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Roche's MabThera gets EU nod for rare disease; Azar grilled on Medicaid plans

Top news

* Roche Holding AG said the European Commission approved MabThera to treat moderate to severe pemphigus vulgaris, a rare autoimmune disease affecting the skin and mucous membranes. MabThera, also sold in the U.S. as Rituxan, is facing biosimilar competition in the EU, primarily from Novartis AG's Rixathon.

* On the third day of his Capitol Hill road show to promote the Trump administration's fiscal 2020 budget request, Health and Human Services Secretary Alex Azar was grilled by senators on a number of issues, including the Trump administration's proposal to mandate work requirements for all able-bodied adults enrolled in Medicaid, the government's insurance program for low-income Americans.

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Azar faced questions from Senate Finance Committee Chairman Chuck Grassley, R-Iowa, who expressed concern about an investigation by the HHS Office of Inspector General, which uncovered security risks and failures in the protection of data generated by U.S. taxpayer-funded researchers.

On the policy front

* Nine months after Judge James Boasberg for the U.S. District Court for the District of Columbia blocked Kentucky's Medicaid work requirements from taking effect, he heard oral arguments for cases challenging work requirements in both Kentucky and Arkansas. Boasberg heard both cases March 14, and his rulings could impact the future of the controversial policy.

Andy Schneider, a research professor with Georgetown University's McCourt School of Public Policy and a former Medicaid policy adviser under the Obama administration, told S&P Global Market Intelligence that the two cases are technically separate, but the rulings are somewhat intertwined and center on one main argument: whether work requirements uphold Medicaid's principals.

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* U.S. Food and Drug Administration Commissioner Scott Gottlieb said the agency is seeking new ways to modernize clinical trials in a bid to advance precision medicine. The FDA is also publishing a final guidance to streamline the development of drugs for severely debilitating or life-threatening hematologic disorders, or blood conditions, other than cancer, while protecting the safety of patients.

* The World Health Organization aims to end the Ebola outbreak in the Democratic Republic of the Congo within six months, Reuters reported. At a news conference, WHO Director General Tedros Adhanom Ghebreyesus said the outbreak — which has so far resulted in 587 deaths — is now contained in two areas, with the number of new cases down by half to 25 per week since January.

* A drug called ivermectin, used to treat various parasite infestations, has the potential to fight malaria, researchers said in a study published in U.K. medical journal The Lancet. Ivermectin can be lethal to mosquitos, lessening the possibilities of malaria being transmitted, according to the study, which was conducted in Burkina Faso.

Drug and product pipeline

* The Institute for Clinical and Economic Review said Novartis' Mayzent is more cost-effective than best supportive care in treating an aggressive form of multiple sclerosis — an autoimmune disorder characterized by nerve damage in the brain and spine. The U.S. price watchdog said Mayzent improved health outcomes of patients compared to the best supportive care, significantly reducing the risk of disability progression with decreased inflammatory disease activity.

Operational activity

* Ian Read, who stepped down as CEO of Pfizer Inc. while retaining his executive chairman role, took home total compensation of $19.5 million in 2018, the New York-based drugmaker's annual report showed. In 2017, Read had the highest 2017 compensation among pharmaceutical company CEOs, bagging a $27.9 million pay package.

* The U.S. Patent and Trademark Office rejected Alvogen Pine Brook LLC's request for a review of the patents on Celgene Corp.'s blood cancer drug Revlimid, Reuters reported. Revlimid accounted for more than 60% of Celgene's overall sales in 2018, or about $9.69 billion.

* Prosecutors raided the Korea Exchange's Seoul office as part of an investigation on Samsung Biologics Co. Ltd.'s 2016 IPO, Nikkei Asian Review reported. The stock market operator is being investigated for allegedly easing regulations to allow the Samsung C&T Corp. unit to list on the South Korean exchange.

* Progenics Pharmaceuticals Inc. filed a lawsuit in Germany against the University of Heidelberg and a Novartis subsidiary over ownership rights to a radiopharmaceutical to treat prostate cancer. New York-based Progenics said the university exclusively licensed the patent filings for radiopharmaceutical PSMA-617 to ABX GmbH, which then sublicensed it to Novartis unit Endocyte Inc.

* S&P Global Ratings lowered the issue-level rating on Endo International PLC senior secured debt to B+ from BB- following plans by the company's unit to refinance senior notes, the amount of which was upsized to $1.5 billion from $1 billion. The downgrade represents the incremental weakening of recovery prospects because secured debt will now represent a larger proportion of the company's capital structure, the agency said.

The day ahead

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

In Asia, the Hang Seng rose 0.56% to 29,012.26, and the Nikkei 225 increased 0.77% to 21,450.85.

In Europe, around midday, the FTSE 100 was up 0.56% to 7,225.49, and the Euronext 100 was up 0.90% to 1,046.14.

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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This S&P Global Market Intelligence news article may contain information about credit ratings issued by S&P Global Ratings. Descriptions in this news article were not prepared by S&P Global Ratings.