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9 drugs recommended for EU approval; right-to-try bypasses US FDA, says author

Top news

* The European Medicines Agency's Committee for Medicinal Products for Human Use recommended nine medicines for approval at its meeting in May, including Amgen Inc. and Novartis AG's Aimovig as a therapy for preventing migraine. The CHMP also recommended restricting the use of Merck & Co. Inc.'s Keytruda and Roche Holding AG's Tecentriq for treating a type of bladder cancer as new data indicates that the therapies may not be as effective as chemotherapy in some patients with low levels of the PD-L1 protein.

* Meanwhile, the U.K. National Institute for Health and Care Excellence, in a draft guidance, recommended Tesaro Inc.'s Zejula be available through the Cancer Drugs Fund to treat patients with relapsed, high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have had two or more courses of platinum-based chemotherapy.

* Sen. Ron Johnson, R-Wis., author of a newly enacted law granting Americans the right to bypass the U.S. Food and Drug Administration's process for seeking access to experimental drugs confirmed that the Right To Try Act was meant to loosen U.S. regulators' authority — confirming what many critics had warned about.

* The FDA issued new guidelines spelling out how and when generics makers can seek waivers from the agency that would allow those companies to develop their own risk evaluation and mitigation strategy plans, which are required programs to ensure that a medicine's benefits outweigh its risks. The guidelines are intended to thwart a blocking tactic used by brand-name companies to forestall competition.

On the policy front

* The Community Oncology Alliance filed a case in the U.S. District Court for the District of Columbia to stop the government from cutting down cancer drug reimbursements. The lawsuit, filed against the U.S. Department of Health and Human Services and the White House Office of Management and Budget, is asking the court to stop the Centers for Medicare and Medicaid Services from implementing a 2% sequester cut to part B drug reimbursement.

* The European Medicines Agency may lose more of its staff than previously expected due to the company's relocation to Amsterdam as a result of Brexit, Bloomberg News reported. Issues such as the effect of Netherlands labor laws on short-term contracts could cause the drug watchdog to lose more employees than anticipated.

Drug and product pipeline

* Johnson & Johnson said its esketamine nasal spray delayed relapse among depression patients and was found to be tolerable in two phase 3 studies.

* Madrigal Pharmaceuticals Inc. said its drug MGL-3196 reduced liver fat and resolved disease symptoms in patients with nonalcoholic steatohepatitis in a mid-stage clinical trial. NASH is a common liver disease that does not have any U.S. FDA-approved treatment.

* Clearside BioMedical Inc. said its drug suprachoroidal CLS-TA improved vision in patients with diabetic macular edema when used in combination with Regeneron Pharmaceuticals Inc.'s Eylea. Diabetic macular edema is caused by diabetic retinopathy, a condition in which diabetes affects vision and can lead to blindness.

* Kitov Pharma Ltd said the U.S. FDA approved its Consensi tablets to treat pain from osteoarthritis and hypertension. The therapy is a combination of already approved osteoarthritis treatment celecoxib and hypertension drug amlodipine besylate.

Operational activity

* Bayer AG is reviewing research and development locations for the company's drugmaking business, and Germany-based employees fear up to 1,000 jobs might be cut in the process, Reuters reported, citing Wirtschaftswoche, a German magazine.

* Regeneron said it will ship its experimental treatment for Ebola virus to the Democratic Republic of the Congo, where more than two dozen people are reported to have died of the infection. The treatment, known as REGN-EB3 or REGN3470-3471-3479, showed signs of treating advanced Ebola virus disease and preventing death from the infection in three animal studies, Regeneron said.

* Utah Attorney General Sean Reyes filed a lawsuit against Purdue Pharma LP, claiming that the company's marking practices for its prescription opioids, including OxyContin, fueled the opioid epidemic in the state. The lawsuit alleges that the company violated state law, including the Utah Consumer Sales Practices Act, relating to Purdue's prescription opioids.

* Indivior PLC said it received a subpoena from the California Insurance Commissioner requesting documents related to its opioid addiction therapy Suboxone.

* Celgene Corp. said its CFO Peter Kellogg will step down from his position and will be replaced by former Johnson & Johnson executive David Elkins. Kellogg will become executive vice president and chief corporate strategy officer until his retirement in mid-2019.

Our features

Healthcare companies adjust FY'18 outlooks after Q1 results: Merck & Co., AbbVie Inc., Bristol-Myers Squibb Co. and Bayer were among the healthcare companies who adjusted either revenue or earnings forecasts for 2018 after the first quarter to reflect anticipated performance growth or decline.

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Other features

* Antibiotic shortages are not only putting ailing patients at risk but are fueling the emergence of superbugs, or drug-resistant bacteria, Reuters writes in a feature, citing a report by Access to Medicine Foundation. Shortages are emerging as a symptom of fragile drug supply chains — where the market is reliant on a few big medicine suppliers.

* Despite government and industry efforts to make prices more accessible to patients in the U.S., researchers are saying there has not been much improvement in healthcare price transparency in the country, Reuters said in a feature.

* The Guardian has a feature on liquid biopsies, or blood tests, that could help doctors screen 10 different types of cancers even before patients show symptoms.

* The Financial Times has special reports about cancer treatments, including immunotherapies and cancer genetics.

* Two owners of the company marketing Merck & Co.'s Gardasil 9 in China have propelled the Bloomberg Billionaires Index following the approval of the cervical cancer vaccine in the country, Bloomberg News writes in a feature.

The day ahead

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

In Asia, the Hang Seng increased 0.08% to 30,492.91, while the Nikkei 225 decreased 0.14% to 22,171.35.

In Europe, around midday, the FTSE 100 was up 0.71% to 7,732.26, and the Euronext 100 was up 1.14% to 1,060.98.

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