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Pfizer had clue of drug's benefit on Alzheimer's; FDA faces recruitment dilemma

Top news

* Pfizer Inc. researchers found in 2015 that the company's blockbuster rheumatoid arthritis therapy Enbrel showed signs of reducing the risks of Alzheimer's disease by about 64%, but the drugmaker opted against pursuing a clinical trial to verify the claim over concerns that a study would not be successful, The Washington Post reported.

* Recruiting and retaining top scientists with the expertise needed to review applications for emerging technologies, like gene and cell-based therapies, is the U.S. Food and Drug Administration's greatest concern right now, the agency's top leaders said. FDA Acting Commissioner Ned Sharpless said the U.S. regulator is wrangling with regulating software and 3D printed medical devices, electronic cigarettes, and therapies that are increasingly being developed for an individual patient. "And all of those innovative areas require new expertise and knowledge," Sharpless said.

* Bristol-Myers Squibb Co. said Tom Lynch is stepping down as chief of research and development, leaving the company by Oct. 1. The company was announcing changes in its leadership upon the conclusion of its $74 billion acquisition of Celgene Corp.

* California, Hawaii, Maine, and the District of Columbia filed lawsuits against OxyContin maker Purdue Pharma LP for its alleged role in the U.S. opioid crisis, CNBC reported. In total, 48 U.S. states are now accusing Purdue of downplaying the risk of addiction to its drug.

* As the number of opioid lawsuits against pharmaceutical manufacturers and distributors continues to rise, the liability they will face depends on a variety of factors, Moody's said in a report. The ability to absorb the impact of lawsuits faced by pharmaceutical companies like Johnson & Johnson, Allergan PLC, Teva Pharmaceutical Industries Ltd., among others, will depend on how much cash they have on hand, their financial leverage and their cash flow situation.

* BioMarin Pharmaceutical Inc.'s medicine Vimizim became the first therapy to be approved in China for treating patients with a type of ultra-rare metabolic disorder called Morquio A syndrome. The condition, which becomes apparent during early childhood, primarily affects the skeleton.

* Ebola cases in Congo have crossed 2,000 while the rate of new cases has tripled in the country, which is facing the second-worst outbreak of the virus on record, Reuters reported. Attacks on Ebola clinics and local mistrust of health workers have contributed to the spread of the disease.

* The Indian state of Kerala has reported a new case of the brain-damaging Nipah virus, Reuters reported. A 23-year old man was tested positive for Nipah and four other people had Nipah-like symptoms, Kerala Health Minister K.K. Shailaja told the agency. Another 80 people were being monitored, including those who were in contact with the affected person.

On the policy front

* The U.S. Supreme Court vacated policy changes from the U.S. Department of Health and Human Services that would have cut billions of dollars in Medicare funding for disproportionate share hospitals, facilities that serve a large number of low-income patients. The court ruled that HHS violated requirements outlined in the Medicare Act when it proposed changes to the funding formula for disproportionate share hospitals in 2014. The department is required to notify the public and seek comment when changing a "substantive legal standard," according to the ruling.

* Nevada has brought in a law that would require pharmaceutical companies to disclose prices and costs linked with their asthma therapies, Stat News reported. The state had enacted a similar law two years ago for diabetes treatments.

* Senate Judiciary Committee Chairman Lindsey Graham said he was "very sympathetic" to the idea of new legislation that would permanently place illicit chemical knock-offs of opioid fentanyl into the same legal class as heroin, Reuters reported. The new classification is proposed by the Justice Department and the Office of National Drug Control Policy in an effort to fight the U.S. opioid drug epidemic.

M&A and capital markets

* Singapore-based Cordlife Group Ltd made an offer to acquire Hong Kong-based, New York-listed Global Cord Blood Corp. The aggregate value of the deal would be S$1.24 billion, or about US$908.6 million.

ASCO conference

* A combination treatment of AbbVie Inc.'s drug Venclexta and Roche Holding AG's Gazyva showed that after two years — one year of treatment and one year after treatment — 88.2% of patients with chronic lymphocytic leukemia showed no sign of disease progression.

* Celgene Corp. said its chimeric antigen receptor T cell therapy Liso-cel reduced cancer in 82% of patients with leukemia or lymphoma, and almost half of the patients achieved complete remission.

* Meanwhile, Novartis AG said a combination of its drugs Tafinlar and Mekinist prolonged the lives of melanoma patients whose cancer has spread over five years in trials with joint data.

* Chinese drugmaker Innovent Biologics Inc. said its drug Tyvyt benefited 67.9% of patients with a type of blood cancer in a phase 2 trial.

Drug and product pipeline

* The U.S. Food and Drug Administration approved Eli Lilly and Co.'s Emgality as the first drug for treating episodic cluster headaches in adults. The drug was already approved for preventing migraine in adults.

* Aimmune Therapeutics Inc. said continued use of its peanut allergy medication AR101 as part of a follow-on study improved the tolerability of peanut protein in patients. Peanut allergy is one of the most common food allergies, affecting more than 6 million people in the U.S. and Europe.

Operational activity

* Sanofi lost a German patent case brought by Amgen Inc. against the French drugmaker's cholesterol medicine Praluent. The U.S. company said Praluent infringed on the intellectual property of its therapy Repatha, both of which use a similar mechanism to treat the condition, Reuters reported.

The day ahead

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

In Asia, the Hang Seng increased 0.50% to 26,895.44, while the Nikkei 225 gained 1.80% to 20,776.10.

In Europe, around midday, the FTSE 100 went up 0.59% to 7,256.51, and the Euronext 100 climbed 0.77% to 1,037.96.

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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