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US to relax opioid treatment rules; Allergan's Restasis open to patent challenge

Top news

* The U.S. Food and Drug Administration plans to soon release two new draft guidance documents aimed at expanding the options for medication-assisted treatments for people addicted to opioids, Health and Human Services Secretary Alex Azar told state governors.

* The U.S. Patent Trial and Appeal Board ruled that patents related to Allergan PLC's eye drug Restasis can be challenged despite the company's patent deal with the Native American tribe St. Regis Mohawk to shield the blockbuster drug from generic competition, Stat News reported.

* Fewer Americans sought medical attention from doctors outside of hospitals for the flu in the past week, though hospitalizations due to the virus continued to climb, the U.S. Centers for Disease Control and Prevention said.

On the policy front

* In 2017, the FDA issued the lowest number of new federal regulations over a 20-year period, according to a PricewaterhouseCoopers report.

M&A and capital markets

* French drugmaker Sanofi secured U.S. antitrust clearance for its $11.6 billion acquisition of Waltham, Mass.-based hemophilia specialist Bioverativ Inc.

* U.S.-based PerkinElmer, Inc. agreed to fully acquire Thebarton, Australia-based RHS Ltd.'s issued share capital for 28 Australian cents per share.

Drug and product pipeline

* Esperion Therapeutics, Inc. is planning to undercut its rivals by pricing its potential heart disease treatment — bempedoic acid — at $9 to $10 a day, or less than $4,000 a year. This would compare to the $14,000-a-year list price of Amgen Inc.'s Repatha, or Regeneron Pharmaceuticals Inc. and Sanofi's Praluent, Bloomberg News reports.

* Japanese drugmaker Kyowa Hakko Kirin Co. Ltd. said the European Commission granted conditional approval for Crysvita in treating a rare musculoskeletal disorder that is characterized by low phosphate levels in the blood.

* The FDA approved KemPharm Inc.'s painkiller Apadaz.

Operational activity

* Israel-based Teva Pharmaceutical Industries Ltd. has closed its offices in New York and Washington, D.C., Israeli newspaper Calcalist reported.

* The U.S. FDA notified India's Sun Pharmaceutical Industries Ltd. of objectionable conditions at its Halol facility in Gujarat, India, following a reinspection.

* India's Dr. Reddy's Laboratories Ltd. said the FDA refused to clear its active pharmaceutical ingredients plant at Srikakulam in Andhra Pradesh. The regulator continued to maintain "official action indicated" status for the plant signaling the presence of objectionable conditions on the site and/or continuance of administrative sanctions.

Our features

* Drug price hikes spark investor demand for socially responsible innovation: Investors are increasingly concerned that drug price increases are not only restricting patients' access to medicines, but also masking a lack of innovation and future opportunities at major pharmaceutical companies.

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Other features

* Lab-developed micro tumors can help predict the effectiveness of various cancer drugs with far more accuracy and in less time than those tested on mice, CNBC reported, citing a study by researchers in Britain and Italy.

* The Financial Times carries a report on three U.K.-based companies — Creo Medical Ltd., Medica Group and Destiny Pharma — that chose to list their shares on London's AIM stock exchange instead of the U.S.

* The Wall Street Journal has a report on new flu diagnostics that are more accurate than their older counterparts. Companies introduced new diagnostics in response to fresh U.S. FDA rules.

The day ahead

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

In Asia, the Hang Seng was up 0.74% to 31498.6. The Nikkei 225 climbed 1.19% to 22,153.63.

In Europe as of midday, the FTSE 100 rose 0.51% to 7,281.51, and the Euronext 100 added 0.67% to 1,033.57.

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