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Coronavirus tracker: Novartis trial tackles the chloroquine question; NIH, Gilead post new remdesivir animal results
release time:2020-04-21

NIH and Gilead researchers published animal study results showing early remdesivir antiviral treatment helped reduce COVID-19 symptoms and lung damage in rhesus macaques. Meanwhile, one member of Congress is calling on the SEC to investigate last week’s leak of remdesivir results and its impact on the stock market.

And while the public markets in general have been upended by COVID-19, biotech IPOs could provide a silver lining with additional windows and opportunities later this year.

Elsewhere, Novartis has secured an FDA go-ahead to test the antimalarial drug hydroxychloroquine in a large U.S. phase 3 trial—and Alexion is planning to test its rare disease drug Ultomiris in severe COVID-19 cases.

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As of Monday, the number of global confirmed cases had surpassed 2.4 million, according to Johns Hopkins University's real-time dashboard, and more than 168,500 people had died.

Please read below for the latest updates. We'll be tracking the latest on this page. Also check out our updated-as-needed lists of drugs in testing, biopharma supply chain statements and travel and work-from-home policies.

See all of FiercePharma's COVID-19 coverage here

UPDATED: Monday, April 20 at 3:46 p.m. ET

Debate about whether the chloroquine family of antimalarial meds work in COVID-19 has dragged on since President Donald Trump publicly touted its use without definite proof. Now, to gather evidence, Novartis is launching a phase 3 clinical trial, planning to enroll about 440 hospitalized patients starting in the next few weeks.

That Novartis study will divide patients into three groups: hydroxychloroquine alone, hydroxychloroquine plus Trump-praised antibiotic azithromycin, and placebo. It follows several investigator-sponsored trials, which have turned up mixed results and are only fueling the debate rather than settling it. These include a recent study in China and one in France.

Researchers at the NIH and Gilead have published results from an animal trial of remdesivir, involving 12 rhesus macaques, showing that early antivrial treatment reduced COVID-19 symptoms and lung damage. Posted on the preprint site bioRxiv, the study replicated remdesivir dosing schedules being tested in an ongoing human trial. Story

Though the COVID-19 pandemic has upended the public markets—and thrown a wrench into what was expected to be a stellar IPO season—the biotech industry could be that particular cloud’s silver lining, as investors look toward additional windows and opportunities later this year. 

Story Alexion is turning to its rare disease drug Ultomiris for COVID-19 after investigators expressed interest in exploring the potential of C5 inhibition. The company plans to start a global clinical trial in about 270 patients with severe respiratory syndromes, and enrollment is expected to begin in May. 

A congressman is calling on the SEC to investigate last week’s leak of remdesivir data, along with its impact on the stock market and a 15% boost in Gilead’s share price. Though the antiviral is not supposed to be a moneymaker for the Big Pharma, news following its development has added billions to Gilead’s market cap. 

An easier oral fluid test for COVID-19, which has been used by the City of Los Angeles to screen for cases, has received a nationwide emergency use authorization from the FDA. 

UPDATED: Monday, April 20 at 9:12 a.m. ET

The FDA has granted emergency use authorizations to four antibody diagnostics—also known as serology tests—that promise to help identify individuals who have been exposed to the novel coronavirus. Now, the agency is working with the CDC and the NIH's National Cancer Institute and National Institute of Allergy and Infectious Diseases to make sure these blood tests work as they should. Story

The pan-European STOXX 600 index ended Friday with its biggest two-week percentage increase since 2015, helped by strong gains from the health sector, including Roche and Novartis, as both contribute their expertise in the pandemic.

Russia’s Health Ministry has been recommending AbbVie's HIV combo therapy Kaletra as a possible treatment for COVID-19 since reports of potential use emerged from China. Now, even before there's any concrete clinical evidence that the drug indeed works, a black market for the drug has developed in Russia, Reuters reported.

Even as the number of infections continues to climb in the U.S., the discussion has turned to reopening the economy. Protests demanding the rescission of lockdown policies have erupted in several states. Trump seemed to back the protests by tweeting “LIBERATE MICHIGAN,” “LIBERATE MINNESOTA,” and more on Friday. Story

Anixa Biosciences is working with Germany-based artificial intelligence life science company OntoChem to find new antiviral meds for COVID-19. Story

Lab operators and health officials still face supply shortages, test backlogs and unreliable results from coronavirus diagnosticsm, The Wall Street Journal reported. Adm. Brett Giroir, the administration’s testing coordinator, said the current testing capacity can only handle about half the demand through April.

Meanwhile, in the U.S., the FDA has stepped up seizures of prescription drugs being sent to American customers from Canada and other countries, where they are sold at cheaper prices, according to Kaiser Health News.

After President Trump again raised the theory that the novel coronavirus came from a bio lab in Wuhan, the lab struck back. "There is no way this virus came from us," Yuan Zhiming, vice director of the Wuhan Institute of Virology, told China's state-run CGTN.

UPDATED: Friday, April 17 at 2:50 p.m. ET

Global analytics firm Clarivate, in a sobering take on the hunt for a COVID-19 vaccine, said two vaccines from Moderna and Inovio will take at least five years to complete the development process through full regulatory approval. And neither company has a high probability of success, Clarivate said. Story

Sanofi has begun working with California startup Luminostics to build an at-home test for COVID-19 that would use a sample reader powered by a user’s personal smartphone. Using an adapter that clips over the phone’s camera and flashbulb, Luminostics’ low-cost, reusable device contains chemicals that faintly glow in the dark when certain targets are present. Story

The Biomedical Advanced Research and Development Authority (BARDA) is committing up to $483 million to bankroll late-stage clinical trials and scale up manufacturing for Moderna's COVID-19 vaccine candidate. Story

General Motors has shipped out its first batch of in-house developed ventilators to U.S. hospitals with severe COVID-19 patients, Reuters reported. GM said the Franciscan Health Olympia Fields hospital in Olympia Fields, Illinois, and Chicago’s Weiss Memorial Hospitals will receive shipments of 10 ventilators each Friday.

The World Health Organization (WHO) is casting doubt on whether recovered COVID-19 patients are developing antibodies to help build up so-called "herd immunity" to the novel coronavirus, according to a Friday briefing. A WHO expert said there was little evidence recovered patients had developed enough antibodies to help prevent reinfection.

UPDATED: Friday, April 17 at 9:25 a.m. ET

Biogen employees are among the first in the U.S. to have contracted the novel coronavirus after an ill-fated leadership meeting in Boston. Now, those who have recovered and their close contacts can volunteer blood samples and other medical data to a biobank the company is building with the Broad Institute of MIT and Harvard and Partners HealthCare to advance research into potential vaccines and treatments.

Roche has developed the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies against SARS-CoV-2. It aims to have this test available by early May in countries accepting the CE mark and is working with the U.S. FDA for an emergency use authorization.

About 40 COVID-19-related clinical trials have been terminated in China, including two closely-watched studies of Gilead Sciences' antiviral drug remdesivir, after a slowdown of the outbreak made it hard to recruit patients.

Meanwhile, leaked early results from the University of Chicago Medical Center suggest remdesivir can swiftly control fever and respiratory symptoms. But as analysts were quick to note, the evidence is anecdotal, with the results coming from a non-controlled study at just one site. Story

Following the lead of AstraZeneca, which recently unveiled plans to test its blood cancer drug Calquence in COVID-19, rival BeiGene is also aiming to test its BTK inhibitor, Brukinsa, against the disease. The Chinese biotech has submitted a phase 2 trial design to the FDA and plans to enroll 42 U.S. patients, Forbes reported.

President Donald Trump recently touted anti-malaria drug chloroquine alongside antibiotic azithromycin as a regimen for COVID-19. As a result, nine drug manufacturers are reporting shortages of the antibiotic to the FDA.

In a statement on Thursday, FDA Commissioner Stephen Hahn cautioned that while the agency can now keep up with key drug review programs, "it is possible that we will not be able to sustain our current level of performance indefinitely," as many staffers have been allocated to work on COVID-19 activities.

AstraZeneca is donating three million surgical masks for U.S. healthcare workers combating COVID-19.

UPDATED: Thursday, April 16 at 3 p.m. ET

Millions of doses of hydroxychloroquine donated to the U.S. by Bayer have come under scrutiny after the quality of the drug's Indian and Pakistani active pharmaceutical ingredients and finished doses may have never passed FDA inspections, sources told Reuters. Bayer has donated 3 million tablets of the drug, called Resochin, to the U.S. national stockpile for treatment of COVID-19. Story

Dynavax and Sinovac are teaming up on a vaccine for COVID-19, combining the former’s vaccine adjuvant with the latter’s chemically inactivated coronavirus vaccine candidate. Story

Africa's confirmed cases of COVID-19 may shoot from the thousands up to around 10 million within the next three to six months, according to a regional WHO official. The projection was described as "tentative" and represented a worst-case scenario.

UPDATED: Thursday, April 16 at 8:56 a.m. ET

Baxter International is hiring 2,000 people to help the company handle higher global demand for medical devices. Of them, 800 are expected to be in the U.S. It's also increasing its air freight capacity to keep supplies of its equipment coming.

It's annual meeting season, and Gilead Sciences is the latest pharma company to transition to a virtual format.

Despite the fact that Fujifilm's Avigan hasn't been proven as an effective COVID-19 treatment, Japan and China are providing the drug to other countries, the Wall Street Journal reports, and politicians in each country are touting its use.

After a Rutgers saliva test won an FDA emergency use authorization, President Donald Trump touted it Wednesday.

If experts can't develop a vaccine in a timely fashion, the U.S. may have to do intermittent social distancing until 2022, Harvard researchers concluded.

The IHME model from the University of Washington has gained nationwide attention, including from the White House, but experts urged caution about relying too much on the model in the Annals of Internal Medicine. The model doesn't use "transmission dynamics," but instead is based on statistics with "no epidemiologic basis," they wrote.

Amid concerns the U.S. official death toll understates the actual number of fatalities, New York officials plan to contact nursing homes to identify victims who haven't been included in the state's tracking.

Inato has launched a platform to search for COVID-19 clinical trials.

UPDATED: Wednesday, April 15 at 3 p.m. ET

After the British drugmaker unveiled its COVID-19 vaccine tie-up with Sanofi, GlaxoSmithKline CEO Emma Walmsley said that multiple COVID-19 shots would likely cross the finish line. In all, there are 71 preclinical vaccine programs underway, while six projects have reached phase 1 and one is in phase 2, according to a tracker from the Vaccine Centre at the London School of Hygiene & Tropical Medicine. Story

The U.S. Department of Health and Human Services will ship out $1.4 billion to secure new ventilators from seven big medtechs. Five of the seven contracts—issued to Medtronic, GE Healthcare, Hill-Rom, ResMed and Vyaire Medical—were delivered under the Defense Production Act, which requires those devicemakers to prioritize the government’s requests before filling other orders. The other two were delivered to Zoll and Hamilton Medical. Story

India is hoping to rapidly expand its production of global active pharmaceutical ingredients to compete with China's dominance in the market amid COVID-19 lockdowns, Bloomberg reported. The country is one of the largest providers of generic drugs to the U.S. Story

In a commentary published recently in the journal Diabetes Research and Clinical Practice, a University of Miami researcher argued that DPP-4 enzyme-inhibiting diabetes meds could help fight COVID-19. Several DPP-4 inhibitors are already on the market, including Boehringer Ingelheim and Eli Lilly’s Tradjenta and Merck & Co.’s Januvia. Story

The World Health Organization has tasked ex-GlaxoSmithKline CEO Andrew Witty with helping accelerate development of a COVID-19 vaccine. Witty, currently the CEO of UnitedHealth Group's Optum unit, is taking a leave of absence from his job until around the end of the year to co-lead the WHO initiative. Story

UPDATED: Wednesday, April 15 at 8:47 a.m. ET

Gilead Sciences is among the companies with promising COVID-19 drugs and the company has now applied for a trademark for potential remdesivir packaging. But at press time, the company's shares were down on word that a second China trial had been stopped for lack of enrollment.

Helping bolster the nationwide testing push, Abbott has shipped more than 500,000 of its rapid COVID-19 tests throughout the U.S.

Amid the race for a COVID-19 vaccine, Pfizer's chief digital officer Lidia Fonseca told Fast Company that technology can help speed the process.

Eli Lilly and Bristol Myers Squibb have unveiled new patient access programs, and now Novo Nordisk has started a free 90-day insulin program for people who've lost insurance due to changes in job status. Story

Fujifilm's Avigan has gained attention as a possible drug for COVID-19, and the company has released details about its plans to ramp up production. Story

After previously lowering antibody testing standards, the FDA has changed course and will now require data proving they work, CNN reports.

A new poll shows that almost half of voters favor using hydroxychloroquine to treat COVID-19 before U.S. researchers complete their study, but only 17% said they'd seek it out for themselves.

As the White House's Tuesday press briefing, President Donald Trump said the U.S. is halting funding to the World Health Organization. Bill Gates and others blasted the move.

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