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Roche gets FDA approval for tumor-agnostic cancer drug; ICER flags DMD drugs

Top news

* Roche Holding AG's biotech arm Genentech Inc. received the U.S. Food and Drug Administration's accelerated approval for Rozlytrek as a treatment for patients who have tumors that express a genetic abnormality known as NTRK gene fusions, regardless of where in the body the tumor is found. The mutations have been identified in breast, colorectal, pancreatic and non-small cell lung cancers.

The drug also received FDA approval to treat non-small cell lung cancer that has spread to other parts of the body in patients who express the ROS1 genetic mutation.

* The Institute for Clinical and Economic Review concluded that the few existing therapies for Duchenne muscular dystrophy — a genetic disorder characterized by progressive muscle degeneration and weakness — require steep discounts to be cost-effective and need more clinical data to demonstrate their benefit. The U.S. pricing watchdog wrote in its final evidence report, published yesterday, that PTC Therapeutics Inc.'s corticosteroid treatment Emflaza would need to be discounted by at least 73% from its current list price to meet "commonly accepted thresholds for cost-effectiveness."

* Health officials are furiously working on proposals to fulfill President Donald Trump's promises to lower U.S. drug costs, but his repeated vows to provide "beautiful" healthcare must rely on a sharply divided Congress, a top administration official acknowledged. "I think that we've been very clear that some of the changes that need to be made are outside of our scope," Centers for Medicare and Medicaid Services Administrator Seema Verma told reporters yesterday about implementing Trump's healthcare plan.

* The U.K. Department of Health will put out a tender for an express freight service capable of delivering life-saving emergency medicines to the country after Brexit, The Financial Times reports. The contract, worth £25 million, is meant to allay concerns surrounding access to emergency medicines following the U.K.'s split from the EU.

M&A and capital markets

* Monopar Therapeutics Inc., a Wilmette, Ill.-based biotechnology company developing treatments for cancer, has filed for an IPO on the Nasdaq stock exchange.

* Caligan Partners LP built a 10% stake in AMAG Pharmaceuticals Inc. and plans to call for changes in the company, such as refreshing the board, trimming costs and focusing on the expansion of its kidney drug business, Bloomberg News reported, citing people familiar with the matter.

Operational activity

* The U.S. Court of Appeals for the Federal Circuit affirmed the validity of Sanofi's patent for prostate cancer drug Jevtana. The federal court's decision also reversed an earlier ruling by the U.S. District Court for the District of New Jersey that had invalidated Sanofi's patent on the method of using Jevtana.

The day ahead

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

In Asia, the Hang Seng rose 0.94% to 25,734.22, and the Nikkei 225 inched up 0.06% to 20,418.81.

In Europe, around midday, the FTSE 100 was up 0.65% to 7,112.80, and the Euronext 100 was up 1.20% to 1,029.76.

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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