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Novartis asthma combo improves lung function; EMA backs 2 drugs for EU approval


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Novartis asthma combo improves lung function; EMA backs 2 drugs for EU approval

Top news

* Novartis AG said its inhaled combination therapy containing indacaterol acetate and mometasone furoate improved lung function and asthma control in patients with inadequately controlled asthma in a late-stage study, called Quartz. The 802-patient phase 3 study compared the fixed-dose combination with mometasone furoate alone delivered via the Twisthaler device in adult and adolescent patients with inadequately controlled asthma who either had or did not have additional maintenance treatment.

The Swiss drugmaker said fixed-dose combination inhalers may help asthmatics by simplifying complex inhaler regimens.

* The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of two new therapies in May, including radiation protection treatment LysaKare, developed by Novartis unit Advanced Accelerator Applications SA. LysaKare is used for protecting the kidneys of patients undergoing a radioactive therapy with lutetium oxodotreotide.

CHMP also backed the approval of Univar Inc.'s Cufence for Wilson's disease, an inherited condition that causes copper to accumulate in vital organs like the liver and brain.

On the policy front

* Previously thought to be primarily an ethical issue, a new study suggests that physician burnout costs the U.S. economy about $4.6 billion every year due to turnover rates and reduced clinical hours. The study, published in the Annals of Internal Medicine, suggests that the impact to the U.S. economy from physician burnout could be as high as $6.3 billion, with $2.6 billion on the low end of the range.

According to the study, physician burnout costs healthcare organizations about $7,600 per employed physician each year, with a range of $3,700 to $11,000. The authors of the study said that while arguments for fixing physician burnout have previously been made on "ethical grounds," their study shows that organizations have a financial incentive to address the issue as well.

* Johnson & Johnson closed U.S. trading down 4.19% to $131.33 per share May 29 as the company spent the second day in Oklahoma district court defending against charges that its marketing practices contributed to the ongoing opioid epidemic. Two defendants in the case, Purdue Pharma LP and Teva Pharmaceutical Industries Ltd., previously settled with the state. Purdue settled in March for $270 million, and Teva settled for $85 million just days before the trial began.

M&A and capital markets

* Hansoh Pharmaceutical Group Co. Ltd. is selling 551 million shares at a price of between HK$13.06 and HK$14.26 apiece in its Hong Kong IPO, Bloomberg News reported, citing deal terms obtained by the news outlet. Gross proceeds from the offering are expected to reach up to US$1 billion.

Hansoh's listing would be the second largest in Hong Kong in 2019, next to Chinese brokerage Shenwan Hongyuan Group Co. Ltd., which raised US$1.16 billion in its IPO, Bloomberg noted.

Drug and product pipeline

* Merck & Co. Inc.'s Keytruda and Bristol-Myers Squibb Co.'s Opdivo will once again face off at the American Society of Clinical Oncology's Annual Meeting on May 31 to June 4, the most recent in a five-year battle for dominance of the cancer market. Both drugs have racked up U.S. Food and Drug Administration nods since their original approvals in 2014.

Keytruda holds the lead with approval in the U.S. for 19 separate indications — including expanded and combination treatments — while Opdivo has 15. Both immuno-oncology drugs work by triggering the immune system to attack cancer cells by inhibiting the PD-1 arm of healthy cells, which in turn prevents the corresponding PD-L1 arm of cancer cells from latching to the healthy cells. They are called immune checkpoint inhibitors.

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* Cara Therapeutics Inc.'s Korsuva injection achieved the main goal of a late-stage study by reducing itching intensity in hemodialysis patients with moderate to severe chronic kidney disease-associated pruritus. The intractable systemic itch condition occurs with high frequency and intensity in patients undergoing hemodialysis and peritoneal dialysis — processes of purifying blood in a person whose kidneys are not working normally.

* Researchers at Boston Children's Hospital have found a possible connection between scratching the skin and allergic reactions in the gut in a recent mouse study supported by the National Institutes of Health. The study showed that scratching the skin results in an increased number of activated mast cells — immune cells that facilitate allergic responses — in the small intestine.

Scientists from Rutgers University-New Brunswick believe that targeting a certain gene before birth could eventually lead to a treatment for Down syndrome that reverses abnormal brain development and improves cognitive function. Down syndrome is the most common chromosomal condition, affecting one in 700 babies in the U.S. Babies born with the condition have an extra copy of chromosome 21.

Researchers noticed changes in the brains of mice treated with the club drug ketamine that suggest depression behaviors will not return post-treatment. The study was recently published in the journal Science.

Operational activity

* GlaxoSmithKline PLC notched a victory in a case implicating the company over an attorney's suicide while taking generic copies of the drugmaker's depression therapy Paxil, FiercePharma reported. The U.S. Supreme Court refused to review a ruling by a lower court that initially sided with GSK on grounds that the U.S. FDA's authority prevented the company from adding a label warning on the drug about possible suicides.

The day ahead

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

In Asia, the Hang Seng lost 0.44% to 27,114.88, while the Nikkei 225 dropped 0.29% to 20,942.53.

In Europe, around midday, the FTSE 100 rose 0.51% to 7,221.79, and the Euronext 100 was up 0.47% to 1,027.79.

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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