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Wednesday, December 23, 2020

Supernus Pharma's ADHD drug study met primary endpoint

 

  • Supernus Pharmaceuticals (NASDAQ:SUPN) +25.6% post-market after saying a phase 3 study for its SPN-812 drug to treat ADHD in adults met its primary endpoint with "robust statistical significance."
  • Supernus says the trial met the primary endpoint in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale, and the phase 3 study met the key secondary efficacy endpoint with statistical significance.
  • The company says SPN-812 already is under review by the U.S. Food and Drug Administration for the treatment of ADHD in pediatric patients age 6-17, and it plans to ask for the drug to be considered for adults as well if it is approved by the FDA.
  • Supernus reported more than a month ago that its New Drug Application for SPN-812 was not yet ready for approval, because the company's in-house laboratory that conducts analytical testing had recently moved.
  • https://seekingalpha.com/news/3646864-supernus-pharmas-adhd-drug-study-met-primary-endpoint

Viveon Health Acquisition kicks-off trading today after pricing $175M IPO

 

  • Viveon Health Acquisition (VHAQ) has priced its initial public offering of 17.5M units at $10/unit.
  • Units to kick-off trading today on the NYSE American under the ticker symbol “VHAQU” beginning December 23, 2020.
  • Each unit consists of one share of common stock, one redeemable warrant with each warrant entitling the holder thereof to purchase one half-share of common stock at a price of $11.50/share, and one right to receive one-twentieth of one share of common stock upon the consummation of an initial business combination.
  • Upon commencing separate trading, the shares of common stock, redeemable warrants, and rights are expected to be listed on the NYSE American under the symbols “VHAQ,” “VHAQW,” and “VHAQR,” respectively.
  • Underwriters' over-allotment is an additional 2.63M units.
  • Chardan acted as sole book running manager in the offering.
  • The offering is expected to close on December 28, 2020.
  • https://seekingalpha.com/news/3646885-viveon-health-acquisition-kicks-off-trading-today-after-pricing-175m-ipo

Volunteers in Russia Sputnik V vaccine trials to no longer receive placebos

 Moscow’s Gamaleya Institute, the developer of the first Russian vaccine against COVID-19, said on Wednesday that volunteers in its large-scale final-stage trials for the Sputnik V shot will no longer receive placebos, RIA news agency reported.

Alexander Ginsburg, the institute’s director, said the Health Ministry had authorised a halt to the administration of placebos to new recruits to the stage III trial.

“Everything there has been proven and the pandemic is ongoing, so a placebo is not good at all,” RIA quoted Ginsburg as saying.

He added that he would like to identify those who had already received a placebo and offer them the vaccination, “but it’s still unclear whether the regulator will allow this”.

Russia rolled out the Sputnik V vaccine to medics and other frontline workers in Moscow this month, and more than 200,000 people have already been vaccinated.

Interim trial data published last week found Sputnik V, which Russian regulators approved in August after less than two months of human testing, to be 91.4% effective.

The emergency authorisation did not, as would be usual, await the results of the gold-standard stage III trial.

In stage III, a large number of volunteers randomly receive either the vaccine or a control injection of placebo, without knowing which they have been given, and their infection rates are compared after a sufficient number have become infected in the natural environment.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/volunteers-in-russias-sputnik-v-vaccine-trials-will-no-longer-receive-placebos-ria-idUSKBN28X11A

Roche Phesgo with Halozyme's ENHANZE tech OK'd in Europe in breast cancer

 

Pfizer nears deal to provide U.S. with more vaccine doses

 

  • Pfizer (NYSE:PFE) is close to an agreement with the Trump administration in which the company would bolster the supply of its coronavirus vaccine for the U.S. by at least tens of millions of doses next year in exchange for a government directive giving it better access to manufacturing supplies, New York Times reports.
  • A deal, which could be announced as early as tomorrow, would help the U.S. at least partly offset a potential vaccine shortage that could leave as many as 110M adult Americans uncovered in H1 2021.
  • The government is asking for 100M additional doses from Pfizer from April through June; the company has indicated it should be able to produce at least 70M doses and possibly more if it can gain more access to supplies and materials.
  • Pfizer and partner BioNTech (NASDAQ:BNTX) as well as rival Moderna are the only two groups that have won U.S. emergency use authorization for their respective COVID-19 vaccine candidates.
  • https://seekingalpha.com/news/3646861-pfizer-nears-deal-to-provide-u-s-vaccine-doses-nyt

AstraZeneca's AZD1222 seen effective against new coronavirus strain

 

  • AstraZeneca (NASDAQ:AZN) says its COVID-19 vaccine should be effective against the new coronavirus variant, with studies under way to fully probe the impact of the mutation - Reuters.
  • “AZD1222 (AstraZeneca’s vaccine candidate) contains the genetic material of the SARS-CoV-2 virus spike protein, and the changes to the genetic code seen in this new viral strain do not appear to change the structure of the spike protein,” an AstraZeneca representative said in an email.
  • “Through vaccination with AZD1222, the body’s immune system is trained to recognize many different parts of the spike protein, so that it can eliminate the virus if it is later exposed,” the AstraZeneca representative added.
  • The mutation known as the B.1.1.7 lineage is up to 70% more transmissible and has prompted stringent lockdowns in U.K. and wave of travel ban.
  • India is likely to approve Oxford-AstraZeneca’s vaccine for emergency use by next week, Reuters reported. This could be the first country to give the regulatory green light for the British drugmaker’s vaccine.
  • The Indian regulator is only considering the two full-dose regimen of the shot despite it showing a lower success rate, the sources said.
  • Also, BioNTech expects that its vaccine will provide protection against U.K. coronavirus variant.
  • https://seekingalpha.com/news/3646878-astrazenecas-azd1222-expected-to-be-effective-against-new-coronavirus-strain-reuters

Tuesday, December 22, 2020

‘I think this is already in U.S,’: Gottlieb on new UK Covid strain

 Former FDA chief Dr. Scott Gottlieb warned that the highly contagious, new mutation of Covid-19 found in the United Kingdom “is already in the U.S.” as more than 40 countries ban travel to and from the U.K. for 48 hours or more. 

“I don’t think a travel ban, at this point, is going to prevent this mutated strain from coming into the United States,” Gottlieb said. “We’re going to have an epidemic that continues to build over the course of the next three or four weeks, we’ll reach a peak, and then we’ll start to see infection rates decline as we see vaccinations get rolled out.”

The new variant of Covid-19 is forcing parts of the United Kingdom back into lockdown. The government imposed the tightest restrictions in London as well as other areas in southeast England, and families are no longer able to gather during Christmas, as previously planned. In an interview on CNBC’s “The News with Shepard Smith” on Monday evening, Gottlieb explained that the new mutation is likely a result of selective pressure on the virus itself. 

“As the virus continues to spread around the world, we’re going to start to see more of these variants, and that’s why it’s important to get the population vaccinated and snuff out these infections,” Gottlieb said. “The more infections you have, the more chances that these variants start to propagate.”

Scientists in the U.K. suggested the Covid variant makes the virus 50% more transmissible, however, there’s currently no sign that it makes the disease worse. Both Eli Lilly and Regeneron, which make the antibody drugs to treat Covid, said their medicines should be effective against the variant. According to ReutersBioNTech Chief Executive Ugur Sahin said his company would investigate the mutation, but looked at the situation with “with a degree of soberness.” BioNTech is Pfizer’s partner on the Covid vaccine. Gottlieb explained to host Shep Smith why he thinks vaccines will need to eventually adapt.

“The question is, is this virus going to change the surface proteins in a way that can obviate either the vaccines or prior immunity, and there’s no indication that it’s doing  that right now, but over time it will evolve in ways where it can probably obviate prior infection or vaccines to some degree, so we’ll probably need to adapt our vaccines over time,” Gottlieb said. 

The first shipments of Moderna’s Covid vaccine hit hospitals across the U.S. today. Moderna’s vaccine is the second one, after Pfizer’s, to be authorized by the FDA. Moderna’s rollout is expected to be double the size with the company planning to ship six million doses out this week compared to Pfizer’s 2.9 million doses last week. Pfizer’s vaccine requires a temperature of minus 94 degrees Fahrenheit, or minus 70 degrees Celsius. Moderna can store its vaccine for up to six months at minus 4 degrees Fahrenheit.

Gottlieb said that the current logistics for vaccine distribution are “good,” but that some challenges may come as the population getting the vaccine widens. 

“I think the challenge is going to be the last mile, trying to distribute these vaccines in the community,” said Gottlieb.  “Right now, in the month of December, we’re distributing these vaccines largely to healthcare workers through medical institutions, the academic hospitals, community hospitals, they know how to distribute a vaccine, know how to find their health care workers.”

https://www.cnbc.com/2020/12/21/uk-covid-strain-this-is-already-in-the-us-says-dr-gottlieb.html