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J&J beats estimates, ups outlook; Takeda sells noncore drug portfolio to Acino

Top news

* Johnson & Johnson, the world's biggest healthcare company by market value, said its third-quarter earnings rose 1.5% year over year and raised its EPS guidance for 2019. The New Brunswick, N.J.-based company's adjusted net earnings for the third quarter rose to $5.67 billion, or $2.12 per share, from $5.59 billion, or $2.05 per share, in the year-ago period. J&J expects 2019 adjusted EPS to be in the range of $8.62 to $8.67, up from its previous estimate range of $8.53 to $8.63.

* Takeda Pharmaceutical Co. Ltd. agreed to sell about 30 over-the-counter and prescription pharmaceutical products sold in the Near East, Middle East and Africa region to Switzerland-based Acino International AG for over $200 million. The move is part of the Japanese company's strategy to divest noncore assets sold in the region and focus on its core business areas.

* Indivior PLC further increased its earnings guidance for 2019, citing the continued stronger-than-expected market performance of its opioid addiction therapy Suboxone Film. The London-listed company now expects group net revenue to be in the range of $750 million to $790 million, up from its previous outlook of $670 million to $720 million.

* The third quarter of 2019 saw 39 healthcare companies going public, raking in an aggregate of $5.75 billion in proceeds, or over half a billion more than what similar companies raised in the same quarter a year ago, according to data compiled by S&P Global Market Intelligence. Nashville, Tenn.-based SmileDirectClub Inc. raised about $1.35 billion in gross proceeds from its IPO, topping the list by proceeds generated.

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On the policy front

* More Americans trust Democrats over Republicans to do a better job handling healthcare in the U.S., including determining the future of Medicare, making sure seniors are able to get the care they need and lowering the costs of prescription drugs, the results of a new poll revealed. The poll conducted by the nonprofit, nonpartisan Kaiser Family Foundation also found that few Americans think President Donald Trump will deliver on his repeated promises to provide a healthcare plan to replace the Affordable Care Act.

M&A and capital markets

* Allergan PLC shareholders approved the Irish company's $84.2 billion acquisition by AbbVie Inc. in two separate meetings held Oct. 14. With the approval, the combined company would be the fifth-largest drugmaker in the world, based on combined 2018 revenue of $48.54 billion.

* BridgeBio Pharma Inc. terminated its bid for the remaining stake in Eidos Therapeutics Inc. as it failed to reach an agreement with a special committee of Eidos' board. BridgeBio, which owns about 66% of Eidos, had offered 1.5 BridgeBio shares for each Eidos share held.

Drug and product pipeline

* The U.S. Food and Drug Administration approved the expanded use of Johnson & Johnson and Bayer AG's Xarelto to prevent blood clots in acutely ill patients who are at the risk of developing blood clot complications but are not at a high risk of bleeding. Xarelto is approved for eight indications, six of which are specifically for treating, preventing and reducing the risk of recurrence of venous thromboembolism — a blood clot that starts in a vein.

* The U.S. FDA needs more time to review Flexion Therapeutics Inc.'s supplemental new drug application for osteoarthritis knee pain therapy Zilretta beyond the expected Oct. 14 decision date. Flexion has asked the FDA to revise Zilretta's label to include results from a Phase 3b clinical trial that evaluated repeated doses of the drug in patients with osteoarthritis knee pain.

* Reata Pharmaceuticals Inc.'s stock rose about 37% in after-hours trading Oct. 14 following news that its medicine omaveloxolone improved certain symptoms of an inherited neuromuscular disorder called Friedreich's ataxia compared to placebo in a phase 2 trial.

* Ultragenyx Pharmaceutical Inc. said the FDA accepted its application seeking approval of UX007 to treat patients with long-chain fatty acid oxidation disorders — a group of rare genetic conditions that prevent the body from breaking down certain fats into energy. The regulator is expected to take a decision by July 31, 2020.

Operational activity

* French pharmaceutical giant Sanofi established its first digital manufacturing facility for biologics production in Framingham, Mass.

* Manufacturing issues are expected to limit U.S. supplies for AstraZeneca PLC's inhaled flu vaccine FluMist, Fierce Pharma reported. In the upcoming flu season, the U.K.-based drugmaker will be able to ship three lots of FluMist to the U.S., which is one-third the number shipped in the 2018-2019 season.

* CSPC Pharmaceutical Group Ltd. is expected to appeal a decision by a Chinese provincial regulator to place its stroke drug NBP in soft capsule form on a watch list, analysts said in reports published Oct. 11. The Zhejiang regulator placed 32 drugs on its watch list, under which a drug comes under extra scrutiny over concerns it is being over-prescribed but it does not preclude hospitals from recommending it.

The day ahead

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

In Asia, the Hang Seng fell 0.07% to 26,503.93, and the Nikkei 225 lifted 1.87% to 22,207.21.

In Europe, around midday, the FTSE 100 fell 0.30% to 7,191.84, and the Euronext 100 was up 0.50% to 1,095.97.

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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