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Saturday, May 9, 2020

Triple antiviral drug shows early promise in COVID-19 trial

A triple drug combination of antiviral medicines helped relieve symptoms in patients with mild to moderate COVID-19 infection and swiftly reduced the amount of virus in their bodies, according to results of a small trial in Hong Kong.
The trial, which involved 127 patients, compared those given the combination drug – made up of the HIV medicine lopinavir–ritonavir, the hepatitis drug ribavirin, and the multiple sclerosis treatment interferon beta – with a control group given just the HIV drug.
The findings, published in the Lancet medical journal, showed that on average, people who got the triple drug reached the point of no detectable virus five days earlier than those in the control group – at 7 days versus 12 days.
“Our trial demonstrates that early treatment of mild to moderate COVID-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient’s body, relieve symptoms, and reduce the risk to health-care workers,” said Kwok-Yung Yuen, a professor at the University of Hong Kong who co-led the research.
He said the lower risk to health workers would be due to the combination drug’s effect in reducing ‘viral shedding’ – which is when the virus is detectable and potentially transmissible.

In the trial, all patients received standard hospital care as needed, including ventilation support, dialysis support, antibiotics and corticosteroids.
Kowk-Yung Yuen said the findings were “encouraging”, but that the triple drug’s effect now needed to be tested in larger numbers of patients and in people with more severe COVID-19 illness.

Independent experts agreed that the findings were positive, but said larger and more detailed studies would be needed.
This … definitely justifies the consideration of adding interferon beta to the list of genuinely, evidence-based, promising treatments to be tested in further randomised trials,” said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.
He said that long years of experience in treating the human immunodeficiency virus (HIV) that causes AIDS have shown that it is best treated with combinations of different drugs “and this could also be the case with COVID-19”.
https://www.reuters.com/article/us-health-coronavirus-triple-drug/triple-antiviral-drug-shows-early-promise-in-covid-19-trial-idUSKBN22K2Z9

Birx to take key role in coronavirus drug distribution

U.S. coronavirus task force response coordinator Dr. Deborah Birx will have a leading role in how the first drug to demonstrate a benefit in treating COVID-19 patients will be distributed to hospitals, the White House said on Friday.
Birx, who has been a fixture in televised task force media briefings, will be one of the chief consultants on how Gilead Sciences Inc’s remdesivir will be supplied, White House spokeswoman Kayleigh McEnany told reporters.
The U.S. Food and Drug Administration last week gave emergency use authorization to remdesivir for patients with severe COVID-19 – the disease caused by the coronavirus – clearing the way for broader use in more hospitals around the United States.
“She’s the person who’s constantly reviewing the numbers, constantly reviewing the data,” McEnany said. “She really has the best grasp as to how that should be distributed.”

The federal government began distributing the drug this week. But doctors across the country, particularly in COVID-19 hotspots like New York and Boston, became concerned after being denied their request to obtain the new therapy, Infectious Disease Society of America President Dr. Thomas File told Reuters on Thursday.
The physician group called on the Trump administration to explain how it will ensure equitable distribution of remdesivir to states and hospitals based on COVID-19 case and hospitalization rates.
The group also stressed the importance of fair allocation to health facilities in communities disproportionately affected by the coronavirus, including African American and Hispanic populations.
Gilead last week donated 1.5 million vials of the drug to U.S. hospitals, enough to treat at least 140,000 patients.

In a large clinical trial released last week, remdesivir, which is given by intravenous infusion, was shown to speed recovery times of hospitalized COVID-19 patients compared to a placebo.
“This drug is promising, and we want to get it to the American people and to the areas that need it most,” McEnany said.The Federal Emergency Management Agency and the Department of Health and Human Services are coordinating the donation and distribution of remdesivir.
https://www.reuters.com/article/us-health-coronavirus-gilead-sciences-bi/white-houses-birx-to-take-key-role-in-coronavirus-drug-distribution-idUSKBN22K2TS

China approves Novartis’ multiple sclerosis treatment Mayzent

Chinese regulators have approved Novartis’ Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday.
Other drugs approved by China’s National Medical Products Administration to treat MS include Novartis’ Gilenya, Bayer’s Betaferon and Sanofi’s Aubagio. China has an estimated 30,000 patients with MS.
https://www.reuters.com/article/us-novartis-china-multiple-sclerosis/china-approves-novartis-multiple-sclerosis-treatment-mayzent-idUSKBN22L0C6

U.S. FDA commissioner in self-quarantine after exposure to person with COVID-19

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.
Hahn immediately took a diagnostic test and was tested negative himself for the novel coronavirus, FDA spokesman Michael Felberbaum said in an emailed statement.
Politico reported earlier that it was Katie Miller, U.S. Vice President Mike Pence’s press secretary, whom Hahn had come into contact with.
Asked by Reuters to confirm the details in the report, the statement did not name the person who was tested positive for COVID-19 with whom the commissioner had met.

Miller, also the wife of one of President Donald Trump’s senior advisers, tested positive on Friday, raising alarm about the virus’ potential spread within the White House’s innermost circle.
The diagnosis of Miller, who is married to White House immigration adviser and speech writer Stephen Miller, was revealed by Trump in a meeting with Republican lawmakers on Friday.
“As Dr. Hahn wrote in a note to staff today, he recently came into contact with an individual who has tested positive for COVID-19. Per CDC guidelines, he is now in self-quarantine for the next two weeks”, the FDA spokesman said.

About 3.90 million cases of the coronavirus have been recorded worldwide with nearly 1.27 million coming from the United States alone, according to a Reuters tally as of late Friday. The worldwide death toll stands at about 270,000 with the United States recording over 75,000 deaths.
The virus, first detected in the central Chinese city of Wuhan late last year, has also driven millions into unemployment as a result of lockdown measures put in place to curb a rise in infections.
https://www.reuters.com/article/uk-health-coronavirus-usa-fda/u-s-fda-commissioner-in-self-quarantine-after-exposure-to-person-with-covid-19-idUSKBN22L098

Pfizer to outsource some drug production, focus on coronavirus vaccine

Pfizer Inc (PFE.N) said on Friday it is in talks to shift more of its medicine production to outside contractors as it prepares for large-scale production of an experimental vaccine to prevent COVID-19, should it prove safe and effective.
The U.S. drugmaker is tapping its network of around 200 outside contractors, which includes Catalent Inc (CTLT.N), Lonza Group AG (LONN.S), and Thermo Fisher Scientific Inc (TMO.N), to play a bigger role in producing some of its existing medicines, Mike McDermott, president of global supply at Pfizer, told Reuters in an interview.
Pfizer did not specify which companies within its network it is in active discussions with about shifting production.
That will help Pfizer shift a portion of production at four of its vaccine manufacturing facilities, including one of its largest U.S. factories, toward the coronavirus vaccine while preventing disruptions in supply of its other products, he said.
“They have been hugely helpful in the past and will help us through this,” McDermott said.
Pfizer and German partner BioNTech SE (22UAy.F) said on Tuesday they have begun delivering doses of their coronavirus vaccine candidates for initial human testing in the United States. Trials in Germany had already begun.
If successful, Pfizer said it hopes to receive emergency use authorization from the U.S. Food and Drug Administration as early as October. It could distribute up to 20 million doses by the end of 2020, and potentially hundreds of millions next year, it said.
The shift to outside production of other medicines will primarily effect vaccines and intravenous drugs. Pfizer currently produces around 1.5 billion doses of intravenously injected vaccines and drugs each year.
McDermott said Pfizer will also add additional shifts to its own factories, hire more workers to take advantage of its unused production capacity, and stockpile current products in preparation for the shift to COVID-19 vaccine production.

Pfizer said earlier this week it was preparing four of its manufacturing sites – three in the United States and one in Belgium – to produce the vaccine, even before clinical trials shows which, if any, of the four potential candidates being tested demonstrates efficacy in preventing infection with the novel coronavirus.
It will cost Pfizer at least $150 million to gear up its facilities for the new vaccine, McDermott said.
Pfizer and BioNTech’s vaccine candidates use messenger RNA (mRNA) technology, which has long been talked about but has yet to produce an approved product. The mRNA technology instructs cells in the body to make specific coronavirus proteins that then produce an immune response.
It has the potential to be among the first vaccines against the virus that has infected more than 1 million people in the United States and killed over 77,000.
Producing vast quantities of vaccines requires that Pfizer and BioNTech work to rapidly scale up their suppliers’ ability to make raw materials for mRNA vaccines, McDermott said, adding that many are small biotechs.
It could also face potential shortages of more basic materials, he added, such as the vials and syringes used to contain and administer vaccines.
Those materials “could become stressed in this environment, where you are trying to produce your … existing products and add in vaccines needed for hundreds of millions or billions of people,” McDermott said.
Contract manufacturers Lonza and Catalent are also working with other drugmakers to help produce potential treatments and vaccines for the coronavirus.
Last week, Lonza said it was working with Moderna Inc (MRNA.O) to help it produce its experimental mRNA vaccine being developed with U.S. government backing.

Catalent agreed last month to help Johnson & Johnson (JNJ.N) manufacture its coronavirus vaccine candidate.
Lonza, Catalent and Thermo Fisher did not immediately respond to requests for comment about their work with Pfizer.
Pfizer also operates its own contract manufacturer, CenterOne, which provides raw materials to other drugmakers.
https://www.reuters.com/article/us-health-coronavirus-pfizer-vaccine/pfizer-to-outsource-some-drug-production-focus-on-coronavirus-vaccine-idUSKBN22K2ZS

Friday, May 8, 2020

6 Ways to Maintain Social Distancing, New Normal in Work Settings

Nearly half of the United States may have eased its stay-at-home mandates in recent weeks, but steep challenges still remain for manufacturing and distribution centers, noted commercial real estate services provider Cushman & Wakefield.
The contagious coronavirus places a new emphasis on social distancing in warehouse environments originally designed for employees to work in close proximity. However, processes can be adjusted and suggestions were compiled from various logistics, industrial and production experts and specialists, according to Cushman & Wakefield.
From encouraging remote working to readjusting work breaks and shift changes, Cushman & Wakefield outlined six recommendations for creating social distancing measures and adjusting to the “new normal” in warehouses.
New measures shouldn’t begin as the employees return, Cushman & Wakefield noted. First, the company should implement disinfecting procedures in accordance with governing authorities and/or best practices before employees return. Along with cleaning, mechanical, HVAC, fire and other “life safety” systems should be available, and municipal occupational health and safety guidelines should be reviewed for updated procedures.
The company should also consider workers’ shift patterns and remind workers of protocols for starting and ending their shift to avoid productivity bottlenecks. Vendors and drivers should also be informed of any new protocols, Cushman & Wakefield added. The checklist also noted companies could consider if office-based workers can work remotely to reduce on-site employees.
For employees that must work on-site, experts suggested developing clear plans for entering and exiting the facility. The checklist included banning visitors to the building and possibly creating restrooms/washrooms for temporary external drivers. Experts also recommended considering temperature checks and/or requiring workers to self-monitor for symptoms and adjusting stay-at-home sick policies when employees have symptoms.
With no vaccine in sight, social distancing has become the go-to answer for combating the virus and warehouses should adjust their work environments to continue that measure, Cushman & Wakefield argued. Industry specialists recommendations included leveraging a mobile app for clocking in/out, staggering break times, increasing space between production stations and leveraging electronics instead of in-person meetings .
Companies should also be prepared to disinfect shared equipment between shifts, experts said. Likewise, organizations should provide additional sanitizers/disinfectant and removable touch screen film at shared touch points, including work equipment and vending machines, experts recommended.
Lastly, companies need to confidently communicate to their employees, Cushman & Wakefield wrote. Companies can project confidence by being unified as employees return to the warehouse. The company should also establish two-way communication, clearly set employee expectations with an emphasis on making them feel secure and ensure a trusting and transparent culture.
https://www.globest.com/2020/05/08/6-ways-to-maintain-social-distancing-new-normal-in-warehouses/

Emergent BioSolutions Virtual Recruiting Aims to Draw Top Biomanufacture Talent

Emergent Biosolutions, with multiple facilities in the BioHealth Capital Region, is hiring for dozens of full-time biomanufacturing positions to propel its existing pipeline forward while also playing a leading role in the global fight against the coronavirus.
The company’s Talent Acquisition team is holding a virtual recruiting event through BioBuzz to spotlight their career opportunities and engage top talent, even in the times of COVID-19. During this event, you can learn more about open positions and work culture at the company’s Emergent Bayview facility in Baltimore, which is designated as a Center for Innovation in Advanced Development and Manufacturing (CIADM) by BARDA and the U.S. Department of Health and Human Services (HHS).
Emergent BioSolutions: Virtual BioManufacturing Recruiting Event
Site Manufacturing leadership, including BJ Hull, Vice President/GM Maryland Sites, will participate in the virtual recruiting event to discuss Emergent’s technology, manufacturing capabilities, and its culture of innovation.
Emergent is looking to hire top talent for a variety of biomanufacturing positions, including:
With over 20 years experience, Emergent is a leading vaccine and therapeutic development and manufacturing company at the forefront of public health threat solutions and preparedness. The company’s leading-edge biomanufacturing capabilities enable rapid, agile and robust development, manufacture and delivery responses to public health emergencies like the coronavirus pandemic, as well threats from anthrax, smallpox, botulism and chemical agents.
You can read more about Emergent’s history and capabilities in the ‘In Conversation’ interview with their Executive Vice President, Manufacturing and Technical Operations, Sean Kirk.
The company has also made numerous headlines recently after its announcement of a partnership with Johnson & Johnson to provide contract development and manufacturing services in support of J&J’s potential COVID-19 vaccine. That announcement comes closely on the heels of Emergent announcing partnerships with Novavax to manufacture the company’s potential COVID-19 vaccine and its novel influenza vaccine, NanoFlu, Vaxart for their experimental Oral Vaccine candidate for COVID-19 and with the U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19.
You can read more about each of these collaborations in the press releases and stories below.
Maryland Vaccine Leader Emergent BioSolutions Creates Virtual Recruiting Event to Attract Top Biomanufacturing Talent