NJ to make face masks mandatory outdoors as U.S. outbreak widens

New Jersey Governor Phil Murphy said on Wednesday he would sign an executive order requiring people to wear face coverings outdoors to prevent a resurgence of the novel coronavirus whenever social distancing is not possible.

More than 15,000 people have died from COVID-19 in New Jersey, ranking it second after neighboring New York state in the total number of deaths, according to a Reuters tally.

A Democrat, Murphy told MSNBC that requiring the public to wear masks outdoors was critical to controlling the spread of the virus in the state, an early hot spot where rates of the virus have started to creep up again.

“There’s no question that face coverings are a game-changer,” he said, acknowledging that it would be hard to enforce the order but saying the state needed to build on the progress made in its battle against the virus.

“We’ve gone through hell in New Jersey. We’ve lost over 13,000 people, we’ve brought our numbers way down. We can’t go through that hell again.”

The order, when formally announced later in the day, would be one of the most stringent coronavirus restriction on public activity in the United States. Many states require use of masks in public indoor areas and recommend they be used outside.

Murphy is taking action as infections skyrocket in many other states, including California, Florida and Texas, and health officials warn of a coming spike in the death toll from the virus, which has killed more than 131,000 Americans.

The U.S. outbreak crossed a grim milestone of over 3 million confirmed cases on Tuesday, roughly equivalent to 1% of the population, as more states reported record numbers of new infections.

In New Jersey, some people voiced surprise that face coverings were not already mandatory.

“I figured that was already the rule – it’s confusing that it’s not clear and I try pretty hard to keep up,” said Calia Nochumson, a 42-year-old high school teacher from Maplewood, New Jersey. She said she was disappointed to see so few people wearing face coverings during a recent trip to the beach.

Ohio is ordering people in seven counties to wear face coverings in public starting on Wednesday evening.

TRUMP PUSHES RETURN TO SCHOOL

President Donald Trump, who owns a golf club in Bedminster, New Jersey, has eschewed the idea of wearing a face mask and has exhorted Americans to return to their daily routines since the end of mandatory lockdowns imposed in March and April.

The Republican president, seeking a second White House term in a Nov. 3 election, threatened on Wednesday to cut off federal funding to schools that fail to open in the autumn due to the coronavirus outbreak.

“The Dems think it would be bad for them politically if U.S. schools open before the November Election, but is important for the children & families. May cut off funding if not open!” Trump posted on Twitter.

It was unclear what specific aid Trump had in mind. States are responsible for primary and secondary education under the U.S. Constitution but the federal government provides some supplementary aid.

SURGE IN NEW CASES

Nineteen states have reported record increases in cases this month and about 24 states have reported disturbingly high infection rates as a percentage of diagnostic tests conducted over the past week.

In Texas alone, the number of hospitalized patients more than doubled in just two weeks, and the number of available hospital intensive care unit beds for adults in Florida has fallen sharply in recent days.

Additional hospitalizations could strain healthcare systems in many areas, leading to an uptick in lives lost. The U.S. death toll rose by 962 on Tuesday, the biggest one-day rise since June 10, according to a Reuters tally.

The surge has forced authorities to backpedal on moves to reopen businesses, such as restaurants and bars, after mandatory lockdowns in March and April reduced economic activity to a virtual standstill and put millions of Americans out of work.

https://www.reuters.com/article/us-health-coronavirus-usa/new-jersey-to-make-face-masks-mandatory-outdoors-as-u-s-outbreak-widens-idUSKBN2492HG

Emergent BioSolutions, Mount Sinai to test COVID-19 blood plasma as preventive

Emergent BioSolutions (EBS +5.4%) is partnering with Mount Sinai to test its experimental COVID-19 hyperimmune globulin treatment, COVID-HIG, derived from the blood plasma of recovered Covid-19 patients.

The trial is being funded with $34.6M from the Department of Defense, and will focus on whether the drug can be used to prevent COVID-19 infections in physicians, nurses and military personnel.

Under the agreement, ImmunoTek Bio Centers will provide Mount Sinai with collection machines to gather plasma from recovered COVID-19 survivors. Mount Sinai will then ship the plasma to Emergent, which will use it to manufacture COVID-HIG.

https://seekingalpha.com/news/3589567-emergent-biosolutions-mount-sinai-to-test-covidminus-19-blood-plasma-preventive-treatment

Merck teams up with cancer startup Foghorn in $425M deal

Two years after its official launch, next-gen cancer biotech Foghorn Therapeutics has nabbed a biobucks deal with Big Pharma Merck.

The Cambridge, Massachusetts-based biotech launched in March 2018 aiming to develop drugs for cancer as well as other serious diseases based on insights into the chromatin regulatory system.

Out of this has come the “gene traffic control” platform, which Merck will now tap to discover and develop new meds against a transcription factor target “believed to be relevant to a broad range of cancer patients.”

The company likens the chromatin regulation, which directs gene expression in cells, to air traffic control: “Just as airports need an air traffic control system to direct which planes move and when, where, and in what order, our bodies need a system to control which genes our cells express, and when, where, in what order, and what quantity.”

A breakdown in chromatin regulation is a “major, unexplored cause” of many diseases, including more than 20% of cancers, the company said. It was first launched by life science VC shop Flagship Pioneering.

Under this new deal, Merck grabs exclusive global rights to develop and sell drugs that target dysregulation of a single transcription factor. Foghorn gets an undisclosed upfront payment and research milestones, with $425 million and royalties on sales also wedded into the deal.

While still in the early stages, new research is shining a light on how this system might work.

In a study published in the journal Science Advances earlier this year, a Northwestern University team pinpointed the role of chromatin: the DNA, RNA and proteins that make up the chromosome. They reported that the way chromatin is packed in the nucleus can cause diverse DNA transcriptional features among cells and control how they respond to stress.

Cancer cells with disordered packing are more likely to adapt to treatments, they reported. The researchers believe targeting chromatin could inhibit cancer cells’ ability to adjust and therefore help boost responses to traditional therapies.

“Genes are like hardware, and chromatin is software,” Vadim Backman, Ph.D., co-senior author of the study, explained in a statement following the paper back in January. “And chromatin packing is the operating system.”

In a separate Science Advances study, Backman and fellow Northwestern bioengineers used mathematical modeling and optical imaging to produce a 3D picture of chromatin folding.

“If the structure of chromatin changes, it can alter the processing of the information stored in the genome, but it does not alter the genes themselves,” Backman said. “Understanding chromatin folding holds the key to understanding how cells differentiate and how cancer happens.”

For cancer cells, treatments represent stressors. The scientists suspected that chromatin, when it’s chaotically packed, can regulate expression of genes in ways that enable cancer cells to become resistant to treatment. But when the packing is neat and orderly, a cancer cell crumbles in response to outside stressors.

After analyzing gene expression data from The Cancer Genome Atlas, the researchers showed that increased transcriptional malleability in tumor cells—which they linked to chromatin packing scaling behavior—correlates to lower patient survival in advanced colorectal, breast and lung cancers.

Backman and colleagues believe targeting chromatin packing could indeed inhibit cancer cells’ ability to adapt, making them vulnerable to treatments.

“We’re excited to partner with Merck given their world-renowned capabilities in cancer research and development,” said Adrian Gottschalk, president and CEO of Foghorn. “Our ability to systematically drug transcription factors using our proprietary product platform opens vast potential to discover and develop novel cancer treatments.”

This gives Merck an early-stage and relatively cheap bet on some next-gen cancer pipeline work as it looks to replicate the kind of success it has seen with checkpoint inhibitor Keytruda.

“There is broad evidence for the role of dysregulated transcription factors in multiple cancer types, but these have been difficult targets to drug,” added Nick Haining, vice president, discovery oncology and immunology, Merck Research Laboratories. “We look forward to working with Foghorn and applying their platform to identify novel candidates to drug transcription factors in cancer.”

https://www.fiercebiotech.com/biotech/merck-teams-up-cancer-startup-foghorn-425m-deal

Novartis, Civica Rx partner to ease hospital shortages in 6 generic injectables

The COVID-19 pandemic and its drain on key drugs used in acute care has put an enormous strain on hospitals in desperate need of medicines for their patients. In a move to shore up chronic shortages of needed meds, Novartis and nonprofit Civica Rx are teaming up to get ahead of shifting demand.

Novartis’ Sandoz will ramp up supply of six generic injectables in high demand at hospitals as part of a deal with Civica to tackle chronic shortages in acute care settings, the Swiss drugmaker said Tuesday.

Sandoz aims to begin shipments later this year of a group of antibiotics, acid reducers, blood thinners, blood pressure regulators and medicines required in the operating room to 1,200 Civica member hospitals. The partners said their long-term contract will help Novartis stay ahead of potential shortages and better plan supply shipments.

“With Sandoz by our side, we will be able to stabilize the supply of more vital medicines used in hospitals daily and in times of crisis,” Civica CEO Martin VanTrieste said in a release.

Novartis and Civica’s push to shore up hospital supply has added urgency as the downstream effects of the COVID-19 pandemic has put a strain on over-the-counter medicines but also drugs used to treat critically ill patients.

In late May, Civica, a generics maker started by hospitals fed up with rising drug prices, joined a Trump administration-funded initiative to produce a domestic generic supply of COVID-19 drugs.

The U.S government floated a four-year, $354 million contract with a fledgling company, Phlow Corporation, to build a generic medicine and active pharmaceutical ingredient (API) plant in Richmond, Virginia, and supply COVID-19 treatments produced there.

The massive deal, awarded by the Biomedical Advanced Research and Development Authority (BARDA), could be expanded up to 10 years and a total of $812 million, making it among the largest in BARDA’s history.

To fulfill the government deal, Phlow teamed up with Civica and API supplier AMPAC, among others. CivicaRx and its partners will manufacture the finished dosage forms of essential medications, including vials and syringes.

The hospital shortages of key drugs used to treat COVID-19 patients—particularly sedatives for ventilated patients—reached such a crisis in early April that the FDA briefly freed compounding pharmacies to produce low-cost versions of those meds.

The FDA’s order, meant to last as long as hospitals continue to encounter shortages of key drugs, applied to compounding pharmacies that aren’t already sanctioned by the FDA as “outsourcing facilities.”

To qualify, the copycat drugs must be listed on the FDA’s shortages list, and hospitals must have exhausted all other options to access a commercial version of the drug.

https://www.fiercepharma.com/pharma/novartis-partners-civica-rx-to-ease-hospital-shortages-for-6-high-demand-generic-injectables

CEO hints Amgen may test Enbrel, other anti-TNF drugs against COVID-19

As Amgen ramps up a clinical trial of its psoriasis drug Otezla in COVID-19, the company’s scientists may be seriously considering whether another of its blockbuster anti-inflammatories, Enbrel, could play a role in tamping down the virus.

CEO Robert Bradway hinted at that possibility during Fortune magazine’s Brainstorm Health virtual conference Tuesday.

“We have a couple of different ways I think to try to help ameliorate what looks to be a maladaptive immune response as [COVID-19] gets far advanced,” Bradway said.

Otezla, a PDE4 blocker, is being studied for its potential to prevent respiratory distress in patients with the virus. But the class of medicines that Enbrel belongs to, TNF inhibitors, is one “that we’re considering, as well, in this regard,” Bradway said.

Amgen did not immediately respond to a request from FiercePharma for further details about its plans to examine TNF inhibition in COVID-19. In addition to Enbrel, which hauled in $5 billion in sales last year, the company’s anti-TNF portfolio includes biosimilar versions of Johnson & Johnson’s Remicade and AbbVie’s Humira.

There are several anti-inflammatory drugs in clinical trials for COVID-19, all with different mechanisms of action. Roche’s rheumatoid arthritis drug Actemra, for example, blocks interleukin-6 (IL-6), a cytokine that promotes inflammation, while Novartis’ Ilaris targets the cytokine IL-1beta. Studies have shown that these and other inflammatory cytokines can cause a dangerous immune reaction in COVID-19 patients.

Some of these trials have faced hurdles, as Bradway pointed out during the Fortune event. Earlier this week, Sanofi and Regeneron halted a U.S. trial of their IL-6 inhibitor Kevzara in coronavirus patients on ventilators after the drug failed to prevent deaths in a phase 3 trial.

And while the response to COVID-19 from the biopharma industry has been admirable, Bradway said, “it’s probably not as well coordinated as it could be.”

That said, Amgen continues to look for ways to contribute to the pandemic response effort. The company is working with Adaptive Biotechnologies to identify neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19. That work “is progressing very quickly. It’s been quite a good collaboration,” David Reese, M.D., executive VP for research and development at Amgen, said during a Goldman Sachs conference call in June.

As for Enbrel and other TNF inhibitors, there have been a few published reports that could be fueling the interest in studying them in COVID-19. A study published in May in the journal Gastroenterology reported that in patients with inflammatory bowel disease, the use of corticosteroids was associated with severe COVID-19 outcomes—but the use of TNF inhibitors was not. And the Annals of Rheumatic Diseases recently published a case study of a COVID patient with spondyloarthritis who was taking Enbrel and ended up with a relatively mild case of the virus that resolved in 10 days, with no need for respiratory support.

While Bradway didn’t provide details about Amgen’s hopes for TNF inhibition in COVID-19, he said during that Fortune event that he’s “optimistic that through time we’ll be able to help bring down the risk of death from this infection.”

https://www.fiercepharma.com/pharma/could-amgen-test-enbrel-or-other-anti-tnf-drugs-against-covid-19-ceo-bradway-drops-a-hint

Becton Dickinson teams up with BARDA in mass vaccinations

Becton, Dickinson (BDX +0.9%) said that it will receive $42M from the federal government to expand its manufacturing capacity for syringes and needles to support vaccination efforts against COVID-19.

The Biomedical Advanced Research and Development Authority (BARDA) will provide the funding as part of Operation Warp Speed, a Trump administration program aimed at having 300M doses of a COVID-19 vaccine by January 2021, that will support the expansion of BD’s manufacturing operations in Nebraska. The total cost of the capital project will be $70M.

The company has also finalized an initial order from the government for 50M needles and syringes to be delivered by the end of December 2020.

https://seekingalpha.com/news/3589549-becton-dickinson-teams-up-barda-in-mass-vaccinations

Walmart jobs ads hint at healthcare insurance move

In another interesting move by Walmart (WMT -1.1%), the retail giant was spotted posting job openings on its careers website for an entity called Walmart Insurance Services LLC.

The posts indicate that the company is looking to hire insurance agents in the Dallas area to sell Medicare insurance.

“We need passionate health insurance professionals to help us build this new business from the ground up and achieve our mission,” reads the job listing.

The new insurance agency filed paperwork with the Arkansas Secretary of State in late June, according to a prior report from Med City News.

Walmart was listed on UBS’ list of names to watch for the consumerization of healthcare.

https://seekingalpha.com/news/3589519-walmart-jobs-ads-hint-healthcare-insurance-move