This summer three experimental vaccines will enter Phase 3 trials, the final stage of testing meant to determine their safety and effectiveness, The Wall Street Journal reported on Wednesday. Moderna's vaccine is set to be first, (MRNA) followed by one co-developed by Oxford University and AstraZeneca PLC (AZN) and one by Johnson & Johnson. (JNJ) Moderna shares gained 3.2% Wednesday.
Small-cap Emergent BioSolutions (NYSE:EBS) has landed another contract to manufacture a possible COVID-19 vaccine, this time with European pharmaceutical giant AstraZeneca. Of course, the contract, said to be worth as much as $87 million, hinges on whether AstraZeneca's vaccine gets approved by the Food and Drug Administration for human use.
Emergent is a contract development and manufacturing organization that has relationships with many biotech and pharmaceutical companies (not to mention the federal government). Back in April, it inked a similar deal with Johnson & Johnson worth up to $135 million.
Emergent BioSolutions (EBS) and Opiant Pharmaceuticals (OPNT) stocks plunged Monday after Teva Pharmaceutical (TEVA) won the right to produce a knock-off their opioid overdose treatment, Narcan.
Dexamethasone, a cheap and widely used steroid, has become the first drug shown to be able to save lives among Covid-19 patients in what scientists hailed as a “major breakthrough”.
[Co-developed by Oxford University and AstraZeneca PLC (AZN)]
Results of trials announced on Tuesday showed dexamethasone, which is used to reduce inflammation in other diseases, reduced death rates by around a third among the most severely ill Covid-19 patients admitted to hospital.
The results suggest the drug should immediately become standard care in patients with severe cases of the pandemic disease, said the researchers who led the trials.
“This is a result that shows that if patients who have Covid-19 and are on ventilators or are on oxygen are given dexamethasone, it will save lives, and it will do so at a remarkably low cost,” said Martin Landray, an Oxford University professor co-leading the trial, known as the RECOVERY trial.
“It’s going to be very hard for any drug really to replace this, given that for less than 50 pounds ($63.26), you can treat eight patients and save a life,” he told reporters in an online briefing.
His co-lead investigator, Peter Horby, said dexamethasone was “the only drug that’s so far shown to reduce mortality - and it reduces it significantly.”
“It is a major breakthrough,” he said. “Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.”
There are currently no approved treatments or vaccines for Covid-19, the disease caused by the new coronavirus which has killed more than 431,000 globally.
Saving ‘countless lives’ The RECOVERY trial compared outcomes of around 2,100 patients who were randomly assigned to get the steroid, with those of around 4,300 patients who did not get it.
The results suggest that one death would be prevented by treatment with dexamethasone among every eight ventilated Covid-19 patients, Landray said, and one death would be prevented among every 25 Covid-19 patients that received the drug and are on oxygen.
Among patients with Covid-19 who did not require respiratory support, there was no benefit from treatment with dexamethasone.
“The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients,” Horby said.
Nick Cammack, a expert on Covid-19 at the Wellcome Trust global health charity, said the findings would “transform the impact of the Covid-19 pandemic on lives and economies across the world”.
“Countless lives will be saved globally,” he said in a statement responding to the results.
The RECOVERY trial was launched in April as a randomised clinical trial to test a range of potential treatments for Covid-19, including low-dose dexamethasone and the malaria drug hydoxycholoroquine.
The hydroxychloroquine arm was halted earlier this month after Horby and Landray said results showed it was “useless” at treating Covid-19 patients.
Global cases of infection with the novel coronavirus have reached over 8 million, according to a Reuters tally, and more than 434,000 people have died after contracting the virus, the first case if which was reported in China in early January.
The Food and Drug Administration has revoked its emergency use authorization for the drugs hydroxychloroquine and chloroquine for the treatment of Covid-19.
Hydroxychloroquine was frequently touted by President Donald Trump, and he has claimed to have used it himself. After reviewing the current research available on the drugs, the FDA determined that the drugs do not meet "the statutory criteria" for emergency use authorization as they are unlikely to be effective in treating Covid-19 based on the latest scientific evidence, the agency noted on its website on Monday. "FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks," FDA chief scientist Denise Hinton wrote in a letter to Gary Disbrow of the Biomedical Advanced Research and Development Authority (BARDA) on Monday. Hydroxychloroquine and chloroquine have been tied to serious cardiac events as well as other side effects among Covid-19 patients.
An inexpensive drug reduces virus deaths, scientists say.
The steroid, dexamethasone, reduced deaths by a third in patients receiving ventilation, and by a fifth in patients receiving only oxygen treatment, the scientists said. They found no benefit from the drug in patients who did not need respiratory support.
Matt Hancock, Britain’s health secretary, said National Health Service doctors would begin treating patients with the drug on Tuesday afternoon.
The government started stockpiling dexamethasone several months ago because it was hopeful about the potential of the drug, Mr. Hancock said, and now has 200,000 doses on hand.
“Dexamethasone is the first drug to be shown to improve survival in Covid-19,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford, and one of the chief investigators for the trial, said in a statement. “The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment.”
Gilead Sciences Inc. said that it will charge U.S. hospitals roughly $3,120 for most patients who need remdesivir, picking a middle ground in a high-profile decision on the cost of one of the first drugs for Covid-19.
Patients suffering from the illness caused by the novel coronavirus are usually given six vials of remdesivir over five days. The price, which comes to $520 a vial, would apply to commercially insured patients in the U.S., according to a letter from Gilead Chief Executive Officer Daniel O’Day posted on the company’s website Monday.
It plans charge $390 a vial, or $2,340 for a five-day regimen, for direct government purchases by the U.S. or other developed countries.
Gilead’s pricing decision is consequential because it sets a precedent for how much future Covid-19 treatments might cost. While it’s higher than some patient groups had pushed for, it was close to a level that some drug-pricing watchdogs have said would be acceptable based on remdesivir’s expected benefit.
Both Gilead/ AstraZeneca own successful Covid-19 drugs
Pfizer’s (PFE) coronavirus vaccine candidate showing progress in a trial phase — and the Federal Reserve’s pledge to keep the monetary spigots open “for years” — sent the Nasdaq Composite (QQQ) to a record close.
A broad rally in tech stocks carried Amazon (AMZN), Netflix (NFLX) Tesla (TSLA) and Microsoft (MSFT) to new record highs, with those companies riding the momentum of business models that are mostly perceived as coronavirus-proof. With the exception of Tesla, the high-flying tech shares are thriving from large numbers of consumers still working remotely.
Stocks closed out a breathtaking second-quarter rally that took them to their best overall quarter since 1998, and best second quarter on record. During that time frame, the S&P 500 saw a near-20% run-up during the April through June period, while the Dow and Nasdaq rose about 17.5% and 30%, respectively.
The historic rally was fueled by a massive fiscal and monetary policy response designed to bolster the virus-stricken economy, and as states and cities across the country began easing their lockdowns. Minutes from the Fed on Wednesday showed the central bank intends to keep its foot on the easing pedal for “years” as the recovery takes shape.
Shares of Inovio Pharmaceuticals (NASDAQ:INO) were crashing 14.6% lower as of 10:55 a.m. EDT on Wednesday after falling as much as 20.7% earlier in the day. The drop stemmed from two factors. First, investors continued to be unimpressed by Inovio's lack of detail on Tuesday in its announcement of interim early-stage study results for COVID-19 vaccine candidate INO-4800. Second, the FDA issued an update on Tuesday that could mean no COVID-19 vaccine will be approved this year.
AstraZeneca said on Friday JCR Pharma will help make a portion of its potential COVID-19 vaccine in Japan and it will import shots as part of its deal to supply the Asian nation with up 120 million doses from early 2021.
It did not give a breakdown for the volume of domestic production and imports or say where the vaccine from overseas would come from.
It also said Daiichi Sankyo Co Ltd, Daiichi Sankyo Biotech Co Ltd, Meiji Seika Pharma Co Ltd and KM Biologics Co Ltd will "support supply" in Japan, but gave no other details.
A shocking announcement out of Russia sent shares of companies working on COVID-19 vaccines and treatments sharply lower.
What happened
Coronavirus-related stocks fell on Tuesday after Russia said it had registered the world's first novel coronavirus vaccine.
By the close of trading, shares of Sorrento Therapeutics (NASDAQ:SRNE), Inovio Pharmaceuticals (NASDAQ:INO), Novavax (NASDAQ:NVAX), BioNTech (NASDAQ:BNTX), and Moderna (NASDAQ:MRNA) were down 25%, 23%, 16%, 7%, and 4%, respectively. So what
Russian President Vladimir Putin said his country's healthcare regulator officially approved the new COVID-19 vaccine. Russia intends to embark on a national immunization program, while also exporting the drug to international markets across the world. "I hope we can start a massive release of this vaccine soon," Putin said.
The news prompted some investors to sell their shares of COVID-19 vaccine and treatment stocks, many of which had seen their share prices soar in recent months on optimism that they could be the first to develop effective solutions for combating the disease. Now what
While many people understandably cheered the news out of Russia, others were skeptical about Putin's claims. Health officials in the U.S. and around the world questioned whether the vaccine is truly safe and effective, particularly since Russia appears to have rushed its testing process. In particular, the vaccine has not yet gone through a phase 3 clinical trial -- a critical step in determining how well it works. Thus, Russia's announcement is certainly not a death knell for any of the companies elsewhere developing coronavirus vaccines or treatments. It's also possible that many of the companies leading the charge against COVID-19 -- including Sorrento, Inovio, Novavax, BioNTech, and Moderna -- could see their stocks rebound in the coming days, particularly if Russia's claims of success in the vaccine race are shown to be unsubstantiated.
Novavax (NVAX) is reportedly struggling to access the raw materials it needs to produce its Covid vaccine, according to a report that sent NVAX stock stumbling Thursday.
Supply talks in Europe have stalled, according to Reuters. Earlier this year, the European Union signed a deal for at least 100 million doses of the Novavax vaccine, with an option to buy another 100 million.
The vaccine isn't yet authorized anywhere. But Novavax says it has begun rolling reviews in the U.K., Europe, Canada, Australia and New Zealand. It's also in talks with the U.S. Food and Drug Administration through an open
Novavax's Covid vaccine has proved highly effective in clinical testing. Test results show it's 96.4% effective against symptomatic cases of Covid-19 caused by the original strain. That's helped boost NVAX stock this year.
That puts Novavax's drug among the top performers. Pfizer (PFE) and BioNTech (BNTX) say their drug was 95% effective in Phase 3 testing. Moderna's (MRNA) vaccine was 94.1% effective.
But, if authorized, the vaccine would be Novavax's first commercial product. A Novavax spokeswoman told Reuters the company is working "through some pandemic-related raw-materials supply shortage," but didn't give further details.
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