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Sarepta therapies fail to get ICER nod; US single-payer debate heats up

Top news

* U.S. drug pricing watchdog Institute for Clinical and Economic Review said Sarepta Therapeutics Inc.'s gene therapies Exondys 51 and golodirsen are not cost-effective in treating Duchenne muscular dystrophy.

* The idea of the U.S. adopting a single-payer healthcare system got its second vetting on Capitol Hill in less than a month, though unlike the first round when lawmakers heard from a slew of witnesses, only congressional analysts testified at the latest House hearing.

Republicans at the May 22 hearing of the House Budget Committee remained staunchly opposed to a single-payer Medicare for All approach to healthcare. And while a number of Democrats expressed support, not everyone in the party was on board, though a House measure has gained more steam.

* In the fifth story in an S&P Global Market Intelligence series focusing on Alzheimer's disease, the Healthcare News Team examines promising therapies and the failures that have riddled the drug pipeline along the way. Many researchers and companies in the Alzheimer's disease space are focused on developing treatments that can slow or reverse the condition, but Biohaven Pharmaceutical Holding Co. Ltd. is looking to fill the gap in therapies for existing symptoms with its drug candidate troriluzole.

* Scott Gottlieb rejoined venture capital firm New Enterprise Associates Inc., a little over a month after he left his role as head of the U.S. Food and Drug Administration. Gottlieb is returning to New Enterprise, where he worked from 2007 to 2017, as a special partner on the firm's healthcare investment team.

* The Democratic Republic of the Congo's health minister, Oly Ilunga Kalenga, said he prefers to stick to Merck & Co. Inc.'s experimental vaccine to treat Ebola in the country, even though Johnson & Johnson has introduced its own version of the shot, Reuters reported. The World Health Organization said that although both experimental vaccines can be administered under strictly controlled research protocols, Merck's Ebola vaccine has proven highly effective and has been used throughout the outbreak.

* Maine confirmed that a school-aged child from Somerset County acquired measles, which means half of the U.S. states has been afflicted by the worst measles outbreak in the country in over two decades. The child, who is vaccinated, did not suffer from any serious complications and has fully recovered.

On the policy front

* U.S. President Donald Trump said that moving forward with an infrastructure package or plans to lower drug prices would be impossible if investigations into his administration continue.

* Seven months after a handful of states passed Medicaid expansion ballot initiatives and elected pro-expansion Democratic governors during the November 2018 midterm elections, state legislative sessions are coming to an end with little fruit to bare as expansion plans remain gnarled in politics, S&P Global Market Intelligence reports.

M&A and capital markets

* Daiichi Sankyo Co. Ltd. denied media reports that it has engaged in talks to sell its unit Daiichi Sankyo Healthcare Co. Ltd. "Although Daiichi Sankyo is constantly examining the potential for a variety of strategic developments with the aim of sustainable business growth, this reporting is not correct," the Tokyo-based drugmaker said. Daiichi has been in negotiations with several companies to sell its wholly owned over-the-counter drug subsidiary, Nikkei Business earlier reported.

Drug and product pipeline

* China's National Medical Products Administration granted conditional approval to GlaxoSmithKline PLC's Shingrix vaccine for shingles, or herpes zoster, a viral infection that causes a painful rash and affects about 3 million adults in China, FiercePharma reported.

* Novartis AG has 25 potential blockbuster medicines in development, including more than 10 planned launches by 2021, CEO Vas Narasimhan said.

Narasimhan said the Swiss drugmaker expects to price its highly anticipated gene therapy Zolgensma "far lower" than the current cost for standard of care of between $4 million and $5 million, Reuters reported. Novartis previously said it is eyeing a price in the range of $1.5 million to $5 million for Zolgensma, which is intended to treat spinal muscular atrophy, a rare neuromuscular disorder. The U.S. FDA is anticipated to make a decision on whether to approve Zolgensma in May.

Operational activity

* Johnson & Johnson is being accused by the city of Baltimore of pursuing sham litigation to delay generic versions of the company's billion-dollar prostate cancer drug Zytiga from entering the market. Baltimore alleges that it paid inflated prices for Zytiga from the time the medicine's original patent expired in December 2016 to the present.

* U.K. drugmakers Alliance Pharma PLC, Focus Pharmaceuticals Ltd., Lexon (UK) Ltd. and Medreich PLC are being accused by the country's Competition and Markets Authority of breaking antitrust rules for allegedly colluding to inflate the price of prochlorperazine, a prescription-only therapy for nausea and dizziness. Alliance Pharma has denied the allegations, saying it did not have an influence on or benefited from any price hikes of prochlorperazine.

The day ahead

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

In Asia, the Hang Seng fell 1.58% to 27,267.13, while the Nikkei 225 was down 0.62% to 21,151.14.

In Europe, around midday, the FTSE 100 was down 1.35% to 7,235.19, and the Euronext 100 decreased 1.45% to 1,033.16.

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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