Hepion Pharma +46% on positive NASH data

Hepion Pharmaceuticals (NASDAQ:HEPA) has jumped 46% after hours after it posted positive lab data for its drug candidate for treating liver disease nonalcoholic steatohepatitis (NASH).

An expanded study with human precision cut liver slices shows that CRV431 prevented experimentally induced liver fibrosis to a greater extent than four other NASH drug candidates (obeticholic acid, elafibranor, resmetirom and Aramchol).

A Phase 1, single ascending dose study previously showed CRV431 to be safe and well tolerated in humans. Currently, CRV431 is being administered to humans in a 28-day multiple ascending dose study.

https://seekingalpha.com/news/3535512-hepion-pharmaplus-46-on-positive-nash-data

Pfizer posts 9% fall in fourth-quarter revenue

Pfizer Inc (PFE.N) reported a 9% drop in fourth-quarter revenue, hurt by intense competition for its pain treatment Lyrica that lost patent protection last year.
Revenue at the company, which is set to spin off its off-patent branded drugs business and combine it with generic drugmaker Mylan NV (MYL.O), fell to $12.69 billion from $13.98 billion a year earlier.
Net loss attributable to Pfizer narrowed to $337 million, or 6 cents per share, in the quarter, from $394 million, or 7 cents per share, a year earlier.
https://www.reuters.com/article/us-pfizer-results/pfizer-posts-9-fall-in-fourth-quarter-revenue-idUSKBN1ZR1AX

Coronavirus outbreak may disrupt Apple’s iPhone production ramp up plans

Apple Inc’s plan to ramp up iPhone production by 10% in the first half of this year may hit a roadblock as the coronavirus outbreak spreads across China, the Nikkei Asian Review reported on Tuesday.

The company has asked its suppliers, many of whom have manufacturing centers in China, to make up to 80 million iPhones in the first half of 2020, the Nikkei reported, citing people familiar with the company’s plans. (https://s.nikkei.com/2O6wXuq)
Apple has booked orders for up to 65 million of its older iPhones and up to 15 million units of a new cut-price model that it plans to unveil in March, according to the report.
However, the mass production which is due to start in the third week of February might be delayed due to the virus outbreak, the Nikkei reported.
The coronavirus outbreak has so far killed more than 100 people and infected over 4,500 in China, stranded tens of millions during the Lunar New Year holiday and rattled global markets.
Apple’s shares rose about 86% in 2019, outperforming a 29% rise in the S&P 500 index. The stock closed down nearly 3% at $308.95 on Monday as coronavirus fears dragged down high-flying U.S. chip and technology stocks.
Cupertino, California-based Apple, which raked in more than $142 billion in iPhone sales in fiscal 2019, has introduced lower priced smartphone variants to woo budget conscious shoppers and check declining sales of its biggest product category.
Last October, Nikkei reported that Apple asked its suppliers to increase production of iPhone 11 models by up to 8 million units, or about 10%, hinting that demand for the recently launched versions of its flagship phone was picking up.
The iPhone maker is set to report its first-quarter earnings after markets close on Tuesday.

https://www.marketscreener.com/APPLE-INC-4849/news/Coronavirus-outbreak-may-disrupt-Apple-s-iPhone-production-ramp-up-plans-Nikkei-29899339/?countview=0

One week sufficient for recovery from mild virus symptoms: China NHC expert

An expert at China’s National Health Commission (NHC) said on Tuesday one week is sufficient for a recovery from mild coronavirus symptoms.
The remarks were made by Li Xingwang at a press conference in Beijing, where he also said mild coronavirus symptoms do not present as pneumonia, but just slight fever.
Separately, Jiao Yahui, of the Bureau of Medical Administration at the NHC, said difficulties encountered by patients in accessing hospital beds for treating the virus have been alleviated, but protective suits are still in short supply.
https://www.reuters.com/article/us-china-health-nhc/one-week-sufficient-for-recovery-from-mild-virus-symptoms-china-nhc-expert-idUSKBN1ZR0AP

China’s Tianjin to set up dedicated hospital to treat coronavirus patients

The city of Tianjin in northern China will establish a dedicated hospital to treat people infected by the coronavirus as part of a “wartime mechanism” to fight the disease, a government-owned paper said on Tuesday, citing the local health commission.
The city will move patients in the existing Haihe hospital to make 600 beds available at any time for potential patients.
https://www.reuters.com/article/us-china-health-tianjin-hospital/chinas-tianjin-to-set-up-dedicated-hospital-to-treat-coronavirus-patients-idUSKBN1ZR036

UK healthcare cost agency rejects J&J’s nasal spray for depression

The National Institute for Health and Care Excellence (NICE), which determines if a drug is included in Britain’s National Healthcare System (NHS), said there was a lack of evidence on how the treatment, chemically called esketamine, fared over rivals, and that it could raise costs.
In the draft guidance, NICE also questioned the effects of stopping the treatment, saying it was unclear if any improvement in symptoms would be maintained after a course, potentially adding to costs.
“Introduction of esketamine into clinical practice in the NHS will be complex because the structure and delivery of services would need to be changed,” said Meindert Boysen, director of the centre for health technology evaluation at NICE.
NHS currently manages treatment-resistant depression with oral medicines, followed by a second drug if symptoms do not improve. Sometimes the state-run health service combines drugs with psychological therapy.
Esketamine is approved as a combination therapy for adults with major depressive disorder who have not benefited from prior treatments.
It is chemically a mirror image of the anaesthetic ketamine that is often abused under the street name “Special K”, and hence requires that it be given under the supervision of a healthcare professional in a clinic.
“Estimates of the costs of providing the clinical service for esketamine were highly uncertain, as are the costs of repeated courses of the drug,” Boysen said.

In the United States, the spray is priced here at $590 for a 56 mg dose and $885 for 84 mg.
Esketamine received approvals from European and U.S. regulators last year, marking a new type of antidepressant in over 30 years and raising hopes for its relatively fast action to treat patients failed by prior treatments.
More than 264 million people of all ages suffer from depression worldwide, according here to the World Health Organization.
https://www.reuters.com/article/us-johnson-johnson-spravato-britain/uk-healthcare-cost-agency-rejects-jjs-nasal-spray-for-depression-idUSKBN1ZR017

FDA gives new priority review for Sanofi and Regeneron’s Dupixent

The U.S. Food & Drug Administration (FDA) regulatory body has accepted for priority review the use of Sanofi and Regeneron’s Dupixent product for children aged 6-11 with moderate-to-severe eczema, the companies said.
Sanofi and Regeneron added in a statement that if Dupixent won approval from the FDA, it would become the first biologic medicine available in the United States for such children.
The FDA is due to make its decision on May 26.
https://www.reuters.com/article/us-sanofi-dupixent/u-s-fda-regulator-gives-new-priority-review-for-sanofi-and-regenerons-dupixent-idUSKBN1ZR0HN