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New drug approved for stubborn tuberculosis; AveXis execs sacked amid scandal

Top news

* The U.S. Food and Drug Administration approved pretomanid tablets in combination with Johnson & Johnson's bedaquiline and antibiotic linezolid to treat highly treatment-resistant tuberculosis, in which bacteria attacks the lungs. Pretomanid, developed by nonprofit organization TB Alliance, is only the third new anti-TB drug the FDA has approved in more than 40 years.

Pretomanid is the second medicine approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs pathway. This guidance, which the U.S. Congress established under the 21st Century Cures Act, is designed to advance the development and approval of antibacterial and antifungal therapies for serious or life-threatening infections in a limited population of patients with unmet need.

* Just over a week after the FDA launched a probe into Novartis AG and its unit AveXis Inc. for manipulating preclinical data for the gene therapy Zolgensma, AveXis announced that it has changed up its senior leadership team. Page Bouchard will become AveXis' senior vice president of research and chief scientific officer — a combination of head of research and development and chief scientific officer. These roles were previously held by Allan Kaspar and Brian Kaspar, respectively.

Brian and Allan Kaspar have not been involved with AveXis since May and are no longer with the company. The announcement comes amid a probe from the FDA regarding the manipulation of data AveXis provided for trials of Zolgensma, a $2.1 million gene therapy for spinal muscular atrophy.

The situation has even drawn the attention of Capitol Hill, where a group of senators has asked the FDA to ensure that the Swiss pharmaceutical giant is held accountable.

* The U.K.'s Department of Health and Social Care is setting up express freight service to deliver vital medicines and medical products into the country after Brexit. Under the £25 million contract, the service will deliver small parcels of medicines or medical products on a 24-hour basis to deal with potential shortages of emergency drugs after Brexit.

* Burundi, an East African country, launched the vaccination of frontline health workers against the Ebola virus disease, starting with those near the border with the Democratic Republic of the Congo. Merck & Co. Inc.'s Ebola vaccine, called rVSV-ZEBOV, is not yet approved but has shown to be effective and safe during outbreaks of the disease in West Africa, according to the World Health Organization.

* Uganda reported a surge of Malaria incidences due to the rainy season, climate change, reduced use of protective nets, population growth and refugee immigration. Malaria cases have risen to 1.4 million as of June this year, compared to 1 million the previous year, the country's health ministry said.

* Surprise medical billing for emergency department visits at in-network hospitals substantially increased in 2010-2016, according to a study from the Journal of the American Medical Association Internal Medicine. Patients' costs associated with those bills nearly tripled in that period.

About 39.1% of visits to emergency departments at in-network hospitals resulted in out-of-network bills, with the rate growing from 32.3% of visits in 2010 to 42.8% in 2016, according to the Aug. 12 study.

On the policy front

* U.S. House Oversight and Reform Committee Chairman Elijah Cummings, D-Md., and Sen. Bernie Sanders, I-Vt., a presidential candidate, reignited their probe into three generic-drug manufacturers' pricing practices and accused the companies of stonewalling the lawmakers' 2014 congressional investigation.

The lawmakers said they were renewing their investigation of Teva Pharmaceutical Industries Ltd., Mylan NV and Heritage Pharmaceuticals Inc. in light of accusations by 44 states that the three companies and other manufacturers had engaged in price-fixing.

* The National Supreme Court of Justice of Mexico ordered the Ministry of Health to publish new guidelines within six months on the use of medical marijuana, following its legalization in June 2017, Reuters reported. The country's top court said the absence of regulation prohibits patients, including children, to access cannabis-based therapies.

M&A and capital markets

* At least three healthcare companies — Liaoning Chengda Biotechnology Co. Ltd., Hutchison China MediTech Ltd. and Qingdao Haier Biomedical Holdings Co. Ltd. — have delayed or canceled plans to list on the Hong Kong stock exchange in the past five months amid rising market uncertainty.

Financial market sentiment is being weighed down mainly by an escalation in U.S.-China trade tensions, slowing economic growth and volatile exchange rates, experts said. Local protests that started in June against a controversial bill permitting extraditions to China are also making investors wary about capital markets.

* Investment bank JPMorgan Chase & Co. is set to collect $123 million for its role in advising Allergan PLC as the Irish company prepares to be acquired by AbbVie Inc. for $84.2 billion. JPMorgan will get the full amount of the fee — one of the largest ever paid out for advising on M&A — once the deal is completed. The bank has already received $12.5 million of the fee upon delivery of the opinion.

Drug and product pipeline

* Eli Lilly and Co.'s Taltz performed better than Janssen Biotech Inc.'s Tremfya in clearing the skin of patients with moderate to severe plaque psoriasis during a head-to-head clinical trial. The phase 4 trial called IXORA-R met its primary goal, with a larger proportion of patients using Taltz seeing completely clear skin after 12 weeks compared to those using Tremfya.

* Regeneron Pharmaceuticals Inc.'s experimental drug evinacumab was effective in treating symptoms of patients with homozygous familial hypercholesterolemia when used with conventional therapy in a late-stage study. The genetic disorder is characterized by high levels of bad cholesterol.

Operational activity

* Genmab A/S said its after-tax profit for the second quarter of 2019 declined year over year to 84.9 million Danish kroner, or 1.35 kroner, from 260.5 million kroner, or 4.21 kroner, in the year-earlier period. Copenhagen-based Genmab increased its revenue guidance for the year to 4.80 billion kroner from the previous guidance of 4.60 billion kroner.

* Canopy Growth Corp.'s net loss for the first quarter of fiscal year 2020 totaled C$3.70 per share, compared with the S&P Global Market Intelligence consensus normalized EPS estimate of 41 Canadian cents.

* Moody's flagged Teva Pharmaceutical for a potential downgrade based on the company's high leverage and large refinancing needs due to opioid-related litigation.

The day ahead

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

In Asia, Hang Seng rose 0.76% to 25,495.46, while the Nikkei 225 fell 1.21% to 20,405.65.

In Europe, around midday, the FTSE 100 fell 1.54% to 7,037.60, and the Euronext 100 dropped 1.36% to 1,010.86.

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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