CVS Health Q3 beat lifts shares

• CVS Health (NYSE:CVS) Q3 results:
• Total revenues: $67,056M (+3.5%); Pharmacy Services: $35,711M (-0.9%); Retail/LTC: $22,725M (+5.9%), Healthcare Benefits: $18,698M (+8.8%).
• Net income: $1,219M (-20.3%); non-GAAP net income: $2,181M (-9.4%); EPS: $0.93 (-20.5%); non-GAAP EPS: $1.66 (-9.8%).
• Cash flow ops (9 mo.): $12,298M (+20.4%).
• 2020 guidance: EPS: $5.60 - 5.70 from $5.16 - 5.29; non-GAAP EPS: $7.35 - 7.45 from $7.14 - 7.27; cash flow ops: $12.75B - 13.25B from $11.0B - 11.5B. Consensus: EPS of $7.23 on revenues of $266.9B.
• https://seekingalpha.com/news/3633055-cvs-health-q3-beat-lifts-shares-up-2
  

Pfizer's tofacitinib shows treatment benefit in ankylosing spondylitis study

• Pfizer (NYSE:PFE) has announced today positive results from a Phase 3 study evaluating efficacy and safety of tofacitinib in adults with active ankylosing spondylitis (AS), is a rare type of arthritis affecting the spine. Data will be presented on Monday, at the American College of Rheumatology/ Association of Rheumatology Professionals Annual Meeting.
• The 270-subject study met its primary and key secondary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 20 and 40 response, respectively, compared to placebo. ASAS is a scale used to define improvement or response to treatment.
• At week 16, 56.4% of patients in tofacitinib arm achieved an ASAS20 response, versus 29.4% in placebo. Also, 40.6% patients achieved the ASAS40 response, with tofacitinib versus placebo (12.5%).
• The most common adverse events were upper respiratory tract infection, nasopharyngitis, diarrhea, alanine aminotransferase  increased, arthralgia and headache.
• The FDA has accepted Pfizer’s marketing application for tofacitinib in AS indication, with agency date in Q2 2021.
• https://seekingalpha.com/news/3633076-pfizers-tofacitinib-shows-treatment-benefit-in-ankylosing-spondylitis-study
  

Assembly Bio plunges on disappointing vebicorvir data in HBV infection study

• Assembly Biosciences (NASDAQ:ASMB) craters 58% in premarket in reaction to vebicorvir data from Phase 2 extension (211) study, which failed to achieve meaningful sustained virologic response (SVR) rates in patients with chronic HBV infection. 39 of 41 patients have now relapsed.
• The study was exploring whether SVR could be achieved after discontinuing therapy in virologically-suppressed patients who had received at least 12-18 months of combination treatment with vebicorvir and a nucleos(t)ide analogue reverse transcriptase inhibitor ((NrtI)).
• The company said vebicorvir Phase 3 program with Beigene remains on track to initiate in China in H1 2021 for chronic suppressive therapy.
• In parallel, it continues to advance second and third core inhibitor candidates. Enrollment and dosing are underway in Phase 2 trial of ABI-H2158 for chronic HBV infection and Phase 1 study of ABI-H3733 in healthy volunteers.
• Additionally, in 1H of 2021, Assembly plans to commence triple combination Phase 2 trials with VBR’s core inhibitor with NrtI and an RNAi therapeutic from Arbutus and, separately, with interferon.
• https://seekingalpha.com/news/3633142-assembly-bio-plunges-on-disappointing-vebicorvir-data-in-hbv-infection-study
  

Mylan Q3 non-GAAP EBITDA up; merger with Upjohn approaches

• Mylan N.V. (NASDAQ:MYL) Q3 results:
• Revenues: $2,972.1M (+0.3%).
• Sales in Europe up 7%. Sales in North America down 5%.
• Net income: $185.7M (-2.2%); non-GAAP net income: $679.7M (+12.5%); EPS: $0.36 (-2.8%); non-GAAP EBITDA: $1,009.7M (+9.4%).
• Cash flow ops: $525.0M (+7.6%).
• No guidance provided.
• This is the final earnings release for Mylan. The company will merge with Pfizer's (NYSE:PFE) Upjohn unit in 10 days. The combined company will do business as Viatris.
• https://seekingalpha.com/news/3633130-mylan-q3-non-gaap-ebitda-up-9-merger-upjohn-approaches
  

Celltrion's COVID-19 antibody drug cut recovery time-early study

South Korean drugmaker Celltrion Inc said on Friday patients treated with its experimental COVID-19 antibody drug in a small-size early-stage trial showed at least a 44% improvement in recovery time.

The result bodes well for Celltrion, which plans to seek conditional approval for the monoclonal antibody treatment, CT-P59, for emergency use by the end of this year in South Korea.

In its global Phase 1 trial that enrolled 18 patients with mild symptoms of COVID-19, 15 participants who received the treatment had a mean recovery time about 44% faster than three people in a placebo group.

No patients treated with CT-P59 in the study had so far required hospitalisation or other antiviral therapy as a result of COVID-19, and the treatment was well tolerated with no clinically significant safety issues, it said.

Celltrion, which is planning global Phase 2 and 3 trials of the drug, said last month it received regulatory approval for Phase 3 clinical trials from South Korea.

Celltrion, which is planning global Phase 2 and 3 trials of the drug, said last month it received regulatory approval for Phase 3 clinical trials from South Korea.

The third-stage trials will be conducted on about 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea.

The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the coronavirus and designed to block it from locking on to human cells.

Celltrion began commercial production of the drug in September, which is likely to amount to around 1 million doses, in anticipation of demand in both domestic and overseas markets.

Monoclonal antibodies are manufactured copies of antibodies created by the body to fight an infection.

Developers of COVID-19 antibody treatments include U.S. firms Eli Lilly and Regeneron, Roche and Novartis.

No monoclonal antibody has been approved against COVID-19 so far

https://www.reuters.com/article/us-health-coronavirus-southkorea-celltri/celltrions-covid-19-antibody-drug-cut-recovery-time-early-study-idUSKBN27M060

AstraZeneca's COVID-19 vaccine to begin clinical trials in China

AstraZeneca Plc plans to start early and mid-stage clinical trials of its COVID-19 vaccine candidate in China this year, a senior executive said on Friday, as it prepares a global rollout of the vaccine.

The vaccine candidate is already in the final stage of clinical trials in other countries, and AstraZeneca and its partner on the project, the University of Oxford, expect data from the late-stage trials this year.

If successful, they will file for emergency approvals in as many countries as possible at the same time, its CEO, Pascal Soriot, said this week.

In China, the company has a deal with Shenzhen Kangtai Biological Products to manufacture the vaccine in the country.

Under the agreement, Shenzhen Kangtai, one of China’s top vaccine makers, will ensure it has annual production capacity of at least 100 million doses of the experimental shot AZD1222 by the end of this year.

The vaccine may be approved for use in China by mid-2021 after gathering safety data from Phase 1 and Phase 2 trials in China and efficacy data from Phase 3 trials overseas, Leon Wang, head of AstraZeneca’s China operation told Reuters.

Wang said its trials in China would use vaccines manufactured by local partner Shenzhen Kangtai.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-china/astrazenecas-covid-19-vaccine-to-begin-clinical-trials-in-china-executive-idUSKBN27M0CV

Coronavirus: Staying safe on trains, planes and automobiles

Many of us rely on public transport to get to work, school, and to meet friends and family. But in the time of COVID-19 is it safe to use these vehicles and is there a difference between them?

Transport has contributed to the spread of coronavirus—locally, regionally and internationally. Despite various measures for passenger screening, quarantine after travel and border control, infected people have still managed to travel—knowingly or unknowingly. We now know that quite a large proportion of people who are infected show no symptoms of COVID-19 and that people are infectious before they show symptoms.

But has transmission of the virus occurred on public transport vehicles? There is very little good scientific evidence on the transmission of infectious disease on public transport vehicles. This is because linking a transmission event to a specific journey is notoriously difficult, as there are so many factors at play. Scientists around the world are trying to unpick the complex interactions between people and the environment that might lead to transmission.

Since the start of the pandemic, a few studies have shown that transmission may have occurred—or could occur—on various public-transport vehicles. Yet these studies have not shown that transmission has actually taken place on the vehicle.

A study looking at trains came up with probabilities of transmission depending on proximity to an infected person using risk modeling. Another study that followed a group of tourists who traveled together by plane used questionnaires to link events and diagnoses over a period of time. Computer simulations of a coach filled with manikins were used to model the possible distribution of virus-laden droplets and estimate the likelihood of passengers encountering these at various locations. Everything we know so far is based on modeling, probability and risk.

One way to identify transmission is to compare the genetic sequence of the virus taken from two infected people that are linked by a contact event. We know there are many SARS-CoV-2 strains, each with a unique sequence.

Only one study looking at transmission on transport vehicles has done this. Contact tracing and viral RNA sequencing (RNA being the genetic material of some viruses) showed that a married couple and two flight attendants who had traveled on a flight from the US to Hong Kong were infected with the same strain. This strain had not been found previously in Hong Kong, and this could indicate that transmission occurred on the flight. However, the four people could also have become infected elsewhere while in the US where very similar viral RNA sequences have been found consistently.

How to travel safely

Taking any form of public transport means coming into contact with other people in an enclosed space. To assess the risk that you might expose yourself to, there are several things to consider: the number of people you might encounter, the length of the journey, and the ventilation on the vehicle.

When thinking about contact with other people, the fewer you encounter, the lower the risk. So consider traveling at off-peak times and make sure that you socially distance as much as possible.

Journeys can last a few minutes or many hours, depending on the distance and the mode of transport. The longer your journey the more chance that you will be exposed to the virus as there is more time for air and surfaces to become contaminated and for you to come in contact with the virus.

The ventilation systems on transport vehicles have been designed for passenger comfort and energy efficiency. There is little regulation of the level of fresh air for passengers, except for airplanes.

The ventilation in aircraft is very tightly regulated and probably the most sophisticated, aside from operating theaters and clean rooms. A recent study by the US Department of Defense showed that the combined effect of the cabin ventilation system and mask-wearing meant that people on the flight were exposed to very few particles circulating in the air. Other vehicles may not have such good ventilation. So if you are on a bus or a train where you can open a window, open it if it is safe to do so.

You should wear a face covering throughout your journey to protect yourself from respiratory droplets that might be contaminated with virus particles on public transport. If you are traveling by taxi or ride-sharing service, such as Uber, crack open the window. Ask yourself which surfaces are likely to have been touched by many people. You will probably have to touch these yourself, so be sure to clean your hands well once you finish your journey.

If you are using a bike-share scheme, consider wiping down the handlebars before you set off. And it is always important that you stick to the measures given by the transport operator.

As you prepare for your journey, consider the three points above (people, duration, fresh air) as they will vary depending on the mode of transport you will use: bus, train, metro, plane, coach, taxi, ride-share, bike-share scheme. Travel safely.

https://medicalxpress.com/news/2020-11-coronavirus-safe-planes-automobiles.html