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AstraZeneca Q1 profit plummets; US approves Amgen, Novartis' migraine drug

Top news

* AstraZeneca PLC's first-quarter core EPS was 48 cents, down 51% year over year. The Cambridge, U.K.-based drugmaker said the strong performance of the company's products in China and new drugs was offset by the decline of its former blockbuster cholesterol drug Crestor in Europe in Japan.

* The U.S. Food and Drug Administration approved Amgen Inc. and Novartis AG's Aimovig for the preventive treatment of migraine headaches in adults. The therapy is priced at $6,900 per year, below Wall Street's expectations of about $10,000 annually, STAT wrote.

On the policy front

* The FDA unveiled a new website aimed at shedding light on situations where brand-name drugmakers may be pursuing gaming tactics to delay generic competition. Among those identified on the site as trying to block generics makers are U.S. drugmakers Pfizer Inc., Biogen Inc., Celgene Corp., Swiss drugmakers Novartis and Roche Holding AG, U.K.-based GlaxoSmithKline PLC and Dublin-based Jazz Pharmaceuticals PLC.

* The World Health Organization is holding an emergency meeting in Geneva on May 18, in part to discuss whether the latest Ebola outbreak in the Democratic Republic of the Congo is a "public health emergency of international concern," a formal classification to compel global support.

* The U.S. House Energy and Commerce Committee cleared 32 bills aimed at addressing the nation's opioid crisis, sending the measures — along with 25 other bills adopted by the panel last week — to the chamber's floor for consideration.

Drug and product pipeline

* Novato, Calif.-based Ultragenyx Pharmaceutical Inc. and Japan's Kyowa Hakko Kirin Co. Ltd. said Crysvita met its main goal in a phase 3 study for treating children with X-linked hypophosphatemia. The disease leads to an increased risk of fractures in adults and rickets in children, resulting in lower-body deformity, delayed growth and decreased height.

* Innovent Biologics Inc., a Suzhou-based private company, said blood cancer patients treated with its experimental drug IBI-308 showed a high response rate in a mid-stage study.

Operational activity

* South Korea's Samsung Biologics Co. Ltd. said Biogen is offering to increase its shareholding in the companies' joint venture, Samsung Bioepis Co. Ltd. The Cambridge, Mass.-based drugmaker is exercising a call option to acquire an additional 44.6% stake in Samsung Bioepis — a developer of biosimilars — for about 700 billion South Korean won.

Our features

Immunotherapy combination studies take the lead ahead of ASCO 2018: The 2018 American Society for Clinical Oncology is expected to bring together more than 32,000 oncology professionals, with more than 2,500 abstracts to be presented on site and an additional 3,350 abstracts to be published online.

Calif., Ohio initiatives seek to cap kidney dialysis charges: A national healthcare union is pushing ballot initiatives in California and Ohio to limit the amount centers can charge for dialysis treatment at 15% more than providers' costs.

Other features

* Takeda Pharmaceutical Co. Ltd. CEO Christophe Weber talked to Reuters about embarking on a cost-cutting plan by selling or spinning off its less valuable research assets. The Japanese drugmaker is preparing for a merger with Dublin-based Shire PLC.

* Indian drugmakers such as Lupin Ltd, Aurobindo Pharma Ltd. and Sun Pharmaceutical Industries Ltd are reducing their exposure to opioid-based drugs given the crisis in the U.S., The Economic Times has a report.

The day ahead

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

In Asia, the Hang Seng increased 0.34% to 31,047.91, and the Nikkei 225 increased 0.40% to 22,930.36.

In Europe, around midday, the FTSE 100 was down 0.17% to 7,775.10, while the Euronext 100 was up 0.10% to 1,084.48.

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