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EMA endorses Pfizer's leukemia drug; UK health chief to tackle medication errors

Top news

* The European Medicines Agency recommended the approval of five new therapies this month, including Pfizer Inc.'s Mylotarg, intended to treat acute myeloid leukemia, a cancer of the blood and bone marrow. Meanwhile, the regulator's Committee for Medicinal Products for Human Use adopted a negative opinion for Puma Biotechnology Inc.'s Nerlynx, which was expected to be a breast cancer treatment.

* Jeremy Hunt, the U.K.'s secretary of state for health and social care, plans to take action to lessen patient deaths caused by medication errors on the National Health Service, the Financial Times wrote. Research at Manchester, Sheffield and York universities concluded that such errors may be leading to about 1,700 deaths annually and potentially costing the NHS roughly £1.6 billion.

* Pharmacy benefit managers, the so-called middlemen in the U.S. pharmacy business, are getting more aggressive in the tactics they use to control costs, Bloomberg News reports.

* Nigeria's Center for Disease Control reported 73 deaths this year caused by an outbreak of Lassa fever, with the number of confirmed cases heightening in the past week, Bloomberg News noted.

On the policy front

* The Center for American Progress, a Washington think tank, has unveiled the latest alternative to the U.S. government's currently run healthcare programs, proposing a structure that would guarantee universal coverage,but would also allow employer-based insurance. The think tank's proposed "Medicare Extra For All" program would also offer participants certain services and therapies for free, like preventive care, treatment for chronic diseases and generic drugs.

* Robert Weaver, President Donald Trump's former nominee to serve as director of the Indian Health Service, said he was forced to withdraw from consideration last Friday, The Wall Street Journal reported. In a letter circulated to some tribal leaders and lobbyists, Weaver said he was pressured to drop out or "face the public humiliation of having the White House withdraw my nomination."

Drug and product pipeline

* The U.S. Food and Drug Administration accepted Shire plc's biologic license application and granted priority review for the company's investigational drug lanadelumab to treat patients with hereditary angioedema, a rare, genetic disease that causes swelling all over the body.

* The FDA granted orphan drug designation to Sydney-based Kazia Therapeutics Ltd.'s investigational drug GDC-0084 for treating glioblastoma multiforme, the most common and aggressive form of primary brain cancer.

Operational activity

* BioMarin Pharmaceutical Inc. reported a lower GAAP net loss of $51.4 million, or 30 cents per share, in the fourth quarter of 2017, compared to a net loss of $90.7 million, or 53 cents per share, a year earlier, due to increased net product revenue and a license payment from Sarepta Therapeutics Inc. The company anticipates full-year GAAP net loss to be in the range of $115 million to $165 million.

* Collegium Pharmaceutical Inc. filed a lawsuit in a U.S. district court, alleging patent infringement by Teva Pharmaceutical Industries Ltd., which is seeking to market a generic version of the opioid painkiller Xtampza, or oxycodone.

Our features

Merck's cancer deal turns up heat in high-stakes immunotherapy market: With its nearly $400 million acquisition, U.S. drugmaker Merck & Co. is creating possibilities for combinations in a competitive class of cancer therapies, a week after rival Bristol-Myers Squibb made its own deal.

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A 10-year, $1.2B plan to map global viruses launches, seeks investors: The Global Virome Project, a 10-year plan to map more than a million unknown viruses, has shed light on its first research steps and its estimated $1.2 billion cost.

Mesoblast CEO readies for US launch after stem cell therapy beats trial goal: A new stem cell therapy being developed by Mesoblast, which looks to control graft versus host disease, is expected to hit the U.S. market in mid-2019, CEO Silviu Itescu told S&P Global Market Intelligence.

The day ahead

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

In Asia, the Hang Seng increased 0.98% to 31,268.15, and the Nikkei 225 inched up 0.72% to 21,892.78.

In Europe, around midday, the FTSE 100 was down 0.19% to 7,238.52, and the Euronext 100 slipped 0.17% to 1,022.25.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.