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Trump lays out drug pricing strategy; US senators probe Novartis

Top news

* U.S. President Donald Trump laid out his strategy to lower the prices of prescription drugs, calling his American Patients First plan the "most sweeping action in history" to reduce the costs of medicines for Americans. Targeted in his plan are pharmacy benefit managers — often called middlemen — which negotiate with biopharmaceutical companies for rebates that insurance plans use to lower premiums.

* Two U.S. Democratic senators are demanding answers from Novartis AG about why it paid $1.2 million to President Donald Trump's lawyer, Michael Cohen, and a shell company he created at a time when the Swiss drugmaker was seeking U.S. approval of its gene therapy Kymriah and negotiating a novel payment arrangement with the federal government.

* Japanese drugmaker Takeda Pharmaceutical Co. Ltd. said its profit climbed 62.6% year over year for the fiscal year ended March 31, and revenue grew 2.2%.

On the policy front

* The World Health Organization flagged 39 Ebola cases in the Democratic Republic of the Congo's town of Bikoro.

* The World Health Organization is planning to employ Merck & Co. Inc.'s Ebola vaccine rVSV-ZEBOV to tackle an outbreak of the disease in the Democratic Republic of Congo, The New York Times wrote. The vaccine was found to be 100% effective in field tests in Guinea in 2016.

* U.S. health agencies, including the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention, are investigating a possible a link between an outbreak of bloodstream infections in children in four states and medical device maker Becton Dickinson and Co.'s syringes, Reuters reported.

M&A and capital markets

* Evelo Biosciences Inc., the Cambridge, Mass.-based developer of microbials to treat cancer, closed its IPO of 5,312,500 common shares at $16 apiece to raise $85 million in gross proceeds.

Drug and product pipeline

* Novartis' Gilenya became the first pill to be approved by the U.S. Food and Drug Administration to treat relapsing multiple sclerosis in children and adolescents ages 10 years and older.

* Perrigo Co. PLC, a maker of generic drugs, expects the U.S. Food and Drug Administration to reject its application to sell a generic version of Teva Pharmaceutical Industries Ltd.'s ProAir inhalation aerosol to treat or prevent certain disorders that affect the airways.

Operational activity

* Amneal Pharmaceuticals Inc. said it would shut down its Hayward, Calif.-based operations and facilities, resulting in 550 job cuts. The Bridgewater, N.J.-based company said the restructuring was a result of streamlining of operations after a recently completed merger with Impax Laboratories Inc.

* Bluebird Bio Inc. expanded its partnership with Germany's Medigene AG, increasing the number of personalized T cell-based cancer therapies to be developed to six from four. The revised agreement involves an upfront payment of $8 million and has a provision of potential milestone payments of up to $250 million for each project.

* U.K.'s Indivior PLC said it reached a settlement with Endo International PLC and IntelGenx Technologies Corp. who are looking to market a generic version of its opioid addiction treatment in the U.S. The settlement permits the companies to sell a generic version of Indivior's Suboxone starting Jan. 1, 2023, or earlier under certain circumstances.

* Akari Therapeutics PLC CEO and director David Solomon resigned following an internal investigation that revealed he used the company's credit card for personal use.

Our features

* Trump targets PBMs, TV ads, foreign 'freeloaders' in drug price strategy: President Donald Trump took aim at pharmacy benefit managers, consumer drug advertising and what he called "foreign freeloaders" in his strategy to lower the costs of prescription medicines in the U.S.

* Drugmakers tout 'golden age' as they brace for Trump action on prices: The lobbying group representing the world's biggest drugmakers touted a "golden age for medicine" as the industry braced for U.S. President Donald Trump to unveil his plan to lower drug costs. New treatments are being developed while drug prices are rising by less than the inflation rate, Pharmaceutical Research and Manufacturers of America, or PhRMA, President and CEO Stephen Ubl said May 10 at a summit in New York sponsored by the Financial Times.

The day ahead

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

In Asia, the Hang Seng was up 1.35% to 31,541.08. The Nikkei 225 rose 0.47% to 22,865.86.

In Europe, as of midday, the FTSE 100 was down 0.20% to 7,709.21 and the Euronext 100 was down 0.13% to 1,069.30.

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