi and Johnson & Johnson's Spravato for treatment-resistant depression were also among the medicines backed for approval. In addition, after a reexamination, the EMA also backed the approval of Amgen Inc. and UCB SA's osteoporosis drug Evenity in the EU. Evenity, which is approved in the U.S. and Canada to treat osteoporosis in postmenopausal women at high risk for fracture, had received a negative opinion in June.

* Johnson & Johnson will pay close to $117 million in a multistate settlement of litigation over the pharma giant's allegedly deceptive marketing practices of its pelvic mesh devices, according to U.S. attorneys general. As per the multistate investigation, J&J misrepresented the devices' safety and did not sufficiently disclose possible side effects, which plaintiffs allege caused severe pain, urinary problems and other injuries.

* In an interview with S&P Global Market Intelligence, James Li, CEO of JW Therapeutics (Shanghai) Co. Ltd. discussed the company's chimeric antigen receptor T cell therapy, or CAR-T therapy, candidates and cost-affordability of such therapies in China. The company is a gene and cell therapy venture between Shanghai-based WuXi AppTec Co. Ltd. and Juno Therapeutics Inc., which was acquired by Celgene Corp. in 2018.

On the policy front

* Two House panels advanced Speaker Nancy Pelosi's legislative package aimed at lowering prescription drug prices to the chamber's floor for consideration — a bill Senate Majority Leader Mitch McConnell, R-Ky., said is dead on arrival on his side of the Capitol. The legislation would allow the federal government to set a maximum price on as many as 250 drugs that lack competition in the U.S., with Medicare beneficiaries paying no more than $2,000 out of pocket each year for their medicines.

M&A and capital markets

* Healx Ltd. — whose Chairman and co-founder David Brown was responsible for developing Viagra — has raised $56 million in a series B fundraising from investors including venture capital group Atomico Investment Holdings Ltd. and Intel Capital. The privately held artificial intelligence company is seeking new uses for old drugs to treat rare diseases through the application of its technology.

Drug and product pipeline

* The U.S. Food and Drug Administration approved the expanded use of Roche Holding AG's Xofluza to treat people at high risk of developing complications from influenza. The Centers for Disease Control and Prevention categorizes high-risk patients as those who are 65 years and older or who have health conditions such as asthma, chronic lung disease, diabetes or heart disease.

* Meanwhile, the U.S. FDA gave tentative approval to Alkermes PLC and Biogen Inc.'s multiple sclerosis drug Vumerity.

* Paratek Pharmaceuticals Inc. withdrew an application with the EMA after the regulator said it would recommend approving the therapy for acute bacterial skin and skin structure infections but not for community-acquired bacterial pneumonia. The company would have to complete another study to earn a nod for the pneumonia indication, according to the EMA.

Operational activity

* Teva Pharmaceutical Industries Ltd. is recalling certain batches of heartburn drug Zantac in the U.K., due to possible contamination with a potential cancer-causing impurity called N-nitrosodimethylamine, or NDMA. Teva is the latest company to be impacted by the issue, with pharmaceutical giants GlaxoSmithKline PLC, Sanofi and Novartis AG conducting similar recalls in the past months due to the presence of NDMA in their ranitidine medicines.

* S&P Global Ratings flagged drug distributors AmerisourceBergen Corp. and Cardinal Health Inc. for a potential downgrade given the impact of proposed multibillion-dollar settlements in ongoing opioid litigations that claim these companies fueled the U.S. opioid epidemic. However, the possibility of a significant opioids settlement in the near term would have no credit impact on McKesson Corp., which is also a defendant in the lawsuits.

The day ahead

Early morning futures indicators pointed to a mixed opening for the U.S. market.

In Asia, the Hang Seng was down 0.48% to 26,719.58, while the Nikkei 225 rose 0.18% to 22,492.68.

In Europe, around midday, the FTSE 100 was up 0.02% to 7,184.10, while the Euronext 100 was down 0.24% to 1,093.13.

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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