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Biogen, Eisai drop late-stage Alzheimer's trials; flu vaccines better in '18-'19


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Biogen, Eisai drop late-stage Alzheimer's trials; flu vaccines better in '18-'19

Top news

* Biogen Inc. and Eisai Co. Ltd. said they will discontinue two phase 3 studies evaluating aducanumab in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia. The companies said the decision is based on results of an analysis of the trials, dubbed Engage and Emerge, that showed they were unlikely to meet their goals upon completion. The trials were not dropped due to any safety concerns.

Biogen and Eisai's decision to abandon its Alzheimer's trials are similar to those made by Roche Holding AG, and Eli Lilly and Co. and AstraZeneca PLC, who also failed to find a cure for the hard-to-treat progressive neurodegenerative disorder. Biogen's shares slumped 25.31% to $239.46 as of 7:32 a.m. ET in premarket trading.

* The effectiveness of this season's flu vaccine was slightly higher in comparison to the flu season of 2017-18, which resulted in 80,000 deaths in the U.S., and the percentage of outpatient visits for flu-like illness was considerably lower.

Flu vaccines were 46% effective against the H1N1 strain of the flu virus and 44% against H3N2 infections, the U.S. Centers for Disease Control and Prevention said in a Feb. 15 report.

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According to the CDC, there were 36.6 hospitalizations per 100,000 people, versus 99.9 hospitalizations per 100,000 individuals in the prior season, as of the week ending March 2. There was also a high severity period with the H1N1 and H3 viruses being the predominant strains, whereas last season it was the H3N2 virus strain.

On the policy front

* The U.S. Food and Drug Administration is temporarily allowing some drug manufacturers to sell blood pressure medicines containing a potential cancer-causing impurity in a bid to balance drug supplies in the country. The agency said it expects the companies to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in about six months.

Carcinogenic impurities have been found in batches of losartan medications from Hetero Labs Ltd., Novartis AG's unit Sandoz Inc., Macleods Pharmaceuticals Ltd. and Torrent Pharmaceuticals Ltd. The impurities in valsartan have been found in medicine batches from Mylan NV and Teva Pharmaceutical Industries Ltd.

* The World Health Organization issued new guidance to accelerate the treatment of multidrug-resistant tuberculosis. As part of the guidance, WHO is urging shifting to fully oral regimens to treat people with the disease. The agency is also recommending backing up treatment with active monitoring of drug safety and providing counseling support to help patients complete their course of treatment.

* A lawsuit challenging New Hampshire's Medicaid work requirements was filed in federal court, claiming that the policy hurts Medicaid recipients and its approval was an "abuse" of authority by the Trump Administration. New Hampshire is the third state facing legal action for attaching the controversial requirements to Medicaid, the dual state and federally run health insurance program for low-income Americans.

The lawsuit argues that work requirements violate the principles of Medicaid by limiting access to care and making it harder to obtain eligibility. Therefore, the document claims that the Trump Administration does not have the authority to approve the states' waivers.

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* Deaths from drug overdose involving addictive painkiller fentanyl in the U.S. accelerated from 2013 to 2016, a report from the CDC's National Vital Statistics System showed. Non-Hispanic black persons had the largest percentage increase in drug overdose death rates from 2011 through 2016 at 140.6% annually. Rates also hiked exponentially across all age groups, with the greatest increases among those aged 25 to 34 at 100% annually and those aged 15 to 24 at 93.9% each year.

M&A and capital markets

* Ares Life Sciences I SARL — also known as Waypoint Capital, the investment vehicle backed by Swiss billionaire Ernesto Bertarelli — is buying out Stallergenes Greer PLC and taking it private. Under the agreement, Waypoint will acquire the entire issued and to be issued ordinary shares of Stallergenes Greer not already held by Waypoint for €37 per share in cash, representing a 42.9% premium to Stallergenes' closing share price of €25.90 on March 20.

Waypoint held an 83.86% stake in Stallergenes as of April 13, 2018, according to S&P Global Market Intelligence data.

Drug and product pipeline

* Jazz Pharmaceuticals PLC said the U.S. FDA approved Sunosi to treat excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

Narcolepsy is a neurological disorder affecting control of sleep and wakefulness. It is characterized by excessive sleepiness and inability to regulate sleep-wake cycles normally. Obstructive sleep apnea is a disorder that causes breathing to repeatedly stop and start during sleep with excessive sleepiness as one of its major symptoms.

* Novo Nordisk A/S submitted two new drug applications with the U.S. FDA for the oral version of its type 2 diabetes medicine semaglutide along with a supplemental new drug application for its other diabetes medicine Ozempic.

The Danish pharmaceutical company is also seeking approval from the U.S. regulator to market oral semaglutide to reduce cardiovascular risk in adult patients with type 2 diabetes.

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* A study by researchers at the Medical Research Council Laboratory of Molecular Biology discovered the atomic structures of the abnormal tau protein filaments linked with chronic traumatic encephalopathy, a head injury-associated neurodegenerative disease, also known as punch drunk syndrome. The scientists also found that these tau structures are different from those found in Alzheimer's disease.

Joanna Latimer, head of neurosciences and mental health at the MRC, said: "Further understanding of how and why tau assembles into disease-specific folds will be crucial in the development of new treatments for [chronic traumatic encephalopathy] and other neurodegenerative diseases which involve defective tau."

Our features

Of Mice Not Men: Promising sepsis remedy; lack of sleep linked to heart problems: Research into an experimental therapy for sepsis has shown that a drug being developed at the Royal College of Surgeons in Ireland has the potential to stop sepsis-causing bacteria from triggering organ damage.

The day ahead

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

In Asia, the Hang Seng declined 0.85% to 29,071.56, while the Nikkei 225 gained 0.20% to 21,608.92.

In Europe, around midday, the FTSE 100 was up 0.62% to 7,335.92, and the Euronext 100 rose 0.03% to 1,044.26.

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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