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Roche drug aces phase 3 study; Trump wants to make acting VA head permanent

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Roche drug aces phase 3 study; Trump wants to make acting VA head permanent

Top news

* Swiss drugmaker Roche Holding AG said a phase 3 trial of Hemlibra showed the drug significantly controlled bleeding in certain patients with hemophilia A.

* During a May 18 White House event, the U.S. President Donald Trump surprised Acting Veterans Affairs Secretary Robert Wilkie with the news he was the president's latest pick to permanently lead the agency.

* ViiV Healthcare Ltd., the Brentford, U.K.-based unit of GlaxoSmithKline PLC, said the European Commission granted marketing authorization to its two-drug, single pill regimen, Juluca, for treating certain patients with HIV-1 infection.

On the policy front

* House Republicans will try this week to push through a bill passed last year by the Senate aimed at giving critically ill patients greater access to experimental drugs beyond the U.S. Food and Drug Administration's current compassionate-use process.

* The Democratic Republic of the Congo's health minister said three new Ebola cases have been confirmed in the city of Mbandaka, marking further spread of the disease in the urban region, CNBC reported. Meanwhile, people in Mbandaka are avoiding body contact as a preventive measure against the disease, Reuters wrote.

* UK Prime Minister Theresa May will highlight the country's scientific strategy in a speech calling on the National Health Service and the industry to use artificial intelligence in diagnosing cancer at early stages and prevent over 20,000 cancer-related deaths each year by 2033, The Independent reported.

Drug and product pipeline

* The U.S. Food and Drug Administration approved Cambridge, U.K.-based AstraZeneca PLC's Lokelma to treat hyperkalemia in adults. Hyperkalemia is a disorder characterized by high levels of potassium in the blood.

* The European Medicines Agency has cautioned against the usage of ViiV Healthcare's HIV medicine dolutegravir in certain women due to the risk of birth defects in babies born to mothers who became pregnant while taking the drug.

* Johnson & Johnson discontinued the development of its investigational drug atabecestat, which was being studied to slow cognitive decline in people at risk of Alzheimer's dementia.

* The U.S. FDA has asked for additional work, including a new formulation and additional studies, before it could approve Agile Therapeutics Inc.'s contraceptive patch, which is known as Twirla.

* The FDA said the use of Merck & Co. Inc.'s cancer drug Keytruda or Roche's Tecentriq as a monotherapy may lead to lower survival rate in certain urothelial cancer patients.

Operational activity

* AstraZeneca, the U.K. drugmaker that has been selling off older blockbuster drugs including the antipsychotic Seroquel, said it is focused on launching a raft of new medicines to drive future growth, rather than acquisitions, as it reported first-quarter sales impacted by generic competition to its former best-selling cholesterol treatment, Crestor.

* Meanwhile, about 35% of AstraZeneca's shareholders rejected the company's pay report at its annual meeting even after company CEO Pascal Soriot's salary was reduced to £9.4 million in 2017 from £14.3 million a year earlier, Reuters reported.

* The Greek parliament voted to abandon an investigation into allegations of kickbacks from Novartis AG to 10 politicians, including former Prime Minister Antonis Samaras, following a committee's conclusion that the parliament had no jurisdiction to investigate the politicians, Reuters reported.

Our features

Hospital clinics could face payment cuts under Trump drug plan: In proposing a plan May 11 to lower drug prices, President Donald Trump's administration is also raising the idea of reducing the amount Medicare pays outpatient hospital clinics for administering drugs for chemotherapy and other procedures.

Merck Ebola vaccine lands in DRC; officials discuss other experimental therapies: Four thousand doses of Merck & Co.'s experimental Ebola vaccine have arrived in the Democratic Republic of the Congo, which has reported 45 cases including 25 deaths from the highly infectious viral disease.

Other features

* The New York Times has a feature on new U.S. Health and Human Services Secretary Alex Azar.

The day ahead

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

In Asia, the Hang Seng was up 0.60% to 31,234.35. The Nikkei 225 added 0.31% to 23,002.37.

In Europe as of midday, the FTSE 100 rose 0.80% to 7,841.15, and the Euronext 100 advanced 0.64% to 1,088.32.

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