Top news
* Merck & Co. Inc. and Eisai Co. Ltd. won approval for a combination of their drugs Keytruda and Lenvima to treat endometrial carcinoma in three countries at once: the U.S., Australia and Canada.
The approval marks the first action under a new collaboration between regulatory bodies in the three countries for simultaneous review of cancer therapies. Participating in the new program, called Project Orbis, is the U.S. Food and Drug Administration, the Australian Therapeutic Goods Administration and Health Canada.
* The Global Preparedness Monitoring Board warned that the world is facing a threat from pandemics that could result in millions dead and economies being disrupted, as governments have "grossly insufficient" efforts to prepare for major disease outbreaks. The independent body, co-convened by the World Health Organization and the World Bank Group, said extended conflicts and forced migration have made it harder for nations to address epidemic-prone viral diseases such as Ebola, flu and SARS, Reuters reported.
* Denmark's Novo Nordisk A/S and France's Sanofi have spent millions of British pounds in stockpiling efforts to ensure that the supply of life-saving insulin would still be available to diabetes patients regardless of the future relationship of the EU and the U.K., Reuters reported. "We're preparing for the worst-case scenario, the most extreme," Novo Nordisk's U.K. general manager, Pinder Sahota, told Reuters. Sanofi's U.K. managing director, Hugo Fry, said the company had figured out the logistics and shipping of insulin supplies in the region.
* Former FDA Commissioner Scott Gottlieb joined the board of healthcare technology company Aetion Inc. Gottlieb will advise the company as it advances the Aetion Evidence Platform, a tool to assess the safety, effectiveness and value of treatments. Since leaving his role at the FDA in April, Gottlieb returned to venture capital firm New Enterprise Associates, became a resident fellow at the American Enterprise Institute and joined the board of pharmaceutical giant Pfizer Inc.
On the policy front
* More assertions by President Donald Trump about the Right to Try Act, a lack of regulations and the emergence of startup companies that aim to profit from the 2018 law have sparked concerns from bioethicists and patient advocates more than a year after the law was enacted.
Trump and some lawmakers have insisted the FDA was not approving compassionate-use requests quickly enough and pushed to get the Right to Try law adopted as an additional option for patients.
* Tennesee released its official proposal to turn its Medicaid program into a block grant, making it the first state to submit a proposal after the Trump administration signaled that it would support such an idea.
The plan, which was released Sept. 17, would cap how much the federal government gives the state each year for the program, with a proposal to cap the program at about $7.86 billion. The proposal would also give the state the flexibility to make certain adjustments to the program without the approval of the Centers for Medicare and Medicaid Services.
* Billions of dollars in federal Medicaid funding for Puerto Rico are scheduled to sunset in September and December, leaving the island's program underfunded by as much as $1 billion and threatening the healthcare coverage of nearly half a million people.
The U.S. House of Representatives Energy and Commerce Committee advanced legislation July 17 that would give Puerto Rico's Medicaid program about $12 billion in extra funds over the next four years and increase the percentage of spending the federal government will match, moves that healthcare experts have applauded. But as the deadline quickly approaches, the House has yet to schedule a full vote, and the Senate has so far not taken up the matter.
M&A and capital markets
* Merck KGaA's €5.8 billion acquisition of Versum Materials Inc. was cleared by the Committee on Foreign Investment in the U.S. after a review.
* SmileDirectClub Inc., which makes invisible dental braces, closed its IPO on the Nasdaq Global Select Market, raising about $1.35 billion in gross proceeds.
* Envista Holdings Corp. priced its IPO at $22 per share — the middle of its previously announced price range — with gross proceeds expected to reach $588.9 million
* SpringWorks Therapeutics Inc. raised $186.3 million in gross proceeds in its IPO on the Nasdaq Global Select Market.
Drug and product pipeline
* The U.K.'s National Institute for Health and Care Excellence recommended Takeda Pharmaceutical Company Ltd.'s medicine Takhzyro, or lanadelumab, to treat patients with hereditary angioedema, a rare genetic disorder that results in recurring attacks of swelling in various parts of the body.
* Following several failed clinical trials that had hoped to treat dementia, drugmakers and researchers are finding new ways to target the cause of the disease, the Financial Times said in a special report. Alzheimer's disease proved to be difficult to treat, but scientists are now better able to target proteins that inhibit communication between neurons, Mark Mintun, vice president of pain and neurodegeneration research and clinical development at Eli Lilly and Co., said.
Operational activity
* Alexion Pharmaceuticals Inc. Executive Vice President and CFO Paul Clancy will step down from the role after filing results for the third quarter, which closes at the end of September. Chief Strategy and Business Officer Aradhana Sarin will step in as the new CFO, while Clancy will serve as a senior adviser through half of 2020.
* A San Diego couple named Li Chen and Yu Zhou are facing charges for allegedly conspiring, attempting and stealing trade secrets related to exosome research from Nationwide Children's Hospital in Columbus, Ohio, and starting their own business in China based off of those secrets, Endpoints News reported.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng lost 0.13% to 26,754.12, and the Nikkei 225 declined 0.18% to 21,960.71.
In Europe, around midday, the FTSE 100 rose 0.05% to 7,324.54, and the Euronext 100 was up 0.16% to 1,089.03.
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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