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Merck KGaA, Pfizer halt cancer trial; FDA approves drug for rare blood disease

Top news

* Germany's Merck KGaA and New York's Pfizer Inc. halted a late-stage trial of their drug Bavencio in patients with ovarian cancer because results of an interim analysis did not support the study's goals.

* Stemline Therapeutics Inc.'s Elzonris became the first medicine to be approved by the U.S. Food and Drug Administration to treat a rare blood disease called blastic plasmacytoid dendritic cell neoplasm that affects the bone marrow and multiple organs.

* Alexion Pharmaceuticals Inc. priced its rare blood disorder drug Ultomiris at $6,404 per 30-milliliter vial as the U.S. Food and Drug Administration approved the drug almost two months ahead of schedule.

On the policy front

* Both sides in the legal battle being waged in Texas over the constitutionality of the Affordable Care Act want a federal judge to permit the case to promptly move forward to an appeal without delay while other aspects of the lawsuit are being decided.

* In the meantime, the latest enrollment figures showed ACA insurance plans remained popular with Americans, though the numbers dipped slightly, despite the Trump administration cutting the sign-up timeline in half, slashing advertising funds and substantially reducing grants for navigators, who help enrollees understand their options and help them with paperwork to obtain financial help and assess provider networks.

* FDA Commissioner Scott Gottlieb took to Twitter over the weekend to try to reassure Americans he still had staff on board to serve the public, despite his agency getting caught in the shutdown turmoil after Congress failed to fund 25% of the U.S. government.

* The U.S. Centers for Medicare and Medicaid Services has approved work requirement waivers for Maine and Michigan, increasing the number of states to have work requirement programs approved to seven.

* The Centers for Medicare and Medicaid Services also finalized its restructuring of the accountable care organization shared savings program and increased certain savings rates from their levels in the August proposed rule.

M&A and capital markets

* Shanghai Junshi Biosciences Co. Ltd. shares surged 22.5% to close at HK$23.75 apiece on the first day of trading in Hong Kong Dec. 24, compared to an issuance price of HK$19.38 each.

Drug and product pipeline

* Camurus AB and its U.S. partner Braeburn Inc.'s opioid use disorder treatment Brixadi was granted tentative approval by the U.S. Food and Drug Administration. Brixadi is an extended-release injection given under the skin that is used to treat patients who are receiving buprenorphine, the current standard of care for opioid withdrawal.

* Acorda Therapeutics Inc. said the U.S. Food and Drug Administration approved its Parkinson's treatment Inbrija. Inbrija is a formulation of one of the main drugs used to treat Parkinson's — levodopa.

* Aimmune Therapeutics Inc. submitted an application with the U.S. Food and Drug Administration seeking approval for its peanut allergy medicine for treating children and adolescents aged 4 to 17 years.

Other features

* The New York Times has a report on so-called health illiteracy which impacts older Americans' ability to understand medical information.

* Reuters has a report on the Centers for Disease Control and Prevention's response to a salmonella outbreak linked to raw turkey products in the U.S. after 216 people fell ill, 84 of whom were hospitalized.

The day ahead

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

In Asia, Hang Seng decreased by 0.40% to 25,651.38, while the Nikkei 225 decreased by 1.11% to 20,166.19.

In Europe, around midday, the FTSE 100 decreased 0.60% to 6,680.60, and the Euronext 100 decreased 1.08% to 899.85.

S&P Global Market Intelligence will not publish the Healthcare Daily Dose on Dec. 25 and will resume publication Dec. 26.

The Daily Dose has an editorial deadline of 6:30 a.m. ET. Some external links may require a subscription. Links are current as of publication time, and we are not responsible if those links are unavailable later.