AAPS Sues the FDA to End Its Arbitrary Restrictions on Hydroxychloroquine

Today, June 2, 2020, the Association of American Physicians & Surgeons (AAPS) filed a lawsuit, AAPS v. FDA, against the Food and Drug Administration to end its arbitrary interference with the use of hydroxychloroquine (HCQ), which President Trump and other world leaders have taken as a prophylaxis against COVID-19.
Two million doses of HCQ are being sent by the Trump Administration to Brazil to help medical workers there safeguard themselves against the spread of the virus. But at the same time the FDA continues to block Americans’ access to this medication.
HCQ has been approved as safe by the FDA for 65 years, and the CDC states on its website that “CDC has no limits on the use of hydroxychloroquine for the prevention of malaria.”
More than 150 million doses have been donated to the strategic national stockpile controlled by the federal government, but unjustified FDA restrictions limit its use to only hospitalized patients for whom a clinical study is unavailable. Hospitals are even returning HCQ to the stockpile because they are not able to use it effectively.
“It is shocking that medical workers in Brazil will have access to HCQ as a prophylaxis while Americans are blocked by the FDA from accessing the same medication for the same use,” observes AAPS Executive Director Jane Orient, M.D.
“There is no legal or factual basis for the FDA to limit use of HCQ,” states AAPS General Counsel Andrew Schlafly. “The FDA’s restrictions on HCQ for Americans are completely indefensible in court.”
Many foreign nations, including China, India, South Korea, Costa Rica, United Arab Emirates, and Turkey, use HCQ for early treatment and prevention of COVID-19,  AAPS points out.
“Entrenched, politically biased officials at the FDA should not be allowed to interfere with Americans’ right to access medication donated to the federal government for public use,” Schlafly says. “By preventing Americans’ use of HCQ as a prophylaxis, the FDA is infringing on First Amendment rights to attend religious services or participate in political events such as political conventions, town halls, and rallies in an important election year.”
“FDA Commissioner Stephen Hahn states that the FDA does not interfere with physicians’ ability to prescribe HCQ, and yet at the same time the FDA denies access by millions of Americans to 150 million doses of it in the national stockpile,” Schlafly adds. “This irrational hoarding by government is an abuse of power.”
The Association of American Physicians and Surgeons (AAPS) has represented physicians of all specialties in all states since 1943. The AAPS motto is omnia pro aegroto, meaning everything for the patient.
PDF of complaint: http://aapsonline.org/judicial/aaps-v-fda-hcq-6-2-2020.pdf

AAPS Sues the FDA to End Its Arbitrary Restrictions on Hydroxychloroquine

Lonza sets new goal to make Moderna COVID-19 vaccine ingredients

Lonza aims to speed completion of two commercial production lines for Moderna Inc’s trial COVID-19 vaccine so manufacturing could start four to six weeks earlier than planned if the project is successful, the Swiss drugmaker’s chairman said on Tuesday.

Lonza, which hopes to make smaller batches of active ingredients for the U.S. biotechnology company’s experimental vaccine by July, now aims to finish a commercial production line in Portsmouth, New Hampshire, a month or so earlier than its original December 2020 target, Albert Baehny told Reuters.
A second commercial line, at Lonza’s site in Visp, Switzerland, had been slated for completion in January or February 2021 but now could be ready in December, he added.
Moderna, which enlisted Lonza in May in a 10-year manufacturing contract, is racing with 100-plus other vaccine projects, having last week dosed initial participants in a 600-patient study.

With accelerated deadlines, Lonza hopes to be ready to make vaccine ingredients quickly, should Moderna’s candidate pass muster with regulators.
“Four to six weeks would be remarkable, if we can gain this time,” Baehny, also Lonza’s interim CEO, said during a video interview. “We know the technology, we feel comfortable with the manufacturing steps. If we can accelerate, let’s do it. This is pandemic speed.”
He acknowledged potential bottlenecks, including hiring 60-70 employees to run each production line, availability of contractors and possible shortages of equipment like fermentation gear, could slow things down.
Lonza is financing the first $60-$70 million commercial production line in Visp, he said.

Moderna, flush with $483 million from the U.S. government and $1 billion-plus in fresh capital, is paying for the first U.S. production line, and up to three more at Lonza facilities in Portsmouth and Visp, Baehny said.
Combined capacity could produce ingredients for 600 million to 1 billion vaccine doses annually, he said, depending on the size of the dose needed.
https://www.reuters.com/article/us-health-coronavirus-vaccine-lonza-excl/exclusive-lonza-sets-new-goal-to-make-moderna-covid-19-vaccine-ingredients-idUSKBN2392C4

Gilead’s next step on covid: inhaled remdesivir, other easier-to-use versions

Gilead Sciences Inc (GILD.O) is developing easier-to-administer versions of its antiviral treatment remdesivir for COVID-19 that could be used outside of hospitals, including ones that can be inhaled, after trials showed moderate effectiveness for the drug given by infusion.

Remdesivir is the only drug so far that has been shown to help patients with COVID-19, but Gilead and other companies are looking for ways to make it work better.
For critically ill patients, Roche (ROG.S) and Eli Lilly and Co (LLY.N) are testing drugs in combination with remdesivir.
Gilead is also seeking to treat the virus earlier. Other antivirals, like influenza pill Tamiflu, work best when given as early as possible after someone becomes infected.
Gilead in a statement on Monday said it is looking at ways to use remdesivir earlier in the course of disease, including via alternate formulations. The company confirmed in an email that it is researching an inhaled version, but declined further comment.

Company executives such as Chief Medical Officer Merdad Parsey and Chief Financial Officer Andrew Dickinson have been doing interviews with Wall Street analysts in recent weeks to discuss the plans, which are in early stages.
They have said that in the longer term, the company is exploring a subcutaneous injection formulation of remdesivir, as well as dry powder versions to be inhaled. Remdesivir cannot be given as a pill because it has a chemical makeup that would degrade in the liver, and the intravenous (IV) formulation is only used by hospitals.
In the short term, Gilead is studying how its existing IV formulation of remdesivir can be diluted for use with a nebulizer – a drug delivery device used to administer medication in the form of a mist inhaled into the lungs.
The idea is that a nebulizer would make remdesivir more directly available to upper airway and lung tissue as the coronavirus is known to attack the lungs. It would also allow for early treatment of coronavirus patients who are not hospitalized.
“People look forward to an inhaled formulation in time,” but development is in the very early stages, said Jefferies analyst Michael Yee, adding that demand may be limited as many people infected with the virus require minimal treatment.

He said Gilead is building up its capacity to supply remdesivir and has begun talking to governments around the world about commercial pricing.
Gilead on Monday reported trial results showing that IV remdesivir provided a modest benefit for hospitalized patients with moderate COVID-19 compared to standard care.
https://www.reuters.com/article/us-health-coronavirus-gilead-sciences/gileads-next-step-on-coronavirus-inhaled-remdesivir-other-easier-to-use-versions-idUSKBN2391FP

Coronavirus ‘clinically no longer exists’ in Italy, doctor says

Coronavirus no longer “clinically” exists in Italy, which has seen the deadly disease lose potency, according to a doctor.
New infections and fatalities from COVID-19, the disease caused by the SARS-CoV-2 virus, fell steadily in the country in May.
“In reality, the virus clinically no longer exists in Italy,” Alberto Zangrillo, the head of the San Raffaele Hospital in Milan told RAI television. “The swabs that were performed over the last 10 days showed a viral load in quantitative terms that was absolutely infinitesimal compared to the ones carried out a month or two months ago.”
Italy has the third highest death toll in the world from COVID-19, with 33,475 deaths and 233,197 confirmed cases as of Tuesday, according to data from Johns Hopkins University.
Italy — the first country in the world to surpass China’s coronavirus death toll — was the first European country to lock down in early March. It began a slow reopening of some cities last month in hopes of kickstarting its dwindled economy.
A second doctor, Matteo Bassetti, agreed that the coronavirus has weakened.

 

“The strength the virus had two months ago is not the same strength it has today,” Bassetti, head of the infectious diseases clinic at the San Martino hospital in the city of Genoa, told the national ANSA news agency. “It is clear that today the COVID-19 disease is different.”
Still, the Italian government urged residents to continue practicing social distancing and other safety measures.
“Pending scientific evidence to support the thesis that the virus has disappeared … I would invite those who say they are sure of it not to confuse Italians,” Sandra Zampa, an undersecretary at the health ministry, said in a statement.
“We should instead invite Italians to maintain the maximum caution, maintain physical distancing, avoid large groups, to frequently wash their hands and to wear masks.”
https://nypost.com/2020/06/02/coronavirus-clinically-no-longer-exists-in-italy-doctor/

Bayer back in court to limit Roundup payouts

If Bayer (OTCPK:BAYRY) wants to keep its total Roundup liability capped at $10B, a problem inherited when it acquired Monsanto in 2018, it will be crucial to get a 2018 California court verdict overturned.

The German chemical giant will ask the state appeals court today to throw out a jury conclusion that the herbicide product caused grounds keeper Lee Johnson’s cancer.

While he was awarded $289M before a judge cut the damages to $78.5M, Bayer has been reaching settlements in thousands of other cases that range from a few thousand dollars to several million per claim.

https://seekingalpha.com/news/3579425-bayer-back-in-court-to-limit-roundup-payouts

Pliant Therapeutics readies upsized IPO

Pliant Therapeutics (PLRX) has filed a preliminary prospectus for its IPO of 9M (from 6M) common shares at $14 – 16.
https://seekingalpha.com/news/3579446-pliant-therapeutics-readies-upsized-ipo

NYPD members forced to return to work in-person amid George Floyd riots

All NYPD employees previously allowed to work from home during the coronavirus crisis must now report for duty in person — another “all hands on deck” move amid escalating citywide looting that has co-opted protests over George Floyd’s police-custody death in Minneapolis, law enforcement sources told the Post Tuesday.
All full-duty uniformed cops previously issued “reasonable accommodations” during the pandemic must report for duty at the Police Academy in College Point, Queens, Tuesday afternoon, according to an internal memo obtained by the Post.
All uniformed members who are not full-duty must report to their permanent commands, the memo says.
“All hands on deck, and by all I mean even the COVID-19-vulnerable,” a police source said of the move.
Another police source said that affected officers are “torn” about returning to work — frustrated about having to sit on the sidelines but “also still concerned about COVID and underlying conditions.”
Even civilian members should “be prepared” to make a return, according to the memo.
The decision comes as the NYPD has moved all its officers to 12-hour shifts this week, a “war time” response “to the ongoing civil unrest,” a police source said Monday.
https://nypost.com/2020/06/02/nypd-members-forced-to-return-to-work-in-person-amid-riots/