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US FDA faces funding challenge; AstraZeneca chief medical officer to depart

Top news

* U.S. Food and Drug Administration Commissioner Scott Gottlieb acknowledged the shutdown and lapse in funding "represents one of the most significant operational challenges" in the agency's recent history.

* AstraZeneca PLC confirmed reports that Chief Medical Officer Sean Bohen is to leave the company following the recent research and development reorganization at the U.K.'s second-largest pharmaceutical company.

* The U.S. Centers for Disease Control and Prevention said about 6.2 million to 7.3 million people got sick due to flu during the 2018-2019 season. Nearly 69,000 to 84,000 people have been hospitalized for flu-related treatment based on the agency's latest the data for the period between Oct. 1, 2018, through Jan. 5.

* The government in Jinhu, in China's Jiangsu province, will launch an investigation after at least 145 children in the county received expired polio vaccines, Global Times reported.

On the policy front

* Democratic lawmakers and various healthcare experts late last week immediately criticized the Trump administration's plan to go around Congress and turn Medicaid into a block-grant program and cap the amount of money the federal government provides to states.

* The impacts of the ongoing partial U.S. government shutdown — now into its fourth week, the longest in U.S. history — have reached into the lawsuit challenging the constitutionality of the Affordable Care Act. Judge Leslie Southwick of the U.S. Court of Appeals for the Fifth Circuit in New Orleans granted a request by the U.S. Department of Justice to put the case on hold in light of the shutdown.

* A California judge issued a preliminary injunction on Trump administration's rule allowing businesses to get exemptions from providing contraceptive coverage under the Affordable Healthcare Act on moral or religious grounds, Reuters reported.

* U.S. drug pricing watchdog Institute for Clinical and Economic Review will include PTC Therapeutics Inc.'s Emflaza in its ongoing price review of several Duchenne muscular dystrophy drugs. Duchenne muscular dystrophy is a genetic disorder characterized by progressive muscle degeneration and weakness.

M&A and capital markets

* Aurora Cannabis Inc. signed a letter of intent to buy privately held Whistler Medical Marijuana Corp. in an all-stock transaction valued at up to about $175 million. The deal valuation includes certain milestone payments regarding Whistler, a Canadian cannabis company, achieving certain operational objectives.

* Cirius Therapeutics Inc. filed a registration statement with the U.S. Securities and Exchange Commission to launch an IPO on the Nasdaq. The San Diego-based clinical-stage pharmaceutical company has applied to list its common shares on the Nasdaq Global Select Market under the symbol CSTX.

* Hoth Therapeutics Inc. plans to offer 1,250,000 common shares in an IPO on Nasdaq at a price ranging between $5.50 per share and $6.50 per share. The biopharmaceutical company expects that its common shares will trade on the Nasdaq Capital Market under the symbol HOTH.

Drug and product pipeline

* Singapore-based ASLAN Pharmaceuticals Ltd. said its gastric cancer drug varlitinib did not meet the main goal of statistically significant tumor reductions in a mid-stage study. The 12-week phase 2 trial evaluated varlitinib as a first-line therapy, in combination with chemotherapy regimen mFOLFOX6, against placebo plus mFOLFOX6.

* Verona Pharma PLC's shares fell after it disclosed that the mid-stage study of nebulized ensifentrine in a common lung disease failed to meet its main goal.

Our features

Eli Lilly's biggest acquisition shows commitment to precision medicine in cancer: Lilly's senior vice president of business development Darren Carroll sat down with S&P Global Market Intelligence to discuss the strategy behind the company's newest deal, its biggest ever by value, and where it goes from here.

Other features

* Personalized healthcare based on a patient's genetic and body makeup is changing the way healthcare is offered, National Geographic wrote.

* Japanese startups are tapping into the healthcare market by developing treatment specifically for the rising number of elderly people in the country, The Wall Street Journal reported.

* The Financial Times published a feature on benefits and risks associated with the therapies being developed using CRISPR-based gene editing technology.

The day ahead

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

In Asia, the Hang Seng was down 1.38% to 26,298.33 while the Nikkei 225 was closed.

In Europe as of midday, the FTSE 100 slid 0.98% to 6,850.48, and the Euronext 100 declined 0.96% to 926.19.

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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